Subject of Possible Rule Making: WAC 296-20-03002 Treatment not authorized.

     Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 51.04.020, 51.04.030.

     Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: This rule is being initiated in response to a lack of efficacy data on the artificial discs and the concern about safety issues with the device. To date seventy-six adverse events have ben reported with the FDA. Adverse events include: (1) Migration of the disc resulting in removal of the disc and fusion of the vertebrae, (2) pedicle fractures on the vertebrae, (3) subsidence, or a settling or sinking of the disc into the vertebrae, and (4) nicking of a vein or artery. In addition, the disc must be placed by approaching the spine from the front, through the abdomen. Large arteries and veins, as well as important nerves, must be mobilized and moved out of the operative area. Following surgery, scar tissue can entrap those arteries, veins and nerves. Subsequent surgery to treat a disc-related problem can be very dangerous because of that scar tissue and the vital structures that it entraps.

     Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Washington workers' compensation benefits as well as the benefits paid to victims of crimes are both governed by Title 51 RCW, Washington's Industrial Insurance Act. There are no other state or federal agencies responsible for interpreting and enforcing the provisions of this act.

     Process for Developing New Rule: Parties interested in participating in the development of these rules may contact the person listed below. The public may also participate by providing written comments during the comment period or giving oral testimony at public hearings. The rule will be developed in consultation with major stakeholders and the following interested parties: Workers' compensation advisory committee, Washington state medical association.

     Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Jami Lifka by phone (360) 902-4941, fax (360) 902-6315, or mail Department of Labor and Industries, Office of the Medical Director, P.O. Box 44321, Olympia, WA 98504-4321.

December 20, 2005

Gary Weeks

Director