Original Notice.

     Preproposal statement of inquiry was filed as WSR 10-13-103.

     Title of Rule and Other Identifying Information: Chapter 246-922 WAC, new sections for management of chronic noncancer pain for podiatrists. The proposed rules also repeal WAC 246-922-510, 246-922-520, 246-922-530, and 246-922-540.

     Hearing Location(s): Highline Hospital and Medical Center, 16251 Sylvester Road S.E., Room 3, Cendar [Cedar] 3 and 4, Burien, WA 98166, on April 14, 2011, at 9:00 a.m.

     Date of Intended Adoption: April 14, 2011.

     Submit Written Comments to: Erin Obenland, P.O. Box 47852, Olympia, WA 98504-7852, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by March 31, 2011.

     Assistance for Persons with Disabilities: Contact Erin Obenland by March 31, 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 podiatric medical board 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. In addition to the required 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 the five boards and commissions to adopt rules on the management of chronic noncancer pain. These include the medical quality assurance commission, board of osteopathic medicine and surgery, nursing care quality assurance commission, dental quality assurance commission, and the podiatric medical board. The proposed rules will provide practitioners who treat patients with chronic noncancer pain with guidance and tools to reduce the risks associated with opioid use.

     Statutory Authority for Adoption: RCW 18.22.240, 18.22.015.

     Statute Being Implemented: RCW 18.22.240.

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

     Name of Proponent: Washington state department of health, podiatric medical board, governmental.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Erin Obenland, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4945.

     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 Erin Obenalnd [Obenland], P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 236-4945, fax (360) 236-2901, e-mail erin.obenland@doh.wa.gov.

February 8, 2011

Blake T. Maresh

Executive Director

OTS-3827.1

NEW SECTION
WAC 246-922-660   Pain management -- Intent.   These rules govern the use of opioids in the treatment of patients for chronic noncancer pain.

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     (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.

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     (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.

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     (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 podiatric 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 podiatric physician; and

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

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     (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 podiatric physician should adjust drug therapy to the individual health needs of the patient. The podiatric 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 podiatric 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.

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

     (7) A written authorization that the podiatric 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 podiatric physician's response to the violation will be documented, as well as the rationale for changes in the treatment plan.

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     (1) During the periodic review, the podiatric 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 podiatric physician's evaluation of progress towards treatment objectives.

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

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

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     (2) Episodic care practitioners should avoid providing opioids for chronic pain management. However, if opioids are provided, the podiatric 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 246-922-666(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.

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     (2) Mandatory consultation at 120 milligrams morphine equivalent dose (MED). In the event a podiatric 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 246-922-671 (exigent) or 246-922-672 (exempt practitioner).

     (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 podiatric physician;

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

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

     (b) A podiatric 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 podiatric physician, the podiatric 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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     (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 podiatric 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 podiatric physician documents the patient's pain and function is stable and the patient is on a nonescalating dosage of opioids.

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     (1) The podiatric physician is a pain management specialist under WAC 246-922-673;

     (2) The podiatric 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.

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

     (4) The podiatric 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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     (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

     (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 a specialty that includes a focus on chronic noncancer 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.

     (4) If a podiatric physician:

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

     (b) Credentialed in a specialty that includes a focus on chronic noncancer 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.

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