Titles of Regulations: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (adding 18VAC85-20-91).

18VAC85-50. Regulations Governing the Practice of Physician Assistants (adding 18VAC85-50-191).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

December 7, 2018 - 8:35 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233

Public Comment Deadline: December 28, 2018.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4621, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system, and § 54.1-2973.1 of the Code of Virginia, which governs the practice of laser hair removal.

Purpose: A review of the practice of laser hair removal in 2016 concluded that the lack of comprehensive regulation over the use of laser technology for hair removal poses a risk of harm to the public's health, safety, and welfare. The purpose of this action is to develop regulations for some mechanism for determining whether someone has been "properly trained" and for the required direction and supervision.

The proposed regulations provide a regulatory framework for "direction and supervision" so that the laser hair technician, the supervising practitioner, and the public will understand the scope of responsibility for such direction and supervision. The intent is to establish minimum competencies for practitioners or persons to whom practitioners delegate the practice of laser hair removal and to specify the responsibilities of licensed practitioners for oversight and supervision in order to protect the health and safety of citizens of the Commonwealth who may become their patients.

Substance: Proposed regulations establish the knowledge and training that a practitioner supervising or performing laser hair removal must have; allows for delegation to a properly trained person, provided the supervising practitioner is readily available when laser hair removal is being performed; and limits any prescribing of controlled substances to practitioners authorized to prescribe in accordance with statutory requirements for establishment of a practitioner-patient relationship.

Issues: The primary advantage to the public is assurance of basic training and technique to avoid serious injury to members of the public. There are no disadvantages for the public; regulations will offer greater protection to clients or patients seeking laser hair removal. There are no advantages or disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 390 of the 2017 Acts of Assembly,¹ the Board of Medicine (Board) proposes to establish training requirements for the practice of laser hair removal and limit the practice to doctors, physician assistants, nurse practitioners, and other persons under the direction and supervision of a licensed doctor, a physician assistant, or a nurse practitioner.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs. Detailed analysis of the benefits and costs can be found in the next section.

Estimated Economic Impact. At the request of a General Assembly member, the Department of Professional and Occupational Regulation (DPOR) and the Department of Health Professions (DHP) reviewed the issue of laser hair removal in 2016 and concluded that the lack of a comprehensive regulation over the use of laser technology for hair removal posed a risk of harm to the public's health, safety and welfare. Subsequently, 2017 House Bill 2119 was introduced, passed, and became law. The legislation specifically limits the practice of laser hair removal to trained doctors, physician assistants, nurse practitioners, and other trained individuals provided they operate under the supervision of a licensed doctor, a physician assistant, or a nurse practitioner.²

Under the proposed regulation, doctors, physician assistants, and other authorized individuals will have to obtain training in skin physiology and histology, skin type and appropriate patient selection, laser safety, operation of laser device or devices to be used, recognition of potential complications and response to any actual complication resulting from a laser hair removal treatment, and demonstrate hands on competence. Doctors and physician assistants practicing laser hair removal when this regulation becomes effective will be deemed to have met the training requirement.³ Individuals who are not doctors or physician assistants but practicing under the supervision of one are required to be trained, but it will be up to the supervisor to ensure that such training is completed.

The costs of training vary from provider to provider. For example, an online research reveals that a provider in Denver, Colorado offers training composed of 20 hours of online training followed by 40 hours of classroom and hands-on training over a span of six days at $6,500, which includes a hotel room, lunches, books, classroom materials, and tuition.⁴ Another provider in Stafford, Virginia offers training composed of two days of at-home training followed by a three-day on-site training at $2,500, which includes books, classroom materials, and tuition, but does not include lodging and meals.⁵ The other major costs of training would include travel expenses and lost wages.

In addition to the training, the proposed regulation requires that the laser hair removal is performed by a doctor or a physician assistant or by a person who is supervised by one. Therefore, a practitioner who does not have such a qualification will have to enter into a supervision arrangement by a licensed doctor, a physician assistant, or a nurse practitioner. A nurse practitioner or physician assistant in turn is required to have a collaborative agreement or practice agreement with a physician under other existing regulations. The cost of securing supervision from a licensed doctor is not known, but will likely be significant. Individuals who are currently operating without supervision will have to cease practicing laser hair removal if they cannot secure a supervision arrangement with a licensed doctor.

According to DHP, the main aim of the proposed regulation is to "[provide] some assurance that a potentially harmful procedure can be performed without risk of injury to a patient and some accountability the performance of laser hair removal." As mentioned above, DPOR and DHP reviewed the issue of laser hair removal in 2016 and concluded that the lack of a comprehensive regulation over the use of laser technology for hair removal posed a risk of harm to the public's health, safety and welfare. Thus, to the extent the proposed regulation reduces those risks, it will be beneficial. However, some businesses currently operating without supervision will have to cease practicing laser hair removal if they cannot secure a supervision arrangement.

Businesses and Entities Affected. The number of businesses practicing laser hair removal and the number of businesses with staff currently working without supervision in Virginia are not known. Similarly, there is no data on the number of laser hair removal customers in Virginia. There are 38,021 doctors of medicine, 3,362 doctors of osteopathic medicine, and 3,612 physician assistants licensed in Virginia.⁶

Localities Particularly Affected. The proposed regulation does not affect any particular locality more than others.

Projected Impact on Employment. If a business currently practicing laser hair removal cannot secure supervision arrangement with a doctor, physician assistant, or a nurse practitioner for its staff, it will have to cease operations. Thus, the proposed supervision agreement may have a negative impact on employment.

Effects on the Use and Value of Private Property. Securing supervision may introduce additional costs to some of the laser hair removal practices and reduce their asset values or may force some to cease their operations.

Real Estate Development Costs. No impact on real estate development costs is expected.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Most of the businesses performing laser hair removal are likely to be small. The legislation and the proposed regulation introduce additional costs associated with securing a supervision arrangement. The additional cost in some cases may be significant enough to force closure.

Alternative Method that Minimizes Adverse Impact. The legislative mandate specifically requires training and supervision. Thus, there is no alternative method that minimizes the potential adverse impact on some small businesses while satisfying the law.

Adverse Impacts:

Businesses. Larger laser hair removal businesses are more likely to have an existing supervision arrangement for their staff and the adverse impact identified above may not be implicated for them.

Localities. The proposed regulation will not adversely affect localities.

Other Entities. The proposed required supervision arrangement may introduce additional compliance costs on laser hair removal businesses. Higher compliance costs or closures could result in price increases and negatively affect consumers.

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¹http://lis.virginia.gov/cgi-bin/legp604.exe?171+ful+CHAP0390

²Practice of laser hair removal by a nurse practitioner is regulated in a separate regulation, 18 VAC 90-30.

³Ibid.

⁴http://rockymountainlasercollege.com/laser-training/cost/, accessed on February 8, 2018.

⁵http://www.nvlet.com/tuition/, accessed on February 8, 2018.

⁶Data source: Department of Health Professions

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

Consistent with Chapter 390 of the 2017 Acts of Assembly, the proposed amendments (i) require laser hair removal be performed by a "properly trained person" who is a licensee or by a "properly trained person under the direction and supervision" of a doctor, physician assistant, or nurse practitioner; and (ii) provide a regulatory framework for such direction and supervision.

18VAC85-20-91. Practice and supervision of laser hair removal.

A. A doctor of medicine or osteopathic medicine may perform or supervise the performance of laser hair removal upon completion of training in the following:

1. Skin physiology and histology;

2. Skin type and appropriate patient selection;

3. Laser safety;

4. Operation of laser device to be used;

5. Recognition of potential complications and response to any actual complication resulting from a laser hair removal treatment; and

6. A minimum number of 10 proctored patient cases with demonstrated competency in treating various skin types.

B. Doctors of medicine or osteopathic medicine who have been performing laser hair removal prior to (the effective date of this regulation) are not required to complete training specified in subsection A of this section.

C. A doctor who delegates the practice of laser hair removal and provides supervision to a person other than a licensed physician assistant or licensed nurse practitioner shall ensure that such person has completed the training required in subsection A of this section.

D. A doctor who performs laser hair removal or who supervises others in the practice shall receive ongoing training as necessary to maintain competency in new techniques and laser devices. The doctor shall ensure that persons the doctor supervises also receive ongoing training to maintain competency.

E. A doctor may delegate laser hair removal to a properly trained person under the doctor's direction and supervision. Direction and supervision shall mean that the doctor is readily available at the time laser hair removal is being performed. The supervising doctor is not required to be physically present but is required to see and evaluate a patient for whom the treatment has resulted in complications prior to the continuance of laser hair removal treatment.

F. Prescribing of medication shall be in accordance with § 54.1-3303 of the Code of Virginia.

18VAC85-50-191. Practice and supervision of laser hair removal.

A. A physician assistant, as authorized pursuant to § 54.1-2952 of the Code of Virginia, may perform or supervise the performance of laser hair removal upon completion of training in the following:

1. Skin physiology and histology;

2. Skin type and appropriate patient selection;

3. Laser safety;

4. Operation of laser device to be used;

5. Recognition of potential complications and response to any actual complication resulting from a laser hair removal treatment; and

6. A minimum number of 10 proctored patient cases with demonstrated competency in treating various skin types.

B. Physician assistants who have been performing laser hair removal prior to (the effective date of this regulation) are not required to complete training specified in subsection A of this section.

C. A physician assistant who delegates the practice of laser hair removal and provides supervision for such practice shall ensure the supervised person has completed the training required in subsection A of this section.

D. A physician assistant who performs laser hair removal or who supervises others in the practice shall receive ongoing training as necessary to maintain competency in new techniques and laser devices. The physician assistant shall ensure that persons the physician assistant supervises also receive ongoing training to maintain competency.

E. A physician assistant may delegate laser hair removal to a properly trained person under the physician assistant's direction and supervision. Direction and supervision shall mean that the physician assistant is readily available at the time laser hair removal is being performed. The supervising physician assistant is not required to be physically present but is required to see and evaluate a patient for whom the treatment has resulted in complications prior to the continuance of laser hair removal treatment.

F. Prescribing of medication shall be in accordance with § 54.1-3303 of the Code of Virginia.