WSR 06-22-102

PROPOSED RULES

DEPARTMENT OF HEALTH


(Podiatric Medical Board)

[ Filed November 1, 2006, 10:58 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 98-22-084.

Title of Rule and Other Identifying Information: The proposed rules will add new sections to chapter 246-922 WAC including WAC 246-922-510 Use of controlled substance for pain control, 246-922-520 What specific guidance should a podiatric physician follow?, 246-922-530 What knowledge should a podiatric physician who elects to treat chronic pain patients possess?, and 246-922-540 How will the board evaluate prescribing for pain?

Hearing Location(s): Clarion Hotel, 3000 South 176th Street, SeaTac, WA 98188, on January 18, 2007, at 9:30 a.m.

Date of Intended Adoption: January 18, 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 12, 2007.

Assistance for Persons with Disabilities: Contact Arlene Robertson by January 12, 2007, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The podiatric medical board (board) adopted pain management guidelines for prescribing, dispensing, and administering opioids. These guidelines became effective 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 podiatric patients is limited. As a result of 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 also 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 18.22.015, 18.130.050.

Statute Being Implemented: Chapter 18.22 RCW.

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

Name of Proponent: Department of health, podiatric medical board, 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.

Small Business Economic Impact Statement

1. Briefly describe the proposed rule: The Washington podiatric medical board (board) adopted podiatric physician guidelines for prescribing, dispensing, and administering opioids, also known as pain management guidelines. These guidelines became effective on September 13, 1996. The guidelines describe approved opioid therapy for acute, chronic, and intractable pain patients. However, the guidelines do not protect the podiatric physician who manages pain through opioid therapy to practice without fear of injudicious discipline from the board regarding such things as drug addition and diversion. As a result, under-treatment of chronic pain affects the public health, safety, and welfare of the residents of Washington state. In order to improve patient care and access to care, new sections in the Washington Administrative Code (WAC) are needed to reassure podiatric physicians they can use opioids to effectively manage pain.

The proposed rule will:

Reassure podiatric physicians 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 podiatric physicians 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 a podiatric physician 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 the board to assess 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
8043 Offices and Clinics of Podiatrists 136 480 3.6 0
8049 Offices and Clinics of Health Practitioners, Not Elsewhere Classified 913 5450 4.5 102.9
8062 General Medical and Surgical Hospitals 146 78593 11.1 758.4

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:

It will be necessary for providers 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. Since podiatrists' scope of practice does not include treatment of systemic conditions, very few podiatric physicians provide long-term pain management. They would only provide this type of care if there is no one else that the patient can be referred to. The number of treating podiatrists is limited to five or six podiatrists within the state. Each of these podiatrists will have only one or two patients they would manage with controlled substances. Since controlled substances cannot be refilled, patients will need to be seen at least once a month to have new prescriptions written for them and their progress monitored. Based on a DOH survey it is estimated that an additional fifteen minutes per visit will be required and will cost the provider an additional $19.34. An average pain management patient will require approximately twelve visits per year. The annual additional cost per pain patient will be [(12 patient visits x $19.34)] $232.08.
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 will require additional time for each pain patient visit to ensure adherence to the podiatric pain guidelines. The costs are estimated to cost an additional $232.08 annually for each pain patient. Since most pain patients will be referred to family practice or pain specialist physicians, management of pain patients will be limited in podiatric practices.

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.

Podiatric Physician Education:

Knowledge of pain management treatment is required for podiatric 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 is estimated at $200. The total cost for obtaining a basic course is estimated to be $1,000. If they choose to take a comprehensive course in pain management, it would only be taken one time.
Periodically it may be necessary for podiatric 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 podiatric physicians obtain educational courses during nonbusiness hours and therefore the additional training would not interfere with their ability to see patients.
Each podiatric physician 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 $1,000. It is assumed that initially all podiatric physicians practicing 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 courses could be used to fulfill the continuing education requirements needed to maintain their license.

Most podiatric physicians 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: Podiatric Physicians


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
8043 Offices & Clinics of Podiatrists 3.6 7.8 $1000 $1000 $277.77 $128.21
8049 Offices and Clinics of Health Practitioners, Not Elsewhere Classified 4.5 27.4 $1000 $1000 $222.22 $36.50
8062 General Medical and Surgical Hospitals 11.1 2027.7 $1000 $1000 $90.09 $.49

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 podiatric physicians.

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-8009.2


NEW SECTION
WAC 246-922-510   Use of controlled substances for pain control.   (1) Purpose. The podiatric medical board 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 podiatric 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 podiatric medical practice. This includes acute, chronic, and intractable pain (RCW 69.50.308(g)) patients.

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NEW SECTION
WAC 246-922-520   What specific guidance should a podiatric physician follow?   (1) The board has adopted guidelines for the management of pain in order to acquaint podiatric physicians 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) Podiatric 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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NEW SECTION
WAC 246-922-530   What knowledge should a podiatric physician who elects to treat chronic pain patients possess?   Podiatric physicians treating pain should be:

(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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NEW SECTION
WAC 246-922-540   How will the board evaluate prescribing for pain?   The podiatric physician'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 podiatric medical practice regarding the treatment of pain.

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Washington State Code Reviser's Office