WSR 18-15-064

PROPOSED RULES

DEPARTMENT OF HEALTH

(Podiatric Medical Board)

[Filed July 16, 2018, 2:19 p.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 17-17-147.

Title of Rule and Other Identifying Information: Chapter 246-922 WAC, the podiatric medical board (board) proposes new sections and changes to existing rule that will establish requirements and standards for prescribing opioid drugs by podiatric physicians consistent with the directives of ESHB 1427.

Hearing Location(s): On September 6, 2018, at 9:00 a.m., at the Red Lion, Spruce Room, One South Grady Way, Renton, WA 98057.

Date of Intended Adoption: September 6, 2018.

Submit Written Comments to: Susan Gragg, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2901, by August 31, 2018.

Assistance for Persons with Disabilities: Contact Susan Gragg, phone 360-236-4941, TTY 360-833-6388 or 711, email susan.gragg@doh.wa.gov, by August 31, 2018.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board is proposing to establish new sections of rule to implement the provisions of ESHB 1427. The bill directed five boards and commissions to consider the agency medical directors' group and the centers for disease control guidelines, and to work in consultation with the department of health, the University of Washington, and the professional associations of each profession to develop requirements for prescribing opioid drugs. The board is also proposing amendments to the current pain management rules to ensure alignment with the proposed opioid prescribing rules, increase consistent rule application, and reduce duplication between existing and new rules.

Reasons Supporting Proposal: The proposed rules are necessary to establish and implement opioid prescribing requirements for podiatric physicians. The proposed rules provide a necessary framework and structure for safe, consistent opioid prescribing practice consistent with the directives of ESHB 1427. The goal is to reduce the number of people who inadvertently become addicted to opioids and, consequently, reduce the burden on opioid treatment programs.

Statutory Authority for Adoption: RCW 18.22.005, 18.22.015, and 18.22.800.

Statute Being Implemented: ESHB 1427 (chapter 297, Laws of 2017), codified in part as RCW 18.22.800.

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

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

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Susan Gragg, 111 Israel Road S.E., Tumwater, WA 98504, 360-236-4941.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Susan Gragg, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4941, fax 360-236-2901, TTY 360-833-6388 or 711, email susan.gragg@doh.wa.gov.

The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The proposed rules impact clinics and hospitals where podiatric physicians practice if the podiatric physician(s) in the business prescribes opioids for pain management. The proposed rules do not apply to podiatric physicians who do not prescribe opioids. The following North American Industrial Classification System (NAICS) six-digit codes, total number of businesses in Washington state in 2013, total combined and average business payroll (rounded to the thousands), and minor cost thresholds have been applied to the proposal:

1. NAICS Code: 621391 Offices of Podiatrists

Total establishments in Washington: 136

Total combined annual payroll: $26,957,000.00

Average annual payroll (total payroll divided by total establishments): $193,213.23

Minor cost threshold (average payroll multiplied by .01): $1,983.21

2. NAICS Code: 621391 [622110] General Medical and Surgical Hospitals

Total establishments in Washington: 100

Total combined annual payroll: $6,566,100,000.00

Average annual payroll (total payroll divided by total establishments): $656,610,000

Minor cost threshold (average payroll multiplied by .01): $656,610

The board has analyzed the anticipated costs of compliance for a business at $65.87 for every patient encounter only when a podiatric physician prescribes opioids, and only if the podiatric physician performs all of the tasks required in the proposed rules. Many of the required tasks in the rules are often performed by other staff (such as medical assistants or licensed practical nurses) at much lower costs. For example, regarding the following tasks:

- Documenting patient history and physical condition.

- Documenting/updating the patient health record.

- Completing a prescription monitoring program (PMP) check.

A podiatric physician performing these tasks would cost the business an estimated $*43.01; or a medical assistant-certified could perform the same tasks for an estimated $6.87*.

Depending on the patient's phase of pain management, the business may incur the following additional cost:

a. From $0 per patient encounter for a patient whose pain level and function meet the expected course of recovery; up to

b. An estimated $77.06 per patient encounter when a practitioner must seek a consultation with another practitioner regarding specific coprescribed controlled drugs, or coprescribing opioids to a patient receiving medication assisted treatment.

Based on these anticipated costs, the board has determined that the proposed rules would not impose more-than-minor costs for businesses that must comply.

*Based on United States Department of Labor Statistics, Occupational Employment and Wages 2017 for 29-1069 Physicians and Surgeons, and 31-9092 Medical Assistants.

July 16, 2018

Blake T. Maresh

Executive Director

((PAIN MANAGEMENT)) OPIOID PRESCRIBING—GENERAL PROVISIONS

AMENDATORY SECTION(Amending WSR 11-10-063, filed 5/2/11, effective 7/1/11)

WAC 246-922-660((Pain management—))Intent and scope.

((These rules)) WAC 246-922-660 through 246-922-790 govern the ((use)) prescribing of opioids in the treatment of ((patients for chronic noncancer)) pain.

AMENDATORY SECTION(Amending WSR 11-10-063, filed 5/2/11, effective 7/1/11)

WAC 246-922-661Exclusions.

((The rules adopted under)) WAC 246-922-660 through ((246-922-673)) 246-922-790 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; ((or

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

(3) The provision of procedural premedications; or

(4) The treatment of inpatient hospital patients. As used in this section, "inpatient" means a person who has been admitted to a hospital for more than twenty-four hours.

AMENDATORY SECTION(Amending WSR 11-10-063, filed 5/2/11, effective 7/1/11)

WAC 246-922-662Definitions.

The definitions in this section apply ((in)) to WAC ((246-922-600 through 246-922-673)) 246-922-660 through 246-922-790 unless the context clearly requires otherwise.

(1) "Aberrant behavior" means behavior that indicates misuse, diversion, unauthorized use of alcohol or other controlled substances, or active opioid use disorder. This includes, but is not limited to: Multiple early refills or renewals or obtaining prescriptions for the same or similar drugs from more than one practitioner or other health care practitioner.

(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;

(d) Continued use despite harm.)) Acute pain is considered to be 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) "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)) more than twelve weeks in duration. Chronic pain includes pain resulting from cancer or treatment of cancer in a patient who is two years post-completion of curative anticancer treatment with no current evidence of disease.

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

(((5))) (6) "Episodic care" means medical care provided by a ((provider)) practitioner other than the designated primary ((provider)) practitioner in the acute care setting, for example, urgent care or emergency department.

(((6))) (7) "High dose" means ninety milligrams morphine equivalent dose, or more, per day.

(8) "High-risk" is a category of patient at increased risk of morbidity or mortality, based on factors and combinations of factors such as medical and behavioral comorbidities, polypharmacy, history of substance use disorder or abuse, aberrant behavior, high dose opioid prescription, or the use of any central nervous system depressant.

(9) "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))) (10) "Hospital" means any institution, place, building, or agency licensed under chapter 70.41 or 71.12 RCW, or designated under chapter 72.23 RCW to provide accommodations, facilities, and services over a continuous period of twenty-four hours or more, for observation, diagnosis, or care of two or more individuals not related to the operator who are suffering from illness, injury, deformity, or abnormality, or from any other condition for which obstetrical, medical, or surgical services would be appropriate for care or diagnosis.

(11) "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.

(12) "Morphine equivalent dose" or "MED" means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

(((8))) (13) "Multidisciplinary pain clinic" means a ((clinic or office)) facility that provides comprehensive pain management and includes care provided by multiple available disciplines, practitioners, or treatment modalities((; for example, physicians, physician assistants, osteopathic physicians, osteopathic physician assistants, advanced registered nurse practitioners, physician therapy, occupational therapy, or other complementary therapies)).

(((9))) (14) "Opioid analgesic" or "opioid" means a drug that is either an opiate 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.

(15) "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)).

(16) "Pain" means an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage.

(17) "Pain management clinic" means a facility in which a majority of patients are receiving chronic pain treatment.

(18) "Perioperative pain" means acute pain that occurs surrounding the performance of surgery.

(19) "Prescription monitoring program" or "PMP" means the Washington state prescription monitoring program authorized under chapter 70.225 RCW.

(20) "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.

(21) "Refill" or "renewal" means a second or subsequent filling of a previously issued prescription that is authorized to be dispensed when the patient has exhausted their current supply. For the purposes of WAC 246-922-660 through 246-922-790, refills or renewals are subject to the same limitations and requirements as initial prescriptions.

(22) "Subacute pain" means a continuation of pain, of six weeks to twelve weeks in duration.

(23) "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 are normal physiological consequences 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 246-922-675Patient notification, secure storage, and disposal.

(1) The podiatric physician shall provide information to the patient educating them of risks associated with the use of opioids as appropriate to the medical condition, the type of patient, and the phase of treatment. The podiatric physician shall document such notification in the patient record.

(2) Patient notification must occur, at a minimum, at the following points of treatment:

(a) The first issuance of a prescription for an opioid; and

(b) The transition between phases of treatment, as follows:

(i) Acute nonoperative pain or acute perioperative pain to subacute pain; and

(ii) Subacute pain to chronic pain.

(3) Patient notification must include information regarding:

(a) The safe and secure storage of opioid prescriptions; and

(b) The proper disposal of unused opioid medications including, but not limited to, the availability of recognized drug take-back programs.

(4) The patient notification requirements in this section shall be deemed fulfilled by providing board-approved patient education information.

NEW SECTION

WAC 246-922-680Use of alternative modalities for pain treatment.

Podiatric physicians shall exercise professional judgment in selecting appropriate treatment modalities for acute, subacute, or perioperative pain, including the use of nonopioid multimodal pharmacologic and nonpharmacologic therapy as an alternative to opioids whenever reasonable, clinically appropriate, evidence-based alternatives exist. Nonopioid pain management modalities may include, but are not limited to, antidepressants, anticonvulsants, anti-inflammatory medications, acetaminophen, interventional procedures, or any nonpharmacological pain treatments, or any combination of the above modalities.

NEW SECTION

WAC 246-922-685Continuing education requirements for opioid prescribing.

(1) In order to prescribe an opioid in Washington state, a podiatric physician licensed to prescribe opioids shall complete a one-time continuing education regarding best practices in the prescribing of opioids and the rules in this chapter on opioid prescribing. The continuing education must be at least one hour in length.

(2) The podiatric physician shall complete the one-time continuing education described in subsection (1) of this section by the end of the podiatric 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 continuing education required under this section counts toward meeting any applicable Category 1 continuing education requirements.

OPIOID PRESCRIBING—ACUTE NONOPERATIVE PAIN AND ACUTE PERIOPERATIVE PAIN

NEW SECTION

WAC 246-922-690Patient evaluation and patient record.

Prior to prescribing opioids for acute nonoperative pain or acute perioperative pain, the podiatric 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, including type, dosage, and quantity prescribed.

NEW SECTION

WAC 246-922-695Acute nonoperative pain.

The podiatric physician shall comply with the requirements in this section when prescribing opioid analgesics for acute nonoperative pain and shall document completion of these requirements in the patient record:

(1) The podiatric physician, or his or her authorized designee, shall conduct queries of the PMP in accordance with the provisions of WAC 246-922-790 and document their review and any concerns in the patient record.

(2) If the podiatric 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. The podiatric physician shall not prescribe beyond a seven day supply without clinical documentation in the patient record to justify the need for such a quantity.

(3) The podiatric physician shall reevaluate the patient who does not follow the expected course of recovery. If documented improvement in function or pain control has not occurred, the podiatric physician shall reconsider the continued use of opioids or whether tapering or discontinuing opioids is clinically indicated.

(4) 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;

(d) Additional planned diagnostic evaluations to investigate causes of continued acute nonoperative pain or other treatments.

(5) Long-acting or extended release opioids are not typically indicated for acute nonoperative pain. Should a podiatric physician need to use a long-acting or extended release opioid for acute pain, the podiatric physician shall document the reason in the patient record.

(6) A podiatric physician shall not discontinue medication assisted treatment medications when treating acute pain, except when consistent with the provisions of WAC 246-922-780.

(7) If the podiatric physician elects to treat a patient with opioids beyond the six-week time period of acute nonoperative pain, the podiatric 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 246-922-705 and 246-922-710 shall apply.

NEW SECTION

WAC 246-922-700Acute perioperative pain.

The podiatric physician shall comply with the requirements in this section when prescribing opioid analgesics for perioperative pain and shall document completion of these requirements in the patient record:

(2) If the podiatric 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. The podiatric 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) 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;

(d) Additional planned diagnostic evaluations or other treatments.

(5) If the podiatric physician elects to prescribe a combination of opioids with a Schedule II-V medication listed in WAC 246-922-775 or prescribes opioids to a patient known to be receiving a medication listed in WAC 246-922-775 from another practitioner, such prescribing must be in accordance with WAC 246-922-775.

(6) If the podiatric physician elects to treat a patient with opioids beyond the six-week time period of acute perioperative pain, the podiatric 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 246-922-705 and 246-922-710 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 PRESCRIBING FOR SUBACUTE PAIN

NEW SECTION

WAC 246-922-705Patient evaluation and patient record.

The podiatric physician shall comply with the requirements in this section when prescribing opioid analgesics for subacute pain and shall document completion of these requirements in the patient record:

(1) Prior to prescribing an opioid for subacute pain, the podiatric physician shall:

(a) Conduct an appropriate history and physical examination or review and update the patient's existing history and examination taken during the acute nonoperative or acute perioperative phase;

(b) Evaluate the nature and intensity of the pain;

(c) Inquire about other medications the patient is prescribed or taking, including type, dosage, and quantity prescribed;

(d) Conduct, or cause his or her authorized designee to conduct, a query of the PMP in accordance with provisions of WAC 246-922-790 and document their review and any concerns in the patient record;

(e) Screen and document the patient's potential for high-risk behavior and adverse events related to opioid therapy. If the podiatric physician determines the patient is high-risk, consider lower dose therapy, shorter intervals between prescriptions, more frequent visits, increased biological specimen testing, and prescribing rescue naloxone;

(f) Obtain a biological specimen test if the patient's function is deteriorating or if pain is escalating;

(g) Screen or refer the patient for further consultation for psychosocial factors which may be impairing recovery including, but not limited to, depression or anxiety.

(2) The podiatric physician treating a patient for subacute pain with opioids shall ensure that, at a minimum, the following are 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 documented improvement in function or pain control forming the basis to continue prescribing opioid analgesics beyond the acute pain episode;

(d) All medications the patient is known to be prescribed or taking;

(e) An appropriate pain treatment plan, including the consideration of, or attempts to use, nonpharmacological modalities and nonopioid therapy;

(f) Results of any aberrant biological specimen testing results and the risk-benefit analysis if opioids are to be continued;

(g) Results of screening or referral for further consultation for psychosocial factors which may be impairing recovery including, but not limited to, depression or anxiety;

(h) Results of screening for the patient's level of risk for aberrant behavior and adverse events related to opioid therapy;

(i) The risk-benefit analysis of any combination of prescribed opioid and benzodiazepines or sedative-hypnotics, if applicable; and

(j) All other required components of the patient record, as established in statute or rule.

(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 may include:

(a) Change in pain level;

(b) Change in physical function;

(d) Additional planned diagnostic evaluations or other treatments.

NEW SECTION

WAC 246-922-710Subacute pain.

(1) The podiatric physician shall recognize the progression of a patient from the acute nonoperative or acute perioperative phase to the subacute phase and take into consideration the risks and benefits of continued opioid prescribing for the patient.

(2) If tapering has not begun prior to the six- to twelve-week subacute phase, the podiatric physician shall reevaluate the patient who does not follow the expected course of recovery. If documented improvement in function or pain control has not occurred, the podiatric physician shall reconsider the continued use of opioids or whether tapering or discontinuing the use of opioids is clinically indicated. The podiatric physician shall make reasonable attempts to discontinue the use of opioids prescribed for the acute pain event by no later than the twelve-week conclusion of the subacute phase.

(3) If the podiatric physician prescribes opioids for effective pain control, such prescription shall be in no greater quantity than needed for the expected duration of pain severe enough to require opioids. The podiatric physician shall not prescribe beyond a fourteen-day supply of opioids without clinical documentation to justify the need for such a quantity during the subacute phase.

(4) If the podiatric physician elects to prescribe a combination of opioids with a medication listed in WAC 246-922-775 or prescribes opioids to a patient known to be receiving a medication listed in WAC 246-922-775 from another practitioner, the podiatric physician shall prescribe in accordance with WAC 246-922-775.

(5) If the podiatric physician elects to treat a patient with opioids beyond the six- to twelve-week subacute phase, the podiatric 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 in WAC 246-922-715 through 246-922-760 shall apply.

OPIOID PRESCRIBING—CHRONIC PAIN MANAGEMENT

NEW SECTION

WAC 246-922-715Patient evaluation and patient record.

(1) For the purpose of this section, "risk assessment tool" means validated tools or questionnaires appropriate for identifying a patient's level of risk for substance abuse or misuse.

(2) The podiatric physician shall evaluate and document the patient's health history and physical examination in the patient record prior to treating for chronic pain.

(a) History. The patient's health history must include:

(i) The nature and intensity of the pain;

(ii) The effect of pain on physical and psychosocial function;

(iii) Current and past treatments for pain, including medications and their efficacy;

(iv) Review of any significant comorbidities;

(v) Any current or historical substance use disorder;

(vi) Current medications and, as related to treatment of the pain, the efficacy of medications tried; and

(vii) Medication allergies.

(b) Evaluation. The patient evaluation prior to opioid prescribing must include:

(i) Appropriate physical examination;

(ii) Consideration of the risks and benefits of chronic pain treatment for the patient;

(iii) Medications the patient is taking including indication(s), type, dosage, quantity prescribed, and, as related to treatment of pain, efficacy of medications tried;

(iv) Review of the PMP in accordance with the provisions of WAC 246-922-790;

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

(vi) Use of a risk assessment tool and assignment of the patient to a high-, moderate-, or low-risk category. The podiatric physician should use caution and shall monitor a patient more frequently when prescribing opioid analgesics to a patient identified as high-risk;

(vii) Any available consultations, particularly as related to the patient's pain;

(viii) Pain related diagnosis, including documentation of the presence of one or more recognized indications for the use of pain medication;

(ix) Treatment plan and objectives including:

(A) Documentation of any medication prescribed;

(B) Biologic specimen testing ordered; and

(x) Written agreements, also known as a "pain contract," for treatment between the patient and the practitioner; and

(xi) Patient counseling concerning risks, benefits, and alternatives to chronic opioid therapy.

(c) The health record must be maintained in an accessible manner, readily available for review, and contain documentation of requirements in this subsection, as well as all other required components of the patient record, as established in statute or rule.

NEW SECTION

WAC 246-922-720Treatment plan.

(1) When the patient enters the chronic pain phase, the podiatric physician shall reevaluate the patient by treating the situation as a new disease.

(2) The chronic pain treatment plan must state the objectives that will be used to determine treatment success and must include:

(a) Any change in pain relief;

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

(3) After treatment begins, the practitioner shall adjust drug therapy to the individual health needs of the patient.

(4) The podiatric physician shall complete patient notification in accordance with the provisions of WAC 246-922-675.

NEW SECTION

WAC 246-922-725Written agreement for treatment.

The podiatric physician shall use a written agreement for treatment with the patient who requires long-term opioid therapy for chronic pain. The written agreement shall outline the patient's responsibilities and must include:

(1) The patient's agreement to provide biological samples for biological specimen testing when requested by the practitioner;

(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, such as violation of a written agreement;

(4) The requirement that all chronic opioid prescriptions are provided by a single prescriber, a single clinic, or a multidisciplinary pain clinic;

(5) The requirement that all chronic opioid prescriptions are to be dispensed by a single pharmacy or pharmacy system whenever possible;

(6) The patient's agreement to not abuse substances that can put the patient at risk for adverse outcomes;

(7) A written authorization for:

(a) The podiatric physician to release the agreement for treatment to:

(i) Local emergency departments;

(ii) Urgent care facilities;

(iii) Other practitioners caring for the patient who might prescribe pain medications; and

(iv) Pharmacies.

(b) The podiatric physician to report known violations of the agreement to the practitioner treating the patient's chronic pain and to the PMP.

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

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

NEW SECTION

WAC 246-922-730Periodic review.

(1) The podiatric 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 246-922-790 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;

(d) Immediately upon indication of concerning aberrant behavior; and

(e) More frequently at the podiatric physician's discretion.

(2) During the periodic review, the podiatric physician shall determine:

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

(b) If pain, function, or quality of life have improved, diminished, or are maintained using objective evidence; and

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

(3) Periodic patient evaluations must also include:

(a) History and physical examination related to the pain;

(b) Use of validated tools to document either maintenance of function and pain control or improvement in function and pain level; and

(c) Review of the PMP to identify any Schedule II-V medications or drugs of concern received by the patient at a frequency determined by the patient's risk category, and otherwise in accordance with the provisions of WAC 246-922-790 and subsection (1) of this section.

(4) The podiatric physician shall assess the appropriateness of continued use of the current treatment plan if the patient's progress or compliance with the current treatment plan is unsatisfactory. The podiatric physician shall consider tapering, changing, or discontinuing treatment in accordance with the provisions of WAC 246-922-755.

NEW SECTION

WAC 246-922-735Consultation—Recommendations and requirements.

(1) The podiatric physician shall consider referring the chronic pain 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. The management of chronic pain in patients with a history of substance abuse or with comorbid psychiatric disorders may require extra care, monitoring, documentation, and consultation with, or referral to, an expert in the management of such patients.

(2) The mandatory consultation threshold is one hundred twenty milligrams MED. Unless the consultation is exempt under WAC 246-922-740 or 246-922-745, a podiatric physician who prescribes a dosage amount at or above the mandatory consultation threshold must comply with the pain management specialist consultation requirements described in WAC 246-922-750. 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 consultation between the pain management specialist and the podiatric physician;

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

(d) Other chronic pain evaluation services as approved by the board.

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

(4) The podiatric physician shall use great caution when prescribing opioids to children and adolescents with chronic pain; appropriate referral to a specialist is encouraged.

NEW SECTION

WAC 246-922-740Consultation—Exemptions for exigent and special circumstances.

A podiatric physician is not required to consult with a pain management specialist as defined in WAC 246-922-750 when they have documented adherence to all standards of practice as defined in WAC 246-922-715 through 246-922-760 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 expected return to their baseline dosage level or below;

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

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

NEW SECTION

WAC 246-922-745Consultation—Exemptions for the podiatric physician.

A podiatric physician is not required to consult with a pain management specialist as defined in WAC 246-922-735 if one or more of the following qualifications are met:

(1) The podiatric physician is a pain management specialist under WAC 246-922-750;

(2) The podiatric physician has successfully completed, every four years, a minimum of twelve continuing education hours on chronic pain management in accordance with WAC 246-922-310. At least two of these hours must be in substance use disorders;

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

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

NEW SECTION

WAC 246-922-750Pain management specialist.

A pain management specialist shall meet one or more of the following qualifications:

(1) An allopathic physician or osteopathic physician:

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

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

(d) Be credentialed in pain management by an entity approved by the Washington state medical quality assurance commission for an allopathic physician or the Washington state board of osteopathic medicine and surgery for an osteopathic physician; or

(e) Have a minimum of three years of clinical experience in a chronic pain management care setting, including:

(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 in the direct provision of pain management care or is in a multidisciplinary pain clinic.

(2) An allopathic physician assistant or osteopathic physician assistant shall have a delegation agreement with an allopathic physician or osteopathic physician pain management specialist and meet all of the following educational and practice requirements:

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

(b) Is 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) Has successfully completed 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 allopathic physician assistant's or osteopathic physician assistant's current practice is the direct provision of pain management care or is in a multidisciplinary pain clinic.

(3) A dentist must be board certified or board eligible in oral medicine or orofacial pain by the American Board of Oral Medicine or the American Board of Orofacial Pain.

(4) An advanced registered nurse practitioner (ARNP) must:

(a) Be credentialed in pain management by a Washington state nursing care quality assurance commission-approved certifying or credentialing entity; or

(b) Meet all of the following:

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

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

(iii) At least thirty percent of the ARNP's current practice is the direct provision of pain management care or is in a multidisciplinary pain clinic.

(5) A podiatric physician must:

(a) Be board certified or board eligible by a specialty that includes a focus on pain management by the American Board of Foot and Ankle Surgery or its predecessor, the American Board of Podiatric Medicine, the American Board of Podiatric Orthopedics and Primary Podiatric Medicine, or other accredited certifying board as approved by the Washington state podiatric medical board; or

(b) Have a minimum of three years of clinical experience in a chronic pain management care clinic;

(c) Be credentialed in pain management by a Washington state podiatric medical board-approved national professional association, pain association, or other credentialing entity;

(d) Have successfully completed a minimum of at least eighteen continuing education hours in pain management during the past two years; and

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

NEW SECTION

WAC 246-922-755Tapering requirements.

(1) The podiatric physician shall assess and document the appropriateness of continued use of the current treatment plan if the patient's response to or compliance with the current treatment plan is unsatisfactory.

(2) The podiatric physician shall consider tapering, changing, discontinuing treatment, or referral for a substance use disorder evaluation when:

(a) The patient requests tapering, changing, discontinuing treatment, or referral for a substance use disorder;

(b) The patient experiences a deterioration in function or pain;

(d) Other treatment modalities are indicated;

(e) There is evidence of misuse, abuse, substance use disorder, or diversion;

(f) The patient experiences a severe adverse event or overdose;

(g) There is unauthorized escalation of doses; or

(h) When the patient is receiving an escalation in opioid dosage with no improvement in pain, function, or quality of life.

NEW SECTION

WAC 246-922-760Patients with chronic pain, including those on high doses—Establishing a relationship with a new practitioner.

(1) When a patient receiving chronic opioid pain medications changes to a new podiatric physician, it is normally appropriate for the podiatric physician to initially maintain the patient's current opioid doses. Over time, the podiatric physician may evaluate if any tapering or other adjustments in the treatment plan can or should be done.

(2) A podiatric physician's treatment of a new high-dose chronic pain patient is exempt from the mandatory consultation requirements of WAC 246-922-735 and the tapering requirements of WAC 246-922-755 for the first three months of newly established care if:

(a) The patient was previously being treated with a dosage of opioids at or above one hundred twenty milligrams 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 demonstrated history in their record of compliance with treatment plans and written agreements as 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 dose.

OPIOID PRESCRIBING—SPECIAL POPULATIONS

NEW SECTION

WAC 246-922-765Special populations—Patients twenty-five years of age or under, pregnant patients, and aging populations.

(1) Patients twenty-five years of age or under. In the treatment of pain for patients twenty-five years of age or under, the podiatric 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. Use of MAT opioids, such as methadone or buprenorphine, by a pregnant patient shall not be discontinued without oversight by the MAT prescribing practitioner. The podiatric physician shall weigh carefully the risks and benefits of opioid detoxification during pregnancy.

(3) Aging populations. As people age, their tolerance and metabolizing of opioids may change. The podiatric physician shall treat pain in a manner commensurate with 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 246-922-770Episodic care of chronic opioid patients.

(1) When providing episodic care for a patient who the podiatric physician knows is being treated with opioids for chronic pain, such as for emergency or urgent care, the podiatric physician shall review the PMP and document their review and any concerns in the patient record.

(2) A podiatric physician providing episodic care to a patient who the podiatric physician knows is being treated with opioids for chronic pain should provide additional opioids equal to the severity of the acute pain. If opioids are provided, the podiatric physician shall limit the use of opioids to the minimum amount necessary to control the acute nonoperative pain, acute perioperative pain, or similar acute exacerbation of pain until the patient can receive care from the practitioner who is managing the patient's chronic pain treatment.

(3) The episodic care podiatric physician shall report known violations of the patient's written agreement to the patient's treatment practitioner who provided the agreement for treatment.

(4) The episodic care podiatric physician shall coordinate care with the patient's chronic pain treatment practitioner if that person is known to the episodic care podiatric physician, when practicable.

OPIOID PRESCRIBING—COPRESCRIBING

NEW SECTION

WAC 246-922-775Coprescribing of opioids with certain medications.

(1) The podiatric physician shall not knowingly prescribe opioids in combination with the following Schedule II-IV medications without documentation of clinical judgment:

(a) Benzodiazepines;

(b) Barbiturates;

(d) Carisoprodol; or

(e) Sleeping medications, also known as Z drugs.

(2) If a patient receiving an opioid prescription is known to be concurrently prescribed one or more of the medications listed in subsection (1) of this section, the podiatric physician prescribing opioids shall consult, or make a reasonable effort to consult, with the other prescriber(s) to establish a patient care plan for the use of the medications concurrently or consider whether one of the medications should be tapered.

NEW SECTION

WAC 246-922-780Coprescribing of opioids for patients receiving medication assistant treatment.

(1) Where practicable, the podiatric physician providing acute nonoperative pain or acute perioperative pain treatment to a patient known to be receiving MAT shall prescribe opioids for pain relief either in consultation with the MAT prescribing practitioner or a pain specialist.

(2) The podiatric physician shall not discontinue MAT medications when treating acute nonoperative pain or acute perioperative pain without documentation of the reason for doing so, nor shall these medications be used to deny necessary operative intervention.

NEW SECTION

WAC 246-922-785Coprescribing of naloxone.

(1) The podiatric physician shall confirm or provide a current prescription for naloxone when high-dose opioids are prescribed to a high-risk patient.

(2) The podiatric physician should counsel and provide an option for a current prescription for naloxone to patients being prescribed opioids as clinically indicated.

OPIOID PRESCRIBING—PRESCRIPTION MONITORING PROGRAM

NEW SECTION

WAC 246-922-790Prescription monitoring program—Required registration, queries, and documentation.

(1) The podiatric physician shall register to access the PMP or demonstrate proof of having registered to access the PMP if the podiatric physician prescribes opioids in Washington state.

(2) The podiatric physician is permitted to delegate performance of a required PMP query to an authorized designee.

(3) At a minimum, the podiatric physician shall ensure a PMP query is performed prior to the prescription of an opioid at the following times:

(a) Upon the second 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

(4) For chronic pain management, the podiatric 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.

(5) The podiatric physician shall ensure a PMP query is performed for any chronic pain patient immediately upon identification of aberrant behavior.

(6) The podiatric physician shall ensure a PMP query is performed when providing episodic care to a patient who the podiatric physician knows to be receiving opioids for chronic pain, in accordance with WAC 246-922-770.

(7) For the purposes of this section, the requirement to consult the PMP does not apply when the PMP or the electronic medical record (EMR) cannot be accessed by the podiatric physician due to a temporary technological or electrical failure.

(8) If the podiatric physician is working in a practice, group, or institution that integrates access to the PMP into the workflow of the EMR, the podiatric physician shall ensure a PMP query is performed for all prescriptions of opioids and sedative hypnotics for acute pain.

(9) Pertinent concerns discovered in the PMP must be documented in the patient record.

REPEALER

The following sections of the Washington Administrative Code are repealed:


WAC 246-922-663	Patient evaluation.
WAC 246-922-664	Treatment plan.
WAC 246-922-665	Informed consent.
WAC 246-922-666	Written agreement for treatment.
WAC 246-922-667	Periodic review.
WAC 246-922-668	Long-acting opioids, including methadone.
WAC 246-922-669	Episodic care.
WAC 246-922-670	Consultation—Recommendations and requirements.
WAC 246-922-671	Consultation—Exemptions for exigent and special circumstances.
WAC 246-922-672	Consultations—Exemptions for the podiatric physician.
WAC 246-922-673	Pain management specialist.