WSR 08-13-093

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Osteopathic Medicine and Surgery)

[ Filed June 18, 2008, 8:40 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-16-064.

Title of Rule and Other Identifying Information: WAC 246-853-630 Use of laser, light, radiofrequency, and plasma devices as applied to the skin (osteopathic physicians) and 246-854-220 Use of laser, light, radiofrequency, and plasma devices as applied to the skin (osteopathic physician assistants).

Hearing Location(s): Oxford Suites, 1701 East Yakima Avenue, Yakima, WA 98901, on July 25, 2008, at 9:30 a.m.

Date of Intended Adoption: July 25, 2008.

Submit Written Comments to: Arlene Robertson, Program Manager, P.O. Box 47866, Olympia, WA 98504-7866, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-4945, by July 14, 2008.

Assistance for Persons with Disabilities: Contact Arlene Robertson by July 14, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules will clarify that the use of laser, light, radiofrequency, and plasma (LLRP) devices classified as prescriptive medical devices by the Food and Drug Administration (FDA) are the practice of osteopathic medicine. The proposed rules will define delegation and supervision for the use of LLRP devices by osteopathic physicians and osteopathic physician assistants.

Reasons Supporting Proposal: The use of an LLRP device penetrates and alters human tissue and can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypopigmentation, and hyperpigmentation. The board of osteopathic medicine and surgery is concerned that individuals who have little or no formal medical training may be using the devices inappropriately and without adequate medical oversight and supervision.

Statutory Authority for Adoption: RCW 18.57.005, 18.57A.020, and 18.130.050.

Statute Being Implemented: Chapters 18.57 and 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.

Small Business Economic Impact Statement

1. Briefly Describe the Proposed Rule: The board of osteopathic medicine and surgery (board) became aware that individuals in the state of Washington were receiving improper skin treatment or hair removal using LLRP devices after the department of health (DOH) received several complaints. The care was being given by unlicensed or unsupervised personnel. Some offices and clinics had a physician on site, some had a physician off-site, and others had no physician involvement at all. The board found that lasers were being used by physician assistants, registered nurses, cosmetologists, estheticians, and even unlicensed persons. The board is concerned that unlicensed or inadequately trained persons are using prescriptive devices on patients.

The board believes when used appropriately, these devices are generally safe and relatively easy to operate. But the potential for patient injury from untrained personnel, or inappropriate and negligent operation is significant. All but nineteen states have rules that regulate the use of LLRP devices. The board wishes to clarify this area of osteopathic medicine and set standards for the use of such devices by osteopathic physicians and osteopathic physician assistants in our state.

The proposed rules:

Define LLRP devices as medical devices that: (a) Use a laser, noncoherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue; and (b) are classified by the federal FDA as prescription devices;
Provide that an osteopathic physician or osteopathic physician assistant must use an LLRP device in accordance with standard medical practice;
State that the use of an LLRP device is the practice of osteopathic medicine;
Require an osteopathic physician or osteopathic physician assistant to be appropriately trained in the physics, safety, and techniques to use LLRP devices prior to using the device and to remain competent during use of the device;
Require an osteopathic physician or osteopathic physician assistant to, prior to authorizing treatment with such a device, take the patient's medical history, perform an appropriate physical examination, make an appropriate diagnosis, recommend appropriate treatment, obtain the patient's informed consent (including informing the patient that a nonphysician may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record;
Permit an osteopathic physician or osteopathic physician assistant to delegate use of the device to a properly trained and licensed allied health care professional under certain circumstances, but require the osteopathic physician or osteopathic physician assistant to develop a specific protocol for the licensed allied health care professional to follow;
Prohibit an osteopathic physician from delegating an LLRP for use on the globe of the eye;
Require the delegating osteopathic physician to be on the immediate premises during the initial treatment to treat complications, provide consultation, and resolve problems, if indicated;
Permit the delegating osteopathic physician to be temporarily absent during treatment of patients with established treatment plans provided a local back-up physician agrees in writing to treat complications, is reachable by phone, and can see the patient within sixty minutes;
Require the delegating osteopathic physician assistant to be on the premises during all treatment with an LLRP device;
Provide that regardless of who operates the device, the osteopathic physician is ultimately responsible for the safety of the patient;
Require the osteopathic physician to establish a quality assurance program;
Provide that the use of devices to penetrate and alter human tissue for a purpose other than to topically penetrate the skin constitutes surgery and is outside the scope of these rules; and
Provide that these rules only apply to osteopathic physicians and osteopathic physician assistants.
2. Is a Small Business Economic Impact Statement (SBEIS) Required for this Rule? DOH has reviewed this proposal and has determined that an SBEIS is required because the rule does impose more than minor costs on an affected business.

3. Which Industries Are Affected by this Rule? The proposed rules will affect osteopathic medical offices and clinics in the state of Washington providing treatment with LLRP devices as applied to the skin.

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 board does not know how many unlicensed individuals use LLRP devices. The International Medical Spa Association estimates there were 2500 medspas in 2008 up from 400 in 2004. Although the FDA requires prescription authority to purchase medical laser devices, unlicensed individuals can obtain the devices through second-hand markets. The FDA focuses on the manufacturers and not the regulation or enforcement of the end user. State medical boards must adopt rules to regulate the use of LLRP devices.

The board assumes that the proposed rules only impact small businesses.

There are potential costs to implement these rules. Osteopathic practitioners who have an LLRP device in their office or clinic may require training to use the device properly. Their staff may also require training on the devices. LLRP marketing companies often provide training at no cost. The osteopathic practitioner may also take a continuing medical education course which costs an average of $225.00. The training required for these devices may be included in the licensee's continuing education requirements, resulting in no additional cost.

The proposed rules require the osteopathic physician or osteopathic physician assistant to complete the initial physical and history of the patient prior to initiating any treatment. This is the standard of care required for every patient. The proposed rules allow the osteopathic practitioner to delegate procedures to trained and licensed allied health care professionals. The cost impact to an osteopathic physician's office may potentially increase by adding an osteopathic physician assistant two days per week at $354/week to supervise allied health care practitioners, to perform medical examinations, and create treatment plans.

In their absence, the osteopathic physician will have to contract with a back-up physician to supervise staff doing procedures that use an LLRP device. We assume that physicians going on extended leave will either close their office or set up reciprocal agreements to cover their patients and therefore we assume there to be no costs.

If an osteopathic physician assistant delegates the use of an LLRP device, the osteopathic physician assistant must be on site for each treatment. Although the supervising osteopathic physician is required to be present at the site with the osteopathic physician assistant, direct supervision is not required. In the absence of the osteopathic physician assistant we assume that clinics will reschedule patient appointments so we assume there will be no costs.

Additional costs would be incurred for establishing a quality assurance program and protocols for allied health care professionals that would be using an LLRP device. These are customarily used in most practices and would only need to be adapted to each individual practice. The delegating osteopathic physician would initially spend four hours establishing the quality assurance program and protocols, assuming an hourly rate of $100, the cost would be $400. An annual review would take approximately two hours and cost $200.

In summary the board assumes the costs to comply with the proposed rule are: A one time start-up cost of $400 to establish a quality assurance program; weekly expenses to delegate which range from $0 to $354; and an annual cost of $200 to review the quality assurance program.

5. Does the Rule Impose a Disproportionate Impact on Small Businesses? There is no disproportionate impact on small businesses because the assumption is that there are no large businesses.

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 osteopathic 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.

June 12, 2008

Blake T. Maresh

Executive Director

OTS-9865.3


NEW SECTION
WAC 246-853-630   Use of laser, light, radiofrequency, and plasma devices as applied to the skin.   (1) For the purposes of this section, laser, light, radiofrequency, and plasma (LLRP) devices are medical devices that:

(a) Use a laser, noncoherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue; and

(b) Are classified by the federal Food and Drug Administration as prescriptive devices.

(2) Because an LLRP device is used to treat disease, injuries, deformities, and other physical conditions in human beings, the use of an LLRP device is the practice of osteopathic medicine under RCW 18.57.001. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypopigmentation and hyperpigmentation.

(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than those in subsection (1) of this section constitutes surgery and is outside the scope of this section.


OSTEOPATHIC PHYSICIAN RESPONSIBILITIES


(4) An osteopathic physician must be appropriately trained in the physics, safety and techniques of using LLRP devices prior to using such a device, and must remain competent for as long as the device is used.

(5) An osteopathic physician must use an LLRP device in accordance with standard medical practice.

(6) Prior to authorizing treatment with an LLRP device, an osteopathic physician must take a history, perform an appropriate physical examination, make an appropriate diagnosis, recommend appropriate treatment, obtain the patient's informed consent (including informing the patient that an allied health care professional may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.

(7) Regardless of who performs LLRP device treatment, the osteopathic physician is ultimately responsible for the safety of the patient.

(8) Regardless of who performs LLRP device treatment, the osteopathic physician is responsible for assuring that each treatment is documented in the patient's medical record.

(9) The osteopathic physician must ensure that there is a quality assurance program for the facility at which LLRP device procedures are performed regarding the selection and treatment of patients. An appropriate quality assurance program shall include the following:

(a) A mechanism to identify complications and problematic effects of treatment and to determine their cause;

(b) A mechanism to review the adherence of supervised allied health care professionals to written protocols;

(c) A mechanism to monitor the quality of treatments;

(d) A mechanism by which the findings of the quality assurance program are reviewed and incorporated into future protocols required by subsection (10)(d) of this section and osteopathic physician supervising practices; and

(e) Ongoing training to maintain and improve the quality of treatment and performance of the treating allied health care professionals.


OSTEOPATHIC PHYSICIAN DELEGATION OF LLRP TREATMENT


(10) An osteopathic physician who meets the requirements in subsections (1) through (9) of this section may delegate an LLRP device procedure to a properly trained allied health care professional licensed under the authority of RCW 18.130.040, whose scope of practice allows the use of a prescriptive LLRP medical device, provided all the following conditions are met:

(a) The treatment in no way involves surgery as that term is understood in the practice of osteopathic medicine;

(b) Such delegated use falls within the supervised allied health care professional's lawful scope of practice;

(c) The LLRP device is not used on the globe of the eye;

(d) An osteopathic physician has a written office protocol for the supervised allied health care professional to follow in using the LLRP device. A written office protocol must include at a minimum the following:

(i) The identity of the individual osteopathic physician authorized to use the LLRP device and responsible for the delegation of the procedure;

(ii) A statement of the activities, decision criteria, and plan the supervised allied health care professional must follow when performing procedures delegated pursuant to this rule;

(iii) Selection criteria to screen patients for the appropriateness of treatments;

(iv) Identification of devices and settings to be used for patients who meet selection criteria;

(v) Methods by which the specified device is to be operated and maintained;

(vi) A description of appropriate care and follow-up for common complications, serious injury, or emergencies; and

(vii) A statement of the activities, decision criteria, and plan the supervised allied health care professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing osteopathic physician concerning specific decisions made;

(e) The supervised allied health care professional has appropriate training including, but not limited to:

(i) Application techniques of each LLRP device;

(ii) Cutaneous medicine;

(iii) Indications and contraindications for such procedures;

(iv) Preprocedural and postprocedural care;

(v) Potential complications; and

(vi) Infectious disease control involved with each treatment;

(f) The delegating osteopathic physician ensures that the supervised allied health care professional uses the LLRP device only in accordance with the written office protocol, and does not exercise independent medical judgment when using the device;

(g) The delegating osteopathic physician shall be on the immediate premises during the patient's initial treatment and be able to treat complications, provide consultation, or resolve problems, if indicated. The supervised allied health care professional may complete the initial treatment if the physician is called away to attend to an emergency;

(h) Existing patients with an established treatment plan may continue to receive care during temporary absences of the delegating osteopathic physician provided there is a local back-up physician, licensed under chapter 18.57 or 18.71 RCW, who satisfies the requirements of subsection (4) of this section. The local back-up physician must agree in writing to treat complications, provide consultation or resolve problems if medically indicated. In case of an emergency the delegating osteopathic physician or a back-up physician shall be reachable by phone and able to see the patient within sixty minutes.

(11) The use of, or the delegation of the use of, an LLRP device by an osteopathic physician assistant is covered by WAC 246-854-220.

(12) This section only applies to the use of LLRP devices by osteopathic physicians and osteopathic physician assistants.

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OTS-9866.3


NEW SECTION
WAC 246-854-220   Use of laser, light, radiofrequency, and plasma devices as applied to the skin.   (1) For the purposes of this section, laser, light, radiofrequency, and plasma (LLRP) devices are medical devices that:

(a) Use a laser, noncoherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue; and

(b) Are classified by the federal Food and Drug Administration as prescriptive devices.

(2) Because an LLRP device is used to treat disease, injuries, deformities and other physical conditions of human beings, the use of an LLRP device is the practice of osteopathic medicine under RCW 18.57.001. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypopigmentation and hyperpigmentation.

(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than those in subsection (1) of this section constitutes surgery and is outside the scope of this section.


OSTEOPATHIC PHYSICIAN ASSISTANT RESPONSIBILITIES


(4) An osteopathic physician assistant may use an LLRP device with the consent of the sponsoring or supervising osteopathic physician who meets the requirements under WAC 246-853-630, is in compliance with the practice arrangement plan approved by the board, and in accordance with standard medical practice.

(5) An osteopathic physician assistant must be appropriately trained in the physics, safety and techniques of using LLRP devices prior to using such a device, and must remain competent for as long as the device is used.

(6) Prior to authorizing treatment with an LLRP device, an osteopathic physician assistant must take a history, perform an appropriate physical examination, make an appropriate diagnosis, recommend appropriate treatment, obtain the patient's informed consent (including informing the patient that an allied health care practitioner may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.


OSTEOPATHIC PHYSICIAN ASSISTANT DELEGATION OF LLRP TREATMENT


(7) An osteopathic physician assistant who meets the above requirements may delegate an LLRP device procedure to a properly trained allied health care professional licensed under the authorization of RCW 18.130.040, whose scope of practice allows the use of a prescriptive LLRP medical device provided all the following conditions are met:

(a) The treatment in no way involves surgery as that term is understood in the practice of medicine;

(b) Such delegated use falls within the supervised allied health care professional's lawful scope of practice;

(c) The LLRP device is not used on the globe of the eye; and

(d) The supervised allied health care professional has appropriate training including, but not limited to:

(i) Application techniques of each LLRP device;

(ii) Cutaneous medicine;

(iii) Indications and contraindications for such procedures;

(iv) Preprocedural and postprocedural care;

(v) Potential complications; and

(vi) Infectious disease control involved with each treatment;

(e) The delegating osteopathic physician assistant has written office protocol for the supervised allied health care professional to follow in using the LLRP device. A written office protocol must include at a minimum the following:

(i) The identity of the individual osteopathic physician assistant authorized to use the device and responsible for the delegation of the procedure;

(ii) A statement of the activities, decision criteria, and plan the supervised allied health care professional must follow when performing procedures delegated pursuant to this rule;

(iii) Selection criteria to screen patients for the appropriateness of treatments;

(iv) Identification of devices and settings to be used for patients who meet selection criteria;

(v) Methods by which the specified device is to be operated and maintained;

(vi) A description of appropriate care and follow-up for common complications, serious injury, or emergencies; and

(vii) A statement of the activities, decision criteria, and plan the supervised allied health care professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing osteopathic physician assistant concerning specific decisions made. Documentation shall be recorded after each procedure on the patient's record or medical chart;

(f) The osteopathic physician assistant is responsible for ensuring that the supervised allied health care professional uses the LLRP device only in accordance with the written office protocol, and does not exercise independent medical judgment when using the device;

(g) The osteopathic physician assistant shall be on the immediate premises during any use of an LLRP device and be able to treat complications, provide consultation, or resolve problems, if indicated.

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Washington State Code Reviser's Office