Podiatric Medical Board’s Rules on Opioid Prescribing

Effective November 1, 2018

By Gail T. McGaffick, JD, WSPMA Legislative Attorney

This article will provide information concerning the Podiatric Medical Board’s (PMB) new rules on opioid prescribing, effective November 1. It will include key points, as well as a section by section analysis to assist podiatric physicians in navigating the new rules. Visit the Department of Health’s (DOH) website for the final version of the rules. The rules will appear online on the leg.wa.gov website sometime during the month of November.

In addition, please note that the Department of Health (DOH) has created a web page with information for prescribers and patients. Please click on the link for “Podiatry” as well as the link for “Public/Patient.”

Please note that any podiatric physician who prescribes opioids after November 1, 2018, is required to register with the Prescription Monitoring Program (PMP). Visit the PMP webpage for information on how to sign up.


Background: In the 2017 legislative session, the Legislature focused on opioid prescribing as one of the ways to combat the opioid addiction crisis. It considered limits on opioid prescriptions, as well as a requirement to check the Prescription Monitoring Program (PMP) prior to every prescription. It was against this backdrop that opioid prescribing professions supported legislation (ESHB 1427) that required the adoption of rules to regulate opioid prescribing.

To implement ESHB 1427, the Department of Health (DOH) established an Opioid Task Force (OTF) composed of representatives from the boards and commissions that regulate opioid prescribers, to include the Podiatric Medical Board (PMB). Drs. Anderson and Wardle were the two main PMB representatives to the OTF. The OTF began its work in September 2017 and concluded in March of this year, after seven full day meetings in various parts of the state, with the issuance of a draft opioid rules. WSPMA submitted numerous detailed comments on the multiple versions of draft opioid rules throughout the OTF process.

Podiatric Medical Board’s Work on Opioid Rules. When the work of the Opioid Task Force was complete, the draft rules were then considered by the various boards and commissions that regulate prescribers of opioids, to include the PMB. That’s because only these regulatory entities have the authority to adopt rules that impact their various professions. While DOH would have preferred that each board and commission adopt the same version of the rules, that did not happen. There are some substantive variations between the five different versions of the rules (DPMs, MDs, DOs, ARNPs, and dentists).

WSPMA participated fully in the PMB’s rule adoption process. In addition to submitting detailed written comments at every opportunity, I also want to acknowledge the assistance of WSPMA General Counsel Martin Ziontz, JD, who attended one PMB meeting and assisted in the review of WSPMA comments. In addition, Dr. Eric Leonheart, attended the PMB meetings as well. Finally, the WSPMA Board and Legislative Committee provided valuable feedback on numerous written comment drafts.

Overview of Podiatric Medical Board’s Opioid Rules: While the rules have been substantially modified due to comments from WSPMA, they are still very detailed, and often complex. Unfortunately, some changes that WSPMA successfully advocated for earlier in the process were rolled back during the September PMB hearing on the proposed rules because of pressure from both the Governor and Attorney General to make changes to essentially include guideline language that other boards and commissions had adopted. I will discuss those changes in this article.

Key points:

  • The proposed rules divide opioid prescribing into the following categories: acute (non-operative pain and perioperative pain), subacute, and chronic. There are specific WAC sections for each type of pain.
    • Acute pain is defined as zero to six weeks in duration
    • Subacute pain is defined as six to twelve weeks in duration
    • Chronic pain is anything over twelve weeks in duration. (It’s important to remember that the PMB has had rules related to chronic pain since 2011.)
  • All DPMs who prescribe opioids must register with the Prescription Monitoring Program (PMP). While state law allows provider groups to sign up for the PMP, the rules require every individual DPM to sign up—whether or not their group is signed up. The folks at the PMP want the ability to send individual reports on prescribing activity to every prescriber.
  • The requirements to query the PMP vary with the type of pain involved. The key WAC is 246-922-790. At a minimum, the DPM or authorized designee must query the PMP and document pertinent concerns in the patient record as follows:
    • Acute pain: At the second refill or renewal of an opioid prescription for acute nonoperative pain or perioperative pain; (For MDs, checking the PMP for acute prescriptions is required on the first refill or renewal.) Due to pressure from the Governor and AG, the PMB has committed to revisiting this issue in 2019, to probably more closely align with Medical Commission requirements.
    • Acute pain: For those DPMs who work in a practice, group, or institution that integrates access to the PMP into the workflow of the EMR, the PMP must be checked for all prescriptions of opioids and coprescribed medications listed in WAC 246-922-775(1) for acute pain.
    • Subacute pain: At the time of transition from acute to subacute pain for acute pain.
    • Chronic pain. At the time of transition from subacute to chronic pain. In addition, the PMP must be checked at a minimum, for a high-risk patient, quarterly; for a moderate-risk patient, semiannually; and for a low-risk patient, annually. Further, the DPM must check the PMP for any chronic pain patient upon identification of aberrant behavior.
    • Episodic care. For DPMs providing episodic care to patients who they know are receiving opioids for chronic pain, the PMP must be queried.
    • The requirement to check the PMP does not apply when the PMP or the EMR cannot be accessed by the DPM due to a temporary technological or electrical failure.
  • Exclusions. The opioid rules do not apply to patients with cancer-related pain; provision of palliative, hospice, or other end-of-life care; provision of procedural premedications; and the treatment of admitted inpatient and observation hospital patients.
  • Co-prescribing of opioids and certain medications. The rules have multiple provisions urging caution and requirements for prescribing opioids with medications listed in WAC 246-922-775.
  • Acute care documentation requirements. While there are no “hard” limits on the number of days allowed for an opioid prescription for acute pain, there are documentation requirements if a prescription exceeds fourteen days for perioperative pain or seven days for acute non-operative pain.
  • Subacute opioid limits. Prescriptions for subacute pain may not exceed 14 days with clinical documentation.
  • CME. One hour of CME on best practices for opioid prescribing and these rules is required by the end of the next full CME reporting cycle after the rules become effective.
  • Patient education. Patient education on the risks of opioids, and proper storage and disposal is required. DOH has developed several tools for DPMs to use. Please see earlier information on the DOH web page.
  • Alternatives to opioids. There is a specific WAC section that asks DPMs to consider the use of alternative modalities for pain treatment.

Section by Section Overview of the PMB’s Opioid Rules—Effective November 1, 2018

In reading the rules in their current format, note that if changes are made to an existing rule, those changes will be underlined for new language, and there will be strike throughs for deletions of existing language. Changes to existing rules will be preceded by the heading “AMENDATORY SECTION.” For those rules where all the language is new, there are no underlines or strikethroughs, and those rules will be preceded by the words “NEW SECTION.” Finally, the proposed rules do amend and replace current rules on chronic pain management, and as a result, some of those existing rules are repealed.

When the rules are codified or incorporated into the existing WAC chapter for podiatry, the underlines and deletions will be removed.

DISCLAIMER: The following is a section by section overview of the PMB’s opioid rules. It is only an overview. It is not intended to be comprehensive, and it does not replace reading the rules.

OPIOID PRESCRIBING—GENERAL PROVISIONS

WAC 246-922-660, Intent and scope. This short intent section simply says: “WAC 246-922-660 through 246-922-790 govern the prescribing of opioids in the treatment of pain.”

WAC 246-922-661, Exclusions. The opioid rules do not apply to patients with cancer-related pain; provision of palliative, hospice, or other end-of-life care; provision of procedural premedications; and the treatment of admitted inpatient and observation hospital patients.

WAC 246-922-662, Definitions. These twenty-three definitions are relevant to the opioid rules.

WAC 246-922-675, Patient notification, secure storage, and disposal. Patients must be educated about the risks of opioids as appropriate to the medical condition, the type of patient, and the phase of treatment; safe and secure storage of opioid prescriptions; and disposal of unused opioids to include drug take-back programs. Patient education/notification must occur, at a minimum, when an opioid prescription is first issued, and transitions between phases of treatment. The Department of Health has developed patient education forms for acute pain, surgical pain, and chronic pain. Hopefully, they will also develop one for subacute pain. Visit the DOH website for patient education tools.

WAC 246-922-680, Use of alternative modalities for pain treatment. DPMs are asked to use professional judgment in selecting appropriate treatment modalities for the treatment of pain, including the use of alternatives to opioids when reasonable, clinically appropriate, evidence-based alternatives exist.

WAC 246-922-685, Continuing education requirements for opioid prescribing. One hour of CME is required on best practices in prescribing opioid and the opioid rules.

OPIOID PRESCRIBING—ACUTE NONOPERATIVE PAIN AND ACUTE PERIOPERATIVE PAIN

WAC 246-922-690, Patient evaluation and patient record. This WAC outlines what is required for a patient evaluation and documentation in the patient record for acute pain (zero to six weeks).

WAC 246-922-695, Acute nonoperative pain. This WAC section lists the requirements for DPMs when prescribing for opioids for acute nonoperative pain. Note subsection (2) which requires documentation of any opioid prescription beyond a seven-day supply. In addition, note the language which states: “A three-day supply will often be sufficient; more than a seven-day supply will rarely be needed.” WSPMA lost the fight to have this language excluded because of pressure from the Governor and Attorney General (AG). Note the requirement in subsection (3) if long-acting or extended release opioids are prescribed. Finally, note the requirements in subsection (7) if prescribing opioids beyond the six-week timeline for acute pain.

WAC 246-922-700, Acute perioperative pain. This WAC section lists the requirements for DPMs when prescribing opioids for acute perioperative pain. Note subsection (2) which requires documentation of any opioid prescription beyond a fourteen-day supply. In addition, note the language which states: “A three-day supply will often be sufficient; more than a seven-day supply will rarely be needed.” The “seven-day supply” language should be “fourteen” to sync with the documentation requirement. But, until it’s corrected, the language stands as is. In addition, note the following guideline language that WSPMA tried to get excluded because of the belief that guidelines don’t belong in rules. But, once again, the Governor and AG exerted pressure, and the PMB decided to include this language. “For more specific best practices, the podiatric 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.” Finally, note the requirements in subsection (6) if prescribing opioids beyond the six-week timeline for acute pain.

OPIOID PRESCRIBING FOR SUBACUTE PAIN

WAC 246-922-705, Patient evaluation and patient record. This WAC outlines what is required for a patient evaluation and documentation in the patient record when prescribing opioids for subacute pain (six to twelve weeks).

WAC 246-922-710, Subacute pain. This WAC contains specific directives for the DPM, with more detailed requirements, now that you are prescribing opioids for subacute pain. Note subsection (3) which requires documentation for any prescription beyond a fourteen-day supply of opioids. Note the requirements in subsection (5) if electing to treat a patient beyond the subacute phase.

OPIOID PRESCRIBING—CHRONIC PAIN MANAGEMENT

WACs 246-922-715 through WAC 246-922-760 deal with chronic pain. Chronic pain is defined as pain lasting longer than 12 weeks. The requirements in these rules become more complex, the longer the patient is on opioids. If you treat chronic pain patients, you will want to read these rules carefully, to include requirements for consultation with a pain management specialist if the patient is prescribed more than 120 MED per day, unless the exemptions apply.

OPIOID PRESCRIBING—SPECIAL POPULATIONS

WAC 246-922-765, Special populations—Patients twenty-five years of age or under, pregnant patients, and aging populations. This WAC outlines specific considerations for these patient groups. Note in particular, the prohibition against discontinuing MAT medications for pregnant patients without oversight by the MAT prescriber.

WAC 246-922-770, Episodic care of chronic opioid patients. This WAC covers those situations where a DPM is treating a patient in a situation such as emergency or urgent care, and the DPM knows the patient is being treated with opioids for chronic pain. Key requirements include checking the PMP, as well as coordinating care with the patient’s chronic pain treatment practitioner—if that person is known to the DPM, when practicable.

OPIOID PRESCRIBING—COPRESCRIBING

WAC 246-922-775, Coprescribing of opioids with certain medications. The DPM shall not knowingly prescribe opioids in combination with certain drugs without documentation of clinical judgment. The drugs include: benzodiazepines, barbiturates, sedatives, carisoprodol, and Z drugs. Please see subsection (2) for consultation requirements.

WAC 246-922-780, Coprescribing of opioids for patients receiving medication (assistant) assisted treatment. As noted, there’s a typo in the title. This WAC explains when a DPM prescribing opioids for acute pain for a patient receiving MAT needs to consult with the MAT prescriber or a pain specialist. It also directs the DPM to not discontinue MAT medications without documentation.

WAC 246-922-785, Coprescribing of naloxone. The DPM shall confirm or provide a current prescription for naloxone when high-dose opioids are prescribed to a high-risk patient. For other patients, the DPM is directed to counsel and provide an option for a prescription as clinically indicated.

OPIOID PRESCRIBING—PRESCRIPTION MONITORING PROGRAM

WAC 246-922-790, Prescription monitoring program—Required registration, queries and documentation. All DPMs who prescribe opioids must register with the Prescription Monitoring Program (PMP).

The requirements to query the PMP vary with the type of pain involved. At a minimum, the DPM or authorized designee must query the PMP and document any concerns in the patient record as follows:

  1. Acute pain: At the second refill or renewal of an opioid prescription for acute nonoperative pain or perioperative pain;
  2. Acute pain: For those DPMs who work in a practice, group, or institution that integrates access to the PMP into the workflow of the EMR, the PMP must be checked for all prescriptions of opioids and coprescribed medications listed in WAC 246-922-775(1) for acute pain. There is a typo in rules. The WAC section noted is the correct one.
  3. Subacute pain: At the time of transition from acute to subacute pain.
  4. Chronic pain. At the time of transition from subacute to chronic pain. In addition, the PMP must be checked at a minimum, for a high-risk patient, quarterly; for a moderate-risk patient, semiannually; and for a low-risk patient, annually. Further, the DPM must check the PMP for any chronic pain patient upon identification of aberrant behavior.
  5. Episodic care. For DPMs providing episodic care to patients who they know are receiving opioids for chronic pain, the PMP must be queried.
  6. The requirement to check the PMP does not apply when the PMP or the EMR cannot be accessed by the DPM due to a temporary technological or electrical failure.

REPEALER

This portion of the rules lists those existing chronic pain rules that are being repealed because they are being replaced by the new chronic pain rules. As a result, when the rules are updated or codified on the leg.wa.gov website, you will no longer be able to see the former chronic pain rules.