Original Notice.

     Preproposal statement of inquiry was filed as WSR 06-13-084.

     Title of Rule and Other Identifying Information: WAC 296-20-03014 Which drugs have specific limitations?, "Injectables."

     Hearing Location(s): Department of Labor and Industries, Room S117, 7273 Linderson Way S.W., Tumwater, WA 98501, on November 27, 2006, at 1:30 p.m.

     Date of Intended Adoption: December 29, 2006.

     Submit Written Comments to: Jami Lifka, Office of the Medical Director, P.O. Box 44321, Olympia, WA 98504-4321, e-mail lifk235@lni.wa.gov, fax (360) 902-6315, by November 27, 2006.

     Assistance for Persons with Disabilities: Contact Office of Information and Assistance by November 15, 2006, TTY (360) 902-5797 or (360) 902-4941.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Under the proposed rule it would be clear under what conditions the department will pay for intrathecal pumps. A worker with cancer or a spinal cord injury may be eligible for an intrathecal pump. Also hospitalized patients and those within forty-eight hours post surgery would be eligible. For safety reasons, under the proposed WAC, payment for permanent placement of the intrathecal infusion pumps would not be allowed for the treatment of chronic, noncancer pain resulting from noncatastrophic injuries.

     Reasons Supporting Proposal: While the pumps may temporarily be modestly effective, there are serious safety concerns. A systematic review done by the University of Washington revealed many serious adverse events including: A potential for life-threatening overdose, potentially life-threatening infection, granulomatous mass formation at the catheter tip endangering neural structures in the spinal canal, impotence, disabling edema, and disabling pruritis (itching). In addition to these serious problems, the pumps' components often break, migrate, or malfunction, thus requiring additional procedures.

     Statutory Authority for Adoption: RCW 51.04.020, 51.04.030.

     Statute Being Implemented: RCW 51.04.020, 51.04.030.

     Rule is necessary because of state court decision, Roller v. Department of Labor and Industries, 128 Wash. App. 922, 117 P.3d 385 (2005).

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

     Name of Agency Personnel Responsible for Drafting: Jamie Lifka, 7273 Linderson Way S.E., Tumwater, WA, (360) 902-4941; Implementation: Gary Franklin, MD, MPH, Office of the 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 34.05.310 (4)(b) 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 cost-benefit analysis requirement.

October 17, 2006

Gary Weeks

Director

OTS-9222.1

AMENDATORY SECTION(Amending WSR 00-01-040, filed 12/7/99, effective 1/20/00)

WAC 296-20-03014   Which drugs have specific limitations?   (1) Injectables. An injectable is a sterile pharmacologic or biologic preparation intended for injecting, infusing or otherwise introducing into the subcutaneous tissue, muscular tissue, a vein, an artery, an organ, spinal intrathecal space, or other body cavities or spaces. Prescriptions for injectable opioids or other analgesics, sedatives, antihistamines, tranquilizers, psychotropics, vitamins, minerals, food supplements, and hormones are not covered.

     Exceptions: The department or self-insurer covers injectable medications under the following circumstances.

     (a) Indicated injectable drugs for the following:

     • Inpatients; or

     • During emergency treatment of a life-threatening condition/injury; or

     • During outpatient treatment of severe soft tissue injuries, burns or fractures when needed for dressing or cast changes; or

     • During the perioperative period and the postoperative period, not to exceed forty-eight hours from the time of discharge.

     (b) Prescriptions of injectable insulin, heparin, anti-migraine medications, or impotency treatment, when proper and necessary.

     (c) Intrathecal infusion pumps and injectable medications prescribed for administration via the intrathecal pump are covered only under the following circumstances (see Table 1):

Table 1:
Coverage exceptions for injectable medication for administration via the intrathecal infusion pump

	Covered	Covered with preauthorization	Noncovered
Injectable medication prescribed for administration via the intrathecal infusion pump for the treatment of pain
• When cancer or other end-stage disease is an accepted condition		X
• As part of an inpatient hospitalization	X
• During the perioperative and postoperative period, not to exceed forty-eight hours from the time of discharge	X
• In noncancer chronic pain condition or injury			X
Injectable medication prescribed for administration via the intrathecal infusion pump for the treatment of spasticity
• When spinal cord injury is an accepted condition		X

     (2) Noninjectable scheduled drugs administered by other than the oral route. Nonoral routes of administration of scheduled drugs that result in systemic availability of the drug equivalent to injectable routes will also not be covered.

     (3) Sedative-hypnotics. During the chronic stage of an industrial injury or occupational disease, payment for scheduled sedatives and hypnotics will not be authorized.

     (4) Benzodiazepines. Payment for prescriptions for benzodiazepines are limited to the following types of patients:

     • Hospitalized patients;

     • Claimants with an accepted psychiatric disorder for which benzodiazepines are indicated;

     • Claimants with an unrelated psychiatric disorder that is retarding recovery but which the department or self-insurer has temporarily authorized treatment (see WAC 296-20-055) and for which benzodiazepines are indicated; and

     • Other outpatients for not more than thirty days for the life of the claim.

     (5) Cancer. When cancer or any other end-stage disease is an accepted condition, the department or self-insurer may authorize payment for any indicated scheduled drug and by any indicated route of administration.

     (6) Spinal cord injuries. When a spinal cord injury is an accepted condition, the department or self-insurer may authorize payment for anti-spasticity medications by any indicated route of administration (e.g., some benzodiazepines, Baclofen). Prior authorization is required.

     Note: See the department formulary for specific limitations and prior authorization requirements of other drugs.

[Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-040, § 296-20-03014, filed 12/7/99, effective 1/20/00.]

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