Original Notice.

     Preproposal statement of inquiry was filed as WSR 13-02-093.

     Title of Rule and Other Identifying Information: Drug rule, the department is proposing to create, amend and delete rules related to the use and payment for drugs prescribed for injured and ill workers.

     Hearing Location(s): The Department of Labor and Industries (L&I), Tukwila Service Location, 12806 Gateway Drive South, Tukwila, WA 98168, on April 23, 2013, at 1:00 p.m.

     Date of Intended Adoption: May 28, 2013.

     Submit Written Comments to: Jami Lifka, P.O. Box 44321, Olympia, WA 98501, or e-mail JamiLifka@Lni.wa.gov or fax (360) 902-6315, written comments must be received no later than 5 p.m., April 23, 2013.

     Assistance for Persons with Disabilities: Contact TTY at 711, (360) 902-4941.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this rule making is to ensure safe, appropriate and effective drug therapy designed to improve clinical outcomes and support successful return to work.

     The proposed rule language updates the coverage of and payment for prescription drugs and describes specific authorization requirements for the payment of opioids. Authorization requirements are based on best practices for prescribing opioids and will lead to safe and effective treatment for injured and ill workers.

     Reasons Supporting Proposal: Washington is among those states with the highest rate of prescription opioid related deaths in the United States. This now exceeds both motor vehicle accidents and firearms as the leading cause of injury related deaths.

     Statutory Authority for Adoption: RCW 51.04.020 and 51.04.030.

     Statute Being Implemented: RCW 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: Other professional groups and federal and state regulatory agencies have adopted guidelines and rules related to this topic.

     This rule-making process was initiated, in part, by ESHB 2876 (chapter 209, Laws of 2010) that directed the department of health to adopt new rules on chronic, noncancer pain management. L&I, in collaboration with its industrial insurance medical advisory committee, has adopted a guideline for prescribing opioids to treat pain in injured workers. The guideline supports the best practices embodied in the DOH pain management rules, the Washington State Agency Medical Directors' Group guidelines, and other federal agencies' recommendations such as the Food and Drug Administration and the Centers for Disease Control and Prevention.

     Name of Proponent: L&I, governmental.

     Name of Agency Personnel Responsible for Drafting and Implementation: Jaymie Mai, PharmD, Pharmacy Manager, Office of the Medical Director, (360) 902-6792; and Enforcement: Vickie Kennedy, Interim Assistant Director, Insurance Services, (360) 902-4997.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed language does not disproportionately impact small businesses. There is no more than a minor cost to businesses in general.

     A cost-benefit analysis is not required under RCW 34.05.328. The proposed rule language does not impose more than a minor cost on businesses.

March 19, 2013

Joel Sacks

Director

OTS-5319.4

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

WAC 296-20-03010   What are the general principles the department uses to determine ((coverage on)) drug((s and medications)) coverage?   ((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.)) In general, the department evaluates data on safety, health outcomes and cost-effectiveness for coverage. The department or self-insurer considers payment for drugs, including biologics and controlled substances, when:

     • The drug is used to treat the industrial injury or occupational disease accepted under the claim; and

     • The drug is prescribed consistent with the department's rules, guidelines and coverage decisions, and either:

     – The drug is approved by the Food and Drug Administration for that condition and prescribed in accordance with labeling, or is licensed by a regulatory entity similar to the Food and Drug Administration for workers who reside outside the United States; or

     – If the drug is prescribed off-label, the use is supported by published scientific evidence of safety and effectiveness from high quality randomized trials (see WAC 296-20-02704). Off-label is defined as use of a drug for an indication which has not received Food and Drug Administration approval or is otherwise not consistent with the drug labeling.

[Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-040, § 296-20-03010, filed 12/7/99, effective 1/20/00.]

     (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)) provider specifically indicates that substitution is not permitted. For example: The ((patient)) worker cannot tolerate substitution. Pharmacists are instructed to fill with generic drugs unless the ((attending physician)) provider specifically indicates substitution is not permitted.

     (4) Evidence-based prescription drug program. In accordance with RCW 70.14.050, the department in cooperation with other state agencies may develop a preferred drug list. Any pharmacist filling a prescription under state purchased health care programs as defined in RCW 41.05.011(2) shall substitute, where identified, a preferred drug for any nonpreferred drug in a given therapeutic class, unless the endorsing practitioner has indicated on the prescription that the nonpreferred drug must be dispensed as written, or the prescription is for a refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug (see RCW 69.41.190), or for the refill of an immunomodulator/antiviral treatment for hepatitis C for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks but no more than forty-eight weeks or the nonendorsing practitioner has received prior authorization from the department to fill the prescription as written, in which case the pharmacist shall dispense the prescribed nonpreferred drug.

     (5) 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. This would apply to any prescription for such conditions even when the endorsing practitioner indicates "dispense as written."

     (6) Pension cases. ((Once)) When the worker is placed on a pension, the department or self-insurer may pay, at the sole discretion of the supervisor of industrial insurance, for only those drugs ((and medications)) authorized for continued medical treatment ((for)) of previously accepted 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)):

     (a) Coverage must be authorized before the treatment is rendered. ((In such pension cases, the department or self-insurer cannot pay for scheduled drugs))

     (b) Controlled substances used to treat continuing pain resulting from an industrial injury or occupational disease are not payable.

     (c) In these cases, up to a ninety-day supply of the drug is payable when:

     (i) Coverage has been authorized; and

     (ii) The drug is not a controlled substance; and

     (iii) The drug is obtained through a designated provider.

[Statutory Authority: RCW 51.04.020, 51.04.030. 07-17-167, § 296-20-03011, filed 8/22/07, effective 9/22/07. Statutory Authority: RCW 51.04.020, 70.14.050. 04-08-040, § 296-20-03011, filed 3/30/04, effective 5/1/04. Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-040, § 296-20-03011, filed 12/7/99, effective 1/20/00.]

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

     • Allowed

     Drugs used routinely for treating accepted industrial injuries and occupational ((illnesses)) diseases, including those on the preferred drug list.

     Example: ((Nonscheduled drugs and other medications)) Preferred nonsteroidal anti-inflammatory drugs 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.

     ((For)) Example: All drugs to treat hypertension require prior authorization because hypertension is not normally an accepted industrial condition. In addition, nonendorsing practitioners must obtain prior authorization for a nonpreferred drug when the category of drugs has a preferred drug.

     • Denied

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

     Example: Most hormones, most nutritional supplements.

[Statutory Authority: RCW 51.04.020, 70.14.050. 04-08-040, § 296-20-03012, filed 3/30/04, effective 5/1/04. Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-040, § 296-20-03012, filed 12/7/99, effective 1/20/00.]

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

     • Notify the provider when opioid prescribing is not in compliance with the department of health's pain management rules, L&I's rules, the agency medical directors' group's interagency guideline on opioid dosing for chronic noncancer pain or L&I's guideline for prescribing opioids to treat pain in injured workers;

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

     • Request a consultation from an appropriate specialist;

     • Request that the ((attending physician)) provider consider reducing the ((prescription,)) dose or discontinuing the drug and provide information on chemical dependency programs, if indicated;

     • Limit the payment for drugs ((on a claim)) to one prescribing ((doctor)) provider.

     (2) If the ((attending physician)) provider 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)) the provider.

     (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.))) If the probability of imminent harm to the worker is high, as determined by the department's medical director, associate medical director or medical consultants, the department or self-insurer may require that the worker transfer care to another network provider.

     (4) Other corrective actions may be taken in accordance with WAC ((296-20-015, Who may treat)) 296-20-01100, Risk of harm.

[Statutory Authority: RCW 51.04.020 and 51.04.030. 00-01-040, § 296-20-03015, filed 12/7/99, effective 1/20/00.]

     (2) Catastrophic injury - A severe injury from which recovery of physical function is not expected, such as a spinal cord injury.

     (3) Clinically meaningful improvement in function - Improvement in function of at least thirty percent as compared to baseline or in response to a dose change. Function can be measured using the two item graded chronic pain scale or other validated tools such as those referenced in the most current agency medical directors' group's interagency guideline on opioid dosing for chronic noncancer pain.

     (4) Clinically meaningful improvement in pain - Improvement in pain intensity of at least thirty percent as compared to baseline or in response to a dose change. Pain can be measured using the two item graded chronic pain scale or other validated tools such as those referenced in the most current agency medical directors' group's interagency guideline on opioid dosing for chronic noncancer pain.

     (5) Chronic noncancer pain - Continuous or intermittent pain arising from a noncancerous condition, injury or surgery and lasting longer than three months.

     (6) Morphine equivalent dose - Conversion of various opioids to an equivalent morphine dose by using the most current recognized conversion tables, such as the agency medical directors' group's dose calculator.

     (7) Step 1 taper - Discontinuing opioids via a gradual dose reduction of approximately ten percent of the original dose per week in a community care setting.

     (8) Step 2 taper - Detoxification through a licensed chemical dependency center and/or discontinuing opioids through a structured intensive multidisciplinary program (see WAC 296-20-12055 through 296-20-12095).

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     Any provider performing a preoperative evaluation for elective surgery in workers on chronic opioid therapy should also check the prescription monitoring program data base and document as part of a treatment plan for post-surgical pain management.

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     • Verify that the worker had clinically meaningful improvement in function and pain with the use of opioids in the acute phase.

     • If indicated, use a validated instrument to screen the worker for comorbid psychiatric conditions (e.g., depression, anxiety, or post traumatic stress disorder) which may impact the response to opioid treatment.

     • Verify that the worker has no contraindication to the use of opioids.

     • Access the state's prescription monitoring program data base, if available, to ensure that the controlled substance history is consistent with the prescribing record and the worker's report.

     • Use a validated screening instrument to verify the absence of a current substance use disorder (excluding nicotine) or a history of opioid use disorder.

     • Administer a baseline urine drug test to verify the absence of cocaine, amphetamines, alcohol, and nonprescribed opioids.

     • Verify that the worker has no evidence of or is not at high risk for serious adverse outcomes from opioid use.

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     • Clinically meaningful improvement in function has been established with opioid use in the acute or subacute phase. If the opioid dose is increased, clinically meaningful improvement in function must be demonstrated in response to the dose change. Effective chronic opioid therapy should result in improved work capacity and/or the ability to progress in vocational retraining; and

     • Reasonable alternatives to opioids have been tried and have failed; and

     • The worker and the provider have signed a pain treatment agreement; and

     • A consultation with a pain management specialist must take place before the worker's dose is increased above 120mg/d morphine equivalent or consistent with exceptions in the department of health's pain management rules. Additional appropriate consultations are recommended if the worker has a comorbid substance use or poorly controlled mental health disorder; and

     • The worker has no contraindication to the use of opioids including, but not limited to, current substance use disorders (excluding nicotine) or history of opioid use disorder; and

     • The worker has no evidence of or is not at high risk for having serious adverse outcomes from opioid use; and

     • The worker has no pattern of recurrent (more than one) aberrant behavior identified by the prescription monitoring program data base or urine drug testing; and

     • A time-limited treatment plan that demonstrates how chronic opioid therapy is likely to improve the worker's work capacity and/or the ability to progress in vocational retraining (e.g., work hardening, vocational services).

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     • Clinically meaningful improvement in function or pain interference with function score of ≤ 4 is maintained with stable dosing. See WAC 296-20-03030 for the definition of clinically meaningful improvement in function. If opioid dose is increased, clinically meaningful improvement in function must be demonstrated in response to the dose change; and

     • A current signed pain treatment agreement; and

     • The worker has no contraindication to the use of opioids including, but not limited to, current substance use disorders (excluding nicotine) or a history of opioid use disorder; and

     • The worker has no evidence of or is not at high risk for serious adverse outcomes from opioid use; and

     • A consultation with a pain management specialist must take place before the worker's dose is increased above 120mg/d morphine equivalent dose or consistent with exceptions in the department of health pain management rules. Additional appropriate consultations are recommended if the worker has a comorbid substance use or poorly controlled mental health disorder; and

     • The worker has no pattern of recurrent (more than one) aberrant behavior identified by the prescription monitoring program data base or urine drug testing.

     Workers receiving chronic opioid therapy should be managed by a single prescribing provider. If the prescribing provider is unavailable, then refills should be addressed by the covering provider and allowed on a limited basis only. See WAC 296-20-03060, Episodic care for pain, regarding unscheduled refills from emergency departments or urgent care facilities.

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     • A current signed pain treatment agreement; and

     • A consultation with a pain management specialist must take place before the worker's dose is increased above 120mg/d morphine equivalent dose or consistent with exceptions in the department of health pain management rules; and

     • The worker has no contraindication to the use of opioids including, but not limited to, current substance use disorders (excluding nicotine) or a history of opioid use disorder; and

     • The dose is stable with no evidence of or is not at high risk for serious adverse outcomes from opioid use; and

     • The worker has no pattern of recurrent (more than one) aberrant behavior identified by the prescription monitoring program data base or urine drug testing.

     Catastrophic injuries are exempt from the requirement of clinically meaningful improvement in function with opioid use.

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     Workers receiving opioid therapy should be managed by a single prescribing provider.

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     • The worker or attending provider requests opioid wean; or

     • The worker is maintained on opioids for at least three months and there is no sustained clinically meaningful improvement in function, as measured by validated instruments; or

     • The worker's risk from continued treatment outweighs the benefit; or

     • The worker has experienced an opioid overdose event related to aberrant behavior or substance use disorder (except nicotine) or a prescribing pattern that is not in compliance with the department of health's pain management rules, L&I's rules, the agency medical directors' group's guideline or L&I's guideline for prescribing opioids to treat pain in injured workers or the worker has experienced any other severe adverse outcome; or

     • There is a pattern of recurrent (more than one) aberrant behaviors (inconsistent urine drug test result, lost prescriptions, multiple requests for early refills, multiple prescribers, unauthorized dose escalation, apparent intoxication, etc.); or

     • Use of opioids is not in compliance with the department of health's pain management rules, L&I's rules, the agency medical directors' group's guideline or L&I's guideline for prescribing opioids to treat pain in injured workers.

     Under these circumstances, the department or self-insurer may pay for an opioid wean or detoxification to facilitate discontinuation of opioids (see WAC 296-20-03080, Weaning or detoxification). However, continued chronic opioid therapy is not payable.

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     • The worker has failed steps 1 and 2 taper (see WAC 296-20-03030 for the definition of step 1 and 2 taper); and

     • The worker is diagnosed with opioid use disorder and this condition is identified as a barrier to recovery; and

     • The provider has documented how time-limited treatment of this condition will allow significantly improved work capacity and/or the ability to progress in vocational retraining; and

     • The provider has submitted a time-limited treatment plan.

     Payment for addiction treatment is limited to six months per worker.

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Report	Due/Needed by Insurer	What Information Should Be Included In the Report?	Special Notes
Report of Industrial Injury or Occupational Disease (form)	Immediately - Within five days of first visit.	See form	Only MD, DO, DC, ND, DPM, DDS, ARNP, PA, and OD may sign and be paid for completion of this form.
Self-Insurance: Provider's Initial Report (form)		If additional space is needed, please attach the information to the application. The claim number should be at the top of the page.
Sixty Day (narrative)	Every sixty days when only conservative (nonsurgical) care has been provided.	(1) The conditions diagnosed, including ICD-9-CM codes and the subjective complaints and objective findings.	Providers may submit legible comprehensive chart notes in lieu of sixty day reports PROVIDED the chart notes include all the information required as noted in the "What Information Should Be Included?" column.
Purpose: Support and document the need for continued care when conservative (nonsurgical) treatment is to continue beyond sixty days
		(2) The relationship of diagnoses, if any, to the industrial injury or exposure.	However, office notes are not acceptable in lieu of requested narrative reports and providers may not bill for the report if chart notes are submitted in place of the report.
		(3) Outline of proposed treatment program, its length, components and expected prognosis including an estimate of when treatment should be concluded and condition(s) stable. An estimated return to work date and the probability, if any, of permanent partial disability resulting from the industrial condition.	((Please see WAC 296-20-03021 and 296-20-03022 for documentation requirements for those workers receiving opioids to treat chronic noncancer pain.))
		(4) Current medications, including dosage and amount prescribed. With repeated prescriptions, include the plan and need for continuing medication.	Providers must include their name, address and date on all chart notes submitted.
		(5) If the worker has not returned to work, indicate whether a vocational assessment will be necessary to evaluate the worker's ability to return to work and why.
		(6) If the worker has not returned to work, a doctor's estimate of physical capacities should be included.
		(7) Response to any specific questions asked by the insurer or vocational counselor.
Opioid Authorization Requirement	Opioids in subacute phase - Six weeks from the date of injury or surgery.	Please see WAC 296-20-03056 through 296-20-03059 for documentation requirements for those workers receiving opioids.
	Opioids in chronic phase - Twelve weeks from the date of injury or surgery.
	Opioids for ongoing chronic therapy - Every ninety days.
Special Reports/Follow-up Reports (narrative)	As soon as possible following request by the department/insurer.	Response to any specific questions asked by the insurer or vocational counselor.	"Special reports" are payable only when requested by the insurer.
Consultation Examination Reports (narrative)	At one hundred twenty days if only conservative (nonsurgical) care has been provided.	(1) Detailed history.	If the injured/ill worker had been seen by the consulting doctor within the past three years for the same condition, the consultation will be considered a follow-up office visit, not consultation.
Purpose: Obtain an objective evaluation of the need for ongoing conservative medical management of the worker.		(2) Comparative history between the history provided by the attending or treating provider and injured worker.
		(3) Detailed physical examination.
The attending or treating provider may choose the consultant.		(4) Condition(s) diagnosed including ICD-9-CM codes, subjective complaints and objective findings.	A copy of the consultation report must be submitted to both the attending or treating provider and the department/insurer.
		(5) Outline of proposed treatment program: Its length, components, expected prognosis including when treatment should be concluded and condition(s) stable.
		(6) Expected degree of recovery from the industrial condition.
		(7) Probability of returning to regular work or modified work and an estimated return to work date.
		(8) Probability, if any, of permanent partial disability resulting from the industrial condition.
		(9) A doctor's estimate of physical capacities should be included if the worker has not returned to work.
		(10) Reports of necessary, reasonable X ray and laboratory studies to establish or confirm diagnosis when indicated.
Attending Provider Review of IME Report (form)	As soon as possible following request by the department/insurer.	Agreement or disagreement with IME findings. If you disagree, provide objective/subjective findings to support your opinion.	Payable only to the attending provider upon request of the department/insurer. PAs can concur with treatment recommendations but not PPD ratings.
Purpose: Obtain the attending provider's opinion about the accuracy of the diagnoses and information provided based on the IME.
Loss of Earning Power (form)	As soon as possible after receipt of the form.	See form	Payable only to the attending or treating provider.
Purpose: Certify the loss of earning power is due to the industrial injury/occupational disease.
Application to Reopen Claim Due to Worsening of Condition (form)	Immediately following identification of worsening after a claim has been closed for sixty days.	See form	Only MD, DO, DC, ND, DPM, DDS, ARNP, PA, and OD may sign and be paid for completion of this form.
Purpose: Document worsening of the accepted condition and need to reopen claim for additional treatment.	Crime Victims: Following identification of worsening after a claim has been closed for ninety days.

     What documentation is required for initial and follow up visits?

     Legible copies of office or progress notes are required for the initial and all follow-up visits.

     What documentation are ancillary providers required to submit to the insurer?

     Ancillary providers are required to submit the following documentation to the department or self-insurer:

Provider	Chart Notes	Reports
Audiology	X	X
Biofeedback	X	X
Dietician		X
Drug Alcohol Treatment	X	X
Free Standing Surgery	X	X
Free Standing Emergency Room	X	X
Head Injury Program	X	X
Home Health Care		X
Infusion Treatment, Professional Services		X
Hospitals	X	X
Laboratories		X
Licensed Massage Therapy	X	X
Medical Transportation		X
Nurse Case Managers		X
Nursing Home	X	X
Occupational Therapist	X	X
Optometrist	X	X
Pain Clinics	X	X
Panel Examinations		X
Physical Therapist	X	X
Prosthetist/Orthotist	X	X
Radiology		X
Skilled Nursing Facility	X	X
Speech Therapist	X	X

[Statutory Authority: 2007 c 263, RCW 51.04.020 and 51.04.030. 08-04-095, § 296-20-06101, filed 2/5/08, effective 2/22/08. Statutory Authority: 2004 c 65 and 2004 c 163. 04-22-085, § 296-20-06101, filed 11/2/04, effective 12/15/04. Statutory Authority: RCW 51.04.020, 51.04.030 and 51.36.060. 00-01-190, § 296-20-06101, filed 12/22/99, effective 1/24/00. Statutory Authority: RCW 51.04.020, 51.04.030 and 1993 c 159. 93-16-072, § 296-20-06101, 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), § 296-20-06101, 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), § 296-20-06101, filed 11/30/81, effective 1/1/82; 81-01-100 (Order 80-29), § 296-20-06101, filed 12/23/80, effective 3/1/81; Order 74-39, § 296-20-06101, filed 11/22/74, effective 1/1/75.]

     The following sections of the Washington Administrative Code are repealed:

WAC 296-20-03016	Is detoxification and/or chemical dependency treatment covered?
WAC 296-20-03019	Under what conditions will the department or self-insurer pay for oral opioid treatment for chronic, noncancer pain?
WAC 296-20-03020	What are the authorization requirements for treatment of chronic, noncancer pain with opioids?
WAC 296-20-03021	What documentation is required to be submitted for continued coverage of opioids to treat chronic, noncancer pain?
WAC 296-20-03022	How long will the department or self-insurer continue to pay for opioids to treat chronic, noncancer pain?
WAC 296-20-03023	When may the department or self-insurer deny payment of opioid medications used to treat chronic, noncancer pain?
WAC 296-20-03024	Will the department or self-insurer pay for nonopioid medications for the treatment of chronic, noncancer pain?