Original Notice.

Preproposal statement of inquiry was filed as WSR 98-14-142.

Title of Rule: Chapter 296-20 WAC, General rules--Medical aid rules; drugs and medication.

Purpose: The purpose of this rule is to clearly describe which drugs are a covered benefit on claims for injured and ill workers and victims of crime.

Statutory Authority for Adoption: RCW 51.04.020(4), 51.04.030.

Statute Being Implemented: RCW 51.04.020(4), 51.04.030.

Summary: This rule includes the following information on drugs and medication - general coverage rules, specific limitations on individual drugs, reference to the department's outpatient drug formulary, documentation requirements, and expanded sections for workers with cancer, spinal cord injuries or chronic, noncancer pain.

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

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 proposed language clearly describes the department's coverage rules on drugs and medication. It includes general coverage rules, specific limitations, information on the department's outpatient drug formulary, documentation requirements, and expanded sections on drug coverage for workers with cancer, spinal cord injuries, or chronic, noncancer pain. Obsolete drug information has been deleted to make the coverage rules more consistent with prescribing practices in the state of Washington. The purpose is to give health care providers a better understanding of what medications the department of self-insurer will pay for before a prescription is written.

Since the drug coverage rules will be easier to understand and more up-to-date, it is anticipated that health care providers will have an easier time voluntarily complying.

Proposal Changes the Following Existing Rules: These new WAC sections will replace WAC 296-20-03003 Drugs and medication and 296-20-030 (7), (8), and (9) Treatment not requiring authorization for accepted conditions.

Specific changes include rewritten, clearer language in response to Executive Order 97-02; removal of obsolete drug information; expanded coverage for injectable drugs; expanded coverage for opioids to treat chronic, noncancer pain; and specific exceptions for patients with cancer or spinal cord injuries.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This proposed change has little or no impact on business. A discussion of economic impact memorandum has been prepared.

RCW 34.05.328 applies to this rule adoption. The rule is being proposed by the Department of Labor and Industries and will make significant amendments to existing regulations on drug coverage.

Hearing Location: On October 26, 1999, at 1:00 p.m., to facilitate public involvement, the public rules hearing will be held simultaneously at four different locations across the state. Participants will be able to see and hear each other via a state-wide video telecommunications system.

Addresses for the four locations:

Lacey Site

Department of Information Services (DIS)

710 Sleater-Kinney Road S.E., Suite Q

Lacey, WA 98504-2445

(360) 407-9487

Seattle Site

1107 S.W. Grady Way, Suite 112

Renton, WA 98055

(425) 277-7290

Spokane Site

Washington Interactive Technologies

1101 North Argonne, Suite 109

Spokane, WA 99201

(509) 921-2371

Yakima Site

Yesterday's Village

15 West Yakima Avenue, Suite 220

Yakima, WA 98902

(509) 454-7878

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 98504-4321, fax (360) 902-4249, by November 3, 1999.

Date of Intended Adoption: December 7, 1999.

September 22, 1999

Gary Moore

Director

OTS-3364.2

AMENDATORY SECTION(Amending WSR 93-16-072, filed 8/1/93, effective 9/1/93)

WAC 296-20-030
Treatment not requiring authorization for accepted conditions.

(1) A maximum of twenty office calls for the treatment of the industrial condition, during the first sixty days, following injury.  Subsequent office calls must be authorized.  Reports of treatment rendered must be filed at sixty day intervals to include number of office visits to date.  See chapter 296-20 WAC and department policies for report requirements and further information.

(2) Initial diagnostic x-rays necessary for evaluation and treatment of the industrial injury or condition.  See WAC 296-20-121 for further information.

(3) The first twelve physical therapy treatments as provided by chapters 296-21, 296-23, and 296-23A WAC, upon consultation by the attending doctor or under his direct supervision.  Additional physical therapy treatment must be authorized and the request substantiated by evidence of improvement.  In no case will the department or self-insurer pay for inpatient hospitalization of a claimant to receive physical therapy treatment only.  USE OF DIAPULSE, THERMATIC (standard model only), SPECTROWAVE AND SUPERPULSE MACHINES AND IONTOPHORESIS IS NOT AUTHORIZED FOR WORKERS ENTITLED TO BENEFITS UNDER THE INDUSTRIAL INSURANCE ACT.

(4) Routine laboratory studies reasonably necessary for diagnosis and/or treatment of the industrial condition.  Other special laboratory studies require authorization.

(5) Routine standard treatment measures rendered on an emergency basis or in connection with minor injuries not otherwise requiring authorization.

(6) Consultation with specialist when indicated.  See WAC 296-20-051 for consultation guidelines.

(7) ((Nonscheduled drugs and medications during the acute phase of treatment for the industrial injury or condition.

(8) Scheduled drugs and other medications known to be addictive, habit forming or dependency inducing may be prescribed in quantities sufficient for treatment for a maximum of twenty-one days.  If drug therapy extends beyond thirty days, see WAC 296-20-03003 regarding management.

(9) Injectable scheduled and other drugs known to be addictive, habit forming, or dependency inducing may be provided only on an in-patient basis.  Hospital admission for administration of drugs for relief of chronic pain only will not be allowed.

(10))) Diagnostic or therapeutic nerve blocks.  See WAC 296-20-03001 for restrictions.

(((11))) (8) Intra-articular injections.  See WAC 296-20-03001 for restrictions.

(((12))) (9) Myelogram if prior to emergency surgery.

[Statutory Authority: RCW 51.04.020, 51.04.030 and 1993 c 159.  93-16-072, § 296-20-030, filed 8/1/93, effective 9/1/93.  Statutory Authority: RCW 51.04.020(4) and 51.04.030.  86-06-032 (Order 86-19), § 296-20-030, filed 2/28/86, effective 4/1/86.  Statutory Authority: RCW 51.04.020(4), 51.04.030, and 51.16.120(3).  81-24-041 (Order 81-28), § 296-20-030, filed 11/30/81, effective 1/1/82; 81-01-100 (Order 80-29), § 296-20-030, filed 12/23/80, effective 3/1/81; Order 76-34, § 296-20-030, filed 11/24/76, effective 1/1/77; Order 75-39, § 296-20-030, filed 11/28/75, effective 1/1/76; Order 74-7, § 296-20-030, filed 1/30/74; Order 71-6, § 296-20-030, filed 6/1/71; Order 70-12, § 296-20-030, filed 12/1/70, effective 1/1/71; Order 68-7, § 296-20-030, filed 11/27/68, effective 1/1/69.]

The department or self-insurer pays for drugs that are deemed proper and necessary to treat the industrial injury or occupational disease accepted under the claim. In general, the department will consider coverage for all FDA approved drugs for stated indications. The department or self-insurer may pay for prescriptions for off label indications when used within current medical standards and prescribed in compliance with published contraindications, precautions and warnings.

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(1) Amount dispensed. The department or self-insurer will pay for no more than a thirty-day supply of a medication dispensed at any one time.

(2) Over-the-counter drugs. Prescriptions for over-the-counter items may be paid. Special compounding fees for over-the-counter items are not payable.

(3) Generic drugs. Prescriptions are to be written for generic drugs unless the attending physician specifically indicates that substitution is not permitted. For example: The patient cannot tolerate substitution. Pharmacists are instructed to fill with generic drugs unless the attending physician specifically indicates substitution is not permitted.

(4) Prescriptions for unrelated medical conditions. The department or self-insurer may consider temporary coverage of prescriptions for conditions not related to the industrial injury when such conditions are retarding recovery. Any treatment for such conditions must have prior authorization per WAC 296-20-055.

(5) Pension cases. Once the worker is placed on a pension, the department or self-insurer may pay for only those drugs and medications authorized for continued medical treatment for conditions previously accepted by the department. Authorization for continued medical and surgical treatment is at the sole discretion of the supervisor of industrial insurance and must be authorized before the treatment is rendered. In such pension cases, the department or self-insurer cannot pay for scheduled drugs used to treat continuing pain resulting from an industrial injury or occupational disease.

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The department's outpatient drug and medication coverage decisions are contained in the department's formulary, as developed by the department in collaboration with the Washington State Medical Association's Industrial Insurance and Rehabilitation Committee.

In the formulary, drugs are listed in the following categories:

• Allowed

Drugs used routinely for treating accepted industrial injuries and occupational illnesses.

Example: Nonscheduled drugs and other medications during the acute phase of treatment for the industrial injury or condition.

• Prior authorization required

Drugs used routinely to treat conditions not normally accepted as work related injuries, drugs which are used to treat unrelated conditions retarding recovery from the accepted condition on the claim, and drugs for which less expensive alternatives exist.

Example: All drugs to treat hypertension because hypertension is not normally an accepted industrial condition.

• Denied

Drugs not normally used for treating industrial injuries or not normally dispensed by outpatient pharmacies.

Example: Most hormones, most nutritional supplements.

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Some of the drugs that are routinely denied may be covered in special circumstances. Requests for coverage under special circumstances require authorization prior to treatment. Examples of drugs that may be covered in special circumstances include:

• Drugs and medications to treat unrelated conditions when retarding recovery;

• Special treatments for unique catastrophic injuries.

The department may require written documentation to support the request.

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(1) Injectables. Prescriptions for injectable narcotics, sedatives, analgesics, 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 except when hospital admission is solely for administration of drugs for relief of chronic pain; 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.

(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.

Exception: Anti-seizure medications.

(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.

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(1) The department or self-insurer may take any or all of the following steps when concerned about the amount or appropriateness of drugs the patient is receiving:

• Notify the attending physician of concerns regarding the medications such as drug interactions, adverse reactions, prescriptions by other providers;

• Require that the attending physician send a treatment plan addressing the drug concerns;

• Request a consultation from an appropriate specialist;

• Request that the attending physician consider reducing the prescription, and provide information on chemical dependency programs;

• Limit payment for drugs on a claim to one prescribing doctor.

(2) If the attending physician or worker does not comply with these requests, or if the probability of imminent harm to the worker is high, the department or self-insurer may discontinue payment for the drug after adequate prior notification has been given to the worker, pharmacy and physician.

(3) Physician failure to reduce or terminate prescription of controlled substances, habit forming or addicting medications, or dependency inducing medications, after department or self-insurer request to do so for an injured worker may result in a transfer of the worker to another physician of the worker's choice. (See WAC 296-20-065.)

(4) Other corrective actions may be taken in accordance with WAC 296-20-015, Who may treat.

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The department or self-insurer may pay for detoxification and/or chemical dependency treatment in the following circumstances:

• The injured worker becomes dependent on medication prescribed for an accepted condition on the claim;

• An addiction is retarding recovery of the accepted condition on the claim.

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Prescriptions must include the department authorized provider number and a physician's signature. The physician's record must contain the name and reason for the medication, the dosage, quantity prescribed and/or dispensed, the route of administration, the frequency, the starting and stopping dates, the expected outcome of treatment, and any adverse effects that occur. Please refer to WAC 296-20-03021 and 296-20-03022 for additional documentation requirements when treating chronic, noncancer pain.

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In general, the department or self-insured employer pays for most drugs in an inpatient hospital setting. Please see WAC 296-20-075, Hospitalization.

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Chronic, noncancer pain may develop after an acute injury episode. It is defined as pain that persists beyond two to four months following the injury.

The department or self-insurer may pay for oral opioids for the treatment of chronic, noncancer pain caused by an accepted condition when that treatment is proper and necessary. See WAC 296-20-01002 for the definition of "proper and necessary" health care services.

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Prior authorization is required for treatment of chronic, noncancer pain with opioids.

The attending physician must submit a written request and obtain approval from the department or self-insurer prior to prescribing opioids for chronic, noncancer pain. The written request must include the following factors:

• A treatment plan with time-limited goals;

• A consideration of prior medical and L&I records;

• A summary of conservative care rendered to the worker that focused on reactivation and return to work;

• A statement on why prior or alternative conservative measures may have failed or are not appropriate as sole treatment;

• A summary of any consultations that have been obtained, particularly those that have addressed factors that may be barriers to recovery;

• A statement that the attending physician has conducted appropriate screening for elements of addiction; and

• An opioid treatment agreement that has been signed by the worker and the attending physician. This agreement must be renewed every six months. The treatment agreement must outline the risks and benefits of opioid use, the conditions under which opioids will be prescribed, the physician's need to document overall improvement in pain and function, and the worker's responsibilities.

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In addition to the general documentation required by the department or self-insurer, the attending physician must submit the following information when treating with opioids:

• Documentation of screenings, consultations, and all other treatment trials;

• Documentation of outcomes and responses, including pain intensity and functional levels; and

• Any modifications to the treatment plan.

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The department of self-insurer will continue to pay for treatment with opioids so long as the physician documents:

• Substantial reduction of the patient's pain intensity; and

• Substantial improvement in the patient's function.

The physician must use a form developed by the department, or a substantially equivalent form, to document the patient's improvement in these two areas.

Once the worker's condition has reached maximum medical improvement, further treatment with opioids is not payable. Opioid treatment past three months of an opioid trial without documentation of substantial improvement is presumed to be not proper and necessary.

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Payment for opioid medications may be denied in any of the following circumstances:

• Absent or inadequate documentation;

• Noncompliance with the treatment plan;

• Pain and functional status have not substantially improved after three months of opioid treatment; or

• Evidence of misuse or abuse of the opioid medication or other drugs, or noncompliance with the attending physician's request for a drug screen.

Other corrective actions may be taken in accordance with WAC 296-20-015, Who may treat.

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The department or self-insurer may pay for nonopioid medication for the treatment of chronic, noncancer pain when it is proper and necessary.

For example, some drugs such as anti-convulsants, anti-depressants, and others have been demonstrated to be useful in the treatment of chronic pain and may be approved when proper and necessary.

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     The following section of the Washington Administrative Code is repealed:

WAC 296-20-03003

Drugs and medication.

© Washington State Code Reviser's Office