WSR 07-19-095

PROPOSED RULES

DEPARTMENT OF

LABOR AND INDUSTRIES

[ Filed September 18, 2007, 2:56 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-15-075.

Title of Rule and Other Identifying Information: Medical aid rules, the industrial insurance chiropractic advisory committee was established by ESSB 5290 (chapter 282, Laws of 2007) to assure workers receive safe, effective chiropractic treatment in a cost-effective manner.

Hearing Location(s): Department of Labor and Industries, 7273 Linderson Way S.W., Tumwater, WA 98501, on October 23, 2007, at 10:00 a.m.

Date of Intended Adoption: November 28, 2007.

Submit Written Comments to: Jami Lifka, Department of Labor and Industries, P.O. Box 44321, Olympia, WA 98504-4321, e-mail lifk235@lni.wa.gov, fax (360) 902-6315, by November 14, 2007.

Assistance for Persons with Disabilities: Contact Office of Information and Assistance by October 1, 2007, TTY (360) 902-5797 or (360) 902-4941.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: WAC 296-20-0100, chiropractic advisory committee, will be amended to consider the details of the committee with regard to the administration and function of the committee. This proposed rule will also amend WAC 296-20-02704 and 296-20-02705 for the same purpose.

Statutory Authority for Adoption: ESSB 5290 (chapter 282, Laws of 2002 [2007]), RCW 51.04.020, 51.04.030.

Statute Being Implemented: ESSB 5290 (chapter 282, Laws of 2007).

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

Name of Proponent: Department of labor and industries, governmental.

Name of Agency Personnel Responsible for Drafting: Jami Lifka, 7273 Linderson Way S.W., Tumwater, (360) 902-4941; Implementation: Gary Franklin, MD, MPh, Medical Director, (360) 902-5020; and Enforcement: Bob Malooly, Assistant Director of Insurance Services, (360) 902-4209.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This rule relates only to internal governmental operations that are not subject to violation by a nongovernment party, and per RCW 34.05.328 (5)(b)(ii) is exempt from the small business economic impact statement requirement.

A cost-benefit analysis is not required under RCW 34.05.328. This rule relates only to internal governmental operations that are not subject to violation by a nongovernment party, and per RCW 34.05.328 (5)(b)(ii) is exempt from the small business economic impact statement requirement.

September 18, 2007

Judy Schurke

Director

OTS-1013.4


AMENDATORY SECTION(Amending Order 88-28, filed 12/1/88, effective 1/1/89)

WAC 296-20-0100   Industrial insurance chiropractic advisory committee.   (((1) The director or the director's designee shall appoint a chiropractic advisory and utilization review committee.

(2) The committee will function as an advisor to the department with respect to policies affecting chiropractic care, quality assurance, clinical management of cases, utilization review, and the establishment of rules. It shall advise and assist the department in the department's relationship with providers of chiropractic care, and assist the department in ensuring that injured workers receive good quality chiropractic care in a safe and effective manner.

(3) The chiropractic advisory committee shall:

(a) Advise the department on standards as to what constitutes effective and accepted chiropractic treatment, for use by attending chiropractors and for chiropractic consultants to use in reviewing cases referred for consultation;

(b) Advise the department on standards and minimum credentials for chiropractic consultants and the content of consultant reports; and

(c) Review the performance of individual chiropractors and chiropractic consultants for conformance with standards and requirements and advise the department of instances where standards and requirements have not been met.

The department shall review the advice and recommendations of the committee and shall promulgate those standards and requirements which it chooses to adopt. The department shall review the advice from the committee on the performance of chiropractors and shall act upon this advice at its sole discretion.

(4) The committee will meet on a monthly basis or as needed. The department will reimburse members of the committee for travel and incidental expenses related to the meetings.)) (1)(a) The director shall appoint an industrial insurance chiropractic advisory committee (committee) composed of up to nine members licensed in Washington from the nominations provided by statewide associations.

(b) At least two of the total nine members must be chiropractors who are recognized for expertise in evidence-based practice or occupational health, or both.

(c) To the extent possible, all members shall have experience or knowledge of treating injured workers or evidence-based practice, or both.

(d) The director may, at his or her discretion, exclude or remove any nominee, committee member, or hired expert if the person does not meet a condition of appointment, including but not limited to:

(i) Having, or failing to disclose, a conflict of interest;

(ii) Breaching a statute, rule, or the committee's bylaws, including a quality of care concern or professional related action alleged by a government agency; or

(iii) If the committee or committee chair recommends removal for good cause shown.

(e) Appointments to the committee shall be up to three year terms, which the department may renew.

(2)(a) The committee will function as an advisor to the department with respect to the provision of safe, effective, and cost-effective health care for injured workers, including but not limited to, policy development regarding chiropractic care for injured workers, the development of practice guidelines and coverage criteria, review of coverage decisions and technology assessments, review of chiropractic programs, and review of rules pertaining to health care issues.

(b) The committee may provide peer review and advise and assist the department in the resolution of controversies, disputes, and issues between the department and the providers of chiropractic care.

(c) After approval by the department, the committee may consult with experts, services, and form ad hoc groups, committees, or subcommittees for the purpose of advising the department on specific topics to fulfill the purposes of the committee. Such experts or ad hoc groups will develop recommendations for the committee's approval.

(d) The committee's function may include, but is not limited to, the following:

(i) Advising the department on coverage decisions from technology assessments based on the best available scientific evidence, from which the department may use the committee's advice for making coverage decisions and for making proper and necessary industrial insurance claim decisions for covered services (see WAC 296-20-02704 for coverage decision criteria);

(ii) Advising the department on treatment guidelines for covered services based on proper and necessary standards, the best available scientific evidence, and the expert opinion of the industrial insurance chiropractic advisory committee. The department may use the committee's advice for provider education, for criteria for the department's utilization review program, and for making proper and necessary industrial insurance claim decisions;

(iii) Advising the department on criteria related to definitions of quality of care and patterns of harmful care;

(iv) Advising the department on issues related to emerging medical conditions and the scientific evidence related to them; and

(v) Advice to the department in (d)(i) through (iv) of this subsection shall not pertain to nor include the review of a specific individual claim.

(e) Committee approval regarding advice to the department shall be based on a consensus of the members present. If after all reasonable efforts a consensus cannot be reached, the committee shall vote using the procedure described in the bylaws. A quorum, which shall be half plus one of the appointed members, must be present to vote and provide approval regarding advice to the department. Implementation of the committee's advice by the department is discretionary and solely the responsibility of the department.

(3) The members of the committee, including hired experts and any ad hoc group or subcommittee:

(a) Are immune from civil liability for any official acts performed in good faith to further the purposes of the industrial insurance chiropractic advisory committee; and

(b) May be compensated for participation in the work of the industrial insurance chiropractic advisory committee in accordance with a personal services contract to be executed after appointment and before commencement of activities related to the work of the industrial insurance chiropractic advisory committee.

(4) The committee shall coordinate with the state health technology assessment program and the state prescription drug program. With regard to issues in which the committee's opinion may differ with findings of the state health technology assessment program or the state prescription drug program, the department must give greater weight to the findings of the state's health technology assessment program and the state's prescription program.

(5) The committee shall operate under conditions set out in bylaws as approved by the department and ratified by the committee.

(6)(a) The committee and ad hoc group or subcommittee shall meet on a schedule as set by the department.

(b) The department shall collaborate with the committee to prepare the agenda for each meeting, including prioritization of issues to be addressed, with the final approval of the agenda given to the department.

(c) All meetings of the committee or ad hoc subcommittee(s) are subject to chapter 42.30 RCW, the Open Public Meetings Act. Notice as to the date, time, location and agenda or topics shall be published on the department's web site, and in the Washington State Register. Additional notification via electronic communication shall be provided to committee members and other interested parties. Publication of the committee meeting shall occur with enough notice to ensure committee members or members of the public who have disabilities have an equal opportunity to participate.

[Statutory Authority: RCW 51.04.020(4) and 51.04.030. 88-24-011 (Order 88-28), 296-20-0100, filed 12/1/88, effective 1/1/89.]


AMENDATORY SECTION(Amending WSR 04-08-040, filed 3/30/04, effective 5/1/04)

WAC 296-20-02704   What criteria does the director or director's designee use to make medical coverage decisions?   (1) In making medical coverage decisions, the director or the director's designee considers information from a variety of sources. These sources include, but are not limited to:

Scientific evidence;

National and community-based opinions;

Informal syntheses of provider opinion;

Experience of the department and other entities;

Regulatory status.

Because of the unique nature of each health care service, the type, quantity and quality of the information available for review may vary. The director or director's designee weighs the quality of the available evidence in making medical coverage decisions.

(2) Scientific evidence.

(a) "Scientific evidence" includes reports and studies published in peer-reviewed scientific and clinical literature. The director or the director's designee will consider the nature and quality of the study, its methodology and rigorousness of design, as well as the quality of the journal in which the study was published.

For treatment services, studies addressing safety, efficacy, and effectiveness of the treatment or procedure for its intended use will be considered.

For diagnostic devices or procedures, studies addressing safety, technical capacity, accuracy or utility of the device or procedure for its intended use will be considered.

(b) The greatest weight will be given to the most rigorously designed studies and on those well-designed studies that are reproducible. The strength of the design will depend on such scientifically accepted methodological principles as randomization, blinding, appropriateness of outcomes, spectrum of cases and controls, appropriate power to detect differences, magnitude and significance of effect. Additional consideration will be given to those studies that focus on sustained health and functional outcomes of workers with occupational conditions rather than unsustained clinical improvements.

(3) National and community-based opinion.

(a) "National opinion" includes, but is not limited to, syntheses of clinical issues that may take the form of published reports in the scientific literature, national consensus documents, formalized documents addressing standards of practice, practice parameters from professional societies or commissions, and technology assessments produced by independent evidence-based practice centers.

The director or the director's designee will consider the nature and quality of the process used to reach consensus or produce the synthesis of expert opinion. This consideration will include, but may not be limited to, the qualifications of participants, potential biases of sponsoring organizations, the inclusion of graded scientific information in the deliberations, the explicit nature of the document, and the processes used for broader review.

(b) "Community-based opinion" refers to advice and recommendations of formal committees made up of clinical providers within the state of Washington. As appropriate to the subject matter, this may include recommendations from the department's formal advisory committees:

The industrial insurance ((and rehabilitation committee of the Washington State Medical Association, which includes a representative from the Washington Osteopathic Medical Association)) medical advisory committee;

The industrial insurance chiropractic advisory committee.

The Washington state pharmacy and therapeutics committee.

The Washington state health technology assessment clinical committee.

(4) "Informal syntheses of provider opinion" includes, but is not limited to, professional opinion surveys.

(5) Experience of the department and other entities.

The director or director's designee may consider data from a variety of sources including the department, other state agencies, federal agencies and other insurers regarding studies, experience and practice with past coverage. Examples of these include, but are not limited to, formal outcome studies, cost-benefit analyses, and adverse event, morbidity or mortality data.

(6) Regulatory status.

The director or director's designee will consider related licensing and approval processes of other state and federal regulatory agencies. This includes, but is not limited to:

The federal food and drug administration's (FDA) regulation of drugs and medical devices (21 U.S.C. 301 et seq. and 21 CFR Chapter 1, Subchapters C, D, & H consistent with the purposes of this chapter, and as now or hereafter amended); and

The Washington state department of health's regulation of scope of practice and standards of practice for licensed health care professionals regulated under Title 18 RCW.

[Statutory Authority: RCW 51.04.020, 70.14.050. 04-08-040, 296-20-02704, filed 3/30/04, effective 5/1/04. Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-037, 296-20-02704, filed 12/7/99, effective 1/8/00.]


AMENDATORY SECTION(Amending WSR 04-08-040, filed 3/30/04, effective 5/1/04)

WAC 296-20-02705   What are treatment and diagnostic guidelines and how are they related to medical coverage decisions?   (1) Treatment and diagnostic guidelines are recommendations for the diagnosis or treatment of accepted conditions. These guidelines are intended to guide providers through the range of the many treatment or diagnostic options available for a particular medical condition. Treatment and diagnostic guidelines are a combination of the best available scientific evidence and a consensus of expert opinion.

(2) The department may develop treatment or diagnostic guidelines to improve outcomes for workers receiving covered health services. As appropriate to the subject matter, the department may develop these guidelines in collaboration with the department's formal advisory committees:

The industrial insurance ((and rehabilitation committee of the Washington State Medical Association, which includes a representative from the Washington Osteopathic Medical Association)) medical advisory committee;

The industrial insurance chiropractic advisory committee.

The Washington state pharmacy and therapeutics committee.

The Washington state health technology assessment clinical committee.

(3) In the process of implementing these guidelines, the department may find it necessary to make a formal medical coverage decision on one or more of the treatment or diagnostic options. The department, not the advisory committees, is responsible for implementing treatment guidelines and for making coverage decisions that result from such implementation.

[Statutory Authority: RCW 51.04.020, 70.14.050. 04-08-040, 296-20-02705, filed 3/30/04, effective 5/1/04. Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-037, 296-20-02705, filed 12/7/99, effective 1/8/00.]

Washington State Code Reviser's Office