Minnesota Association For Aesthetic Safety

H.F. No. 3937, as introduced - 85th Legislative Session (2007-2008)   Posted on Mar 10, 2008

1.1     A bill for an act

1.2     relating to health; regulating the use of lasers, intense pulsed light devices, and

1.3     radio frequency devices;amending Minnesota Statutes 2006, section 147.081,

1.4     subdivision 3; proposing coding for new law in Minnesota Statutes, chapter 147.

1.5     BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF

MINNESOTA

:

 

1.6        Section 1. Minnesota Statutes 2006, section 147.081, subdivision 3, is amended to read:
1.7        Subd. 3. Practice of medicine defined. For purposes of this chapter, a person not
1.8     exempted under section 147.09 is "practicing medicine" or engaged in the "practice of
1.9     medicine" if the person does any of the following:
1.10    (1) advertises, holds out to the public, or represents in any manner that the person is
1.11    authorized to practice medicine in this state;
1.12    (2) offers or undertakes to prescribe, give, or administer any drug or medicine for
1.13    the use of another;
1.14    (3) offers or undertakes to prevent or to diagnose, correct, or treat in any manner or
1.15    by any means, methods, devices, or instrumentalities, any disease, illness, pain, wound,
1.16    fracture, infirmity, deformity or defect of any person;
1.17    (4) offers or undertakes to perform any surgical operation including any invasive
1.18    or noninvasive procedures involving the use of a laser or laser assisted device, upon any
1.19    person unless authorized under section 147.38;
1.20    (5) offers to undertake to use hypnosis for the treatment or relief of any wound,
1.21    fracture, or bodily injury, infirmity, or disease; or
1.22    (6) uses in the conduct of any occupation or profession pertaining to the diagnosis
1.23    of human disease or conditions, the designation "doctor of medicine," "medical doctor,"
2.1     "doctor of osteopathy," "osteopath," "osteopathic physician," "physician," "surgeon,"
2.2     "M.D.," "D.O.," or any combination of these designations.

2.3        Sec. 2. [147.38] USE OF LASERS.
2.4        Subdivision 1. Definitions. (a) For the purpose of this section, the following
2.5     definitions have the meanings given.
2.6     (b) "Ablative treatment" means treatment that is expected or intended to remove,
2.7     burn, or vaporize the epithelium, or its supporting structures, the dermis or subcutaneous
2.8     tissues, including fat.
2.9     (c) "Health practitioner" means a physician assistant registered under chapter 147A;
2.10    a licensed advanced practice registered nurse, registered nurse, or licensed practical nurse
2.11    licensed under sections 148.171 to 148.285; a licensed clinical esthetician licensed under
2.12    chapter 154; or a medical technician who has complied with the training requirements
2.13    described under subdivision 4.
2.14    (d) "Nonablative treatment" means treatment using a laser, intense pulsed light
2.15    device, or radio frequency device that is not expected or intended to remove, burn, or
2.16    vaporize the epidermal surface of the skin. This definition includes treatments related to
2.17    laser hair removal.
2.18    (e) "Physician" means a physician or osteopath licensed under this chapter.
2.19    (f) "Supervisor" means a physician experienced in ablative and nonablative
2.20    treatment.
2.21    (g) "Supervision" means the process of control and direction by which the supervisor
2.22    accepts full professional responsibility for the supervisee, instructs the supervisee, and
2.23    oversees or directs the work of the supervisee. The process must meet the following
2.24    conditions:
2.25    (1) the supervisor must be present and available on the premise more than 50 percent
2.26    of the time the supervisee is performing the treatment procedure and must be immediately
2.27    available for consultation, assistance, and direction as needed;
2.28    (2) the supervisor must review, approve, and sign the treatment plan if developed
2.29    by the supervisee before the treatment is performed; and
2.30    (3) the supervisor must review and countersign the patient's medical record of
2.31    treatment provided by the supervisee within five working days after the treatment is
2.32    performed.
2.33    (h) "Written protocol" means an ongoing order by the physician that is maintained
2.34    on-site at the facility at which the treatment is to be performed. The written protocol
2.35    must provide, at a minimum, the following:
3.1     (1) a statement identifying the physician who is authorized to use the specific device
3.2     and to delegate the use;
3.3     (2) specific criteria to screen patients for the appropriateness of a nonablative
3.4     treatment;
3.5     (3) for patients who meet the selection criteria, the identification of devices and
3.6     setting to be used;
3.7     (4) a description of appropriate care and follow-up for common complications,
3.8     serious injury, or emergencies that may result from the nonablative treatment; and
3.9     (5) a description of the plan to be followed when a treatment procedure is to be
3.10    delegated to a health practitioner, including the method to be used for documenting
3.11    decisions, communicating with the delegating physician, and recording all treatment
3.12    provided in the patient's medical record.
3.13      Subd. 2. General restrictions on the use of lasers, intense pulsed light devices,
3.14    and radio frequency devices. (a) The use of a laser, intense pulsed light device, or radio
3.15    frequency device for ablative treatments for the purpose of treating a physical disease,
3.16    disorder, deformity, or injury shall constitute the practice of medicine under section
3.17    147.081 and may only be performed by a physician.
3.18    (b) The use of a laser, intense pulsed light device, or radio frequency device for
3.19    nonablative treatments may be performed by a health practitioner if the treatment has been
3.20    delegated to the health practitioner by a physician according to subdivision 3 and the
3.21    health practitioner has met the training requirements described in subdivision 4.
3.22    (c) The use of a laser, nonlaser medical light-emitting device, or radio frequency
3.23    device on the eye or ocular adnexa shall only be performed by a physician.
3.24      Subd. 3. Delegation of nonablative treatment. (a) A supervising physician may
3.25    delegate the performance of a nonablative treatment to a health practitioner through the
3.26    use of a written protocol if the following requirements are met:
3.27    (1) a written protocol is in place at the facility where the treatment procedure is to
3.28    be performed;
3.29    (2) the supervising physician agrees to supervise the performance of the health
3.30    practitioner who is performing the nonablative treatment;
3.31    (3) prior to the performance of the initial nonablative treatment, the patient is initially
3.32    examined by the supervising physician who is to perform the treatment. If the patient is
3.33    examined by the health practitioner, the diagnosis and treatment plan must be reviewed
3.34    and approved by the supervising physician before the treatment is performed; and
3.35    (4) the supervising physician receives periodic status reports, as established in the
3.36    written protocol.
4.1     (b) If the supervising physician is unavailable to supervise the health practitioner as
4.2     required under this section, supervision may be delegated to another physician who has
4.3     the same level of training in nonablative treatment procedures as the supervising physician
4.4     and is associated with the supervising physician or the facility where the treatment is to be
4.5     performed. The physician providing supervision must affirm in writing that the physician
4.6     is familiar with the written protocols in use at the facility and will be responsible for
4.7     providing supervisory care according to those protocols and the requirements of this
4.8     section.
4.9        Subd. 4. Training requirements for health practitioners. (a) The supervising
4.10    physician must ensure prior to delegating the performance of any nonablative treatment to
4.11    a health practitioner that the health practitioner has complied with the following training
4.12    requirements:
4.13    (1) the health practitioner has completed and documented clinical and academic
4.14    training as established by the Board of Medical Practice in the following subjects:
4.15    (i) the fundamentals of laser operation;
4.16    (ii) the bioeffects of laser radiation on the eye and skin;
4.17    (iii) the significance of specular and diffuse reflections;
4.18    (iv) the nonbeam hazards of lasers;
4.19    (v) the nonionizing radiation hazards;
4.20    (vi) laser and laser system classifications; and
4.21    (vii) control measures; and
4.22    (2) the health practitioner has documented that they have completed training in
4.23    nonablative devices as established by the board and in each procedure that the health
4.24    practitioner may be performing using the devices.
4.25    (b) Before a health practitioner can perform any nonablative treatments, the health
4.26    practitioner must perform at least five treatments under the direct observation of the
4.27    supervising physician. For purposes of this section, "direct supervision" means that the
4.28    physician is present when the treatment is being performed.
4.29      Subd. 5. Quality assurance. Prior to delegating the performance of a nonablative
4.30    treatment procedure, the supervising physician must ensure that there is a quality
4.31    assurance program at the facility at which the procedure is to be performed. The quality
4.32    assurance program, at a minimum, must include the following elements:
4.33    (1) a mechanism to identify and determine the cause of complications and
4.34    unintended effects of nonablative treatments;
4.35    (2) a mechanism to review the adherence to the written protocol under which the
4.36    delegated procedure is being performed;
5.1     (3) a mechanism to monitor the quality of the nonablative treatment performed;
5.2     (4) a mechanism by which the findings of the quality assurance program are
5.3     reviewed and incorporated into future written protocols and delegation orders; and
5.4     (5) ongoing training of health practitioners to improve the quality and performance
5.5     of nonablative treatments.

5.6        Sec. 3. REVISOR'S INSTRUCTION.
5.7     The revisor of statutes shall change "sections 147.01 to 147.22" to "this chapter"
5.8     wherever it appears in Minnesota Statutes.

 

Bill was introduced by Senator Marty/Rep. Rund