DEPARTMENT OF HEALTH

(Board of Osteopathic Medicine and Surgery)

[Filed December 23, 2019, 2:40 p.m.]

Preproposal statement of inquiry was filed as WSR 17-24-016.

Title of Rule and Other Identifying Information: Chapter 246-853 WAC, Osteopathic physicians and surgeons, the board of osteopathic medicine and surgery (board) is considering rule amendments to several sections to ensure that the rules are clear, up-to-date, and align with best practices. The board will also consider adding a new section describing the process for issuing expedited temporary practice permits for military spouses.

Hearing Location(s): On February 7, 2020, at 9:00 a.m., at the Department of Health, Creekside at Center Point, Suite 310, Room 309, 20425 72nd Avenue South, Kent, WA 98032.

Date of Intended Adoption: February 7, 2020.

Submit Written Comments to: Susan Gragg, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2901, by January 31, 2020.

Assistance for Persons with Disabilities: Contact Susan Gragg, phone 360-236-4941, fax 360-236-2901, TTY 360-833-6388 or 711, email osteopathic@doh.wa.gov, by January 31, 2020.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board is proposing rule amendments to chapter 246-853 WAC. The proposed amendments include implementing a process for issuing expedited temporary practice permits for military spouses. RCW 18.340.020 requires health profession disciplining authorities to establish procedures to expedite temporary practice permits for military spouses, or a registered domestic partner of a military service member.

The board's proposed amendments also include clarification of continuing education opportunities, updating and clarifying HIV/AIDs education standards, clarifying the use of public forms of advertising, updating reentry to practice requirements, and minor updates regarding use of laser, light radiofrequency, and plasma devices.

Reasons Supporting Proposal: RCW 43.70.041, passed by the legislature in 2013, requires government agencies and regulatory entities to perform periodic rule review. This followed an earlier executive order (EO 06-02) for regulatory improvement - Improve, simplify, and assist. The objective of the statute and EO is to simplify and streamline the process for permitting, licensing, and regulation. The board completed review of chapter 246-853 WAC in 2017 and identified several sections of rule that may need updates and amendments. These proposed revisions include amendments to the continuing education, advertising, mandatory reporting, HIV/AIDs training, and reentry to practice requirements, as well as the use of lasers by physicians. The proposed amendments streamline language, repeal outdated and redundant rule sections, and ensures the rules are clear for osteopathic physicians and surgeons.

Chapter 18.340 RCW directs disciplinary authorities to establish a temporary permit for military spouses. RCW 1.12.080 requires that the interpretation of the term "spouse" be applied equally to state-registered domestic partners. Military spouses and state-registered domestic partners who hold out-of-state credentials may receive temporary practice permits while completing any specific additional requirements in Washington that are not related to the profession's training or practice standard. The proposed rule adopts the secretary rule, WAC 246-12-051, by reference for qualified applicants who hold out-of-state credentials as osteopathic physicians and surgeons to obtain a temporary permit. By adopting the secretary rules, the board ensures consistent standards with other health care professions for temporary permits for military spouses and state-registered domestic partners.

Statutory Authority for Adoption: RCW 18.57.005, 18.130.050, and 18.340.020.

Statute Being Implemented: RCW 18.340.020 and 18.57.050.

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

Name of Proponent: Board of osteopathic medicine and surgery, 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, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4941, 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 rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule; and rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect.

Explanation of exemptions: Proposed new WAC 246-853-136 is exempted under RCW 34.05.310 (4)(c). Proposed changes in WAC 246-853-070, 246-853-080, 246-853-100, 246-853-140, 246-853-230, and 246-853-630 are considered exempt under subsection (4)(d) as these changes only make clarifying changes to the rule to make them clearer for licensees.

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 costs on businesses. The proposed rule may impose costs on individual providers.

Renee Fullerton, MPH

AMENDATORY SECTION(Amending WSR 90-24-055, filed 12/3/90, effective 1/31/91)

WAC 246-853-070Categories of creditable continuing professional education activities.

For those licensed osteopathic physicians unable to satisfy the one hundred fifty hour continuing professional education requirement by meeting the certification options in WAC 246-853-080(2), the following are categories of creditable continuing medical education activities approved by the board. The credits must be earned in the thirty-six month period preceding application for renewal of licensure. One clock hour shall equal one credit hour ((for the purpose of satisfying the one hundred fifty hour continuing professional education requirement)).

(1) Category 1 - A minimum of sixty credit hours of the total one hundred fifty hour requirements are mandatory under this general category.

(a) Category 1-A - Formal educational programs sponsored by nationally recognized osteopathic or medical institutions, organizations and their affiliates.

Examples of recognized sponsors include, but are not limited to:

(i) Formal medical associations including, but not limited to, the American Osteopathic Association (AOA) or the American Medical Association (AMA);

(ii) Accredited osteopathic or medical schools and hospitals((.));

(iii) Osteopathic or medical societies and specialty practice organizations((.));

(iv) Continuing medical education institutes((.));

(v) Governmental health agencies and institutions((.));

(vi) Residencies, fellowships and preceptorships; or

(vii) Interactive online courses and materials that assign a specific number of credits or contact hours and are provided by nationally recognized osteopathic and medical institutions, organizations, and their affiliates.

(b) Category 1-B - Preparation in publishable form of an original scientific paper (defined as one which reflects a search of the literature, appends a bibliography, and contains original data gathered by the author) and initial presentation before a postdoctoral audience qualified to critique the author's statements. Maximum allowable credit for the initial presentation will be ten credit hours per scientific paper. A copy of the paper in publishable form shall be submitted to the board. Publication of the above paper or another paper in a professional journal approved by the board may receive credits as approved by the board up to a maximum of fifteen credit hours per scientific paper.

(c) Category 1-C - Serving as a teacher, lecturer, preceptor or moderator-participant in any formal educational program. Such teaching would include classes in colleges of osteopathic medicine and medical colleges and lecturing to hospital interns, residents and staff. Total credits allowed under Category 1-C are forty-five per three-year period, with one hour's credit for each hour of actual instruction.

(((A)))(2)(a) Category 2-A - Home study - The board strongly believes that participation in formal professional education programs is essential in fulfilling a physician's total education needs. The board is also concerned that the content and educational quality of many unsolicited home study materials are not subject to impartial professional review and evaluation. It is the individual physician's responsibility to select home study materials that will be of actual benefit. For these reasons, the board has limited the number of credits which may be granted for home study, and has adopted strict guidelines in granting these credits.

(i) Reading - Credits may be granted for reading the Journal of the AOA or AMA, and other selected journals published by recognized osteopathic organizations. One-half credit per issue is granted for reading alone. An additional one-half credit per issue is granted if the quiz found in the AOA Journal is completed and returned to the division of continuing medical education. Credit for all other reading is limited to recognized scientific journals listed in Index Medicus. One-half credit per issue is granted for reading these recognized journals.

(ii) Listening - Credits may be granted for listening to programs distributed by the AOA audio-educational service. Other ((audio-tape))audio programs sponsored by nationally recognized organizations and companies are also eligible for credit. One-half credit per ((tape))audio program may be granted. An additional one-half credit may be granted for each AOA audio-educational service program if the quiz card for the tape found in the AOA Journal is completed and returned.

(iii) Other home study courses - Subject-oriented and refresher home study courses and programs sponsored by recognized professional organizations are eligible for credit. The number of credit hours indicated by the sponsor will be accepted by the board.

(b) A maximum of ninety credit hours per three-year period may be granted for all home study activities under Category 2-A.

(((B)))(c) Category 2-B - Preparation and personal presentation of a scientific exhibit at a county, regional, state or national professional meeting. Total credits allowed under Category 2-B are thirty per three-year period, with ten credits granted for each new and different scientific exhibit. Appropriate documentation must be submitted with the request for credit.

(((C)))(d) Category 2-C - All other programs and modalities of continuing professional education. Included under this category are informal educational activities such as observation at medical centers; programs dealing with experimental and investigative areas of medical practice, and programs conducted by nonrecognized sponsors.

(e) Total credits allowed under Category 2-C are thirty hours per three-year period.

AMENDATORY SECTION(Amending WSR 98-05-060, filed 2/13/98, effective 3/16/98)

WAC 246-853-080Continuing education.

(1) Licensed osteopathic physicians and surgeons must complete one hundred fifty hours of creditable continuing medical education (CME) every three years ((as required)) in accordance with chapter 246-12 WAC, Part 7.

(2) ((Certification of compliance with the requirement for continuing medical education of the American Osteopathic Association, or receipt of the AMA physicians recognitions award or a current certification of continuing medical education from medical practice academies shall be deemed sufficient to satisfy the requirements of these regulations.

(3) Original certification or recertification within the previous six years by a specialty board will be considered as evidence of equivalent compliance with these continuing professional education requirements.))To satisfy the CME requirements in subsection (1) of this section, a licensed osteopathic physician and surgeon may:

(a) Certify or recertify with the American Board of Osteopathic Medical Specialties (ABOMS) or the American Board of Medical Specialties (ABMS) within the last six years;

(b) Hold a current American Osteopathic Association (AOA) certificate of excellence in CME; or

AMENDATORY SECTION(Amending WSR 91-20-120, filed 9/30/91, effective 10/31/91)

WAC 246-853-100Prohibited publicity and advertising.

An osteopathic physician shall not use or allow to be used any form of public communications or advertising connected with his or her profession or in his or her professional capacity as an osteopathic physician which:

(1) Is false, fraudulent, deceptive or misleading;

(2) Uses testimonials that are false, fraudulent, deceptive, unethical, misleading, or are compensated for in any form;

(3) Guarantees any treatment or result;

(4) Makes claims of professional superiority;

(5) States or includes prices for professional services except as provided for in WAC 246-853-110;

(6) Fails to identify the physician as an osteopathic physician as described in RCW 18.57.140;

(7) Otherwise exceeds the limits of WAC 246-853-110.

WAC 246-853-136Temporary practice permit—Military spouse eligibility and issuance.

A military spouse or state registered domestic partner of a military person may receive a temporary practice permit while completing any specific additional requirements that are not related to training or practice standards for osteopathic physicians and surgeons. The board adopts the procedural rules as adopted by the department of health in WAC 246-12-051.

AMENDATORY SECTION(Amending WSR 90-24-055, filed 12/3/90, effective 1/31/91)

WAC 246-853-140Mandatory reporting.

(((1) All reports required by these regulations shall be submitted to the board as soon as possible, but no later than sixty days after a determination is made.

(2) A report should contain the following information if known:

(a) The name, address, and telephone number of the person making the report.

(b) The name, address, and telephone number of the physician or physician's assistant being reported.

(d) A brief description or summary of the facts which give rise to the issuance of the report, including dates of occurrences.

(e) If court action is involved, the name of the court in which the action is filed along with the date of filing and docket number.

(f) Any further information which would aid in the evaluation of the report.))Osteopathic physician and surgeon licensees must comply with the uniform mandatory reporting rules found in WAC 246-16-200 through 246-16-270.

AMENDATORY SECTION(Amending WSR 98-05-060, filed 2/13/98, effective 3/16/98)

WAC 246-853-230HIV/AIDS education and training.

Applicants must complete a one-time, seven clock hour((s of))course in HIV/AIDS education ((as required)) in accordance with chapter 246-12 WAC, Part 8.

AMENDATORY SECTION(Amending WSR 15-16-085, filed 7/31/15, effective 8/31/15)

WAC 246-853-245Reentry to practice requirements.

(1) An osteopathic physician and surgeon who has not ((been in active practice))actively practiced medicine for a period of at least ((five))three years in any jurisdiction in the United States must fulfill one of the following:

(((1)))(a) Successfully pass a board approved competency evaluation;

(((2)))(b) Successfully pass a board approved exam;

(((3)))(c) Successfully complete a board approved retraining program arranged by the osteopathic physician; or

(((4)))(d) Successfully complete a board approved reentry to practice or monitoring program.

(2) For the purposes of this section, a person is considered to have actively practiced medicine if they can demonstrate that they hold an active, unrestricted license as an osteopathic physician and surgeon in the United States.

AMENDATORY SECTION(Amending WSR 15-16-085, filed 7/31/15, effective 8/31/15)

WAC 246-853-630Use of laser, light, radiofrequency, and plasma devices as applied to the skin.

(1) For the purposes of this section, laser, light, radiofrequency, and plasma (LLRP) devices are medical devices that:

(a) Use a laser, noncoherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue, or use high frequency ultrasound or other technologies to deliver energy to or through the skin; and

(b) Are classified by the federal Food and Drug Administration as prescriptive devices.

(2) Because an LLRP device is used to treat disease, injuries, deformities, and other physical conditions in human beings, the use of an LLRP device is the practice of osteopathic medicine under RCW 18.57.001. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypopigmentation and hyperpigmentation.

(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than those in subsection (1) of this section constitutes surgery and is outside the scope of this section.

OSTEOPATHIC PHYSICIAN RESPONSIBILITIES

(4) An osteopathic physician must be appropriately trained in the physics, safety, and techniques of using LLRP devices prior to using such a device, and must remain competent for as long as the device is used.

(5) An osteopathic physician must use an LLRP device in accordance with standard medical practice.

(6) Prior to authorizing treatment with an LLRP device, an osteopathic physician must take a history, perform an appropriate physical examination, make an appropriate diagnosis, recommend appropriate treatment, obtain the patient's informed consent (including informing the patient that a nonphysician may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.

(7) Regardless of who performs LLRP device treatment, the osteopathic physician is ultimately responsible for the safety of the patient.

(8) Regardless of who performs LLRP device treatment, the osteopathic physician is responsible for assuring that each treatment is documented in the patient's medical record.

(9) The osteopathic physician must ensure that there is a quality assurance program for the facility at which LLRP device procedures are performed regarding the selection and treatment of patients. An appropriate quality assurance program shall include the following:

(a) A mechanism to identify complications and problematic effects of treatment and to determine their cause;

(b) A mechanism to review the adherence of supervised professionals to written protocols;

(d) A mechanism by which the findings of the quality assurance program are reviewed and incorporated into future protocols required by subsection (10)(d) of this section and osteopathic physician supervising practices; and

(e) Ongoing training to maintain and improve the quality of treatment and performance of the treating professionals.

OSTEOPATHIC PHYSICIAN DELEGATION OF LLRP TREATMENT

(10) An osteopathic physician who meets the requirements in subsections (1) through (9) of this section may delegate an LLRP device procedure to a properly trained and licensed professional, whose licensure and scope of practice allows the use of a prescriptive LLRP medical device, provided all the following conditions are met:

(a) The treatment in no way involves surgery as that term is understood in the practice of osteopathic medicine;

(b) Such delegated use falls within the supervised professional's lawful scope of practice;

(d) An osteopathic physician has a written office protocol for the supervised professional to follow in using the LLRP device. A written office protocol must include at a minimum the following:

(i) The identity of the individual osteopathic physician authorized to use the LLRP device and responsible for the delegation of the procedure;

(ii) A statement of the activities, decision criteria, and plan the supervised professional must follow when performing procedures delegated pursuant to this rule;

(iii) Selection criteria to screen patients for the appropriateness of treatments;

(iv) Identification of devices and settings to be used for patients who meet selection criteria;

(v) Methods by which the specified device is to be operated and maintained;

(vi) A description of appropriate care and follow-up for common complications, serious injury, or emergencies; and

(vii) A statement of the activities, decision criteria, and plan the supervised professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing osteopathic physician concerning specific decisions made((;)).

(e) The supervised professional has appropriate training including, but not limited to:

(i) Application techniques of each LLRP device;

(ii) Cutaneous medicine;

(iii) Indications and contraindications for such procedures;

(iv) Preprocedural and postprocedural care;

(v) Potential complications; and

(vi) Infectious disease control involved with each treatment((;)).

(f) The delegating osteopathic physician ensures that the supervised professional uses the LLRP device only in accordance with the written office protocol, and does not exercise independent medical judgment when using the device;

(g) The delegating osteopathic physician shall be on the immediate premises during the patient's initial treatment and be able to treat complications, provide consultation, or resolve problems, if indicated. The supervised professional may complete the initial treatment if the physician is called away to attend to an emergency;

(h) Existing patients with an established treatment plan may continue to receive care during temporary absences of the delegating osteopathic physician provided there is a local back-up physician, licensed under chapter 18.57 or 18.71 RCW, who satisfies the requirements of subsection (4) of this section. The local back-up physician must agree in writing to treat complications, provide consultation or resolve problems if medically indicated. In case of an emergency the delegating osteopathic physician or a back-up physician shall be reachable by phone and able to see the patient within sixty minutes.

(11) The use of, or the delegation of the use of, an LLRP device by an osteopathic physician assistant is covered by WAC 246-854-220.

(((12) This section only applies to the use of LLRP devices by osteopathic physicians and osteopathic physician assistants.))

The following sections of the Washington Administrative Code are repealed:

General provisions for mandatory reporting rules.

Health care institutions.

Medical associations or societies.

Health care service contractors and disability insurance carriers.

State and federal agencies.

Professional review organizations.

Brief adjudicative proceedings—Denials based on failure to meet education, experience, or examination prerequisites for licensure.

WAC 246-853-130	General provisions for mandatory reporting rules.
WAC 246-853-150	Health care institutions.
WAC 246-853-160	Medical associations or societies.
WAC 246-853-170	Health care service contractors and disability insurance carriers.
WAC 246-853-180	Courts.
WAC 246-853-190	State and federal agencies.
WAC 246-853-200	Professional review organizations.
WAC 246-853-400	Brief adjudicative proceedings—Denials based on failure to meet education, experience, or examination prerequisites for licensure.