WSR 18-23-061
PERMANENT RULES
DEPARTMENT OF HEALTH
(Medical Quality Assurance Commission)
[Filed November 16, 2018, 10:42 a.m., effective January 1, 2019]
Effective Date of Rule: January 1, 2019.
Other Findings Required by Other Provisions of Law as Precondition to Adoption or Effectiveness of Rule: The statute requires the rules to be effective on January 1, 2019.
Purpose: Chapters 246-918 WAC (allopathic) physician assistants and chapter 246-919 WAC (allopathic physicians) medical quality assurance commission, the medical quality assurance commission (commission) has adopted new sections, amendments, and repeal of sections to existing rule that establishes requirements and standards for prescribing opioid drugs by allopathic physicians and allopathic physician assistants. The adopted rules provide a necessary framework and structure for safe, consistent opioid prescribing practice consistent with the directives of ESHB 1427.
Citation of Rules Affected by this Order: New WAC 246-918-815, 246-918-820, 246-918-825, 246-918-830, 246-918-835, 246-918-840, 246-918-845, 246-918-850, 246-918-855, 246-918-860, 246-918-865, 246-918-870, 246-918-875, 246-918-880, 246-918-885, 246-918-890, 246-918-895, 246-918-900, 246-918-905, 246-918-910, 246-918-915, 246-918-920, 246-918-925, 246-918-930, 246-918-935, 246-919-865, 246-919-870, 246-919-875, 246-919-880, 246-919-885, 246-919-890, 246-919-895, 246-919-900, 246-919-905, 246-919-910, 246-919-915, 246-919-920, 246-919-925, 246-919-930, 246-919-935, 246-919-940, 246-919-945, 246-919-950, 246-919-955, 246-919-960, 246-919-965, 246-919-970, 246-919-975, 246-919-980 and 246-919-985; repealing WAC 236-918-803, 236-918-804, 236-918-805, 236-918-806, 236-918-807, 236-918-808, 236-918-809, 236-918-810, 236-918-811, 236-918-812, 236-918-813, 246-919-853, 246-919-854, 246-919-855, 246-919-856, 246-919-857, 246-919-858, 246-919-859, 246-919-860, 246-919-861, 246-919-862 and 246-919-863; and amending WAC 246-918-800, 246-918-801, 246-918-802, 246-919-850, 246-919-851, and 246-919-852.
Statutory Authority for Adoption: RCW 18.71.017, 18.71.800, and 18.71A.800.
Other Authority: ESHB 1427 (chapter 297, Laws of 2017), codified in part as RCW 18.71.800 and 18.71A.800.
Adopted under notice filed as WSR 18-15-055 on July 16, 2018.
Changes Other than Editing from Proposed to Adopted Version: The following nonsubstantial changes were adopted at the public hearing by the commission that differ from the proposed rules.
1. WAC 246-918-802(7) and 246-919-852(7), definitions. Final adopted language: "'Designee' means a licensed health care practitioner authorized by a prescriber to request and receive prescription monitoring program (PMP) data on their behalf." As a result of adding this definition, the commission deleted all references to "as defined in WAC 246-470-050" throughout the physician and physician assistant rules. Reasons for this change: A definition for "designee" was added as a new subsection (7). This term is used in rule so a definition is being added for clarification. The subsequent subsections were renumbered to reflect this addition. Adding the definition of designee made the need for the phrase "as defined in WAC 246-470-050" no longer needed in the rest of the sections and was deleted.
2. WAC 246-918-895 (2)-(6), pain management specialistChronic pain. Final adopted language: "(2) If an allopathic physician, in accordance with WAC 246-919-945. (3) If an osteopathic physician, in accordance with WAC 246-853-750. (4) If a dentist, in accordance with WAC 246-817-965. (5) If a podiatric physician, in accordance with WAC 246-922-750. (6) If an advanced registered nurse practitioner, in accordance with WAC 246-840-493." Reason for this change: The commission determined the MD and PA chapters should be substantially similar. Adding this new language makes them so.
3. WAC 246-918-802(13) and 246-919-852(13), definitions (formerly subsection (12) in the proposed rules, now adopted as renumbered subsection (13)). Final adopted language: "'Low-risk' is a category of patient at low risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, and dose of opioids of less than a fifty milligram morphine equivalent dose per day." Reason for this change: The commission determined adding "per day" to the end of the definition was necessary for clarification.
4. WAC 246-918-802(15) and 246-919-852(15), definitions (formerly subsection (14) in the proposed rules, now adopted as renumbered subsection (15)). Final adopted language: "'Moderate-risk' is a category of patient at moderate risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, past history of substance use disorder or abuse, aberrant behavior, and dose of opioids between fifty to ninety milligram morphine equivalent doses per day." Reason for this change: The commission determined adding "per day" to the end of the definition was necessary for clarification.
5. WAC 246-918-802(18) and 246-919-852(18), definitions (formerly subsection (17) in the proposed rules, now adopted as renumbered subsection (18)). Final adopted language: "'Opioid' means a drug that is either an opiate that is derived from the opium poppy or opiate-like that is a semi-synthetic or synthetic drug. Examples include morphine, codeine, hydrocodone, oxycodone, fentanyl, meperidine, tramadol, buprenorphine, and methadone when used to treat pain." Reason for this change: The commission determined adding "when used to treat pain" to the end of the definition was necessary for clarification.
6. WAC 246-918-820 Use of alternative modalities for pain treatment. Final adopted language: "The physician assistant shall exercise their professional judgment in selecting appropriate treatment modalities for acute nonoperative, acute perioperative, subacute, or chronic pain including the use of multimodal pharmacologic and nonpharmacologic therapy as an alternative to opioids whenever reasonable, clinically appropriate, evidence-based alternatives exist." WAC 246-919-870 Use of alternative modalities for pain treatment. Final adopted language: "The physician shall exercise their professional judgment in selecting appropriate treatment modalities for acute nonoperative, acute perioperative, subacute, or chronic pain including the use of multimodal pharmacologic and nonpharmacologic therapy as an alternative to opioids whenever reasonable, clinically appropriate, evidence-based alternatives exist." Reason for change: The commission determined adding "or chronic pain" was necessary for clarification.
7. WAC 246-918-825(1), Continuing education requirements for opioid prescribing. Final adopted language: "To prescribe an opioid in Washington state, a physician assistant licensed to prescribe opioids shall complete a one-time continuing education requirement regarding best practices in the prescribing of opioids or the opioid prescribing rules in this chapter." WAC 246-919-875(1), Continuing education requirements for opioid prescribing. Final adopted language: "To prescribe an opioid in Washington state, a physician licensed to prescribe opioids shall complete a one-time continuing education requirement regarding best practices in the prescribing of opioids or the opioid prescribing rules in this chapter." Reason for this change: The commission determined adding "regarding best practices in the prescribing of opioids or" was necessary to add more options for providers to complete this CME requirement.
8. WAC 246-918-845 (2)(b) and 246-919-895 (2)(b), Patient evaluation and patient recordSubacute pain. Final adopted language: "The observed or reported effect on function or pain control forming the basis to continue prescribing opioids beyond the acute pain episode;". Reason for this change: The commission determined adding "or reported" was necessary for clarification.
9. WAC 246-918-850(2), Treatment planSubacute pain. Final adopted rule language: "During the subacute phase the physician assistant shall not prescribe beyond a fourteen-day supply of opioids without clinical documentation to justify the need for such a quantity." WAC 246-919-900(2), Treatment planSubacute pain. Final adopted rule language: "During the subacute phase the physician shall not prescribe beyond a fourteen-day supply of opioids without clinical documentation to justify the need for such a quantity." Reason for this change: The commission determined moving "During the subacute phase" to the beginning of the sentence was necessary for clarification.
10. WAC 246-918-855 (1)(c) and 246-919-905 (1)(c), Patient evaluation and patient recordChronic pain. Final adopted language: "Current and relevant past treatments for pain, including opioids and other medications and their efficacy;". Reason for this change: The commission determined adding "and relevant" was necessary for clarification.
11. WAC 246-918-870(4) and 246-919-920(4), Periodic reviewChronic pain (formerly WAC 246-918-865(9) and 246-919-915(9)). Final adopted language: Subsections (9) in both MD and PA WAC 246-918-865 and 246-918-915 were moved to WAC 246-918-870(4) and 246-918-920(4), Periodic reviewChronic pain. No other changes were made. Reason for this change: WAC 246-918-865(9) and 246-919-915(9), Written agreement for treatmentChronic pain were moved to WAC 246-918-870(4) and 246-919-920(4), Periodic reviewChronic pain, because the commission determined it aligned better with Periodic reviewChronic pain section.
12. WAC 246-918-800 through 246-918-935 and 246-919-850 through 246-919-985. Final adopted language: Changed the term "podiatrist" to "podiatric physician" throughout MD and PA chapters. Reason for this change: All references to podiatrist were changed to podiatric physician throughout the pain management sections because this is the proper term for these providers.
13. WAC 246-918-802(1) and 246-919-852(1), Definitions. Final adopted language: "'Aberrant behavior' means behavior that indicates current misuse, diversion, unauthorized use of alcohol or other controlled substances, or multiple early refills (renewals)." Reason for this change: The term "active opioid use disorder" was deleted from this definition because the commission determined opioid use disorder is not an aberrant behavior.
14. WAC 246-918-840(1), Treatment planAcute perioperative pain. Final adopted language: "The physician assistant should consider prescribing nonopioids as the first line of pain control in patients, unless not clinically appropriate, in accordance with the provisions of WAC 246-918-820." WAC 246-919-890(1), Treatment planAcute perioperative pain. Final adopted language: "The physician should consider prescribing nonopioids as the first line of pain control in patients, unless not clinically appropriate, in accordance with the provisions of WAC 246-919-870." Reason for this change: The word "shall" was changed to "should" for clarity and consistency with WAC 246-919-885(1). 
15. WAC 246-918-870 (2)(c) Periodic review. Final adopted language: "If continuation or modification of medications for pain management treatment is necessary based on the physician assistant's evaluation of progress towards or maintenance of treatment objectives and compliance with the treatment plan." WAC 246-919-920 (2)(c), Periodic review. Final adopted language: "If continuation or modification of medications for pain management treatment is necessary based on the physician's evaluation of progress towards or maintenance of treatment objectives and compliance with the treatment plan." Reason for this change: The phrase "or maintenance of" was added for clarity to ensure that the goal for some patients is maintenance of pain level and functional level rather than improvement (progress).
16. WAC 246-918-870 (3)(b) and 246-919-920 (3)(b), Periodic reviewChronic pain. Final adopted language: "Use of validated tools or patient report from reliable patients to document either maintenance or change in function and pain control;". Reason for this change: The phrase "or patient report from reliable patients" was added because it clarified accepted sources of information.
17. WAC 246-918-885 ConsultationExemptions for exigent and special circumstances. Final rule language: WAC 246-918-885, "A physician assistant is not required to consult with a pain management specialist as defined in WAC 246-918-895 when the physician assistant has documented adherence to all standards of practice as defined in WAC 246-918-855 through 246-918-875 and when one or more of the following conditions are met:". WAC 246-919-935 ConsultationExemptions for exigent and special circumstances. Final rule language: "A physician is not required to consult with a pain management specialist as defined in WAC 246-919-945 when the physician has documented adherence to all standards of practice as defined in WAC 246-919-905 through 246-919-940, and when one or more of the following conditions are met:". Reason for this change: Updated the WAC numbers referenced in the first paragraph to align with the new WAC numbers used in the revised pain management sections.
18. WAC 246-918-915(2), Episodic care of chronic opioid patients. Final adopted rule language: "A physician assistant providing episodic care to a patient who the physician assistant knows is being treated with opioids for chronic pain should provide additional analgesics, including opioids when appropriate, to adequately treat acute pain." WAC 246-919-965(2), Episodic care of chronic opioid patients. Final adopted rule language: "A physician providing episodic care to a patient who the physician knows is being treated with opioids for chronic pain should provide additional analgesics, including opioids when appropriate, to adequately treat acute pain." Reason for this change: The phrase "when appropriate" was added to clarify that opioids should be prescribed only when appropriate.
19. WAC 246-918-925(1), Coprescribing of opioids for patients receiving medication assisted treatment. Final adopted language: "Where practicable, the physician assistant providing acute nonoperative pain or acute perioperative pain treatment to a patient who is known to be receiving MAT medications shall prescribe opioids for pain relief when appropriate for pain relief either in consultation with a MAT prescribing practitioner or a pain specialist." WAC 246-919-975(1), Coprescribing of opioids for patients receiving medication assisted treatment. Final adopted language: "Where practicable, the physician providing acute nonoperative pain or acute perioperative pain treatment to a patient who is known to be receiving MAT medications shall prescribe opioids for pain relief when appropriate for pain relief either in consultation with a MAT prescribing practitioner or a pain specialist." Reason for this change: The phrase "when appropriate" was added to clarify that opioids should be prescribed only when appropriate.
20. WAC 246-918-801 Exclusions. Final adopted language: "WAC 246-918-800 through 246-918-935 do not apply to:
(1) The treatment of patients with cancer-related pain;
(2) The provision of palliative, hospice, or other end-of-life care;
(3) The treatment of inpatient hospital patients who are patients who have been admitted to a hospital for more than twenty-four hours; or
(4) The provision of procedural medications."
Reason for this change: The commission determined the MD and PA chapters should be substantially similar. Adding this new language to the PA sections makes them so.
21. WAC 246-919-895 (2)(h), final adopted language: "The risk-benefit analysis of any combination of prescribed opioid and benzodiazepines or sedative-hypnotics, if applicable." Reason for this change: The "; and" should have been removed as it was inadvertently left in rule after editing subsection (2).
A final cost-benefit analysis is available by contacting Daidria Amelia Underwood, P.O. Box 47866, phone 360-236-2727, fax 360-236-2795, TTY 360-833-6388 or 711, email daidria.underwood@doh.wa.gov, web site wmc.wa.gov.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 50, Amended 6, Repealed 22.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 50, Amended 6, Repealed 22.
Date Adopted: August 22, 2018.
Melanie de Leon
Executive Director
OPIOID PRESCRIBINGGENERAL PROVISIONS
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-918-800((Pain management))Intent and scope.
((These))The rules in WAC 246-918-800 through 246-918-935 govern the ((use))prescribing 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.))
The Washington state medical quality assurance commission (commission) recognizes that principles of quality medical practice dictate that the people of the state of Washington have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity, mortality, and costs associated with untreated or inappropriately treated pain. For the purposes of ((this))these rules, the inappropriate treatment of pain includes nontreatment, undertreatment, overtreatment, and the continued use of ineffective treatments.
The diagnosis and treatment of pain is integral to the practice of medicine. The commission encourages physician assistants to view pain management as a part of quality medical practice for all patients with pain, including acute ((or)), perioperative, subacute, and chronic((, and it is especially urgent for patients who experience pain as a result of terminal illness))pain. All physician assistants should become knowledgeable about assessing patients' pain and effective methods of pain treatment, as well as statutory requirements for prescribing ((controlled substances))opioids, including co-occurring prescriptions. Accordingly, ((this rule has been developed to))these rules clarify the commission's position on pain control, particularly as related to the use of controlled substances, to alleviate physician assistant uncertainty and to encourage better pain management.
Inappropriate pain treatment may result from a physician assistant's lack of knowledge about pain management. Fears of investigation or sanction by federal, state, ((and))or local agencies may also result in inappropriate treatment of pain. Appropriate pain management is the treating physician assistant's responsibility. As such, the commission will consider the inappropriate treatment of pain to be a departure from standards of practice and will investigate such allegations, recognizing that some types of pain cannot be completely relieved, and taking into account whether the treatment is appropriate for the diagnosis.
The commission recognizes that controlled substances including opioids((analgesics)) may be essential in the treatment of acute, subacute, perioperative, or chronic pain due to disease, illness, trauma, or surgery ((and chronic pain, whether due to cancer or noncancer origins)). The commission will refer to current clinical practice guidelines and expert review in approaching cases involving management of pain. The medical management of pain should consider current clinical knowledge and scientific research and the use of pharmacologic and nonpharmacologic modalities according to the judgment of the physician assistant. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity, duration, impact of the pain, and treatment outcomes. Physician assistants should recognize that tolerance and physical dependence are normal consequences of sustained use of opioids((analgesics)) and are not the same as ((addiction))opioid use disorder.
The commission is obligated under the laws of the state of Washington to protect the public health and safety. The commission recognizes that the use of opioids((analgesics)) for other than legitimate medical purposes poses a threat to the individual and society ((and that)). The inappropriate prescribing of controlled substances, including opioids((analgesics)), may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Accordingly, the commission expects that physician assistants incorporate safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances.
Physician assistants should not fear disciplinary action from the commission for ordering, prescribing, dispensing or administering controlled substances, including opioids((analgesics)), for a legitimate medical purpose and in the course of professional practice. The commission will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician assistant-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state or federal law is required.
The commission will judge the validity of the physician assistant's treatment of the patient based on available documentation, rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors.
These rules are designed to assist ((practitioners))physician assistants in providing appropriate medical care for patients. ((They are not inflexible rules or rigid practice requirements and are not intended, nor should they be used, to establish a legal standard of care outside the context of the medical quality assurance committee's jurisdiction.
The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the practitioner based on all the circumstances presented. Thus, an approach that differs from the rules, standing alone, does not necessarily imply that the approach was below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the rules when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of these rules. However, a practitioner who employs an approach substantially different from these rules is advised to document in the patient record information sufficient to justify the approach taken.))
The practice of medicine involves not only the science, but also the art of dealing with the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment.
Therefore, it should be recognized that adherence to these rules will not ((assure))guarantee an accurate diagnosis or a successful outcome. The sole purpose of these rules is to assist ((practitioners))physician assistants in following a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care.
For more specific best practices, the physician assistant may refer to clinical practice guidelines including, but not limited to, those produced by the agency medical directors' group, the Centers for Disease Control and Prevention, or the Bree Collaborative.
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-918-801Exclusions.
((The rules adopted under)) WAC 246-918-800 through ((246-918-813))246-918-935 do not apply to:
(1) ((To))The treatment of patients with cancer-related pain;
(2) 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.))
(3) The treatment of inpatient hospital patients who are patients who have been admitted to a hospital for more than twenty-four hours; or
(4) The provision of procedural medications.
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-918-802Definitions.
The definitions ((in this section)) apply ((in))to WAC 246-918-800 through ((246-918-813))246-918-935 unless the context clearly requires otherwise.
(1) "Aberrant behavior" means behavior that indicates current misuse, diversion, unauthorized use of alcohol or other controlled substances, or multiple early refills (renewals).
(2) "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)))Acute pain is of six weeks or less in duration.
(3) "Biological specimen test" or "biological specimen testing" means tests of urine, hair, or other biological samples for various drugs and metabolites.
(4) "Cancer-related pain" means pain that is an unpleasant, persistent, subjective sensory and emotional experience associated with actual or potential tissue injury or damage or described in such terms and is related to cancer or cancer treatment that interferes with usual functioning.
(5) "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. Chronic pain is considered to be pain that persists for more than twelve weeks.
(((4) "Comorbidity))(6) "Comorbidities" means a preexisting or coexisting physical or psychiatric disease or condition.
(((5)))(7) "Designee" means a licensed health care practitioner authorized by a prescriber to request and receive prescription monitoring program (PMP) data on their behalf.
(8) "Episodic care" means noncontinuing medical or dental care provided by a ((practitioner))physician assistant other than the designated primary ((care practitioner in the acute care setting, for example, urgent care or emergency department.
(6)))prescriber for a patient with chronic pain.
(9) "High dose" means a ninety milligram morphine equivalent dose (MED), or more, per day.
(10) "High-risk" is a category of patient at high risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, current substance use disorder or abuse, aberrant behavior, dose of opioids, or the use of any concurrent central nervous system depressant.
(11) "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)).
(((7)))(12) "Hospital" as defined in chapters 70.41, 71.12 RCW, and RCW 72.23.020.
(13) "Low-risk" is a category of patient at low risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, and dose of opioids of less than a fifty milligram morphine equivalent dose per day.
(14) "Medication assisted treatment" or "MAT" means the use of pharmacologic therapy, often in combination with counseling and behavioral therapies, for the treatment of substance use disorders.
(15) "Moderate-risk" is a category of patient at moderate risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, past history of substance use disorder or abuse, aberrant behavior, and dose of opioids between fifty to ninety milligram morphine equivalent doses per day.
(16) "Morphine equivalent dose" or "MED" means a conversion of various opioids to a morphine equivalent dose ((by the use of accepted))using the agency medical directors group or other conversion table((s))approved by the commission. MED is considered the same as morphine milligram equivalent or MME.
(((8)))(17) "Multidisciplinary pain clinic" means a ((clinic or office that provides comprehensive pain management and includes care provided by multiple available disciplines or treatment modalities, for example, medical care through physicians, physician assistants, osteopathic physicians, osteopathic physician assistants, advanced registered nurse practitioners, and physical therapy, occupational therapy, or other complementary therapies.
(9)))health care delivery facility staffed by physicians of different specialties and other nonphysician health care providers who specialize in the diagnosis and management of patients with chronic pain.
(18) "Opioid" means a drug that is either an opiate that is derived from the opium poppy or opiate-like that is a semi-synthetic or synthetic drug. Examples include morphine, codeine, hydrocodone, oxycodone, fentanyl, meperidine, tramadol, buprenorphine, and methadone when used to treat pain.
(19) "Palliative care" means care that maintains or improves the quality of life of patients and their families facing serious, advanced, or 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.))
(20) "Perioperative pain" means acute pain that occurs surrounding the performance of surgery.
(21) "Prescription monitoring program" or "PMP" means the Washington state prescription monitoring program authorized under chapter 70.225 RCW. Other jurisdictions may refer to this as the prescription drug monitoring program or PDMP.
(22) "Practitioner" means an advanced registered nurse practitioner licensed under chapter 18.79 RCW, a dentist licensed under chapter 18.32 RCW, a physician licensed under chapter 18.71 or 18.57 RCW, a physician assistant licensed under chapter 18.71A or 18.57A RCW, or a podiatric physician licensed under chapter 18.22 RCW.
(23) "Refill" or "renewal" means a second or subsequent filling of a previously issued prescription.
(24) "Subacute pain" is considered to be a continuation of pain that is six to twelve weeks in duration.
(25) "Substance use disorder" means a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Substance use disorder is not the same as physical dependence or tolerance that is a normal physiological consequence of extended opioid therapy for pain. It is characterized by behaviors that include, but are not limited to, impaired control over drug use, craving, compulsive use, or continued use despite harm.
NEW SECTION
WAC 246-918-815Patient notification, secure storage, and disposal.
(1) The physician assistant shall ensure the patient is provided the following information at the first issuance of a prescription for opioids and at the transition from acute to subacute, and subacute to chronic:
(a) Risks associated with the use of opioids as appropriate to the medical condition, the type of patient, and the phase of treatment;
(b) The safe and secure storage of opioid prescriptions; and
(c) The proper disposal of unused opioid medications including, but not limited to, the availability of recognized drug take-back programs.
(2) This requirement may be satisfied with a document provided by the department of health.
NEW SECTION
WAC 246-918-820Use of alternative modalities for pain treatment.
The physician assistant shall exercise their professional judgment in selecting appropriate treatment modalities for acute nonoperative, acute perioperative, subacute, or chronic pain including the use of multimodal pharmacologic and nonpharmacologic therapy as an alternative to opioids whenever reasonable, clinically appropriate, evidence-based alternatives exist.
NEW SECTION
WAC 246-918-825Continuing education requirements for opioid prescribing.
(1) To prescribe an opioid in Washington state, a physician assistant licensed to prescribe opioids shall complete a one-time continuing education requirement regarding best practices in the prescribing of opioids or the opioid prescribing rules in this chapter. The continuing education must be at least one hour in length.
(2) The physician assistant shall complete the one-time continuing education requirement described in subsection (1) of this section by the end of the physician assistant's first full continuing education reporting period after January 1, 2019, or during the first full continuing education reporting period after initial licensure, whichever is later.
(3) The hours spent completing training in prescribing of opioids count toward meeting applicable continuing education requirements in the same category specified in WAC 246-919-460.
OPIOID PRESCRIBINGACUTE NONOPERATIVE PAIN AND ACUTE PERIOPERATIVE PAIN
NEW SECTION
WAC 246-918-830Patient evaluation and patient recordAcute nonoperative pain.
Prior to issuing an opioid prescription for acute nonoperative pain or acute perioperative pain, the physician assistant shall:
(1) Conduct and document an appropriate history and physical examination, including screening for risk factors for overdose and severe postoperative pain;
(2) Evaluate the nature and intensity of the pain or anticipated pain following surgery; and
(3) Inquire about any other medications the patient is prescribed or is taking.
NEW SECTION
WAC 246-918-835Treatment planAcute nonoperative pain.
The physician assistant shall comply with the requirements in this section when prescribing opioids for acute nonoperative pain.
(1) The physician assistant should consider prescribing nonopioids as the first line of pain control in patients unless not clinically appropriate in accordance with the provisions of WAC 246-918-820.
(2) The physician assistant, or their designee, shall conduct queries of the PMP in accordance with the provisions of WAC 246-918-935.
(3) If the physician assistant prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain severe enough to require opioids. A three-day supply or less will often be sufficient. The physician assistant shall not prescribe beyond a seven-day supply without clinical documentation in the patient record to justify the need for such a quantity.
(4) The physician assistant shall reevaluate the patient who does not follow the expected course of recovery, and reconsider the continued use of opioids or whether tapering or discontinuing opioids is clinically indicated.
(5) Follow-up visits for pain control must include objectives or metrics to be used to determine treatment success if opioids are to be continued. This may include:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations.
(6) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-918-920, such prescribing must be in accordance with WAC 246-918-920.
(7) Long-acting or extended release opioids are not indicated for acute nonoperative pain.
(8) Medication assisted treatment medications must not be discontinued when treating acute pain, except as consistent with the provisions of WAC 246-918-925.
(9) If the physician assistant elects to treat a patient with opioids beyond the six-week time period of acute nonoperative pain, the physician assistant shall document in the patient record that the patient is transitioning from acute pain to subacute pain. Rules governing the treatment of subacute pain in WAC 246-918-845 and 246-918-850 shall apply.
NEW SECTION
WAC 246-918-840Treatment planAcute perioperative pain.
The physician assistant shall comply with the requirements in this section when prescribing opioids for perioperative pain.
(1) The physician assistant should consider prescribing nonopioids as the first line of pain control in patients unless not clinically appropriate in accordance with the provisions of WAC 246-918-820.
(2) The physician assistant, or their designee, shall conduct queries of the PMP in accordance with the provisions of WAC 246-918-935.
(3) If the physician assistant prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain severe enough to require opioids. A three-day supply or less will often be sufficient. The physician assistant shall not prescribe beyond a fourteen-day supply from the time of discharge without clinical documentation in the patient record to justify the need for such a quantity.
(4) The physician assistant shall reevaluate a patient who does not follow the expected course of recovery and reconsider the continued use of opioids or whether tapering or discontinuing opioids is clinically indicated.
(5) Follow-up visits for pain control should include objectives or metrics to be used to determine treatment success if opioids are to be continued. This may include:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations or other treatments.
(6) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-918-920, such prescribing must be in accordance with WAC 246-918-920.
(7) Long-acting or extended release opioids are not indicated for acute perioperative pain.
(8) Medication assisted treatment medications must not be discontinued when treating acute perioperative pain, except as consistent with the provisions of WAC 246-918-925.
(9) If the physician assistant elects to treat a patient with opioids beyond the six-week time period of acute perioperative pain, the physician assistant shall document in the patient record that the patient is transitioning from acute pain to subacute pain. Rules governing the treatment of subacute pain, WAC 246-918-845 and 246-918-850, shall apply unless there is documented improvement in function or pain control and there is a documented plan and timing for discontinuation of all opioid medications.
OPIOID PRESCRIBINGSUBACUTE PAIN
NEW SECTION
WAC 246-918-845Patient evaluation and patient recordSubacute pain.
The physician assistant shall comply with the requirements in this section when prescribing opioids for subacute pain.
(1) Prior to issuing an opioid prescription for subacute pain, the physician assistant shall assess the rationale for continuing opioid therapy:
(a) Conduct an appropriate history and physical examination;
(b) Reevaluate the nature and intensity of the pain;
(c) Conduct, or cause their designee to conduct, a query of the PMP in accordance with the provisions of WAC 246-918-935;
(d) Screen the patient's level of risk for aberrant behavior and adverse events related to opioid therapy;
(e) Obtain a biological specimen test if the patient's functional status is deteriorating or if pain is escalating; and
(f) Screen or refer the patient for further consultation for psychosocial factors if the patient's functional status is deteriorating or if pain is escalating.
(2) The physician assistant treating a patient for subacute pain with opioids shall ensure that, at a minimum, the following is documented in the patient record:
(a) The presence of one or more recognized diagnoses or indications for the use of opioid pain medication;
(b) The observed or reported effect on function or pain control forming the basis to continue prescribing opioids beyond the acute pain episode;
(c) Pertinent concerns discovered in the PMP;
(d) An appropriate pain treatment plan including the consideration of, or attempts to use, nonpharmacological modalities and nonopioid therapy;
(e) The action plan for any aberrant biological specimen testing results and the risk-benefit analysis if opioids are to be continued;
(f) Results of psychosocial screening or consultation;
(g) Results of screening for the patient's level of risk for aberrant behavior and adverse events related to opioid therapy, and mitigation strategies; and
(h) The risk-benefit analysis of any combination of prescribed opioid and benzodiazepines or sedative-hypnotics, if applicable.
(3) Follow-up visits for pain control must include objectives or metrics to be used to determine treatment success if opioids are to be continued. This includes, at a minimum:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations or other treatments.
NEW SECTION
WAC 246-918-850Treatment planSubacute pain.
The physician assistant, having recognized the progression of a patient from the acute nonoperative or acute perioperative phase to the subacute phase shall develop an opioid treatment plan.
(1) If tapering has not begun prior to the six- to twelve-week subacute phase, the physician assistant shall reevaluate the patient. Based on effect on function or pain control, the physician assistant shall consider whether opioids will be continued, tapered, or discontinued.
(2) If the physician assistant prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain that is severe enough to require opioids. During the subacute phase the physician assistant shall not prescribe beyond a fourteen-day supply of opioids without clinical documentation to justify the need for such a quantity.
(3) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-918-920, such prescribing must be in accordance with WAC 246-918-920.
(4) If the physician assistant elects to treat a patient with opioids beyond the six- to twelve-week subacute phase, the physician assistant shall document in the patient record that the patient is transitioning from subacute pain to chronic pain. Rules governing the treatment of chronic pain, WAC 246-918-855 through 246-918-905, shall apply.
OPIOID PRESCRIBINGCHRONIC PAIN MANAGEMENT
NEW SECTION
WAC 246-918-855Patient evaluation and patient recordChronic pain.
When the patient enters the chronic pain phase, the patient shall be reevaluated as if presenting with a new disease. The physician assistant shall include in the patient's record:
(1) An appropriate history including:
(a) The nature and intensity of the pain;
(b) The effect of pain on physical and psychosocial function;
(c) Current and relevant past treatments for pain, including opioids and other medications and their efficacy; and
(d) Review of comorbidities with particular attention to psychiatric and substance use.
(2) Appropriate physical examination.
(3) Ancillary information and tools to include:
(a) Review of the PMP to identify any medications received by the patient in accordance with the provisions of WAC 246-919-985;
(b) Any pertinent diagnostic, therapeutic, and laboratory results;
(c) Pertinent consultations; and
(d) Use of a risk assessment tool that is a professionally developed, clinically recommended questionnaire appropriate for characterizing a patient's level of risk for opioid or other substance use disorders to assign the patient to a high-, moderate-, or low-risk category.
(4) Assessment. The physician assistant must document medical decision making to include:
(a) Pain related diagnosis, including documentation of the presence of one or more recognized indications for the use of pain medication;
(b) Consideration of the risks and benefits of chronic opioid treatment for the patient;
(c) The observed or reported effect on function or pain control forming the basis to continue prescribing opioids; and
(d) Pertinent concerns discovered in the PMP.
(5) Treatment plan as provided in WAC 246-918-860.
NEW SECTION
WAC 246-918-860Treatment planChronic pain.
The physician assistant, having recognized the progression of a patient from the subacute phase to the chronic phase, shall develop an opioid treatment plan as follows:
(1) Treatment plan and objectives including:
(a) Documentation of any medication prescribed;
(b) Biologic specimen testing ordered;
(c) Any labs, diagnostic evaluations, referrals, or imaging ordered;
(d) Other planned treatments; and
(e) Written agreement for treatment as provided in WAC 246-918-865.
(2) The physician assistant shall complete patient notification in accordance with the provisions of WAC 246-918-815 or provide this information in the written agreement.
NEW SECTION
WAC 246-918-865Written agreement for treatmentChronic pain.
The physician assistant shall use a written agreement that outlines the patient's responsibilities for opioid therapy. This written agreement for treatment must include the following provisions:
(1) The patient's agreement to provide samples for biological specimen testing 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 opioid therapy may be discontinued;
(4) The requirement that all opioid prescriptions for chronic pain are provided by a single prescriber or a single clinic, except as provided in WAC 246-918-915 for episodic care;
(5) The requirement that all opioid prescriptions for chronic pain are to be dispensed by a single pharmacy or pharmacy system whenever possible;
(6) The patient's agreement to not abuse alcohol or use other medically unauthorized substances;
(7) A violation of the agreement may result in a tapering or discontinuation of the prescription; and
(8) The patient's responsibility to safeguard all medications and keep them in a secure location.
NEW SECTION
WAC 246-918-870Periodic reviewChronic pain.
(1) The physician assistant shall periodically review the course of treatment for chronic pain. The frequency of visits, biological testing, and PMP queries in accordance with the provisions of WAC 246-918-935, must be determined based on the patient's risk category:
(a) For a high-risk patient, at least quarterly;
(b) For a moderate-risk patient, at least semiannually;
(c) For a low-risk patient, at least annually;
(d) Immediately upon indication of concerning aberrant behavior; and
(e) More frequently at the physician assistant's discretion.
(2) During the periodic review, the physician assistant shall determine:
(a) The patient's compliance with any medication treatment plan;
(b) If pain, function, and quality of life have improved, diminished, or are maintained; and
(c) If continuation or modification of medications for pain management treatment is necessary based on the physician assistant's evaluation of progress towards or maintenance of treatment objectives and compliance with the treatment plan.
(3) Periodic patient evaluations must also include:
(a) History and physical examination related to the pain;
(b) Use of validated tools or patient report from reliable patients to document either maintenance or change in function and pain control; and
(c) Review of the Washington state PMP at a frequency determined by the patient's risk category in accordance with the provisions of WAC 246-918-935 and subsection (1) of this section.
(4) 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 246-918-875Long-acting opioidsChronic pain.
Long-acting opioids 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. The physician assistant prescribing long-acting opioids should have a one-time completion of at least four hours of continuing education relating to this topic.
NEW SECTION
WAC 246-918-880ConsultationRecommendations and requirementsChronic pain.
(1) 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 pain patients who are under eighteen years of age or who are potential high-risk patients.
(2) The mandatory consultation threshold is one hundred twenty milligrams MED. In the event a physician assistant prescribes a dosage amount that meets or exceeds the consultation threshold of one hundred twenty milligrams MED per day, a consultation with a pain management specialist as described in WAC 246-918-895 is required, unless the consultation is exempted under WAC 246-918-885 or 246-918-890.
(3) The mandatory consultation must consist of at least one of the following:
(a) An office visit with the patient and the pain management specialist;
(b) A telephone, electronic, or in-person consultation between the pain management specialist and the physician assistant;
(c) 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; or
(d) Other chronic pain evaluation services as approved by the commission.
(4) A physician assistant shall document each consultation with the pain management specialist.
NEW SECTION
WAC 246-918-885ConsultationExemptions for exigent and special circumstancesChronic pain.
A physician assistant is not required to consult with a pain management specialist as defined in WAC 246-918-895 when the physician assistant has documented adherence to all standards of practice as defined in WAC 246-918-855 through 246-918-875 and when one or more of the following conditions are met:
(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 an expected return to their baseline dosage level or below;
(3) The physician assistant documents reasonable attempts to obtain a consultation with a pain management specialist and the circumstances justifying prescribing above one hundred twenty milligrams morphine equivalent dose (MED) per day without first obtaining a consultation; or
(4) The physician assistant documents the patient's pain and function are stable and the patient is on a nonescalating dosage of opioids.
NEW SECTION
WAC 246-918-890ConsultationExemptions for the physician assistantChronic pain.
The physician assistant is exempt from the consultation requirement in WAC 246-918-880 if one or more of the following qualifications are met:
(1) The physician assistant is a pain management specialist under WAC 246-918-895;
(2) The physician assistant has successfully completed a minimum of twelve category I continuing education hours on chronic pain management within the previous four years. At least two of these hours must be dedicated to substance use disorders;
(3) The physician assistant is a pain management physician assistant working in a multidisciplinary chronic pain treatment center or a multidisciplinary academic research facility; or
(4) The physician assistant has a minimum of three years of clinical experience in a chronic pain management setting, and at least thirty percent of their current practice is the direct provision of pain management care.
NEW SECTION
WAC 246-918-895Pain management specialistChronic pain.
A pain management specialist shall meet one or more of the following qualifications:
(1) If an allopathic physician assistant or osteopathic physician assistant must have a delegation agreement with a physician pain management specialist and meets the educational requirements and practice requirements listed below:
(a) A minimum of three years of clinical experience in a chronic pain management care setting;
(b) Credentialed in pain management by an entity approved by the Washington state medical quality assurance commission for an allopathic physician assistant or the Washington state board of osteopathic medicine and surgery for an osteopathic physician assistant;
(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 physician assistant's current practice is the direct provision of pain management care or in a multidisciplinary pain clinic.
(2) If an allopathic physician, in accordance with WAC 246-919-945.
(3) If an osteopathic physician, in accordance with WAC 246-853-750.
(4) If a dentist, in accordance with WAC 246-817-965.
(5) If a podiatric physician, in accordance with WAC 246-922-750.
(6) If an advanced registered nurse practitioner, in accordance with WAC 246-840-493.
NEW SECTION
WAC 246-918-900Tapering considerationsChronic pain.
The physician assistant shall consider tapering or referral for a substance use disorder evaluation when:
(1) The patient requests;
(2) The patient experiences a deterioration in function or pain;
(3) The patient is noncompliant with the written agreement;
(4) Other treatment modalities are indicated;
(5) There is evidence of misuse, abuse, substance use disorder, or diversion;
(6) The patient experiences a severe adverse event or overdose;
(7) There is unauthorized escalation of doses; or
(8) The patient is receiving an escalation in opioid dosage with no improvement in their pain or function.
NEW SECTION
WAC 246-918-905Patients with chronic pain, including those on high doses of opioids, establishing a relationship with a new physician assistant.
(1) When a patient receiving chronic opioid pain medications changes to a new physician assistant, it is normally appropriate for the new physician assistant to initially maintain the patient's current opioid doses. Over time, the physician assistant may evaluate if any tapering or other adjustments in the treatment plan can or should be done.
(2) A physician assistant's treatment of a new high dose chronic pain patient is exempt from the mandatory consultation requirements of WAC 246-918-880 if:
(a) The patient was previously being treated with a dosage of opioids in excess of a one hundred twenty milligram MED for chronic pain under an established written agreement for treatment of the same chronic condition or conditions;
(b) The patient's dose is stable and nonescalating;
(c) The patient has a history of compliance with treatment plans and written agreements documented by medical records and PMP queries; and
(d) The patient has documented functional stability, pain control, or improvements in function or pain control at the presenting opioid dose.
(3) With respect to the treatment of a new patient under subsection (1) or (2) of this section, this exemption applies for the first three months of newly established care, after which the requirements of WAC 246-918-880 shall apply.
OPIOID PRESCRIBINGSPECIAL POPULATIONS
NEW SECTION
WAC 246-918-910Special populationsChildren or adolescent patients, pregnant patients, and aging populations.
(1) Children or adolescent patients. In the treatment of pain for children or adolescent patients, the physician assistant shall treat pain in a manner equal to that of an adult but must account for the weight of the patient and adjust the dosage prescribed accordingly.
(2) Pregnant patients. The physician assistant shall not initiate opioid detoxification without consultation with a provider with expertise in addiction medicine. Medication assisted treatment for opioids, such as methadone or buprenorphine, must not be discontinued during pregnancy without consultation with a MAT prescribing practitioner.
(3) Aging populations. As people age, their sensitivities to and metabolizing of opioids may change. The physician assistant shall consider the distinctive needs of patients who are sixty-five years of age or older and who have been on chronic opioid therapy or who are initiating opioid treatment.
NEW SECTION
WAC 246-918-915Episodic care of chronic opioid patients.
(1) When providing episodic care for a patient who the physician assistant knows is being treated with opioids for chronic pain, such as for emergency or urgent care, the physician assistant, or their designee, shall review the PMP and document their review and any concerns.
(2) A physician assistant providing episodic care to a patient who the physician assistant knows is being treated with opioids for chronic pain should provide additional analgesics, including opioids when appropriate, to adequately treat acute pain. If opioids are provided, the physician assistant shall limit the use of opioids to the minimum amount necessary to control the acute pain until the patient can receive care from the practitioner who is managing the patient's chronic pain.
(3) The episodic care physician assistant shall coordinate care with the patient's chronic pain treatment practitioner, if possible.
OPIOID PRESCRIBINGCOPRESCRIBING
NEW SECTION
WAC 246-918-920Coprescribing of opioids with certain medications.
(1) The physician assistant shall not knowingly prescribe opioids in combination with the following medications without documentation of medical decision making:
(a) Benzodiazepines;
(b) Barbiturates;
(c) Sedatives;
(d) Carisoprodol; or
(e) Nonbenzodiazepine hypnotics.
(2) If, because of a prior prescription by another provider, a prescription written by a physician assistant results in a combination of opioids and medications described in subsection (1) of this section, the physician assistant issuing the new prescription shall consult with the other prescriber to establish a patient care plan surrounding these medications. This provision does not apply to emergency care.
NEW SECTION
WAC 246-918-925Coprescribing of opioids for patients receiving medication assisted treatment.
(1) Where practicable, the physician assistant providing acute nonoperative pain or acute perioperative pain treatment to a patient who is known to be receiving MAT medications shall prescribe opioids when appropriate for pain relief either in consultation with a MAT prescribing practitioner or a pain specialist.
(2) The physician assistant providing acute nonoperative pain or acute perioperative pain treatment shall not discontinue MAT medications without documentation of the reason for doing so, nor shall the use of these medications be used to deny necessary operative intervention.
NEW SECTION
WAC 246-918-930Coprescribing of naloxone.
The opioid prescribing physician assistant shall confirm or provide a current prescription for naloxone when opioids are prescribed to a high-risk patient.
OPIOID PRESCRIBINGPRESCRIPTION MONITORING PROGRAM
NEW SECTION
WAC 246-918-935Prescription monitoring programRequired registration, queries, and documentation.
(1) The physician assistant shall register to access the PMP or demonstrate proof of having assured access to the PMP if they prescribe Schedule II-V medications in Washington state.
(2) The physician assistant is permitted to delegate performance of a required PMP query to an authorized designee.
(3) At a minimum, the physician assistant shall ensure a PMP query is performed prior to the prescription of an opioid or of a medication listed in WAC 246-918-920 at the following times:
(a) Upon the first refill or renewal of an opioid prescription for acute nonoperative pain or acute perioperative pain;
(b) The time of transition from acute to subacute pain; and
(c) The time of transition from subacute to chronic pain.
(4) For chronic pain management, the physician assistant shall ensure a PMP query is performed at a minimum frequency determined by the patient's risk assessment, as follows:
(a) For a high-risk patient, a PMP query shall be completed at least quarterly;
(b) For a moderate-risk patient, a PMP query shall be completed at least semiannually; and
(c) For a low-risk patient, a PMP query shall be completed at least annually.
(5) The physician assistant shall ensure a PMP query is performed for any chronic pain patient immediately upon identification of aberrant behavior.
(6) The physician assistant shall ensure a PMP query is performed when providing episodic care to a patient who the physician assistant knows to be receiving opioids for chronic pain, in accordance with WAC 246-918-915.
(7) If the physician assistant is using an electronic medical record (EMR) that integrates access to the PMP into the workflow of the EMR, the physician assistant shall ensure a PMP query is performed for all prescriptions of opioids and medications listed in WAC 246-918-920.
(8) For the purposes of this section, the requirement to consult the PMP does not apply when the PMP or the EMR cannot be accessed by the physician assistant or their designee due to a temporary technological or electrical failure.
(9) Pertinent concerns discovered in the PMP shall be documented in the patient record.
REPEALER
The following sections of the Washington Administrative Code are repealed:
WAC 246-918-803
Patient evaluation.
WAC 246-918-804
Treatment plan.
WAC 246-918-805
Informed consent.
WAC 246-918-806
Written agreement for treatment.
WAC 246-918-807
Periodic review.
WAC 246-918-808
Long-acting opioids, including methadone.
WAC 246-918-809
Episodic care.
WAC 246-918-810
Consultation—Recommendations and requirements.
WAC 246-918-811
Consultation—Exemptions for exigent and special circumstances.
WAC 246-918-812
Consultation—Exemptions for the physician assistant.
WAC 246-918-813
Pain management specialist.
((PAIN MANAGEMENT))OPIOID PRESCRIBINGGENERAL PROVISIONS
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-919-850((Pain management))Intent and scope.
((These))The rules in WAC 246-919-850 through 246-919-985 govern the ((use))prescribing of opioids in the treatment of ((patients for chronic noncancer)) pain.
The Washington state medical quality assurance commission (commission) recognizes that principles of quality medical practice dictate that the people of the state of Washington have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity, mortality, and costs associated with untreated or inappropriately treated pain. For the purposes of ((this))these rules, the inappropriate treatment of pain includes nontreatment, undertreatment, overtreatment, and the continued use of ineffective treatments.
The diagnosis and treatment of pain is integral to the practice of medicine. The commission encourages physicians to view pain management as a part of quality medical practice for all patients with pain((,))including acute ((or)), perioperative, subacute, and chronic((, and it is especially urgent for patients who experience)) pain ((as a result of terminal illness)). All physicians should become knowledgeable about assessing patients' pain and effective methods of pain treatment, as well as become knowledgeable about the statutory requirements for prescribing ((controlled substances))opioids including co-occurring prescriptions. Accordingly, ((this rule has been developed to))these rules clarify the commission's position on pain control, particularly as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.
Inappropriate pain treatment may result from a physician's lack of knowledge about pain management. Fears of investigation or sanction by federal, state, ((and))or local agencies may also result in inappropriate treatment of pain. Appropriate pain management is the treating physician's responsibility. As such, the commission will consider the inappropriate treatment of pain to be a departure from standards of practice and will investigate such allegations, recognizing that some types of pain cannot be completely relieved, and taking into account whether the treatment is appropriate for the diagnosis.
The commission recognizes that controlled substances including opioids((analgesics)) may be essential in the treatment of acute, subacute, perioperative, or chronic pain due to disease, illness, trauma or surgery ((and chronic pain, whether due to cancer or noncancer origins)). The commission will refer to current clinical practice guidelines and expert review in approaching cases involving management of pain.
The medical management of pain should consider current clinical knowledge ((and)), scientific research, and the use of pharmacologic and nonpharmacologic modalities according to the judgment of the physician. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity, duration, impact of the pain, and treatment outcomes. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioids((analgesics)) and are not the same as ((addiction))opioid use disorder.
The commission is obligated under the laws of the state of Washington to protect the public health and safety. The commission recognizes that the use of opioids((analgesics)) for other than legitimate medical purposes poses a threat to the individual and society ((and that)). The inappropriate prescribing of controlled substances, including opioids((analgesics)), may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Accordingly, the commission expects that physicians incorporate safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances.
Physicians should not fear disciplinary action from the commission for ordering, prescribing, dispensing or administering controlled substances, including opioids((analgesics)), for a legitimate medical purpose and in the course of professional practice. The commission will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state or federal law is required.
The commission will judge the validity of the physician's treatment of the patient based on available documentation, rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors.
These rules are designed to assist ((practitioners))physicians in providing appropriate medical care for patients. ((They are not inflexible rules or rigid practice requirements and are not intended, nor should they be used, to establish a legal standard of care outside the context of the medical quality assurance committee's jurisdiction.
The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the practitioner based on all the circumstances presented. Thus, an approach that differs from the rules, standing alone, does not necessarily imply that the approach was below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the rules when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of these rules. However, a practitioner who employs an approach substantially different from these rules is advised to document in the patient record information sufficient to justify the approach taken.))
The practice of medicine involves not only the science, but also the art of dealing with the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment.
Therefore, it should be recognized that adherence to these rules will not ((assure))guarantee an accurate diagnosis or a successful outcome. The sole purpose of these rules is to assist ((practitioners))physicians in following a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care.
For more specific best practices, the physician may refer to clinical practice guidelines including, but not limited to, those produced by the agency medical directors' group, the Centers for Disease Control and Prevention, or the Bree Collaborative.
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-919-851Exclusions.
((The rules adopted under)) WAC 246-919-850 through ((246-919-863))246-919-985 do not apply to:
(1) ((To))The treatment of patients with cancer-related pain;
(2) 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.))
(3) The treatment of inpatient hospital patients who are patients who have been admitted to a hospital for more than twenty-four hours; or
(4) The provision of procedural medications.
AMENDATORY SECTION(Amending WSR 11-12-025, filed 5/24/11, effective 1/2/12)
WAC 246-919-852Definitions.
The following definitions ((in))apply to WAC 246-919-850 through ((246-919-863 apply))246-919-985 unless the context clearly requires otherwise.
(1) "Aberrant behavior" means behavior that indicates current misuse, diversion, unauthorized use of alcohol or other controlled substances, or multiple early refills (renewals).
(2) "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)))Acute pain is six weeks or less in duration.
(3) "Biological specimen test" or "biological specimen testing" means tests of urine, hair, or other biological samples for various drugs and metabolites.
(4) "Cancer-related pain" means pain that is an unpleasant, persistent, subjective sensory and emotional experience associated with actual or potential tissue injury or damage or described in such terms and is related to cancer or cancer treatment that interferes with usual functioning.
(5) "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))which may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years. Chronic pain is considered to be pain that persists for more than twelve weeks.
(((4) "Comorbidity))(6) "Comorbidities" means a preexisting or coexisting physical or psychiatric disease or condition.
(((5)))(7) "Designee" means a licensed health care practitioner authorized by a prescriber to request and receive prescription monitoring program (PMP) data on their behalf.
(8) "Episodic care" means noncontinuing medical or dental care provided by a ((practitioner))physician other than the designated primary ((care practitioner in the acute care setting, for example, urgent care or emergency department.
(6)))prescriber for a patient with chronic pain.
(9) "High dose" means a ninety milligram morphine equivalent dose (MED), or more, per day.
(10) "High-risk" is a category of patient at high risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, current substance use disorder or abuse, aberrant behavior, dose of opioids, or the use of any concurrent central nervous system depressant.
(11) "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)).
(((7)))(12) "Hospital" means any health care institution licensed pursuant to chapters 70.41 and 71.12 RCW, and RCW 72.23.020.
(13) "Low-risk" is a category of patient at low risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, and dose of opioids of less than a fifty milligram morphine equivalent dose per day.
(14) "Medication assisted treatment" or "MAT" means the use of pharmacologic therapy, often in combination with counseling and behavioral therapies, for the treatment of substance use disorders.
(15) "Moderate-risk" is a category of patient at moderate risk of opioid-induced morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, past history of substance use disorder or abuse, aberrant behavior, and dose of opioids between fifty to ninety milligram morphine equivalent doses per day.
(16) "Morphine equivalent dose" or "MED" means a conversion of various opioids to a morphine equivalent dose ((by the use of accepted))using the agency medical directors' group or other conversion table((s))approved by the commission. MED is considered the same as morphine milligram equivalent or MME.
(((8)))(17) "Multidisciplinary pain clinic" means a ((clinic or office that provides comprehensive pain management and includes care provided by multiple available disciplines or treatment modalities, for example, medical care through physicians, physician assistants, osteopathic physicians, osteopathic physician assistants, advanced registered nurse practitioners, and physical therapy, occupational therapy, or other complementary therapies.
(9)))health care delivery facility staffed by physicians of different specialties and other nonphysician health care providers who specialize in the diagnosis and management of patients with chronic pain.
(18) "Opioid" means a drug that is either an opiate that is derived from the opium poppy or opiate-like that is a semisynthetic or synthetic drug. Examples include morphine, codeine, hydrocodone, oxycodone, fentanyl, meperidine, tramadol, buprenorphine, and methadone when used to treat pain.
(19) "Palliative care" means care that maintains or improves the quality of life of patients and their families facing serious, advanced, or 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.))
(20) "Perioperative pain" means acute pain that occurs surrounding the performance of surgery.
(21) "Prescription monitoring program" or "PMP" means the Washington state prescription monitoring program authorized under chapter 70.225 RCW. Other jurisdictions may refer to this as the prescription drug monitoring program or "PDMP."
(22) "Practitioner" means an advanced registered nurse practitioner licensed under chapter 18.79 RCW, a dentist licensed under chapter 18.32 RCW, a physician licensed under chapter 18.71 or 18.57 RCW, a physician assistant licensed under chapter 18.71A or 18.57A RCW, or a podiatric physician licensed under chapter 18.22 RCW.
(23) "Refill" or "renewal" means a second or subsequent filling of a previously issued prescription.
(24) "Subacute pain" is considered to be a continuation of pain that is six- to twelve-weeks in duration.
(25) "Substance use disorder" means a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Substance use disorder is not the same as physical dependence or tolerance that is a normal physiological consequence of extended opioid therapy for pain. It is characterized by behaviors that include, but are not limited to, impaired control over drug use, craving, compulsive use, or continued use despite harm.
NEW SECTION
WAC 246-919-865Patient notification, secure storage, and disposal.
(1) The physician shall ensure the patient is provided the following information at the first issuance of a prescription for opioids and at the transition from acute to subacute, and subacute to chronic:
(a) Risks associated with the use of opioids as appropriate to the medical condition, the type of patient, and the phase of treatment;
(b) The safe and secure storage of opioid prescriptions; and
(c) The proper disposal of unused opioid medications including, but not limited to, the availability of recognized drug take-back programs.
(2) This requirement may be satisfied with a document provided by the department of health.
NEW SECTION
WAC 246-919-870Use of alternative modalities for pain treatment.
The physician shall exercise their professional judgment in selecting appropriate treatment modalities for acute nonoperative, acute perioperative, subacute, or chronic pain including the use of multimodal pharmacologic and nonpharmacologic therapy as an alternative to opioids whenever reasonable, clinically appropriate, evidence-based alternatives exist.
NEW SECTION
WAC 246-919-875Continuing education requirements for opioid prescribing.
(1) To prescribe an opioid in Washington state, a physician licensed to prescribe opioids shall complete a one-time continuing education requirement regarding best practices in the prescribing of opioids or the opioid prescribing rules in this chapter. The continuing education must be at least one hour in length.
(2) The physician shall complete the one-time continuing education requirement described in subsection (1) of this section by the end of the physician's first full continuing education reporting period after January 1, 2019, or during the first full continuing education reporting period after initial licensure, whichever is later.
(3) The hours spent completing training in prescribing of opioids count toward meeting applicable continuing education requirements in the same category specified in WAC 246-919-460.
OPIOID PRESCRIBINGACUTE NONOPERATIVE PAIN AND ACUTE PERIOPERATIVE PAIN
NEW SECTION
WAC 246-919-880Patient evaluation and patient recordAcute nonoperative pain.
Prior to issuing an opioid prescription for acute nonoperative pain or acute perioperative pain, the physician shall:
(1) Conduct and document an appropriate history and physical examination including screening for risk factors for overdose and severe postoperative pain;
(2) Evaluate the nature and intensity of the pain or anticipated pain following surgery; and
(3) Inquire about any other medications the patient is prescribed or is taking.
NEW SECTION
WAC 246-919-885Treatment planacute nonoperative pain.
The physician shall comply with the requirements in this section when prescribing opioids for acute nonoperative pain.
(1) The physician should consider prescribing nonopioids as the first line of pain control in patients unless not clinically appropriate in accordance with the provisions of WAC 246-919-870.
(2) The physician, or their designee, shall conduct queries of the PMP in accordance with the provisions of WAC 246-919-985.
(3) If the physician prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain severe enough to require opioids. A three-day supply or less will often be sufficient. The physician shall not prescribe beyond a seven-day supply without clinical documentation in the patient record to justify the need for such a quantity.
(4) The physician shall reevaluate the patient who does not follow the expected course of recovery, and reconsider the continued use of opioids or whether tapering or discontinuing opioids is clinically indicated.
(5) Follow-up visits for pain control must include objectives or metrics to be used to determine treatment success if opioids are to be continued. This may include:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations.
(6) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-919-970, such prescribing must be in accordance with WAC 246-919-970.
(7) Long-acting or extended release opioids are not indicated for acute nonoperative pain.
(8) Medication assisted treatment medications must not be discontinued when treating acute pain, except as consistent with the provisions of WAC 246-919-975.
(9) If the physician elects to treat a patient with opioids beyond the six-week time period of acute nonoperative pain, the physician shall document in the patient record that the patient is transitioning from acute pain to subacute pain. Rules governing the treatment of subacute pain in WAC 246-919-895 and 246-919-900 shall apply.
NEW SECTION
WAC 246-919-890Treatment planAcute perioperative pain.
The physician shall comply with the requirements in this section when prescribing opioids for perioperative pain.
(1) The physician should consider prescribing nonopioids as the first line of pain control in patients, unless not clinically appropriate, in accordance with the provisions of WAC 246-919-870.
(2) The physician, or their designee, shall conduct queries of the PMP in accordance with the provisions of WAC 246-919-985.
(3) If the physician prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain severe enough to require opioids. A three-day supply or less will often be sufficient. The physician shall not prescribe beyond a fourteen-day supply from the time of discharge without clinical documentation in the patient record to justify the need for such a quantity.
(4) The physician shall reevaluate a patient who does not follow the expected course of recovery and reconsider the continued use of opioids or whether tapering or discontinuing opioids is clinically indicated.
(5) Follow-up visits for pain control should include objectives or metrics to be used to determine treatment success if opioids are to be continued. This may include:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations or other treatments.
(6) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-919-970, such prescribing must be in accordance with WAC 246-919-970.
(7) Long-acting or extended release opioids are not indicated for acute perioperative pain.
(8) Medication assisted treatment medications must not be discontinued when treating acute perioperative pain except as consistent with the provisions of WAC 246-919-975.
(9) If the physician elects to treat a patient with opioids beyond the six-week time period of acute perioperative pain, the physician shall document in the patient record that the patient is transitioning from acute pain to subacute pain. Rules governing the treatment of subacute pain, WAC 246-919-895 and 246-919-900 shall apply unless there is documented improvement in function or pain control and there is a documented plan and timing for discontinuation of all opioid medications.
OPIOID PRESCRIBINGSUBACUTE PAIN
NEW SECTION
WAC 246-919-895Patient evaluation and patient recordSubacute pain.
The physician shall comply with the requirements in this section when prescribing opioids for subacute pain.
(1) Prior to issuing an opioid prescription for subacute pain, the physician shall assess the rationale for continuing opioid therapy as follows:
(a) Conduct an appropriate history and physical examination;
(b) Reevaluate the nature and intensity of the pain;
(c) Conduct, or cause their designee to conduct, a query of the PMP in accordance with the provisions of WAC 246-919-985;
(d) Screen the patient's level of risk for aberrant behavior and adverse events related to opioid therapy;
(e) Obtain a biological specimen test if the patient's functional status is deteriorating or if pain is escalating; and
(f) Screen or refer the patient for further consultation for psychosocial factors if the patient's functional status is deteriorating or if pain is escalating.
(2) The physician treating a patient for subacute pain with opioids shall ensure that, at a minimum, the following is documented in the patient record:
(a) The presence of one or more recognized diagnoses or indications for the use of opioid pain medication;
(b) The observed or reported effect on function or pain control forming the basis to continue prescribing opioids beyond the acute pain episode;
(c) Pertinent concerns discovered in the PMP;
(d) An appropriate pain treatment plan including the consideration of, or attempts to use, nonpharmacological modalities and nonopioid therapy;
(e) The action plan for any aberrant biological specimen testing results and the risk-benefit analysis if opioids are to be continued;
(f) Results of psychosocial screening or consultation;
(g) Results of screening for the patient's level of risk for aberrant behavior and adverse events related to opioid therapy, and mitigation strategies; and
(h) The risk-benefit analysis of any combination of prescribed opioid and benzodiazepines or sedative-hypnotics, if applicable.
(3) Follow-up visits for pain control must include objectives or metrics to be used to determine treatment success if opioids are to be continued. This includes, at a minimum:
(a) Change in pain level;
(b) Change in physical function;
(c) Change in psychosocial function; and
(d) Additional indicated diagnostic evaluations or other treatments.
NEW SECTION
WAC 246-919-900Treatment planSubacute pain.
The physician, having recognized the progression of a patient from the acute nonoperative or acute perioperative phase to the subacute phase shall develop an opioid treatment plan.
(1) If tapering has not begun prior to the six- to twelve-week subacute phase, the physician shall reevaluate the patient. Based on effect on function or pain control, the physician shall consider whether opioids will be continued, tapered, or discontinued.
(2) If the physician prescribes opioids for effective pain control, such prescription must not be in a greater quantity than needed for the expected duration of pain that is severe enough to require opioids. During the subacute phase the physician shall not prescribe beyond a fourteen-day supply of opioids without clinical documentation to justify the need for such a quantity.
(3) If a prescription results in the patient receiving a combination of opioids with a sedative medication listed in WAC 246-919-970, such prescribing must be in accordance with WAC 246-919-970.
(4) If the physician elects to treat a patient with opioids beyond the six- to twelve-week subacute phase, the physician shall document in the patient record that the patient is transitioning from subacute pain to chronic pain. Rules governing the treatment of chronic pain, WAC 246-919-905 through 246-919-955, shall apply.
OPIOID PRESCRIBINGCHRONIC PAIN MANAGEMENT
NEW SECTION
WAC 246-919-905Patient evaluation and patient recordChronic pain.
When the patient enters the chronic pain phase, the patient shall be reevaluated as if presenting with a new disease. The physician shall include in the patient's record:
(1) An appropriate history including:
(a) The nature and intensity of the pain;
(b) The effect of pain on physical and psychosocial function;
(c) Current and relevant past treatments for pain, including opioids and other medications and their efficacy; and
(d) Review of comorbidities with particular attention to psychiatric and substance use.
(2) Appropriate physical examination.
(3) Ancillary information and tools to include:
(a) Review of the PMP to identify any medications received by the patient in accordance with the provisions of WAC 246-919-985;
(b) Any pertinent diagnostic, therapeutic, and laboratory results;
(c) Pertinent consultations; and
(d) Use of a risk assessment tool that is a professionally developed, clinically recommended questionnaire appropriate for characterizing a patient's level of risk for opioid or other substance use disorders to assign the patient to a high-, moderate-, or low-risk category.
(4) Assessment. The physician must document medical decision making to include:
(a) Pain related diagnosis, including documentation of the presence of one or more recognized indications for the use of pain medication;
(b) Consideration of the risks and benefits of chronic opioid treatment for the patient;
(c) The observed or reported effect on function or pain control forming the basis to continue prescribing opioids; and
(d) Pertinent concerns discovered in the PMP.
(5) Treatment plan as provided in WAC 246-919-910.
NEW SECTION
WAC 246-919-910Treatment planChronic pain.
The physician, having recognized the progression of a patient from the subacute phase to the chronic phase, shall develop an opioid treatment plan as follows:
(1) Treatment plan and objectives including:
(a) Documentation of any medication prescribed;
(b) Biologic specimen testing ordered;
(c) Any labs, diagnostic evaluations, referrals, or imaging ordered;
(d) Other planned treatments; and
(e) Written agreement for treatment as provided in WAC 246-919-915.
(2) The physician shall complete patient notification in accordance with the provisions of WAC 246-919-865 or provide this information in the written agreement.
NEW SECTION
WAC 246-919-915Written agreement for treatmentChronic pain.
The physician shall use a written agreement that outlines the patient's responsibilities for opioid therapy. This written agreement for treatment must include the following provisions:
(1) The patient's agreement to provide samples for biological specimen testing 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 opioid therapy may be discontinued;
(4) The requirement that all opioid prescriptions for chronic pain are provided by a single prescriber or a single clinic, except as provided in WAC 246-919-965 for episodic care;
(5) The requirement that all opioid prescriptions for chronic pain are to be dispensed by a single pharmacy or pharmacy system whenever possible;
(6) The patient's agreement to not abuse alcohol or use other medically unauthorized substances;
(7) A violation of the agreement may result in a tapering or discontinuation of the prescription; and
(8) The patient's responsibility to safeguard all medications and keep them in a secure location.
NEW SECTION
WAC 246-919-920Periodic reviewChronic pain.
(1) The physician shall periodically review the course of treatment for chronic pain. The frequency of visits, biological testing, and PMP queries in accordance with the provisions of WAC 246-919-985, must be determined based on the patient's risk category:
(a) For a high-risk patient, at least quarterly;
(b) For a moderate-risk patient, at least semiannually;
(c) For a low-risk patient, at least annually;
(d) Immediately upon indication of concerning aberrant behavior; and
(e) More frequently at the physician's discretion.
(2) During the periodic review, the physician shall determine:
(a) The patient's compliance with any medication treatment plan;
(b) If pain, function, and quality of life have improved, diminished, or are maintained; and
(c) If continuation or modification of medications for pain management treatment is necessary based on the physician's evaluation of progress towards or maintenance of treatment objectives and compliance with the treatment plan.
(3) Periodic patient evaluations must also include:
(a) History and physical examination related to the pain;
(b) Use of validated tools or patient report from reliable patients to document either maintenance or change in function and pain control; and
(c) Review of the Washington state PMP at a frequency determined by the patient's risk category in accordance with the provisions of WAC 246-919-985 and subsection (1) of this section.
(4) 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 246-919-925Long-acting opioidsChronic pain.
Long-acting opioids 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 should have a one-time completion of at least four hours of continuing education relating to this topic.
NEW SECTION
WAC 246-919-930ConsultationRecommendations and requirementsChronic pain.
(1) 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 pain patients who are under eighteen years of age or who are potential high-risk patients.
(2) The mandatory consultation threshold is one hundred twenty milligrams MED. In the event a physician prescribes a dosage amount that meets or exceeds the consultation threshold of one hundred twenty milligrams MED per day, a consultation with a pain management specialist as described in WAC 246-919-945 is required, unless the consultation is exempted under WAC 246-919-935 or 246-919-940.
(3) The mandatory consultation must consist of at least one of the following:
(a) An office visit with the patient and the pain management specialist;
(b) A telephone, electronic, or in-person consultation between the pain management specialist and the physician;
(c) 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; or
(d) Other chronic pain evaluation services as approved by the commission.
(4) A physician shall document each consultation with the pain management specialist.
NEW SECTION
WAC 246-919-935ConsultationExemptions for exigent and special circumstancesChronic pain.
A physician is not required to consult with a pain management specialist as defined in WAC 246-919-945 when the physician has documented adherence to all standards of practice as defined in WAC 246-919-905 through 246-919-925, and when one or more of the following conditions are met:
(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 an expected return to their baseline dosage level or below;
(3) The physician documents reasonable attempts to obtain a consultation with a pain management specialist and the circumstances justifying prescribing above one hundred twenty milligrams morphine equivalent dose (MED) per day without first obtaining a consultation; or
(4) The physician documents the patient's pain and function are stable and the patient is on a nonescalating dosage of opioids.
NEW SECTION
WAC 246-919-940ConsultationExemptions for the physicianChronic pain.
The physician is exempt from the consultation requirement in WAC 246-919-930 if one or more of the following qualifications is met:
(1) The physician is a pain management specialist under WAC 246-919-945;
(2) The physician has successfully completed a minimum of twelve category I continuing education hours on chronic pain management within the previous four years. At least two of these hours must be dedicated to substance use disorders;
(3) The physician is a pain management physician working in a multidisciplinary chronic pain treatment center or a multidisciplinary academic research facility; or
(4) The physician has a minimum of three years of clinical experience in a chronic pain management setting, and at least thirty percent of their current practice is the direct provision of pain management care.
NEW SECTION
WAC 246-919-945Pain management specialistChronic pain.
A pain management specialist shall meet one or more of the following qualifications:
(1) If an allopathic physician or osteopathic physician:
(a) Is 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, neurology, rheumatology, or anesthesiology;
(b) Has a subspecialty certificate in pain medicine by an ABMS-approved board;
(c) Has a certification of added qualification in pain management by the AOA;
(d) Is credentialed in pain management by an entity approved by the commission for an allopathic physician or the Washington state board of osteopathic medicine and surgery for an osteopathic physician;
(e) Has a minimum of three years of clinical experience in a chronic pain management care setting; and
(i) Has successful completion of a minimum of at least eighteen continuing education hours in pain management during the past two years for an allopathic physician or three years for an osteopathic physician; and
(ii) Has at least thirty percent of the allopathic physician's or osteopathic physician's current practice is the direct provision of pain management care or is in a multidisciplinary pain clinic.
(2) If an allopathic physician assistant, in accordance with WAC 246-918-895.
(3) If an osteopathic physician assistant, in accordance with WAC 246-854-330.
(4) If a dentist, in accordance with WAC 246-817-965.
(5) If a podiatric physician, in accordance with WAC 246-922-750.
(6) If an advanced registered nurse practitioner, in accordance with WAC 246-840-493.
NEW SECTION
WAC 246-919-950Tapering considerationsChronic pain.
The physician shall consider tapering or referral for a substance use disorder evaluation when:
(1) The patient requests;
(2) The patient experiences a deterioration in function or pain;
(3) The patient is noncompliant with the written agreement;
(4) Other treatment modalities are indicated;
(5) There is evidence of misuse, abuse, substance use disorder, or diversion;
(6) The patient experiences a severe adverse event or overdose;
(7) There is unauthorized escalation of doses; or
(8) The patient is receiving an escalation in opioid dosage with no improvement in their pain or function.
NEW SECTION
WAC 246-919-955Patients with chronic pain, including those on high doses of opioids, establishing a relationship with a new physician.
(1) When a patient receiving chronic opioid pain medications changes to a new physician, it is normally appropriate for the new physician to initially maintain the patient's current opioid doses. Over time, the physician may evaluate if any tapering or other adjustments in the treatment plan can or should be done.
(2) A physician's treatment of a new high dose chronic pain patient is exempt from the mandatory consultation requirements of WAC 246-919-930 if:
(a) The patient was previously being treated with a dosage of opioids in excess of a one hundred twenty milligram MED for chronic pain under an established written agreement for treatment of the same chronic condition or conditions;
(b) The patient's dose is stable and nonescalating;
(c) The patient has a history of compliance with treatment plans and written agreements documented by medical records and PMP queries; and
(d) The patient has documented functional stability, pain control, or improvements in function or pain control at the presenting opioid dose.
(3) With respect to the treatment of a new patient under subsection (1) or (2) of this section, this exemption applies for the first three months of newly established care, after which the requirements of WAC 246-919-930 shall apply.
OPIOID PRESCRIBINGSPECIAL POPULATIONS
NEW SECTION
WAC 246-919-960Special populationsChildren or adolescent patients, pregnant patients, and aging populations.
(1) Children or adolescent patients. In the treatment of pain for children or adolescent patients, the physician shall treat pain in a manner equal to that of an adult but must account for the weight of the patient and adjust the dosage prescribed accordingly.
(2) Pregnant patients. The physician shall not initiate opioid detoxification without consultation with a provider with expertise in addiction medicine. Medication assisted treatment for opioids, such as methadone or buprenorphine, must not be discontinued during pregnancy without consultation with a MAT prescribing practitioner.
(3) Aging populations. As people age, their sensitivities to and metabolizing of opioids may change. The physician shall consider the distinctive needs of patients who are sixty-five years of age or older and who have been on chronic opioid therapy or who are initiating opioid treatment.
NEW SECTION
WAC 246-919-965Episodic care of chronic opioid patients.
(1) When providing episodic care for a patient who the physician knows is being treated with opioids for chronic pain, such as for emergency or urgent care, the physician or their designee, shall review the PMP and document their review and any concerns.
(2) A physician providing episodic care to a patient who the physician knows is being treated with opioids for chronic pain should provide additional analgesics, including opioids when appropriate, to adequately treat acute pain. If opioids are provided, the physician shall limit the use of opioids to the minimum amount necessary to control the acute pain until the patient can receive care from the practitioner who is managing the patient's chronic pain.
(3) The episodic care physician shall coordinate care with the patient's chronic pain treatment practitioner, if possible.
OPIOID PRESCRIBINGCOPRESCRIBING
NEW SECTION
WAC 246-919-970Coprescribing of opioids with certain medications.
(1) The physician shall not knowingly prescribe opioids in combination with the following medications without documentation of medical decision making:
(a) Benzodiazepines;
(b) Barbiturates;
(c) Sedatives;
(d) Carisoprodol; or
(e) Nonbenzodiazepine hypnotics.
(2) If, because of a prior prescription by another provider, a prescription written by a physician results in a combination of opioids and medications described in subsection (1) of this section, the physician issuing the new prescription shall consult with the other prescriber to establish a patient care plan surrounding these medications. This provision does not apply to emergency care.
NEW SECTION
WAC 246-919-975Coprescribing of opioids for patients receiving medication assisted treatment.
(1) Where practicable, the physician providing acute nonoperative pain or acute perioperative pain treatment to a patient who is known to be receiving MAT medications shall prescribe opioids when appropriate for pain relief either in consultation with a MAT prescribing practitioner or a pain specialist.
(2) The physician providing acute nonoperative pain or acute perioperative pain treatment shall not discontinue MAT medications without documentation of the reason for doing so, nor shall the use of these medications be used to deny necessary operative intervention.
NEW SECTION
WAC 246-919-980Coprescribing of naloxone.
The opioid prescribing physician shall confirm or provide a current prescription for naloxone when opioids are prescribed to a high-risk patient.
OPIOID PRESCRIBINGPRESCRIPTION MONITORING PROGRAM
NEW SECTION
WAC 246-919-985Prescription monitoring programRequired registration, queries, and documentation.
(1) The physician shall register to access the PMP or demonstrate proof of having assured access to the PMP if they prescribe Schedule II-V medications in Washington state.
(2) The physician is permitted to delegate performance of a required PMP query to an authorized designee.
(3) At a minimum, the physician shall ensure a PMP query is performed prior to the prescription of an opioid or of a medication listed in WAC 246-919-970 at the following times:
(a) Upon the first refill or renewal of an opioid prescription for acute nonoperative pain or acute perioperative pain;
(b) The time of transition from acute to subacute pain; and
(c) The time of transition from subacute to chronic pain.
(4) For chronic pain management, the physician shall ensure a PMP query is performed at a minimum frequency determined by the patient's risk assessment, as follows:
(a) For a high-risk patient, a PMP query shall be completed at least quarterly;
(b) For a moderate-risk patient, a PMP query shall be completed at least semiannually; and
(c) For a low-risk patient, a PMP query shall be completed at least annually.
(5) The physician shall ensure a PMP query is performed for any chronic pain patient immediately upon identification of aberrant behavior.
(6) The physician shall ensure a PMP query is performed when providing episodic care to a patient who the physician knows to be receiving opioids for chronic pain, in accordance with WAC 246-919-965.
(7) If the physician is using an electronic medical record (EMR) that integrates access to the PMP into the workflow of the EMR, the physician shall ensure a PMP query is performed for all prescriptions of opioids and medications listed in WAC 246-919-970.
(8) For the purposes of this section, the requirement to consult the PMP does not apply when the PMP or the EMR cannot be accessed by the physician or their designee due to a temporary technological or electrical failure.
(9) Pertinent concerns discovered in the PMP shall be documented in the patient record.
REPEALER
The following sections of the Washington Administrative Code are repealed:
WAC 246-919-853
Patient evaluation.
WAC 246-919-854
Treatment plan.
WAC 246-919-855
Informed consent.
WAC 246-919-856
Written agreement for treatment.
WAC 246-919-857
Periodic review.
WAC 246-919-858
Long-acting opioids, including methadone.
WAC 246-919-859
Episodic care.
WAC 246-919-860
Consultation—Recommendations and requirements.
WAC 246-919-861
Consultation—Exemptions for exigent and special circumstances.
WAC 246-919-862
Consultation—Exemptions for the physician.
WAC 246-919-863
Pain management specialist.