PROPOSED RULES
LABOR AND INDUSTRIES
Original Notice.
Preproposal statement of inquiry was filed as WSR 98-12-102.
Title of Rule: Addition of WAC 296-20-02701, 296-20-02702, 296-20-02703, 296-20-02704, 296-20-02705, and 296-20-02850; all relating to criteria used by the department to make medical coverage decisions.
Purpose: To make clear the objective methods and the variety of information sources the department uses to make medical coverage decisions.
Statutory Authority for Adoption: RCW 51.04.020, 51.04.030.
Statute Being Implemented: RCW 51.04.030.
Summary: The revised rule defines medical coverage decisions (MCDs), identifies who makes and who uses MCDs, describes where MCDs can be found, identifies the criteria used to make MCDs, clarifies the difference between MCDs and treatment guidelines, and identifies when exceptions may be made to MCDs.
Name of Agency Personnel Responsible for Drafting: Jami Lifka, 7273 Linderson Way S.W., Tumwater, WA, (360) 902-4941; Implementation and Enforcement: Gary Franklin, MD, 7273 Linderson Way S.W., Tumwater, WA, (360) 902-5020.
Name of Proponent: Department of Labor and Industries, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The purpose of these new sections is to make clear the objective methods and the variety of information sources the department uses to make medical coverage decisions.
These new sections:
| • | Define medical coverage decisions, |
| • | Identify who makes and who uses medical coverage decisions, |
| • | Identify where medical coverage decisions can be found, |
| • | Describe the criteria used by the department to make medical coverage decisions, |
| • | Clarify the difference between medical coverage decisions and treatment or diagnostic guidelines, and |
| • | Identify when exceptions may be made to medical coverage decisions. |
Proposal does not change existing rules.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The department believes that this new language does not require preparation of a small business economic impact statement. This rule has no or minor impact on business, relates to internal government operations, and is statutorily mandated.
RCW 34.05.328 does not apply to this rule adoption. This rule relates to internal government operations and is statutorily mandated.
Hearing Location: Department of Labor and Industries, 7273 Linderson Way S.W., Tumwater, WA 98501, on August 6, 1999, at 9:00 a.m.
Assistance for Persons with Disabilities: Contact Jami Lifka, by phone (360) 902-4941, fax (360) 902-4249, or TDD 1-800-833-6388.
Submit Written Comments to: Jami Lifka, Department of Labor and Industries, P.O. Box 44321, Olympia, WA 98501-4321, fax (360) 902-4249, by August 14, 1999.
Date of Intended Adoption: September 14, 1999.
June 22, 1999
Gary Moore
Director
OTS-3033.2
NEW SECTION
WAC 296-20-02700
What is a medical coverage decision?
A medical coverage decision is a general policy decision by the director or the director’s designee to include or exclude a specific health care service or supply as a covered benefit. These decisions are made to insure quality of care and prompt treatment of workers. Medical coverage decisions include, but are not limited to, decisions on health care services and supplies rendered for the purpose of diagnosis, treatment or prognosis, such as:
• Ancillary services including, but not limited to, home health care services, ambulatory services, specific rehabilitative modalities;
• Devices;
• Diagnostic tests;
• Drugs, biologics, and other therapeutic modalities;
• Durable medical equipment;
• Procedures;
• Prognostic tests; and
• Supplies.
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The director or the director's designee makes medical coverage decisions.
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Self-insured employers and state fund claim managers use medical coverage decisions to help them make claim-specific decisions. For example, the director or director’s designee may find that a particular medical device is effective in treating a specific category of injuries. The medical coverage decision might be that that device is a covered benefit for that category of injuries. The self-insured employer or state fund claim manager would make a claim-specific decision to pay or deny payment for that device based on a number of factors, one of which is whether the accepted condition on that claim matches the approved category of injuries in the medical coverage decision.
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(1) The Medical Aid Rules, fee schedules, and provider bulletins and updates specify covered and noncovered services and supplies.
(2) For additional information on existing medical coverage decisions or if you have a question about a new and emerging technology, device, or off-label use of a drug, contact the office of the medical director at:
Department of Labor and Industries
Office of the Medical Director
P.O. Box 44321
Olympia, WA 98504-4321
(3) For questions about what will be authorized on a specific claim, contact the
self-insured employer or state fund claim manager.
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(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;
• The chiropractic advisory 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); 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.
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(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;
• The chiropractic advisory 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.
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(1) The department or self-insurer will not authorize nor pay for treatment measures of an unusual, controversial, obsolete, or experimental nature. (See WAC 296-20-03002.) Under certain conditions, the director or the director's designee may determine that such treatment is appropriate. In making such a decision, the director or director's designee will consider factors including, but not limited to, the following:
(a) Scientific studies investigating the safety and efficacy of the treatment are incomplete, or if completed, have conflicting conclusions, and:
• Preliminary data indicates the treatment or diagnostic procedure or device has improved net health and functional outcomes; and
• No alternative treatment or diagnostic is available; or (b) The treatment or diagnostic procedure or device is prescribed as part of:
• A controlled, clinical trial that has been reviewed and approved by an institutional review board that was established in accordance with a department of health and human services (DHHS) regulations (45 CFR Part 46); and
• For medical devices not yet cleared for marketing, the clinical evaluation has an approved investigational device exemption (IDE) in accordance with food and drug administration (FDA) regulations (21 CFR Parts 50, 56, and 812); and
• For drugs not yet cleared for marketing, the clinical evaluation has been approved in accordance with food and drug administration (FDA) regulations (21 CFR Part 312); or
(c) The usually indicated procedure or diagnostic test would likely be harmful for the patient because of other unrelated conditions.
(2) The health care provider must submit a written request and obtain approval from the department or self-insurer, prior to using an unusual, controversial, obsolete, or experimental treatment. The written requests must contain a description of the treatment, the reason for the request, potential risks and expected benefits, length of care and estimated cost of treatment.
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