Original Notice.

     Preproposal statement of inquiry was filed as WSR 06-01-068.

     Title of Rule and Other Identifying Information: WAC 296-20-03002 Treatment not authorized, "artificial discs."

     Hearing Location(s): Department of Labor and Industries, Room S 117, 7273 Linderson Way S.W., Tumwater, WA 98501, on April 7, 2006, at 1:30 p.m.

     Date of Intended Adoption: May 22, 2006.

     Submit Written Comments to: Josh Morse, Office of the Medical Director, P.O. Box 44321, Olympia, WA 98504-4321, e-mail mojo235@lni.wa.gov, fax (360) 902-6315, by April 14, 2006, 5 p.m.

     Assistance for Persons with Disabilities: Contact Office of Information and Assistance by March 24, 2006, TTY (360) 902-5797 or (360) 902-4941.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: This rule making is being proposed to put into rule an existing medical coverage decision to not cover lumbar artificial discs. The purpose is to supervise the care and treatment of injured workers and victims of crime. The anticipated effect would be safer and more efficacious treatment. The Charite III disc, the only artificial disc approved by the Food and Drug Administration (FDA), was approved for marketing in 2004. Since that time, more than seventy serious adverse events have been reported to the FDA from its use.

     Reasons Supporting Proposal: Lumbar artificial disc replacement is intended to address pain due to degenerative disc disease. The department reviewed the best scientific evidence on artificial discs and made a noncoverage decision because there was not substantial scientific support and thus the device has not been proven to be safe and efficacious. Putting this noncoverage decision in rule will give the department more legal support when challenged and ensure the safety of workers.

     Statutory Authority for Adoption: RCW 51.04.020, 51.04.030.

     Statute Being Implemented: RCW 51.04.020, 51.04.030.

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

     Agency Comments or Recommendations, if any, as to Statutory Language, Implementation, Enforcement, and Fiscal Matters: This proposed language focuses on the only artificial disc currently approved by the federal FDA, lumbar artificial discs.

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

     Name of Agency Personnel Responsible for Drafting: Jamie 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 for Insurance Services, (360) 902-4209.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. This administrative rule codifies current department policy. The policy is to not cover a particular medical device. The rule relates only to internal governmental operations, and the rule is not subject to violation by a nongovernment party.

     Additionally, a small business economic impact statement is unnecessary because the rule is a mere codification of existing policy and no small businesses would be impacted by the adoption of this rule. Currently, by policy, the department does not pay for this treatment, providers have already been informed through a provider bulletin of department policy that this treatment is not covered, and putting this policy into rule does not affect any provider's revenue vis a vis the department.

     A cost-benefit analysis is not required under RCW 34.05.328. This administrative rule codifies current department policy. The policy is to not cover a particular medical device. The rule relates only to internal governmental operations, and the rule is not subject to violation by a nongovernment party.

     Additionally, a cost-benefit analysis is unnecessary. Currently, by policy, the department does not pay for this treatment, providers have already been informed through a provider bulletin of department policy that this treatment is not covered, and putting this policy into rule does not affect any provider's revenue vis a vis the department.

February 28, 2006

Gary Weeks

Director

OTS-8604.2

AMENDATORY SECTION(Amending Order 86-19, filed 2/28/86, effective 4/1/86)

WAC 296-20-03002   Treatment not authorized.   The department or self-insurer will not allow nor pay for following treatment:

     (1) Use of diapulse, thermatic (standard model only), spectrowave and superpulse machines on workers entitled to benefits under the Industrial Insurance Act.

     (2) Iontophoresis; prolotherapy; acupuncture; injections of colchicine; injections of fibrosing or sclerosing agents; and injections of substances other than anesthetic or contrast into the subarachnoid space (intra-thecal injections).

     (3) Lumbar artificial disc replacement with Charite lumbar artificial disc.

     (4) Treatment to improve or maintain general health (i.e., prescriptions and/or injection of vitamins or referrals to special programs such as health spas, swim programs, exercise programs, athletic-fitness clubs, diet programs, social counseling).

     (((4))) (5) Continued treatment beyond stabilization of the industrial condition(s), i.e., maintenance care, except where necessary to monitor prescription of medication necessary to maintain stabilization i.e., anti-convulsive, anti-spasmodic, etc.

     (((5))) (6) After consultation and advice to the department or self-insurer, any treatment measure deemed to be dangerous or inappropriate for the injured worker in question.

     (((6))) (7) Treatment measures of an unusual, controversial, obsolete, or experimental nature (see WAC 296-20-045). Under certain conditions, treatment in this category may be approved by the department or self-insurer. Approval must be obtained prior to treatment. Requests must contain a description of the treatment, reason for the request with benefits and results expected.

[Statutory Authority: RCW 51.04.020(4) and 51.04.030. 86-06-032 (Order 86-19), § 296-20-03002, filed 2/28/86, effective 4/1/86; 83-16-066 (Order 83-23), § 296-20-03002, filed 8/2/83. Statutory Authority: RCW 51.04.020(4), 51.04.030, and 51.16.120(3). 81-24-041 (Order 81-28), § 296-20-03002, filed 11/30/81, effective 1/1/82; 81-01-100 (Order 80-29), § 296-20-03002, filed 12/23/80, effective 3/1/81; Order 76-34, § 296-20-03002, filed 11/24/76, effective 1/1/77.]

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