Original Notice.

     Preproposal statement of inquiry was filed as WSR 98-22-086.

     Title of Rule and Other Identifying Information: Adds new sections WAC 246-853-510/246-854-120 Use of controlled substances for pain control, 246-853-520 What specific guidance should an osteopathic physician follow?, 246-854-130 What specific guidance should an osteopathic physician assistant follow?, 246-853-530 What knowledge should an osteopathic physician who elects to treat chronic pain patients possess?, 246-854-140 What knowledge should an osteopathic physician assistant who elects to treat chronic pain patients possess?, and 246-853-540/246-854-150 How will the board evaluate prescribing for pain?

     Hearing Location(s): St. Francis Hospital, 34515 9th Avenue South, Federal Way, WA 98003, on January 26, 2007, at 9:30 a.m.

     Date of Intended Adoption: January 26, 2007.

     Submit Written Comments to: Arlene Robertson, P.O. Box 47866, Olympia, WA 98504-7866, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2406, by January 19, 2007.

     Assistance for Persons with Disabilities: Contact Arlene Robertson by January 19, 2007, TTY (800) 833-6388 or 711.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board of osteopathic medicine and surgery (board) adopted pain management guidelines for osteopathic physicians and osteopathic physician assistants for prescribing, dispensing, and administering opioids on November 1, 1996. However guidelines are used as a reference tool but do not have the force of law. Rules are being established to set standards when prescribing and treating acute, chronic and intractable pain patients. Currently without rules in place the access to pain management care for osteopathic patients is limited. By establishing rules[,] under treatment of chronic pain may be reduced and access to care enhanced.

     Reasons Supporting Proposal: The proposed rules will alleviate the legal concerns and apprehensions of providers when managing pain with opioid therapy. The proposed rules will increase access to appropriate medical treatment for pain management patients. Productivity and quality of life of patients will be improved with effective pain management.

     Statutory Authority for Adoption: RCW 18.57.005, 18.130.050.

     Statute Being Implemented: Chapters 18.57, 18.57A RCW.

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

     Name of Proponent: Department of health, board of osteopathic medicine and surgery, governmental.

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

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

     The proposed rule will:

•	Reassure osteopathic physicians and osteopathic physician assistants who are treating pain consistent with currently acceptable medical practice that they need not fear disciplinary action by the board for prescribing, dispensing, or administering controlled substances, including opioids.
•	Advise osteopathic physicians and osteopathic physician assistants to follow the preestablished pain management guidelines that 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.
•	Describe the need for an osteopathic physician or an osteopathic physician assistant to possess knowledge about the complexity of pain terminology and treatment modalities.
•	Assure that patient care is clinically sound. The proposal will provide a basis for assessing care provided against established standards.

     2. Is a small business economic impact statement (SBEIS) required for this rule? Yes. The proposed rules have more than a minor impact on small businesses.

     3. Which industries are affected by this rule? In preparing this SBEIS, the department of health (DOH) used the following codes:

SIC Industry Code and Title	# of Businesses	# of Employees	Average # of Employees for Smallest Businesses <=50	Average # of Employees for Largest Businesses >50
8031 Osteopathic Physicians, offices & clinics of	120	680	4.8
8049 Offices and Clinics of Health Practitioners, Not Elsewhere Classified	913	5450	4.5	102.9
8051 Skilled Nursing Care Facilities	281	26407	14.7	116
8062 General Medical and Surgical Hospitals	146	78593	11.1	758.4
8063 Psychiatric Hospitals	6	3177	N/A	147.3
8069 Specialty Hospitals, Except Psychiatric	23	4106	15.4	167.7
8082 Home Health Care Services	93	1484	7.0	64.3

     4. What are the costs of complying with this rule for small businesses (those with fifty or fewer employees) and for the largest 10% of businesses affected? The costs associated with the proposed rules include:

     Time with Patient and Record Keeping:

•	If an osteopathic physician were to treat a patient for pain management, it will be necessary for them to spend additional time with each patient. Periodic reviews of pain patients will be required to ensure effective interventions and compliance with treatment modalities, including opioid therapy. Based on a DOH survey it is estimated that an additional fifteen minutes per visit will be required and will cost an osteopathic physician an additional $19.34. Since controlled substances (i.e. opioids) cannot be refilled, patients will need to be seen at least once a month to have new prescriptions written for them and to monitor their progress. If an osteopathic physician spends fifteen minutes per patient in a seven hour day, it is estimated an average of twenty-eight patients would be seen per day. If an osteopathic physician sees one pain patient per year, the annual cost to treat the one patient would be $232.08 [(twelve patient visits) x $19.34]. If one-fourth of an osteopathic physician's patient visits are pain patients (seven patient visits per day/four days a week), the costs would be $135.38 per day, $2166.08 per month or $25,992.96 per year. It is assumed that the additional costs to the osteopathic physician would range from $232.08 to $25,992.96, depending on the number of pain patients that are treated.
•	If an osteopathic physician assistant were to treat a patient for pain management, it will also be necessary for them to spend additional time with each patient. Periodic reviews of pain patients will be required to ensure effective interventions and compliance with treatment modalities, including opioid therapy. Based on a DOH survey it is estimated that an additional fifteen minutes per visit will be required and will cost an osteopathic physician assistant an additional $9.44. Since controlled substances (i.e. opioids) cannot be refilled, patients will need to be seen at least once a month to have new prescriptions written for them and to monitor their progress. If an osteopathic physician assistant spends fifteen minutes per patient in a seven hour day, it is estimated an average of twenty-eight patients would be seen per day. If an osteopathic physician assistant sees one pain patient per year, the annual cost to treat the one patient would be $113.28 [(twelve patient visits) x $9.44]. If one-fourth of an osteopathic physician assistant's patient visits are pain patients (seven patient visits per day/four days a week), the additional cost would be $66.08 per day, $1057.28 per month or $12,687.36 per year. It is assumed that the costs to the osteopathic physician assistant would range from $113.28 to $12,687.36, depending on the number of pain patients that are treated.
•	Since these types of patients are considered more complex and take more time to manage, the practitioner can charge more for their services. It is likely that the additional time spent will be reimbursed by insurance carriers.
•	More frequent patient screenings will therefore require additional record keeping and maintenance. Since the standard of care requires record keeping, the costs associated with this are assumed to be minimal.

     The proposed rules require additional time for each pain patient visit to ensure proper adherence to the osteopathic pain guidelines. The costs could potentially range from $232.08 for one pain patient and $25,992.96 annually for approximately 1456 patient visits, estimated to be one-fourth of the practice time for an osteopathic physician. The costs estimated for osteopathic physician assistants would range from $113.28 for one pain patient and $12,687.36 annually for approximately 1456 patient visits, estimated to be one-fourth of the practice time for an osteopathic physician assistant.

     Since reimbursement rates are determined by the complexity of a patient's condition, systems evaluated, diagnostic tests performed, etc., it is likely that the estimated costs to the practitioner would be fully or partially reimbursed.

     Osteopathic Physician Education:

•	Knowledge of pain management treatment is required for osteopathic physicians to treat chronic pain patients. It is estimated that a basic training course will consist of a minimum of eight hours. The cost of a course is estimated to be $800. In addition, personal expenses and costs associated with the course are estimated at $200. The total cost for obtaining a basic course is estimated to be $1000. If they choose to take a comprehensive course in pain management, it would only be taken one time.
•	Periodically it may be necessary for osteopathic physicians to obtain additional education to continue to treat chronic pain patients by keeping informed about new therapies and medications. Since continuing education is required to maintain their license, any additional courses pertaining to the practice of pain management could be obtained to fulfill that requirement. The additional education would be related to their general practice and not attributed directly to the cost of the proposed rule.
•	Most osteopathic physicians obtain educational courses during nonbusiness hours and therefore the additional training would not interfere with their ability to see patients.

     Osteopathic Physician Assistant Education:

•	Knowledge of pain management treatment is required for osteopathic physician assistants to treat chronic pain patients. It is estimated that a basic training course will consist of a minimum of eight hours. The cost of a course are estimated to be $800. In addition, personal expenses and costs associated with the course are estimated at $200. The total cost for obtaining a basic course is estimated to be $1000. If they choose to take a comprehensive course in pain management, it would only be taken one time.
•	Periodically it may be necessary for osteopathic physician assistants to obtain additional education to continue to treat chronic pain patients by keeping informed about new therapies and medications. Since continuing education is required to maintain their license, any additional courses pertaining to the practice of pain management could be obtained to fulfill that requirement. The additional education would be related to their general practice and not be attributed directly to the cost of the proposed rule.
•	Most osteopathic physician assistants obtain educational courses during nonbusiness hours and therefore the additional training would not interfere with their ability to see patients.

     Each practitioner who chooses to treat chronic pain patients may decide to take a comprehensive training course to gain knowledge regarding pain management. An initial comprehensive training course is estimated to cost a practitioner $800 with attendance costs of $200. It is assumed that initially all practitioners who practice pain management will take a comprehensive training course. Subsequent continuing education courses may also be obtained periodically to learn new treatment modalities and become familiar with new medications. However, if a practitioner chose to take additional courses in pain management, these would be taken to benefit their general practice and those costs would not be attributed directly to the proposed rules. These additional courses could be used to fulfill the continuing education requirements needed to maintain their license.

     Most osteopathic physicians and physician assistants obtain educational courses during nonbusiness hours and therefore the additional training would not interfere with their ability to see patients. The cost is the same for all practitioners. However, for those businesses that pay for practitioners' education, the costs will vary depending on the number of practitioners in each business that treats pain patients.

     The education costs of compliance with the proposed rules are $1,000 and are the same for practitioners in small businesses as those in large businesses if practitioners pay for the costs of their education.

     5. Does the rule impose a disproportionate impact on small businesses? If practitioners pay for the costs of their education, then the $1,000 education costs will be the same for all. However, if education costs were paid by institutions that hire these practitioners then small businesses would disproportionately be impacted as the following table indicates.

     Education: Osteopathic Physician and Osteopathic Physician Assistants

SIC Industry Code and Title	Average # of Employees for Smallest Businesses	Average # of Employees for 10% of Largest Businesses	Costs of Rule Change Small Businesses	Costs of Rule Change Large Businesses	Average Cost Per Employee Small Businesses	Average Cost Per Employee Large Businesses
8031 Osteopathic Physicians, offices & clinics of	4.8	13.2	$1000	$1000	$208.33	$75.76
8049 Offices and Clinics of Health Practitioners, Not Elsewhere Classified	4.5	27.4	$1000	$1000	$222.22	$36.50
8051 Skilled Nursing Care Facilities	14.7	144.2	$1000	$1000	$68.03	$6.93
8062 General Medical and Surgical Hospitals	11.1	2027.7	$1000	$1000	$90.09	$.49
8063 Psychiatric Hospitals	N/A	147.3	N/A	$1000	N/A	$6.78
8069 Specialty Hospitals, Except Psychiatric	15.4	167.7	$1000	$1000	$64.94	$5.96
8082 Home Health Care Services	14.2	162.6	$1000	$1000	$70.42	$6.15

     Both small and large businesses may incur a benefit from the additional time spent to properly manage pain with, among other remedies, opioids. Additional time taken to appropriately treat a patient's pain with medications could alleviate the cost incurred for unnecessary return visits because of ineffective pain interventions and improper self-medicating.

     6. If the rule imposes a disproportionate impact on small businesses, what efforts were taken to reduce that impact (or why is it not "legal and feasible" to do so) by: It is not legal or feasible to mitigate the impact to small businesses because the standard of care must be followed by all osteopathic physicians and physician assistants.

     7. How are small businesses involved in the development of this rule? Small businesses have been involved through individuals on the DOH interested parties list and also through professional associations.

     A copy of the statement may be obtained by contacting Arlene Robertson, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-4945, fax (360) 236-2406, e-mail arlene.robertson@doh.wa.gov.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Arlene Robertson, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-4945, fax (360) 236-2406, e-mail arlene.robertson@doh.wa.gov.

October 31, 2006

Blake T. Maresh

Executive Director

OTS-8007.2

NEW SECTION
WAC 246-853-510   Use of controlled substances for pain control.   (1) Purpose. The board of osteopathic medicine and surgery 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 board wishes to reassure osteopathic physicians that they need not fear disciplinary action from the board for prescribing, dispensing, or administering controlled substances, including opioids, when treating pain so long as the care provided is consistent with currently acceptable osteopathic medical practice. This includes acute, chronic, and intractable pain (RCW 69.50.308(g)) patients.

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     (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) Osteopathic physicians 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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     (1) Knowledgeable about the complex nature of pain;

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

     (3) Knowledgeable about acceptable pain treatment modalities.

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OTS-8008.2

NEW SECTION
WAC 246-854-120   Use of controlled substances for pain control.   (1) Purpose. The board of osteopathic medicine and surgery 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 board wishes to reassure osteopathic physician assistants that they need not fear disciplinary action from the board for prescribing, dispensing, or administering controlled substances, including 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)) patients.

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     (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) Osteopathic physician assistants 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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     (1) Knowledgeable about the complex nature of pain;

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

     (3) Knowledgeable about acceptable pain treatment modalities.

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