WSR 09-14-106

PROPOSED RULES

DEPARTMENT OF

LABOR AND INDUSTRIES

[ Filed June 30, 2009, 12:46 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 09-10-081.

Title of Rule and Other Identifying Information: Comprehensive treatment for chronic noncancer pain, structured intensive multidisciplinary program (SIMP), lumbar fusions, and intervertebral artificial disc replacements.

The subject of this rule making is the implementation of two health technology clinical committee (HTCC) coverage determinations. This rule would establish a definition and criteria for a SIMP for the comprehensive treatment of chronic noncancer pain and establish who is eligible for certain lumbar fusions or implantation of an intervertebral artificial disc. In addition, this rule making will clarify that the lumbar Charite artificial disc is a covered device by deleting current language in WAC 296-20-03002 that lists it as a noncovered device.

Hearing Location(s): Department of Labor and Industries, Room S119, 7273 Linderson Way S.W., Tumwater, WA 98501, on August 14, 2009, at 10:00 a.m.

Date of Intended Adoption: September 14, 2009.

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 August 14, 2009.

Assistance for Persons with Disabilities: Contact office of information and assistance, by August 1, 2009, TTY (360) 902-5797 or (360) 902-4941.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this rule is to implement the lumbar fusion and artificial disc determinations made by the statutory HTCC. According to RCW 70.14.120, the department must comply with HTCC coverage decisions. The rule will implement the HTCC coverage determinations by defining a structured intensive multidisciplinary program (SIMP) and what it means to successfully complete such a program.

In addition, this rule making will clarify that the lumbar Charite artificial disc is a covered device by deleting current language in WAC 296-20-03002 that lists it as a noncovered device.

Reasons Supporting Proposal: See Purpose above.

Statutory Authority for Adoption: RCW 70.14.120, 51.04.020, 51.04.030.

Statute Being Implemented: RCW 70.14.120.

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: The rule supports a redesigned department policy and fee schedule for purchasing comprehensive treatment for the management of chronic noncancer pain. The policy and fee schedule were developed in collaboration with all the current commission on accreditation of rehabilitation facilities (CARF) accredited providers of comprehensive treatment for chronic noncancer pain in Washington state.

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

Name of Agency Personnel Responsible for Drafting: Jami Lifka, 7273 Linderson Way S.W., 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. There is no disproportionate cost to small business.

A cost-benefit analysis is not required under RCW 34.05.328. There is no more than minimal cost to business.

June 30, 2009

Judy Schurke

Director

OTS-2443.2


AMENDATORY SECTION(Amending WSR 06-15-110, filed 7/18/06, effective 8/18/06)

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).

(((5))) (4) 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.

(((6))) (5) 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.

(((7))) (6) 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, 51.04.030. 06-15-110, 296-20-03002, filed 7/18/06, effective 8/18/06. 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.]

OTS-2444.2


NEW SECTION
WAC 296-20-12055   Structured intensive multidisciplinary program (SIMP) for chronic noncancer pain.   (1) Injured workers eligible for benefits under Title 51 RCW may be evaluated for and enrolled in a comprehensive treatment program for chronic noncancer pain if it meets the definition of a structured, intensive, multidisciplinary program (SIMP). The goals for this program are to help workers recover their function, reduce or eliminate disability, and improve the quality of their lives by helping them cope effectively with chronic noncancer pain.

(2) Prior authorization is required for all workers to participate in a SIMP for functional recovery from chronic pain.

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NEW SECTION
WAC 296-20-12060   SIMP requirements for lumbar fusion and artificial disc replacement candidates.   Special conditions and requirements apply to workers who are considering having a lumbar fusion or lumbar intervertebral artificial disc replacement due to uncomplicated degenerative disc disease (referred to as lumbar surgery candidates as defined in WAC 296-20-12065). Lumbar surgery candidates must successfully complete a SIMP to obtain authorization for a lumbar fusion or a lumbar intervertebral artificial disc replacement. Refer to WAC 296-20-12095 for referral and prior authorization information.

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NEW SECTION
WAC 296-20-12065   SIMP definitions.   The definitions in this section refer to terms used in WAC 296-20-12055 through 296-20-12095.


(1) SIMP means a chronic pain management program with the following four components:

Structured means care is delivered through regular scheduled modules of assessment, education, treatment, and follow up evaluation where workers interact directly with licensed health care practitioners. Workers follow a treatment plan designed specifically to meet their needs.

Intensive means the treatment phase is delivered on a daily basis, six to eight hours per day, five days per week, for up to four consecutive weeks. Slight variations can be allowed if necessary to meet the worker's needs.

Multidisciplinary (interdisciplinary) means that structured care is delivered and directed by licensed health care professionals with expertise in pain management in at least the areas of medicine, psychology, and physical therapy or occupational therapy. The SIMP may add vocational, nursing, and additional health services depending on the workers' needs and covered benefits.

Program means an interdisciplinary pain rehabilitation program that provides outcome-focused, coordinated, goal-oriented team services. Care coordination is included within and across each service area. The program benefits workers who have impairments associated with pain that impact their participation in daily activities and their ability to work. This program measures and improves the functioning of persons with pain and encourages their appropriate use of healthcare systems and services.

(2) Uncomplicated degenerative disc disease (UDDD) means chronic low back pain of discogenic origin without objective clinical evidence of any of the following conditions:

Radiculopathy;

Functional neurologic deficits;

Spondylolisthesis (> grade 1);

Isthmic spondylolysis;

Primary neurogenic claudication associated with stenosis;

Fracture, tumor, infection, inflammatory disease; or

Degenerative disease associated with significant deformity.

(3) Lumbar surgery candidate means an injured worker who is considering having a lumbar fusion or lumbar intervertebral artificial disc replacement due to uncomplicated degenerative disc disease.

(4) Important associated conditions means medical or psychological conditions (often referred to as comorbid conditions) that hinder functional recovery from chronic pain.

(5) Treatment plan means an individualized plan of action and care developed by licensed health care professionals that addresses the worker's identified needs and goals. It describes the intensity, duration, frequency, setting, and timeline for treatment and addresses the elements described in the treatment phase. It is established during the evaluation phase and may be revised during the treatment phase.

(6) Valid tests and instruments mean those that have been shown to be scientifically accurate and reliable for tracking functional progress over time.

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NEW SECTION
WAC 296-20-12070   SIMP evaluation phase.   See WAC 296-20-12095 SIMP referral and prior authorization requirements, for information about how and when each phase may be prior authorized by the claim manager.

Evaluation phase:

The Evaluation phase occurs before the treatment phase and includes treatment plan development and a report. Only one evaluation is allowed per authorization but it can be conducted over one to two days. The evaluation phase includes all of the following components:

(1) A history and physical exam along with a medical evaluation by a physician;

(2) Review of medical records and reports, including diagnostic tests and previous efforts at pain management;

(3) Assessment of any important associated conditions that may hinder recovery (e.g., opioid dependence and other substance use disorders, smoking, significant mental health disorders, and unmanaged chronic disease). If such conditions exist, see WAC 296-20-12095 SIMP referral and prior authorization requirements;

(4) Assessment of past and current use of all pain management medications, including over the counter, prescription, scheduled, and illicit drugs;

(5) Psychological and social assessment by a licensed clinical psychologist using valid tests and instruments;

(6) Identification of the worker's family and support resources;

(7) Identification of the worker's reasons and motivation for participation and improvement;

(8) Identification of factors that may affect participation in the program;

(9) Assessment of pain and function using valid tests and instruments; it should include the current levels, future goals, and the estimated treatment time to achieve them for each of the following areas:

Activities of daily living (ADLs);

Range of motion (ROM);

Strength;

Stamina;

Capacity for and interest in returning to work.

(10) If the claim manager has assigned a vocational counselor, the SIMP provider must coordinate with the vocational counselor to assess the likelihood of the worker's ability to return to work and in what capacity;

(11) A summary report of the evaluation and a preliminary recommended treatment plan. If there are any barriers preventing the worker from moving on to the treatment phase, the report should explain the circumstances;

(12) For lumbar surgery candidates, the report should address their expectation and interest in having surgery.

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NEW SECTION
WAC 296-20-12075   SIMP treatment phase.   Treatment phase services may be provided for up to twenty consecutive days (excluding weekends and holidays) depending on individual needs and progress toward treatment goals. Each treatment day lasts six to eight hours. Services are coordinated and provided by an interdisciplinary team of physicians, psychologists, physical or occupational therapists, and may include nurses, vocational counselors, and care coordinators. Treatment must include all the following elements:

(1) Graded exercise: Progressive physical activities guided by a physical or occupational therapist that promote flexibility, strength, and endurance to improve function and independence;

(2) Cognitive behavioral therapy: Individual or group cognitive behavioral therapy with the psychologist, psychiatrist or psychiatric advanced registered nurse practitioner;

(3) Coordination of health services: Coordination and communication with the attending provider, claim manager, family, employer, and community resources as needed to accomplish the goals set forth in the treatment plan;

For lumbar surgery candidates, communication and consultation with the spine surgeon is recommended;

(4) Education and skill development on the factors that contribute to pain, responses to pain, and effective pain management;

For lumbar surgery candidates, this includes provision and review of a patient education aid, provided by the insurer, describing the risks associated with lumbar fusion;

(5) Tracking of pain and function: Individual medical assessment of pain and function levels using valid tests and instruments;

(6) Ongoing assessment of important associated conditions, medication tapering, and clinical assessment of progress toward goals; opioid and mental health issues can be treated concomitantly with pain management treatment;

(7) Performance of real or simulated work or daily functional tasks;

(8) SIMP vocational services may include instruction regarding workers' compensation requirements. Vocational services with return to work goals are needed in accordance with the return to work action plan when a vocational referral has been made;

(9) A home care plan for the worker to continue exercises, cognitive and behavioral techniques and other skills learned during the treatment phase;

(10) A report at the conclusion of the treatment phase that addresses all the following questions:

To what extent did the worker meet his or her treatment goals?

What changes, if any, have occurred in the worker's medical and psycho-social conditions, including dependence on opioids and other medications?

What changes, if any, have occurred in the worker's pain level and functional capacity as measured by valid tests and instruments?

What changes, if any, have occurred in the worker's ability to manage pain?

What is the status of the worker's readiness to return to work or daily activities?

How much and what kind of follow up care does the worker need?

For lumbar surgery candidates, what is the worker's current expectation and interest in having surgery?

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NEW SECTION
WAC 296-20-12080   SIMP follow up phase.   (1) So long as the claim remains open, a follow up phase may occur within six months after the treatment phase has concluded. This phase is not a substitute for and cannot serve as an extended treatment phase. The goals of the follow up phase are to:

(a) Improve and reinforce the pain management gains made during the treatment phase;

(b) Help the worker integrate the knowledge and skills gained during the treatment phase into his or her job, daily activities, and family and community life;

(c) Evaluate the degree of improvement in the worker's condition at regular intervals and produce a written report describing the evaluation results.

(2) Site of the follow up phase. The activities of the follow up phase may occur at the original multidisciplinary clinic (clinic-based) or at the worker's home, workplace, or healthcare provider office (community-based). This approach permits maximum flexibility for workers whose needs may range from intensive, focused follow up care at the clinic to more independent episodes of care closer to home. It also enables workers to establish relationships with providers in their communities so they have increased access to healthcare resources.

(3) Face-to-face vs. nonface-to-face services: Follow up services are payable as "face-to-face" and "nonface-to-face" services. Face-to-face services are when the provider interacts directly with the worker, the worker's family, employer, or other healthcare providers. Nonface-to-face services are when the SIMP provider uses the telephone or other electronic media to communicate with the worker, worker's family, employer, or other healthcare providers for the purpose of coordinating care in the worker's home community. Both are subject to the following limits:

(a) Face-to-face services: Up to twenty-four hours are allowed with a maximum of four hours per day.

(b) Nonface-to-face services: Up to forty hours are allowed.

(4) Reporting requirements.

(a) If a worker has been receiving follow up services, a summary report must be submitted to the insurer that provides the following information:

The worker's status, including whether the worker returned to work, how pain is being managed, medication use, whether the worker is getting services in his or her community, activity levels, and support systems;

What was done during the follow up phase;

What resulted from the follow up care; and

Measures of pain and function using valid tests and instruments.

(b) This summary report must be submitted at the following intervals:

For nonlumbar surgery candidates: At one and three months.

For lumbar surgery candidates (regardless of whether they had lumbar surgery after successfully completing SIMP treatment): At one, three, and six months.

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NEW SECTION
WAC 296-20-12085   Requirements the SIMP provider must meet.   Refer to department policy on comprehensive treatment for chronic noncancer pain for requirements the SIMP provider must meet.

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NEW SECTION
WAC 296-20-12090   Requirements the worker must meet for a SIMP.   An injured worker must make a good faith effort to participate and comply with the treatment plan prescribed for him or her by the SIMP provider. To successfully complete a SIMP, the worker must meet all the requirements in this section. The worker must:

(1) Be medically and physically stable enough to safely tolerate and participate in all physical activities and treatments that are part of his or her treatment plan;

(2) Be psychologically stable enough to understand and follow instructions and to put forth an effort to work toward the goals that are part of his or her treatment plan;

(3) Agree to be evaluated and comply with treatment prescribed for any important associated conditions that hinder progress or recovery (e.g., opioid dependence and other substance use disorders, smoking, and significant mental health disorders);

(4) Attend each day and each session that is part of his or her treatment plan. Sessions may be made up if, in the opinion of the provider, they do not interfere with the worker's progress toward treatment plan goals;

(5) Cooperate and comply with his or her treatment plan;

(6) Not pose a threat or risk to himself or herself, to staff, or to others;

(7) Review and sign a participation agreement with the provider;

(8) Participate with coordination efforts at the end of the treatment phase to help him or her transition back to his or her home, community, and workplace.

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NEW SECTION
WAC 296-20-12095   SIMP referral and prior authorization requirements.   (1) All SIMP services require:

Prior authorization by the claim manager; and

A referral from the worker's attending provider.

An occupational nurse consultant, claim manager, or insurer assigned vocational counselor may recommend a SIMP for the worker, but this cannot substitute for a referral from the attending provider.

(2) When the attending provider refers a worker to a chronic pain management program, the claim manager may authorize an evaluation if the worker has had unresolved chronic pain for longer than three months despite conservative care and has one or more of the following conditions:

(a) Is unable to return to work due to the chronic pain;

(b) Has returned to work but needs help with chronic pain management;

(c) Has significant pain medication dependence, tolerance, abuse, or addiction;

(d) Is a lumbar surgery candidate. It is recommended that lumbar surgery candidates be evaluated by a SIMP provider prior to requesting surgery.

(3) Prior authorization for the evaluation phase occurs first and includes only one evaluation. Once authorized, the SIMP provider verifies the worker meets the requirements set forth in WAC 296-20-12090 and can fully participate in the program. If the worker:

(a) Meets the requirements and the SIMP provider recommends they move on to the treatment phase, the SIMP provider must provide the insurer with a report and treatment plan as described under the evaluation phase.

(b) Does not meet the requirements, the SIMP provider must provide the insurer with a report explaining what requirements are not met and the goals the worker must meet before he or she can return and participate in the program. If the worker is found to have important associated conditions during the evaluation phase that prevent him or her from participating in the treatment phase, the SIMP provider must either treat the worker or recommend to the worker's attending provider and the claim manager what type of treatment the worker needs.

(4) The treatment phase must be prior authorized separately from the evaluation phase. Treatment phase authorization includes authorization for the follow up phase.

(5) SIMP services are authorized on an individual basis. If there are extenuating circumstances that warrant additional treatment or a restart of the program, providers must submit this request along with supporting documentation to the claim manager.

(6) If a lumbar surgery candidate previously participated in a SIMP as a lumbar surgery candidate but did not successfully complete treatment, one additional SIMP may be authorized only if:

(a) The worker obtains an additional surgical recommendation noting clinical changes one year or more after the date first referred to a SIMP; or

(b) The reason the worker did not participate fully or successfully complete a SIMP the first time was because of associated conditions that are now fully resolved.

(7) If a lumbar surgery candidate successfully completed a SIMP and did not have surgery, and in the future becomes a lumbar surgery candidate again, another SIMP may be authorized but is not required.

(8) If a worker's treatment is interrupted due to significant family or life circumstances such as a death in the family, the claim manager may authorize resuming or restarting the SIMP if recommended by the SIMP provider.

(9) If a SIMP provider plans to travel to the worker's community to deliver face-to-face services, mileage may be reimbursed, but only if it is authorized prior to travel. Lodging, meals, or any per diem expenses are not reimbursable. Actual travel time is not included in the twenty-four-hour limit as stated in WAC 296-20-12080. When requesting prior authorization for mileage, the SIMP provider must explain the reason for the visit and how it will benefit the worker.

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Washington State Code Reviser's Office