WSR 99-18-086

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed August 31, 1999, 4:40 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 98-21-079.

Title of Rule: Pain management rules.

Purpose: These rules will promote a better understanding of the accepted standard of practice for physicians and patients in Washington state and encourage effective treatment of chronic and intractable pain.

Other Identifying Information: WAC 246-919-800, 246-919-810, 246-919-820, and 246-919-830.

Statutory Authority for Adoption: RCW 18.71.017 and 18.130.050(1).

Statute Being Implemented: RCW 18.130.050(12) and 18.130.340.

Summary: These regulations stress the importance of effective treatment for patients who suffer from chronic or intractable pain. The regulations also note that the treatment of pain with opioids can be consistent with currently accepted medical practice. The regulations encourage effective treatment while retaining individual physician judgment, as well as allowing for potential treatment advances that may occur in the future.

Reasons Supporting Proposal: While the Medical Quality Assurance Commission and the Department of Health rarely utilize regulation or rule writing to address standard of care issues, it has been determined there is a need to address the under-treatment of chronic and intractable pain, which continues to be a concern in Washington state.

Name of Agency Personnel Responsible for Drafting: George Heye, MD, Medical Consultant, 1300 S.E. Quince Street, Olympia, (360) 236-4795; Implementation: Beverly Teeter, Administrator, 1300 S.E. Quince Street, Olympia, (360) 236-4788; and Enforcement: Bonnie King, Executive Director, 1300 S.E. Quince Street, Olympia, (360) 236-4789.

Name of Proponent: Medical Quality Assurance Commission and Department of Health, governmental.

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

Explanation of Rule, its Purpose, and Anticipated Effects: These rules have been developed in response to information gathered during a public forum held July 1998 regarding the 1996 Guidelines for Management of Pain. Public input indicated that though the guidelines represented an advancement in the treatment of chronic pain, they did not go far enough to affect the existence of substantial under-treatment of patients with chronic pain. In addition, there is an outdated perception on the part of physicians that the use of opioids in the treatment of chronic pain conditions will result in adverse action by the state disciplining authority. Through an extensive collaborative effort, the rules were written to encourage effective treatment of chronic pain, retain individual physician judgment, and allow for future advances in the treatment of chronic pain.

Proposal does not change existing rules.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

All licensed practitioners are governed under chapter 18.71 RCW. Each physician must apply for his or her own license. Since physician licenses are granted to individuals rather than entities with multiple persons, businesses affected by the proposed rule amendments have only one employee.

The standard industrial code (SIC) identified for physicians is:

SIC CODE ECONOMIC ACTIVITY MINOR COST
801 Offices and Clinics of Doctors of Medicine $240
The costs to comply with this rule, for physicians who choose to comply, have been identified as:

WAC NUMBER ACTIVITY COST
246-918-410 and 246-919-810 (1)(2) Initial Review of Guidelines $340
246-918-410 and 246-919-810(3) Revised Guidelines 170
246-918-420 and 246-919-820 Continuing Education 300
The costs for the initial review of the guidelines and the continuing education are more than the minor costs for this activity. However, since licenses are granted to individuals who all qualify as small businesses, rather than entities with multiple persons, there cannot be a disproportionate impact. When there is no disproportionate impact, mitigation is not necessary.

Public involvement has been solicited from interested party lists and from licensees via an article in the Medical Quality Assurance Commission UPDATE! publication. In addition, two public rule writing workshops were held, one on November 4, 1998, in Spokane and one on November 5, 1998, in SeaTac.

Opportunity for written and verbal comments will also be provided during the formal public rules hearing to be held in the summer of 1999.

A copy of the statement may be obtained by writing to Susan Anthony, Licensing Program Manager, Department of Health, Medical Quality Assurance Commission, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-4787, fax (360) 586-4573.

RCW 34.05.328 does not apply to this rule adoption. These rules offer guidance which practitioners should follow, however they do not mandate a specific type of treatment, recordkeeping or training so they do not equate to a specific directive.

Hearing Location: Videoconferencing, Department of Information Services Interactive Technologies - 4 Sites: Renton (Seattle), 1107 S.W. Grady Way, Suite 112, (425) 277-7290; Spokane, North 1101 Argonne, Suite 109, (509) 921-2371; Lacey, 710 Sleater-Kinney Road, Suite Q, (360) 407-9487; Yakima, 15 West Yakima Avenue, Suite 220, (509) 454-7878; on October 7, 1999, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Susan Anthony by October 1, 1999, TDD (800) 833-6388, or (360) 236-4787.

Submit Written Comments to: Susan Anthony, fax (360) 586-4573, by October 1, 1999.

Date of Intended Adoption: October 7, 1999.

August 4, 1999

Bonnie King

Executive Director

OTS-2897.4

PAIN MANAGEMENT
NEW SECTION
WAC 246-919-800
Purpose.

(1) The medical quality assurance commission recognizes that effective pain management is an essential component of quality medical care and that no single approach to the treatment of pain is exclusively correct.

(2) The commission wishes to reassure practitioners that they need not fear disciplinary action from the commission for prescribing, dispensing, or administering opioids when treating pain so long as the care provided is consistent with currently acceptable medical practice. This includes acute, chronic and intractable pain (RCW 69.50.308(g)).

(3) While many other medications may be appropriate in the treatment of pain, these regulations specifically address the use of opioids. As used in these regulations, the term opioid means any natural or synthetic medication that has morphine like activity.

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NEW SECTION
WAC 246-919-810
What specific guidance should a practitioner follow?

(1) The commission has adopted guidelines for the management of pain in order to acquaint practitioners with recognized national standards in the field of pain treatment.

(2) These guidelines specifically address the patient evaluation and treatment plan, informed consent, periodic reviews, use of consultations, and the necessity for maintaining accurate and complete medical records.

(3) These guidelines may be revised from time to time to reflect changes in the practice of pain management.

(4) Practitioners who cannot or choose not to treat patients who have complex or chronic pain conditions should offer appropriate referrals for those patients.

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NEW SECTION
WAC 246-919-820
What knowledge should a practitioner possess to treat pain patients?

Practitioners treating pain should be:

(1) Knowledgeable about the complex nature of pain;

(2) Familiar with the pain treatment terms used in the commission's pain treatment guidelines; and

(3) Knowledgeable about acceptable pain treatment modalities.

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NEW SECTION
WAC 246-919-830
How will the commission evaluate prescribing for pain?

(1) The practitioner's treatment will be evaluated by a review of the provided care to see if it is clinically sound and in accordance with currently acceptable medical practice regarding the treatment of pain.

(2) No disciplinary action will be taken against a practitioner based solely on the quantity and/or frequency of opioids prescribed.

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