Minnesota Legislature
HF 1860
as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:55am
Bill Text Versions
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| Introduction | Posted on 03/18/2009 |
Current Version - as introduced
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A bill for an act
relating to health; regulating the use of lasers, intense pulsed light devices, and
radio frequency devices; amending Minnesota Statutes 2008, section 147.081,
subdivision 3; proposing coding for new law in Minnesota Statutes, chapter 147.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
Minnesota Statutes 2008, section 147.081, subdivision 3, is amended to read:
Subd. 3.
Practice of medicine defined.
For purposes of this chapter, a person not
exempted under section 147.09 is "practicing medicine" or engaged in the "practice of
medicine" if the person does any of the following:
(1) advertises, holds out to the public, or represents in any manner that the person is
authorized to practice medicine in this state;
(2) offers or undertakes to prescribe, give, or administer any drug or medicine for
the use of another;
(3) offers or undertakes to prevent or to diagnose, correct, or treat in any manner or
by any means, methods, devices, or instrumentalities, any disease, illness, pain, wound,
fracture, infirmity, deformity or defect of any person;
(4) offers or undertakes to perform any surgical operation including any invasive
or noninvasive procedures involving the use of a laser or laser assisted device, upon any
personnew text begin unless authorized under section 147.38new text end ;
(5) offers to undertake to use hypnosis for the treatment or relief of any wound,
fracture, or bodily injury, infirmity, or disease; or
(6) uses in the conduct of any occupation or profession pertaining to the diagnosis
of human disease or conditions, the designation "doctor of medicine," "medical doctor,"
"doctor of osteopathy," "osteopath," "osteopathic physician," "physician," "surgeon,"
"M.D.," "D.O.," or any combination of these designations.
Sec. 2.
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[147.38] USE OF LASERS.
new text end
new text begin Subdivision 1. new text end
new text begin Definitions. new text end
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(a) For the purpose of this section, the following
definitions have the meanings given.
new text end
new text begin
(b) "Ablative treatment" means a procedure using a laser, intense pulsed light device,
or radio frequency device that is expected or intended to remove, burn, or vaporize live
epithelium or its supporting structures, the dermis, or subcutaneous tissues, including fat.
new text end
new text begin
(c) "Advanced medical practitioner" means a physician assistant licensed under
chapter 147A or an advanced practice registered nurse licensed under sections 148.171 to
148.285.
new text end
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(d) "Health practitioner" means a registered nurse or licensed practical nurse licensed
under sections 148.171 to 148.285 or a clinical esthetician licensed under chapter 154.
new text end
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(e) "Nonablative treatment" means a procedure using a laser, intense pulsed light
device, or radio frequency device that is not expected or intended to remove, burn, or
vaporize the live epidermal surface of the skin. This definition includes treatments related
to laser hair removal.
new text end
new text begin
(f) "Physician" means a physician or osteopath who is licensed under this chapter, is
practicing within the state of Minnesota, and whose practice includes performing laser and
energy-based treatments.
new text end
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(g) "Supervision" means the overseeing of and accepting responsibility for the
delegated nonablative treatments performed by advanced medical practitioners, health
practitioners, and technicians. Supervision must only be provided by a physician as
defined in paragraph (f).
new text end
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(h) "Technician" means a medical technician or an electrologist.
new text end
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(i) "Written protocol" means an ongoing order that is maintained on site at the
facility at which the treatment is to be performed.
new text end
new text begin Subd. 2. new text end
new text begin
General restrictions on the use of lasers, intense pulsed light devices,
and radio frequency devices.
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(a) The use of a laser, intense pulsed light device, or radio
frequency device for ablative treatments may only be performed by a physician.
new text end
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(b) The use of a laser, intense pulsed light device, or radio frequency device for
nonablative treatments may be performed by an advanced medical practitioner or health
practitioner if the treatment has been delegated in accordance with subdivision 3; the
delegating physician provides the appropriate supervision in accordance with subdivision
4; and the advanced medical practitioner or health practitioner has met the training
requirements in accordance with subdivision 5.
new text end
new text begin
(c) Laser-assisted hair removal may be performed by a technician if the nonablative
treatment has been delegated in accordance with subdivision 3; the delegating physician
provides the appropriate supervision in accordance with subdivision 4; and the technician
has met the training requirements in accordance with subdivision 5.
new text end
new text begin Subd. 3. new text end
new text begin Delegation of nonablative treatment. new text end
new text begin
(a) A physician may delegate the
performance of a nonablative treatment through the use of a written protocol. The written
protocol must provide, at a minimum:
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(1) specific criteria to screen clients for the appropriateness of a nonablative
treatment, including case selection and assessment guidelines;
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(2) for clients who meet the selection criteria, the identification of the devices and
settings to be used;
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(3) a description of appropriate care and follow-up for common complications,
injuries, or adverse reactions that may result from the nonablative treatment, including
a plan to manage medical emergencies;
new text end
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(4) a description of the treatment plan to be followed for each treatment procedure
delegated under the written protocol, including the method to be used for documenting
decisions, communicating with the delegating physician, and recording all treatment
provided in the client's record;
new text end
new text begin
(5) a referral process for situations when an advanced medical practitioner, health
practitioner, or technician encounters an unidentifiable or suspicious-looking skin lesion
or condition that may require a physician's attention; and
new text end
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(6) a quality assurance plan for monitoring care provided by the advanced medical
practitioner, health practitioner, or technician, including patient care review and any
necessary follow-up.
new text end
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(b) The delegating physician shall accept full professional responsibility for all
nonablative treatment procedures performed by an advanced medical practitioner, health
practitioner, or technician.
new text end
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(c) Prior to delegating the performance of any nonablative treatment, the delegating
physician must ensure that the advanced medical practitioner, health practitioner, or
technician has satisfactorily met the training requirements described in subdivision 5.
The delegating physician is responsible for ensuring that the practitioner or technician
performing the treatment has demonstrated sufficient proficiency in performing a specific
treatment.
new text end
new text begin
(d) The written protocol must be annually reviewed by the delegating physician
and the advanced medical practitioner, health practitioner, or technician and updated as
necessary. The written protocol must be provided to the board or to any client upon request.
new text end
new text begin Subd. 4. new text end
new text begin Supervision. new text end
new text begin
(a) An advanced medical practitioner may perform a
delegated nonablative treatment under the general supervision of the delegating physician.
For purposes of this section, general supervision does not require the on-site presence of
the delegating physician so long as the physician and the advanced medical practitioner
are or can be in contact with one another by telephone or other telecommunication device.
new text end
new text begin
(b) A health practitioner or technician may perform any delegated nonablative
treatment authorized under subdivision 2 under the indirect supervision of the delegating
physician. For purposes of this section, indirect supervision requires the delegating
physician be present on site at a minimum of one day per week. The health practitioner
or technician must be able to contact the delegating physician by telephone or other
telecommunication device.
new text end
new text begin
(c) A delegating physician may provide supervision at no more than two facility
locations where nonablative treatments are being performed under a written protocol.
new text end
new text begin Subd. 5. new text end
new text begin Training requirements. new text end
new text begin
(a) Prior to the delegation of any nonablative
treatment, an advanced medical practitioner, health practitioner, or technician must comply
with the following training requirements:
new text end
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(1) successful completion of the academic training requirements established by the
Board of Medical Practice. The training must include the following subjects:
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(i) fundamentals of laser operation;
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(ii) bioeffects of laser radiation on the eye and skin;
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(iii) significance of specular and diffuse reflections;
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(iv) nonbeam hazards of lasers;
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(v) nonionizing radiation hazards;
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(vi) laser and laser system classifications;
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(vii) control measures; and
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(viii) precautions and contraindications of the use of lasers and energy-related
devices in nonablative treatments; and
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(2) successful completion of a clinical application training program in the use of
lasers, intense pulsed light devices, or radio frequency devices, as approved by the board,
that includes the actual use of each type of device that may be delegated to the advanced
medical practitioner, health practitioner, or technician. The training must result in the
demonstration of the ability to competently use a laser, intense pulsed light device, or
radio frequency device for nonablative treatments as determined by a course instructor
or clinical trainer.
new text end
new text begin
(b) Before an advanced medical practitioner, health practitioner, or technician is
permitted to perform a nonablative treatment under the written protocol, the practitioner
or technician must provide documentation to the delegating physician stating that the
requirements of this subdivision have been met, and must demonstrate to the satisfaction
of the delegating physician that the practitioner or technician is proficient in the treatment
to be delegated. Documentation must include the name and address of the facility or
organization at which the training took place, a description of each course or workshop
taken, and a transcript or certification indicating successful completion of the required
training.
new text end
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(c) Practitioners and technicians performing nonablative treatments must complete a
minimum of six continuing education credit hours in the use of lasers and energy-related
devices each biennium. This requirement is in addition to any other continuing education
requirements the practitioner is required to meet under the practitioner's license renewal
process. The delegating physician must ensure that the practitioner or technician has
met the continuing education requirement.
new text end
new text begin
(d) The Board of Medical Practice shall establish academic and clinical training
criteria as required under this subdivision. These requirements may vary based on the level
of education and training required for licensure of the particular practitioner category.
new text end
new text begin Subd. 6. new text end
new text begin Quality assurance. new text end
new text begin
Prior to delegating the performance of a nonablative
treatment procedure, the physician must ensure that there is a quality assurance program at
the facility at which the procedure is to be performed. The quality assurance program, at a
minimum, must include the following elements:
new text end
new text begin
(1) a mechanism to identify and determine the cause of complications and
unintended effects of the nonablative treatments performed at the facility;
new text end
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(2) a mechanism to review the adherence to the written protocol under which
delegated procedures are being performed;
new text end
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(3) a mechanism to monitor the quality of the nonablative treatments performed;
new text end
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(4) a mechanism by which the findings of the quality assurance program are
reviewed and incorporated into future written protocols and delegation orders; and
new text end
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(5) ongoing training to improve the quality and performance of nonablative
treatments.
new text end
new text begin Subd. 7. new text end
new text begin Facility restrictions. new text end
new text begin
Any facility performing nonablative treatments
for primarily aesthetic purposes:
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(1) may not use any word in its name or in its advertising to the public that indicates
or implies that the facility is a medical facility or that it provides medical services;
new text end
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(2) must inform the client prior to initiating any treatment that the treatment provided
by the facility is primarily for aesthetic purposes and not intended to diagnose or treat
a medical condition; and
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(3) must have a medical director who is licensed under this chapter.
new text end
new text begin Subd. 8. new text end
new text begin Violation. new text end
new text begin
Any physician or osteopath who permits an advanced medical
practitioner, health practitioner, technician, or any other person to perform a procedure
using a laser, intense pulsed light device, or radio frequency device other than as authorized
under this section shall be deemed as enabling the unlawful practice of medicine and the
person performing the procedure shall be deemed in violation of section 147.081.
new text end
Sec. 3. new text begin REVISOR'S INSTRUCTION.
new text end
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(a) The revisor of statutes shall change "sections 147.01 to 147.22" to "chapter 147"
wherever it appears in Minnesota Statutes, not including chapter 147.
new text end
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(b) In chapter 147, change "sections 147.01 to 147.22" to "this chapter."
new text end