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FLORIDA
Thank you to IMSA member:
Cheryl Whitman of Beautiful Forever Medical Spa Business Consulting
EM: CherylWhitman1@aol.com,
www.medicalspaconsultant.com
New Laws Regulates Med Spa Operation
Businesses Make Beauty Convenient
By Patty Pensa
South Florida Sun-Sentinel
Posted July 2 2006
In the mix of stores that defines what is high-end -- think Tiffany & Co., Cartier and Dana Buchman -- a new business has found its niche blending consumerism with the timeless pursuit of perfection.
Considering that Town Center at Boca Raton caters to the upper crust, it's no surprise that Sleek MedSpa chose it as its first Florida location. The business, which opened in spring, joins the growing trend of "medical spas" trying to make a shot of Botox cozy and convenient.
"We're just making Boca beautiful one wrinkle at a time," said Andrew Rudnick, Sleek's chief executive officer.
Business has been brisk, Rudnick said, as the store benefits from foot traffic passing Williams-Sonoma or Tiffany's to get to Saks Fifth Avenue.
The concept: slip in an appointment while spending the day shopping. On the other end of the county, Radiance Medspa is in the trendy Downtown at the Gardens shopping center in Palm Beach.
Such spas have emerged in malls, city office buildings and storefronts across the country but not without attention from legislators and medical associations. A new state law that took effect Saturday says dermatologists and plastic surgeons are the only specialists who can supervise medical spas.
Though other parts of the law affect primary care doctors, too, some say medical spas were the target. A medical supervisor can run no more than two offices offering mainly skin care, and by 2011 it would be only one.
"Cosmetic skin care is a growing industry and med spas are probably going to be a vital part of that growth," said Dr. Dan Meirson, a Pompano Beach dermatologist and immediate past president of the Florida Society of Dermatology and Dermatological Surgery.
"Our concern is with the safety of patients going to any med spa or doctor's office."
The state dermatological society lobbied for the law to ensure doctors are involved in patient care. Rudnick, who began his business in Boston, said the law won't hurt his medical spas.
He'd simply hire different medical supervisors for future spas -- which Rudnick is planning from Miami to the Palm Beaches.
Special thanks go to:
Eric Light of The Strawberry Hill Group
EM: Strawbryhillgrp@aol.com,
www.thestrawberryhillgroup.com
for assisting the IMSA in trying to have this bill sent back to committee
CALIFORNIA
IMSA Legislation News
Dear Hannelore Leavy,
There has been much press lately about California Assembly Bill 2398 and we at the International Medical Spa Association feel this is a very important matter.
An important hearing was held in Sacramento on April 25th regarding this bill. The committee decided to put this topic on a watch and work with the California Nurses Board to address the educational and supervisional needs at California medspas.
Although it appears this matter is being "shelved" for the moment, this is actually an ongoing issue, relevant to all states, and will now go to the Appropriations Committee. This bill could significantly impact medspa owners, managing service organizations, medspa physicians and staff, medspa consumers and all vendors serving the California medspa industry.
California Assembly Bill 2398
The International Medical Spa Association, an association with a large number of members in California, and over 1,000 members worldwide, is concerned that California Assembly Bill 2398 may be unwarranted restraint of trade that threatens the public's safety and undermines a doctor's or small business owner's right to earn a living.
The Bill has nothing to do with consumer safety. It was drawn up with the support of a sepcial interest group (the American Society of Dermatologic Surgery) representing dermatologists with a vested business interest in restricting who can own or operate a medical spa. Since a dermatologist can become board certified without receiving any training in esthetic procedures, there is no guarantee that these specialists will have any greater knowledge of esthetic procedures than other doctors, healthcare professionals, and estheticians.
The negative comments about medical spa safety and the need for greater supervision made to the committee belie the facts that medical spa malpractice insurance premiums have actually come down over the last two years.
Our Association believes that medical spas need to offer the highest level of care possible. That is why we define a medical spa as "a facility that works under the supervision of a licensed healthcare professional working within their scope of practice, with a staff working within their scope of practice."
We do agree that a non-doctor licensed healthcare professional should be supervised by a MD or DO. However, we do NOT believe that a doctor or DO acting as a medical director should be required to be on-site. Instead, the International Medical Spa Association believes there should be a better definition of "indirect supervision"; including the medical director's distance from the facility and how many facilities he or she can supervise.
Damaging valuable California businesses, restricting access to services, and potentially driving up costs for consumers in order to protect a special class of physicians is unwarranted, unwise and unfair; particularly when there is no demonstrated risk to consumers and the public health.
The International Medical Spa Association joins with the American Academy of Family Practioners, the American Academy for Anti-Aging Medicine, as well as thousands of physicians and osteopaths in the State of California, respectfully asking that you, as a member of the California legislature, delay the passage of Assembly Bill 2398, and instead return it back to committee for a full and impartial hearing. Please be mindful of the fact that there have been rumblings of various grassroots lobbying efforts, aided by attorneys. A list of Assembly Members is provided for your benefit. More information is also posted at the MedcalSpaMD Blog.
Kindest Regards,
Eric Light, President
International Medical Spa Association
www.medicalspaassociation.org
201-865-2065 / 201-865-3961
e-mail: medspaassn@aol.com
Thank you to IMSA member:
Cheryl Whitman of Beautiful Forever Medical Spa Business Consulting
EM: CherylWhitman1@aol.com,
www.medicalspaconsultant.com
California State Bill 1423 has been temporarily held back
The proposed bill that would make have made constant supervision by a physician necessary for any type of medical spa treatment has been held back momentarily because of an extremely negative reaction from vast amounts of California physicians and medical spa personnel.
Senator Figueroa's SB 1423 has been completely amended to reflect these points of opposition. The bill mandates a complete review of the issues of "elective cosmetic medical procedures" by the Medical Board and Board of Nursing to be completed and reported to the Legislature by January 1, 2008.
Amendments to SB 1423 (Figueroa)
May 26, 2006 version
- Delete current contents of the bill.
- Require the Medical Board of California, in conjunction with the Board of Registered Nursing, to evaluate issues surrounding the use of laser or intense light pulse device for elective cosmetic procedures by health care practitioners. The evaluation and study include by not be limited to:
- The appropriate level of physician supervision needed.
- The appropriate level of training to ensure competency.
- Guidelines for standardized procedures and protocols that shall address at a minimum:
(i) patient selection;
(ii) patient education, instruction and informed consent;
(iii) use of topical agents;
(iv) procedures to be followed in the event of foreseeable complications or side effects from the treatment;
(v) procedures governing emergency and urgent care situations.
- Who should be able to purchase and own laser equipment
- To the extent that the Boards have the authority to promulgate regulations to implement changes pursuant to their findings and recommendations, they should be required to do so.
- Require a report to the Legislature by January 1, 2008.
Special thanks go to
John Buckingham of Solana MedSpas
EM: john@solanamedspa.com,
www.solanamedspas.com
Received from Gina Meyer:
I'm sure all of you are aware of the California legislature already - if not actively involved in the reform. This is from one of the specialty groups I insure that know of my work with the medical spa industry. He has mentioned the CA Board has become actively involved as of late with sending out information with regards to what the CA Board does/does not allow (which with a little reserve I think is a good thing).
Action Report - Medical Board of California -
Use of Mid-level Practitioners For Laser, Dermabrators, Botox, and Other Treatments
Due to an ongoing influx of calls to the board regarding who may perform what type of medical/cosmetic procedure and where, the following frequently asked questions and responses are provided for informational purposes and as a reminder. This is a reprint and update to an article published in the October 2002 Action Report.
Who may use lasers or intense pulse light devices to remove hair, spider veins, and tattoos?
Physicians may use lasers or intense pulse light devices. In addition, physician assistants and registered nurses (not licensed vocational nurses) may perform these treatments under a physician’s supervision. Unlicensed medical assistants, licensed vocational nurses, cosmetologists, electrologists, or estheticians may not legally perform these treatments under any circumstance, nor may registered nurses or physician assistants perform them independently, without supervision.
Who may inject Botox?
Physicians may inject Botox, or they may direct registered nurses, licensed vocational nurses, or physician assistants to perform the injection under their supervision. No unlicensed persons, such as medical assistants, may inject Botox.
I’ve been approached by a nurse to be her “sponsoring physician” for her laser and Botox practice; would that he legal?
No. There is no such thing as a “sponsoring physician.” Nurses may not, under California law, employ or contract with a physician for supervision. A nurse may not have a private practice with no actual supervision. While the laws governing nursing recognize “the existence of overlapping functions between physicians and registered nurses” and permit “additional sharing of functions within organized health care systems that provide for collaboration between physicians and registered nurses” (Business and Professions Code section 2725), nurses only ma$ perform medical functions under “standardized procedures.” The board does not believe this allows a nurse to have a private medical cosmetic practice without any physician supervision.
I’ve been asked by a layperson to serve as “medical director” for a “medi-spa” that provides laser and other cosmetic medical services; would that be legal?
No. No one who cannot legally practice medicine can offer or provide medical services (Business and Professions Code
section 2052). A physician contracting with or acting as an employee of a lay-owned business would be aiding and abetting the unlicensed practice of medicine (Business and Professions Code sections 2264, 2286, and 2400). To offer or provide these services, the business must be a physician owned medical practice or a professional medical corporation with a physician being the majority shareholder.
I see these ads for “Botox Parties” and think that it has to be illegal. Is it?
The law does not restrict where Botox treatments may be performed, as long as they are performed by a physician or by a registered nurse, licensed vocational nurse, or physician assistant under a physician’s supervision.
Who may perform microdermabrasion?
It depends. If it’s a cosmetic treatment, that is to say it only affects the outermost layer of the skin or the stratum corneum, then a licensed cosmetician or esthetician may perform the treatment. If it’s a medical treatment, that is to say it penetrates to deeper levels of the epidermis, then it must be performed by a physician, or by a registered nurse or physician assistant under supervision. Treatments to remove scarring, blemishes, or wrinkles would be considered a medical treatment. Unlicensed personnel, including medical assistants, may not perform any type of microdermabrasion.
I would like to provide non-medical dermabrasion, and hire an esthetician to perform that and also cosmetic facial and skin treatments. What do I need to do?
It is legal for physicians to hire licensed cosmetologists or estheticians to perform cosmetology services, if they have obtained a facility permit from the Bureau of Barbering and Cosmetology. You may apply for a permit with the Department of Consumer Affairs @CA), Bureau of Barbering and Cosmetology, 2420 Del Paso Blvd., Sacramento, CA 95834. You may obtain application forms at the DCA Web site at www.dca.ca.gov. All licensed cosmetologists, including esthetic&, must perform their services in a facility with a permit.
Why can’t I use a medical assistant instead of a nurse?
Medical assistants are not licensed professionals. While doctors have become accustomed to their assistance in medical office practices, medical assistants are not required to have any degree, nor do they have to pass an examination or be licensed. For that reason, the law only allows them to perform technical supportive services as described in sections 2069-2071 of the Business and Professions Code, and Title 16, California Code of Regulations, sections 1366-1366.4.
What is the penalty if I get caught using or helping an unlicensed person to perform medical treatment?
The law provides a number of sanctions, ranging from license discipline to criminal prosecution, for aiding and abetting the unlicensed practice of medicine. Physicians could be charged with aiding and abetting unlicensed practice, and the employee could be charged with unlicensed practice.
I understand that all of these practices may be illegal, but I see advertisements all the time for these kinds of illegal practices. What should I do?
You may file a complaint with the Medical Board. To do so, please send the advertisement, the publication name and date, and your address and telephone number where you may be reached for further information, to our Central Complaint Unit at 1426 Howe Avenue, Suite 54, Sacramento, CA 95825. The board will contact the business, inform them of the law, and direct them to cease any illegal practice. If it is simply the advertisement that is misleading, they will be directed to change or clarify the ad. It is impossible to cover all of the relevant legal issues in a short article, and these questions and answers are not a substitute for professional legal advice. Physicians may want to consult with their attorneys or malpractice carriers about the use of their office personnel. In addition, the board has a number of written materials with more thorough information on this subject. There are legal opinions on the use of lasers and dermabrasion, materials outlining the legal limitations on use of medical assistants, as well as the actual statutes and regulations. To request any of these documents, please contact the Medical Board of California, 1426 Howe Avenue, Suite 92, Sacramento, CA 95825, or call (916) 263-2389.
Medical Board of California New Officers for 2006/2007 Full Board
Steve Alexander, President
Lorie G. Rice, M.P.H., Vice. President
Richard D. Fantozzi, M.D., Secretary
Division of Medical Quality
Cesar Aristelguieta, M.D., President
Martin Greenberg, Ph.D., Vice President
Barbara Yaroslavsky, Secretary
Division of Licensing
Richard D. Fantozzi, M.D., President
Laurie C. Gregg, M.D., Vice President
Hedy Chang, Secretary
MISSISSIPPI
Thank you to IMSA member:
Mona Sappenfield of Mona Spa and Laser Center
EM: spmona@bellsouth.net,
www.monaspaandlaser.com
Mississippi State Board of Cosmetology
POSITION STATEMENT
TOPIC: The use of LASER DEVICES in Cosmetic Practice.
Rule 113.I. of the Mississippi State Board of Cosmetology, Standards
Related to Competent Practice, states:
“A practitioner may provide advanced services which are within his or her
scope of practice, as defined in §73-7-2, Laws of the State of Mississippi,
Code of 1972, Annotated, amended, under the following conditions:
A. The practitioner obtains appropriate education relative to the
services to be provided;
B. The practitioner demonstrates appropriate knowledge, skills, and
abilities to provide the service;
C. The practitioner maintains documentation satisfactory to the Board
of meeting the requirements of items A. and B. of this rule;
D. The service does not involve a function or procedure which is
prohibited by any other law or rule.
Mississippi Code of 1972, Annotated, amended, §73-7-2 (b) defines the
practice of cosmetology in part as, “any one (1) or a combination of the
following practices if they are performed on a persons head, face, neck,
shoulder, arms, hands, legs, or feet for cosmetic purposes: (iii)
Cleansing, stimulating, manipulating, beautifying or applying oils,
antiseptics, clays, lotions or other preparations, either by hand or
mechanical or electrical apparatus.”
§73-7-2(d) defines the practice of esthetics, in part as, “any one (1) or a
combination of the following practices: (iv) waxing, stimulating, cleaning or
beautifying the face, neck, arms or legs of a person by any method with the
aid of the hands or any mechanical or electrical apparatus, or by the use of
a cosmetic or a cosmetic preparation.”
POSITION STATEMENT
TOPIC: The use of LASER DEVICES in Cosmetic Practice.
The Mississippi State Board of Medical Licensure has issued the following
opinion:
“...any laser therapy in Mississippi should be the responsibility of a
licensed physician. Whether this is under the direct and close supervision of a physician or whether a physician is available to whoever he has designated to utilize the laser is the prerogative of the physician, as long as he realizes that he is responsible for the person he is supervising.”
It is the interpretation of The Mississippi State Board of Cosmetology that under Rule 113.I.D., a cosmetologist or esthetician is prohibited from using a laser in any cosmetic procedure, unless the cosmetologist or esthetician is under the supervision of a physician.
Statement of Adoption:
This is to certify that the above Position
was adopted by the Mississippi State
Board of Cosmetology at the meeting
of the Board on February 27, 2006.
- Nelda Luckett, Executive Director
WASHINGTON STATE
Thank you to IMSA member:
Mona Sappenfield of Mona Spa and Laser Center
EM: spmona@bellsouth.net,
www.monaspaandlaser.com
WAC 246-919-605 Use of laser, light, radio frequency,
and plasma devices as applied to the skin.
(1) For the purposes of this rule, laser, light, radio frequency, and plasma devices (hereafter LLRP devices) are medical devices that:
(a) Use a laser, non coherent light, intense pulsed light, radio frequency, or plasma to topically penetrate skin and alter human tissue; and
(b) Are classified by the federal Food and Drug Administration as prescription devices.
(2) Because an LLRP device penetrates and alters human tissue, the use of an LLRP device is the practice of medicine under RCW 18.71.011. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypo pigmentation and hyper pigmentation.
(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than the purpose set forth in subsection (1) of this section constitutes surgery and is outside the scope of this section.
(4) PHYSICIAN RESPONSIBILITIES: A 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) A physician must use an LLRP device in accordance with standard medical practice.
(6) Prior to authorizing treatment with an LLRP device, a 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 a non physician 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 physician is ultimately responsible for the safety of the patient.
(8) Regardless of who performs LLRP device treatment, the physician is responsible for assuring that each treatment is documented in the patient's medical record.
(9) The 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 untoward effects of treatment and to determine their cause;
(b) A mechanism to review the adherence of supervised 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 physician supervising practices; and
(e) Ongoing training to maintain and improve the quality of treatment and performance of treating professionals.
(10) PHYSICIAN DELEGATION OF LLRP TREATMENT: A physician who meets the above requirements may delegate an LLRP device procedure to a properly trained and licensed professional, whose licensure and scope of practice allow the use of an LLRP 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 professional's lawful scope of practice;
(c) The LLRP device is not used on the globe of the eye;
(d) A physician has a written office protocol for the supervised 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 physician 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 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 professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made;
(e) The supervised professional has appropriate training in, at a minimum, application techniques of each LLRP device, cutaneous medicine, indications and contraindications for such procedures, pre procedural and post procedural care, potential complications and infectious disease control involved with each treatment;
(f) The delegating physician ensures that the supervised 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 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 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 physician provided that there is a local back-up physician 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. The local 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 a physician assistant is covered by WAC 246-918-125.
WAC 246-918-125 Use of laser, light, radio frequency,
and plasma devices as applied to the skin.
(1) For the purposes of this rule, laser, light, radio frequency, and plasma devices (hereafter LLRP devices) are medical devices that:
(a) Use a laser, non coherent light, intense pulsed light, radio frequency, or plasma to topically penetrate skin and alter human tissue; and
(b) Are classified by the federal Food and Drug Administration as prescription devices.
(2) Because an LLRP device penetrates and alters human tissue, the use of an LLRP device is the practice of medicine under RCW 18.71.011. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypo pigmentation and hyper pigmentation.
(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than the purpose set forth in subsection (1) of this section constitutes surgery and is outside the scope of this section.
(4) PHYSICIAN ASSISTANT RESPONSIBILITIES: A 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.
(5) A physician assistant may use an LLRP device so long as it is with the consent of the sponsoring or supervising physician, it is in compliance with the practice arrangement plan approved by the commission, and it is in accordance with standard medical practice.
(6) Prior to authorizing treatment with an LLRP device, a 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 a non physician may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.
(7) PHYSICIAN ASSISTANT DELEGATION OF LLRP TREATMENT: A physician assistant who meets the above requirements may delegate an LLRP device procedure to a properly trained and licensed professional, whose licensure and scope of practice allow the use of an LLRP 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 professional's lawful scope of practice;
(c) The LLRP device is not used on the globe of the eye; and
(d) The supervised professional has appropriate training in, at a minimum, application techniques of each LLRP device, cutaneous medicine, indications and contraindications for such procedures, pre procedural and post procedural care, potential complications and infectious disease control involved with each treatment.
(e) The delegating physician assistant has written office protocol for the supervised 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 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 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 professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician assistant concerning specific decisions made. Documentation shall be recorded after each procedure, and may be performed on the patient's record or medical chart.
(f) The physician assistant is responsible for ensuring that the supervised 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 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.
Look for possible legislation changes in the following states:
New York, Massachusetts, Indiana and Pennsylvania
The International Medical Spa Association only acts in the capacity of forwarding this information and cannot be held liable for any misinformation. You MUST verify these laws and regulations with your local Medical State Board and other government agencies and your legal advisors.
Thank you.
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