WSR 11-03-063

PROPOSED RULES

DEPARTMENT OF HEALTH


(Medical Quality Assurance Commission)

[ Filed January 18, 2011, 8:55 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 10-13-094.

Title of Rule and Other Identifying Information: WAC 246-919-850 through 246-919-863 (physicians) and WAC 246-918-800 through 246-918-813 (physician assistants), new sections for management of chronic noncancer pain. The proposed rules also repeal WAC 246-919-800 through 246-919-830 (physician).

Hearing Location(s): Department of Health, 310 Israel Road S.E., Rooms 152/153, Tumwater, WA 98501, on March 2, 2011, at 3:00 p.m.

Date of Intended Adoption: March 2, 2011.

Submit Written Comments to: Julie Kitten, Department of Health, Medical Quality Assurance Commission, P.O. Box 47866, Olympia, WA 98504-7866, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2795, by February 23, 2011.

Assistance for Persons with Disabilities: Contact Julie Kitten by February 23, 2011, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: ESHB 2876 (chapter 209, Laws of 2010) directs the medical quality assurance commission to repeal existing pain management rules and adopt new rules for the management of chronic noncancer pain. The proposed rules include the mandatory elements for dosing criteria, guidance on specialty consultations, guidance on tracking clinical progress, and guidance on tracking opioid use. To address the mandatory elements, the proposed rules also define the criteria to be considered a pain management specialist, describe elements for a patient evaluation and written treatment plan, describe when periodic reviews are required, and provide for practitioner exemptions from the consultation requirement.

Reasons Supporting Proposal: ESHB 2876 requires five health profession boards and commissions to adopt rules on management of chronic noncancer pain. The boards and commissions include the medical quality assurance commission, board of osteopathic medicine and surgery, nursing care quality assurance commission, dental quality assurance commission, and podiatric medical board. Proposed rules provide practitioners who treat pain patients with guidance and tools to reduce the risks associated with opioid use.

Statutory Authority for Adoption: RCW 18.71.450, 18.71A.100, 18.71.017, 18.71A.020.

Statute Being Implemented: RCW 18.71.450, 18.71A.100.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of health, medical quality assurance commission, governmental.

Name of Agency Personnel Responsible for Drafting: Julie Kitten, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-2757; Implementation and Enforcement: Maryella Jansen, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-2755.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Julie Kitten, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-2757, fax (360) 236-2795, e-mail julie.kitten@doh.wa.gov.

January 18, 2011

Maryella E. Jansen

Executive Director

OTS-3822.2


NEW SECTION
WAC 246-918-800   Pain management -- Intent.   These rules govern the use of opioids in the treatment of patients for chronic noncancer pain.

Nothing in these rules in any way restricts the current scope of practice of physician assistants as set forth in chapters 18.71A and 18.57A RCW and the working agreements between the physician and physician assistant, which may include pain management.

[]


NEW SECTION
WAC 246-918-801   Exclusions.   The rules adopted under this section do not apply:

(1) To the provision of palliative, hospice, or other end-of-life care; or

(2) To the management of acute pain caused by an injury or surgical procedure.

[]


NEW SECTION
WAC 246-918-802   Definitions.   The definitions in this section apply throughout the section unless the context clearly requires otherwise.

(1) "Acute pain" means the normal, predicted physiological response to a noxious chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, trauma, and disease. It is generally time-limited, often less than three months in duration, and usually less than six months.

(2) "Addiction" means a primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include:

(a) Impaired control over drug use;

(b) Craving;

(c) Compulsive use; or

(d) Continued use despite harm.

(3) "Chronic noncancer pain" means a state in which noncancer pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

(4) "Comorbidity" means a preexisting or coexisting physical or psychiatric disease or condition.

(5) "Hospice" means a model of care that focuses on relieving symptoms and supporting patients with a life expectancy of six months or less. Hospice involves an interdisciplinary approach to provide health care, pain management, and emotional and spiritual support. The emphasis is on comfort, quality of life and patient and family support. Hospice can be provided in the patient's home as well as freestanding hospice facilities, hospitals, nursing homes, or other long-term care facilities.

(6) "Palliative" means care that improves the quality of life of patients and their families facing life-threatening illness. With palliative care particular attention is given to the prevention, assessment, and treatment of pain and other symptoms, and to the provision of psychological, spiritual, and emotional support.

(7) "Physical dependence" means a physiologic state of adaptation to a specific psychoactive substance characterized by the emergence of a withdrawal syndrome during abstinence that may be relieved in total or in part by readministration of the substance.

(8) "Psychological dependence" means a subjective sense of need for a specific substance, either for its positive effects or to avoid negative effects associated with its abstinence.

(9) "Tolerance" means a physiological state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

[]


NEW SECTION
WAC 246-918-803   Patient evaluation.   The physician assistant shall obtain, evaluate, and document the patient's health history and physical examination in the health record prior to treating for chronic noncancer pain.

(1) The patient's health history shall include:

(a) Current and past treatments for pain;

(b) Comorbidities; and

(c) Any substance abuse.

(2) The patient's health history should include:

(a) A review of any available prescription monitoring program or emergency department-based information exchange; and

(b) Any relevant information from a pharmacist provided to the physician assistant.

(3) The initial patient evaluation shall include:

(a) Physical examination;

(b) The nature and intensity of the pain;

(c) The effect of the pain on physical and psychological function;

(d) Medications including indication(s), date, type, dosage, and quantity prescribed;

(e) A risk screening of the patient for potential comorbidities and risk factors using an appropriate screening tool. The screening should address:

(i) History of addiction;

(ii) Abuse or aberrant behavior regarding opioid use;

(iii) Psychiatric conditions;

(iv) Regular concomitant use of benzodiazepines, alcohol, or other central nervous system medications;

(v) Poorly controlled depression or anxiety;

(vi) Evidence or risk of significant adverse events, including falls or fractures;

(vii) Receipt of opioids from more than one prescribing practitioner or practitioner group;

(viii) Repeated visits to emergency departments seeking opioids;

(ix) History of sleep apnea or other respiratory risk factors;

(x) Possible or current pregnancy; and

(xi) History of allergies or intolerances.

(4) The initial patient evaluation should include:

(a) Any available diagnostic, therapeutic, and laboratory results; and

(b) Any available consultations.

(5) The health record shall be maintained in an accessible manner, readily available for review, and should include:

(a) The diagnosis, treatment plan, and objectives;

(b) Documentation of the presence of one or more recognized indications for the use of pain medication;

(c) Documentation of any medication prescribed;

(d) Results of periodic reviews;

(e) Any written agreements for treatment between the patient and the physician assistant; and

(f) The physician assistant's instructions to the patient.

[]


NEW SECTION
WAC 246-918-804   Treatment plan.   (1) The written treatment plan shall state the objectives that will be used to determine treatment success and shall include, at a minimum:

(a) Any change in pain relief;

(b) Any change in physical and psychosocial function; and

(c) Additional diagnostic evaluations or other planned treatments.

(2) After treatment begins the physician assistant should adjust drug therapy to the individual health needs of the patient. The physician assistant shall include indications for medication use on the prescription and require photo identification of the person picking up the prescription in order to fill. The physician assistant shall advise the patient that it is the patient's responsibility to safeguard all medications and keep them in a secure location.

(3) Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

[]


NEW SECTION
WAC 246-918-805   Informed consent.   The physician assistant shall discuss the risks and benefits of treatment options with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without health care decision-making capacity.

[]


NEW SECTION
WAC 246-918-806   Written agreement for treatment.   Chronic noncancer pain patients should receive all chronic pain management prescriptions from one physician assistant and one pharmacy whenever possible. If the patient is at high risk for medication abuse, or has a history of substance abuse, or psychiatric comorbidities, the prescribing physician assistant shall use a written agreement for treatment with the patient outlining patient responsibilities. This written agreement for treatment shall include:

(1) The patient's agreement to provide biological samples for urine/serum medical level screening when requested by the physician assistant;

(2) The patient's agreement to take medications at the dose and frequency prescribed with a specific protocol for lost prescriptions and early refills;

(3) Reasons for which drug therapy may be discontinued (e.g., violation of agreement);

(4) The requirement that all chronic pain management prescriptions are provided by a single prescriber and dispensed by a single pharmacy;

(5) The patient's agreement to not abuse alcohol or use other medically unauthorized substances;

(6) A written authorization for:

(a) The physician assistant to release the agreement for treatment to local emergency departments, urgent care facilities, and pharmacies; and

(b) Other practitioners to report violations of the agreement back to the physician assistant;

(7) A written authorization that the physician assistant may notify the proper authorities if he or she has reason to believe the patient has engaged in illegal activity;

(8) Acknowledgment that a violation of the agreement may result in a tapering or discontinuation of the prescription;

(9) Acknowledgment that it is the patient's responsibility to safeguard all medications and keep them in a secure location; and

(10) Acknowledgment that if the patient violates the terms of the agreement, the violation and the physician assistant's response to the violation will be documented, as well as the rationale for changes in the treatment plan.

[]


NEW SECTION
WAC 246-918-807   Periodic review.   The physician assistant shall periodically review the course of treatment for chronic noncancer pain, the patient's state of health, and any new information about the etiology of the pain. Generally, periodic reviews shall take place at least every six months. However, for treatment of stable patients with chronic noncancer pain involving nonescalating daily dosages of 40 milligrams of a morphine equivalent dose (MED) or less, periodic reviews shall take place at least annually.

(1) During the periodic review, the physician assistant shall determine:

(a) Patient's compliance with any medication treatment plan;

(b) If pain, function, or quality of life have improved or diminished using objective evidence, considering any available information from family members or other caregivers; and

(c) If continuation or modification of medications for pain management treatment is necessary based on the physician assistant's evaluation of progress towards treatment objectives.

(2) The physician assistant shall assess the appropriateness of continued use of the current treatment plan if the patient's progress or compliance with current treatment plan is unsatisfactory. The physician assistant shall consider tapering, changing, or discontinuing treatment when:

(a) Function or pain does not improve after a trial period;

(b) There is evidence of significant adverse effects;

(c) Other treatment modalities are indicated; or

(d) There is evidence of misuse, addiction, or diversion.

(3) The physician assistant should periodically review information from any available prescription monitoring program or emergency department-based information exchange.

(4) The physician assistant should periodically review any relevant information from a pharmacist provided to the physician assistant.

[]


NEW SECTION
WAC 246-918-808   Long-acting opioids, including methadone.   Long-acting opioids, including methadone, should only be prescribed by a physician assistant who is familiar with its risks and use, and who is prepared to conduct the necessary careful monitoring. Special attention should be given to patients who are initiating such treatment. A physician assistant prescribing long-acting opioids or methadone should have a one-time completion of at least four continuing education hours relating to this topic.

[]


NEW SECTION
WAC 246-918-809   Episodic care.   (1) When evaluating patients for episodic care, such as emergency or urgent care, the physician assistant should review any available prescription monitoring program, emergency department-based information exchange, or other tracking system.

(2) Episodic care practitioners should avoid providing opioids for chronic pain management. However, if opioids are provided, the physician assistant should limit the use of opioids for a chronic noncancer pain patient to the minimum amount necessary to control the pain until the patient can receive care from a primary care practitioner.

(3) Prescriptions for opioids written by an episodic care practitioner shall include indications for use or the International Classification of Diseases (ICD) code and shall be written to require photo identification of the person picking up the prescription in order to fill.

(4) If a patient has signed a written agreement for treatment and has provided a written authorization to release the agreement under WAC 246-918-806(6) to episodic care practitioners, then the episodic care practitioner should report known violations of the agreement back to the patient's treatment practitioner who provided the agreement for treatment.

[]


NEW SECTION
WAC 246-918-810   Consultation.   (1) Consultation. The physician assistant shall consider referring the patient for additional evaluation and treatment as needed to achieve treatment objectives. Special attention should be given to those chronic noncancer pain patients who are under eighteen years of age, or who are at risk for medication misuse, abuse, or diversion. The management of pain in patients with a history of substance abuse or with comorbid psychiatric disorders may require extra care, monitoring, documentation, and consultation with, or referral to, an expert in the management of such patients.

(2) Mandatory consultation at 120 milligrams morphine equivalent dose (MED). In the event a practitioner prescribes a dosage amount that meets or exceeds the consultation threshold of 120 milligrams MED per day, a consultation with a pain management specialist is required, unless the consultation is exempted under WAC 246-918-811 or 246-918-812.

(a) The mandatory consultation shall consist of at least one of the following:

(i) An office visit with the patient and the pain management specialist;

(ii) A telephone consultation between the pain management specialist and the physician assistant;

(iii) An electronic consultation between the pain management specialist and the physician assistant; or

(iv) An audio-visual evaluation conducted by the pain management specialist remotely, where the patient is present with either the physician assistant or a licensed health care practitioner designated by the physician assistant or the pain management specialist.

(b) A physician assistant shall document each mandatory consultation with the pain management specialist. Any written record of the consultation by the pain management specialist shall be maintained as a patient record by the specialist. If the specialist provides a written record of the consultation to the physician assistant, the physician assistant shall maintain it as part of the patient record.

(3) Nothing in this chapter shall limit any person's ability to contractually require a consultation with a pain management specialist at any time. For the purposes of this section, "person" means an individual, a trust or estate, a firm, a partnership, a corporation (including associations, joint stock companies, and insurance companies), the state, or a political subdivision or instrumentality of the state, including a municipal corporation or a hospital district.

[]


NEW SECTION
WAC 246-918-811   Exigent and special circumstances under which the 120 milligrams MED may be exceeded without consultation with a pain management specialist.   A physician assistant is not required to consult with a pain management specialist when he or she has documented adherence to all standards of practice as defined in this chapter and when any one or more of the following conditions apply:

(1) The patient is following a tapering schedule;

(2) The patient requires treatment for acute pain which may or may not include hospitalization, requiring a temporary escalation in opioid dosage, with expected return to or below their baseline dosage level;

(3) The physician assistant documents reasonable attempts to obtain a consultation with a pain management specialist and the circumstances justifying prescribing above 120 milligrams MED per day without first obtaining a consultation; or

(4) The physician assistant documents that the patient's pain and function is stable and that the patient is on a nonescalating dosage of opioids.

[]


NEW SECTION
WAC 246-918-812   Physician assistant exempt from consultation requirement.   The physician assistant is exempt from the consultation requirement in WAC 246-918-810 if one or more of the following qualifications are met:

(1) The sponsoring physician is a pain management specialist under WAC 246-918-813;

(2) The sponsoring physician and the physician assistant have successfully completed, within the last two years, a minimum of twelve continuing education hours on chronic pain management approved by the profession's continuing education accrediting organization, with at least two of these hours dedicated to long-acting opioids, to include methadone; or

(3) The physician assistant is a pain management practitioner working in a multidisciplinary chronic pain treatment center, or a multidisciplinary academic research facility.

[]


NEW SECTION
WAC 246-918-813   Pain management specialist.   A pain management specialist shall meet one or more of the following qualifications:

(1) If a physician or osteopathic physician:

(a) Board certified or board eligible by an American Board of Medical Specialties-approved board (ABMS) or by the American Osteopathic Association (AOA) in physical medicine and rehabilitation, rehabilitation medicine, neurology, rheumatology, or anesthesiology; or

(b) Has a subspecialty certificate in pain medicine by an ABMS-approved board; or

(c) Has a certification of added qualification in pain management by the AOA; or

(d) A minimum of three years of clinical experience in a chronic pain management care setting; and

(i) Credentialed in pain management by an entity approved by the medical quality assurance commission for allopathic physicians or the board of osteopathic medicine and surgery for osteopathic physicians; and

(ii) Successful completion of a minimum of at least eighteen continuing education hours in pain management during the past two years; and

(iii) At least thirty percent of the physician's current practice is the direct provision of pain management care.

(2) If a dentist: Board certified or board eligible in oral medicine or orofacial pain by the American Board of Oral Medicine or the American Board of Orofacial Pain.

(3) If an advanced registered nurse practitioner (ARNP):

(a) A minimum of three years of clinical experience in a chronic pain management care setting;

(b) Credentialed in pain management by a Nursing Care Quality Assurance Commission-approved national professional association, pain association, or other credentialing entity;

(c) Successful completion of a minimum of at least eighteen continuing education hours in pain management during the past two years; and

(d) At least thirty percent of the ARNP's current practice is the direct provision of pain management care.

(4) If a podiatric physician:

(a) A minimum of three years of clinical experience in a chronic pain management care setting;

(b) Credentialed in pain management by a Podiatric Medical Board-approved national professional association, pain association, or other credentialing entity; and

(c) Successful completion of a minimum of at least eighteen hours of continuing education in pain management during the past two years, and at least thirty percent of the podiatric physician's current practice is the direct provision of pain management care; or

(d) Board certified or board eligible in a specialty that includes a focus on pain management by the American Board of Podiatric Surgery, the American Board of Podiatric Orthopedics and Primary Podiatric Medicine, or other accredited certifying board as approved by the Washington state podiatric medical board.

[]

OTS-3705.1


REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 246-919-800 Purpose.
WAC 246-919-810 What specific guidance should a practitioner follow?
WAC 246-919-820 What knowledge should a practitioner possess to treat pain patients?
WAC 246-919-830 How will the commission evaluate prescribing for pain?

OTS-3823.2


NEW SECTION
WAC 246-919-850   Pain management -- Intent.   These rules govern the use of opioids in the treatment of patients for chronic noncancer pain.

[]


NEW SECTION
WAC 246-919-851   Exclusions.   The rules adopted under this section do not apply:

(1) To the provision of palliative, hospice, or other end-of-life care; or

(2) To the management of acute pain caused by an injury or surgical procedure.

[]


NEW SECTION
WAC 246-919-852   Definitions.   The definitions in this section apply throughout the section unless the context clearly requires otherwise.

(1) "Acute pain" means the normal, predicted physiological response to a noxious chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, trauma, and disease. It is generally time-limited, often less than three months in duration, and usually less than six months.

(2) "Addiction" means a primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include:

(a) Impaired control over drug use;

(b) Craving;

(c) Compulsive use; or

(d) Continued use despite harm.

(3) "Chronic noncancer pain" means a state in which noncancer pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

(4) "Comorbidity" means a preexisting or coexisting physical or psychiatric disease or condition.

(5) "Hospice" means a model of care that focuses on relieving symptoms and supporting patients with a life expectancy of six months or less. Hospice involves an interdisciplinary approach to provide health care, pain management, and emotional and spiritual support. The emphasis is on comfort, quality of life and patient and family support. Hospice can be provided in the patient's home as well as freestanding hospice facilities, hospitals, nursing homes, or other long-term care facilities.

(6) "Palliative" means care that improves the quality of life of patients and their families facing life-threatening illness. With palliative care particular attention is given to the prevention, assessment, and treatment of pain and other symptoms, and to the provision of psychological, spiritual, and emotional support.

(7) "Physical dependence" means a physiologic state of adaptation to a specific psychoactive substance characterized by the emergence of a withdrawal syndrome during abstinence that may be relieved in total or in part by readministration of the substance.

(8) "Psychological dependence" means a subjective sense of need for a specific substance, either for its positive effects or to avoid negative effects associated with its abstinence.

(9) "Tolerance" means a physiological state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

[]


NEW SECTION
WAC 246-919-853   Patient evaluation.   The physician shall obtain, evaluate, and document the patient's health history and physical examination in the health record prior to treating for chronic noncancer pain.

(1) The patient's health history shall include:

(a) Current and past treatments for pain;

(b) Comorbidities; and

(c) Any substance abuse.

(2) The patient's health history should include:

(a) A review of any available prescription monitoring program or emergency department-based information exchange; and

(b) Any relevant information from a pharmacist provided to a physician.

(3) The initial patient evaluation shall include:

(a) Physical examination;

(b) The nature and intensity of the pain;

(c) The effect of the pain on physical and psychological function;

(d) Medications including indication(s), date, type, dosage, and quantity prescribed;

(e) A risk screening of the patient for potential comorbidities and risk factors using an appropriate screening tool. The screening should address:

(i) History of addiction;

(ii) Abuse or aberrant behavior regarding opioid use;

(iii) Psychiatric conditions;

(iv) Regular concomitant use of benzodiazepines, alcohol, or other central nervous system medications;

(v) Poorly controlled depression or anxiety;

(vi) Evidence or risk of significant adverse events, including falls or fractures;

(vii) Receipt of opioids from more than one prescribing practitioner or practitioner group;

(viii) Repeated visits to emergency departments seeking opioids;

(ix) History of sleep apnea or other respiratory risk factors;

(x) Possible or current pregnancy; and

(xi) History of allergies or intolerances.

(4) The initial patient evaluation should include:

(a) Any available diagnostic, therapeutic, and laboratory results; and

(b) Any available consultations.

(5) The health record shall be maintained in an accessible manner, readily available for review, and should include:

(a) The diagnosis, treatment plan, and objectives;

(b) Documentation of the presence of one or more recognized indications for the use of pain medication;

(c) Documentation of any medication prescribed;

(d) Results of periodic reviews;

(e) Any written agreements for treatment between the patient and the physician; and

(f) The physician's instructions to the patient.

[]


NEW SECTION
WAC 246-919-854   Treatment plan.   (1) The written treatment plan shall state the objectives that will be used to determine treatment success and shall include, at a minimum:

(a) Any change in pain relief;

(b) Any change in physical and psychosocial function; and

(c) Additional diagnostic evaluations or other planned treatments.

(2) After treatment begins the physician should adjust drug therapy to the individual health needs of the patient. The physician shall include indications for medication use on the prescription and require photo identification of the person picking up the prescription in order to fill. The physician shall advise the patient that it is the patient's responsibility to safeguard all medications and keep them in a secure location.

(3) Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

[]


NEW SECTION
WAC 246-919-855   Informed consent.   The physician shall discuss the risks and benefits of treatment options with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without health care decision-making capacity.

[]


NEW SECTION
WAC 246-919-856   Written agreement for treatment.   Chronic noncancer pain patients should receive all chronic pain management prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse, or has a history of substance abuse, or psychiatric comorbidities, the prescribing physician shall use a written agreement for treatment with the patient outlining patient responsibilities. This written agreement for treatment shall include:

(1) The patient's agreement to provide biological samples for urine/serum medical level screening when requested by the physician;

(2) The patient's agreement to take medications at the dose and frequency prescribed with a specific protocol for lost prescriptions and early refills;

(3) Reasons for which drug therapy may be discontinued (e.g., violation of agreement);

(4) The requirement that all chronic pain management prescriptions are provided by a single prescriber and dispensed by a single pharmacy;

(5) The patient's agreement to not abuse alcohol or use other medically unauthorized substances;

(6) A written authorization for:

(a) The physician to release the agreement for treatment to local emergency departments, urgent care facilities, and pharmacies; and

(b) Other practitioners to report violations of the agreement back to the physician;

(7) A written authorization that the physician may notify the proper authorities if he or she has reason to believe the patient has engaged in illegal activity;

(8) Acknowledgment that a violation of the agreement may result in a tapering or discontinuation of the prescription;

(9) Acknowledgment that it is the patient's responsibility to safeguard all medications and keep them in a secure location; and

(10) Acknowledgment that if the patient violates the terms of the agreement, the violation and the physician's response to the violation will be documented, as well as the rationale for changes in the treatment plan.

[]


NEW SECTION
WAC 246-919-857   Periodic review.   The physician shall periodically review the course of treatment for chronic noncancer pain, the patient's state of health, and any new information about the etiology of the pain. Generally, periodic reviews shall take place at least every six months. However, for treatment of stable patients with chronic noncancer pain involving nonescalating daily dosages of 40 milligrams of a morphine equivalent dose (MED) or less, periodic reviews shall take place at least annually.

(1) During the periodic review, the physician shall determine:

(a) Patient's compliance with any medication treatment plan;

(b) If pain, function, or quality of life have improved or diminished using objective evidence, considering any available information from family members or other caregivers; and

(c) If continuation or modification of medications for pain management treatment is necessary based on the physician's evaluation of progress towards treatment objectives.

(2) The physician shall assess the appropriateness of continued use of the current treatment plan if the patient's progress or compliance with current treatment plan is unsatisfactory. The physician shall consider tapering, changing, or discontinuing treatment when:

(a) Function or pain does not improve after a trial period;

(b) There is evidence of significant adverse effects;

(c) Other treatment modalities are indicated; or

(d) There is evidence of misuse, addiction, or diversion.

(3) The physician should periodically review information from any available prescription monitoring program or emergency department-based information exchange.

(4) The physician should periodically review any relevant information from a pharmacist provided to the physician.

[]


NEW SECTION
WAC 246-919-858   Long-acting opioids, including methadone.   Long-acting opioids, including methadone, should only be prescribed by a physician who is familiar with its risks and use, and who is prepared to conduct the necessary careful monitoring. Special attention should be given to patients who are initiating such treatment. The physician prescribing long-acting opioids or methadone should have a one-time completion of at least four hours of continuing education relating to this topic.

[]


NEW SECTION
WAC 246-919-859   Episodic care.   (1) When evaluating patients for episodic care, such as emergency or urgent care, the physician should review any available prescription monitoring program, emergency department-based information exchange, or other tracking system.

(2) Episodic care practitioners should avoid providing opioids for chronic pain management. However, if opioids are provided, the physician should limit the use of opioids for a chronic noncancer pain patient to the minimum amount necessary to control the pain until the patient can receive care from a primary care practitioner.

(3) Prescriptions for opioids written by an episodic care practitioner shall include indications for use or the International Classification of Diseases (ICD) code and shall be written to require photo identification of the person picking up the prescription in order to fill.

(4) If a patient has signed a written agreement for treatment and has provided a written authorization to release the agreement under WAC 246-919-856(6) to episodic care practitioners, then the episodic care practitioner should report known violations of the agreement back to the patient's treatment practitioner who provided the agreement for treatment.

[]


NEW SECTION
WAC 246-919-860   Consultation.   (1) Consultation. The physician shall consider referring the patient for additional evaluation and treatment as needed to achieve treatment objectives. Special attention should be given to those chronic noncancer pain patients who are under eighteen years of age, or who are at risk for medication misuse, abuse, or diversion. The management of pain in patients with a history of substance abuse or with comorbid psychiatric disorders may require extra care, monitoring, documentation, and consultation with, or referral to, an expert in the management of such patients.

(2) Mandatory consultation at 120 milligrams morphine equivalent dose (MED). In the event a physician prescribes a dosage amount that meets or exceeds the consultation threshold of 120 milligrams MED per day, a consultation with a pain management specialist is required, unless the consultation is exempted under WAC 246-919-861 or 246-919-862.

(a) The mandatory consultation shall consist of at least one of the following:

(i) An office visit with the patient and the pain management specialist;

(ii) A telephone consultation between the pain management specialist and the physician;

(iii) An electronic consultation between the pain management specialist and the physician; or

(iv) An audio-visual evaluation conducted by the pain management specialist remotely, where the patient is present with either the physician or a licensed health care practitioner designated by the physician or the pain management specialist.

(b) A physician shall document each mandatory consultation with the pain management specialist. Any written record of the consultation by the pain management specialist shall be maintained as a patient record by the specialist. If the specialist provides a written record of the consultation to the physician, the physician shall maintain it as part of the patient record.

(3) Nothing in this chapter shall limit any person's ability to contractually require a consultation with a pain management specialist at any time. For the purposes of this section, "person" means an individual, a trust or estate, a firm, a partnership, a corporation (including associations, joint stock companies, and insurance companies), the state, or a political subdivision or instrumentality of the state, including a municipal corporation or a hospital district.

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NEW SECTION
WAC 246-919-861   Exigent and special circumstances under which the 120 milligrams MED may be exceeded without consultation with a pain management specialist.   A physician is not required to consult with a pain management specialist when he or she has documented adherence to all standards of practice as defined in this chapter and when any one or more of the following conditions apply:

(1) The patient is following a tapering schedule;

(2) The patient requires treatment for acute pain which may or may not include hospitalization, requiring a temporary escalation in opioid dosage, with expected return to or below their baseline dosage level;

(3) The physician documents reasonable attempts to obtain a consultation with a pain management specialist and the circumstances justifying prescribing above 120 milligrams MED per day without first obtaining a consultation; or

(4) The physician documents the patient's pain and function is stable and the patient is on a nonescalating dosage of opioids.

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NEW SECTION
WAC 246-919-862   Physician exempt from consultation requirement.   The physician is exempt from the consultation requirement in WAC 246-919-860 if one or more of the following qualifications are met:

(1) The physician is a pain management specialist under WAC 246-919-863;

(2) The physician has successfully completed, within the last two years, a minimum of twelve continuing education hours on chronic pain management approved by the profession's continuing education accrediting organization, with at least two of these hours dedicated to long acting opioids, to include methadone; or

(3) The physician is a pain management practitioner working in a multidisciplinary chronic pain treatment center, or a multidisciplinary academic research facility; or

(4) The physician has a minimum three years of clinical experience in a chronic pain management setting, and at least thirty percent of his or her current practice is the direct provision of pain management care.

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NEW SECTION
WAC 246-919-863   Pain management specialist.   A pain management specialist shall meet one or more of the following qualifications:

(1) If a physician or osteopathic physician:

(a) Board certified or board eligible by an American Board of Medical Specialties-approved board (ABMS) or by the American Osteopathic Association (AOA) in physical medicine and rehabilitation, rehabilitation medicine, neurology, rheumatology, or anesthesiology; or

(b) Has a subspecialty certificate in pain medicine by an ABMS-approved board; or

(c) Has a certification of added qualification in pain management by the AOA; or

(d) A minimum of three years of clinical experience in a chronic pain management care setting; and

(i) Credentialed in pain management by an entity approved by the medical quality assurance commission for allopathic physicians or the board of osteopathic medicine and surgery for osteopathic physicians; and

(ii) Successful completion of a minimum of at least eighteen continuing education hours in pain management during the past two years; and

(iii) At least thirty percent of the physician's current practice is the direct provision of pain management care.

(2) If a dentist: Board certified or board eligible in oral medicine or orofacial pain by the American Board of Oral Medicine or the American Board of Orofacial Pain.

(3) If an advanced registered nurse practitioner (ARNP):

(a) A minimum of three years of clinical experience in a chronic pain management care setting;

(b) Credentialed in pain management by a Nursing Care Quality Assurance Commission-approved national professional association, pain association, or other credentialing entity;

(c) Successful completion of a minimum of at least eighteen continuing education hours in pain management during the past two years; and

(d) At least 30 percent of the ARNP's current practice is the direct provision of pain management care.

(4) If a podiatric physician:

(a) A minimum of three years of clinical experience in a chronic pain management care setting;

(b) Credentialed in pain management by a Podiatric Medical Board-approved national professional association, pain association, or other credentialing entity; and

(c) Successful completion of a minimum of at least eighteen hours of continuing education in pain management during the past two years, and at least thirty percent of the podiatrist's current practice is the direct provision of pain management care; or

(d) Board certified or board eligible in a specialty that includes a focus on pain management by the American Board of Podiatric Surgery, the American Board of Podiatric Orthopedics and Primary Podiatric Medicine, or other accredited certifying board as approved by the Washington state podiatric medical board.

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Washington State Code Reviser's Office