The Medical Spa Movement and Regulatory Uncertainty
By Anne S. Kimbol, J.D., LL.M. and Craig A. Conway, J.D., LL.M.
caconway@central.uh.edu
Few things in the regulation of health care professionals and entities bring the same level
of emotion and turmoil as scope of practice battles. Some of the latest firing lines – i.e.
staffing at freestanding emergency rooms, redi-clinics, and medical spas – involve face
offs between not just physicians and non-physicians, but also between various groups of
physicians.
Medical Spa Overview
Medical spas are one of the fastest-growing segments of the spa industry with nearly
2,500 nationwide as compared with 500 in 2004.1 They generate billions in revenue
annually, and often involving a number of different professionals including physicians,
cosmetologists, electrologists, aestheticians, and nurses.2 Competition among these
professionals for customers seeking the services and procedures provided by medical
spas can be intense and often pit medically-trained individuals, who are licensed by the
state against unlicensed individuals performing arguably medical procedures.
The preferred business model and practice for medical spas is for a spa owner to form an
alliance with a physician in order to obtain FDA-regulated devices and pharmaceuticals.3
The physician then remains offsite and delegates the cosmetic procedures to nonphysicians to administer to those seeking the services.4 This practice is not legal in all
states, but the model generally describes the structure where a non-physician performs
the procedures.5 The lack of direct physician oversight is converse to the model
recommended by the International Medical Spa Association, a New Jersey trade group,
which defines a medical spa as follows:
[a] medical spa is a facility that operates under the full-time, on-site
supervision of a licensed health care professional. The facility operates
within the scope of practice of its staff, and offers traditional,
complementary, and alternative health practices and treatments in a spalike setting. Practitioners working within a medical spa will be governed
by their appropriate licensing board, if licensure is required.6
1
See Jean P. Fisher, Regulation Issue Hits Medical Spas, THE NEWS & OBSERV., (Jan. 23, 2005), available
at http://www.newsobserver.com/news/health_science/medical_spas/story/181235.html (last visited June 3,
2009).
2
Liz Kowalczyk, New Standards Urged for Treatment at Spas, BOSTON GLOBE, (Feb. 24, 2009), available
at
http://www.boston.com/news/local/massachusetts/articles/2009/02/24/new_standards_urged_for_treat
ment _at_spas/ (last visited June 3, 2009).
3
Andrew D. Swain, The Hidden Dangers of ‘Medical’ Spas, 45 TRIAL 40, 40 (May 2009).
4
Id.
5
Id.
6
The Int’l Med. Spa Assoc., Medical Spa Definitions and Guidelines, available at http://www.medicalspaa
ssociation.org/guidelines.htm (last visited June 3, 2009).
As a result of the increasing number of non-physicians administering topical anesthetics
to individuals, or using lasers to remove tattoos or skin blotches, consumers are at an
increased risk of complications – and states are turning their attention towards regulating
the spas.
Consumers’ Adverse Results and Complications
In the soothing atmosphere of a medical spa, with its soft background music and dimly-lit
rooms, the idea of risk and complications to an individual resulting from laser hair
removal, Botox® injections, or chemical peels would seem unlikely. However, the data
being released by the medical community suggests otherwise. The FDA has reported two
deaths related to the misuse of topical anesthetics in connection with laser hair removal
procedures,7 and recently issued a Public Health Advisory statement for the medications.8
The FDA’s statement noted that when topical anesthetics are applied to the skin surface,
“they can be absorbed into the blood stream and, if used improperly, may cause lifethreatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma,
or even death.”9 Even injectable drugs to remove wrinkles such as Botox® have been
known to cause complications and even death.10 Temporary adverse reactions resulting
from improperly-performed spa treatments include pain, swelling, redness, discoloration
of the skin, and blistering.11
Though serious complications and fatalities are not the norm, the number of patients
seeking medical attention due to poorly-performed spa procedures has increased.12
Further, medical associations have issued warnings to patients about the risks of
receiving low-cost cosmetic procedures performed in a non-medical setting.13 The end
result is that more states are looking to place increased restrictions on medical spas and
those who perform the procedures.
The Scope of Practice Battle
Medical spas raise several regulatory questions. At the heart of the matter is defining the
line between the practice of medicine and the practice of cosmetology and aestheticians.
7
Swain, supra note 3, at 40 (citing Diane Gorgos, Dermatology Nursing News: Lidocaine-Induced Deaths
Raise Questions about Med-spa Management, 17 DERMATOLOGY NURSING 389, 390 (Oct. 2005)).
8
Press Release, FDA, FDA Alerts Public about Danger of Skin Numbing Products, (Jan. 16, 2009),
available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm109068.htm (last
visited June 3, 2009).
9
Id.
10
Swain, supra note 3, at 41 (citing Press Release, FDA, FDA Notifies Public of Adverse Reactions Linked
to Botox Use, (Feb. 8, 2008), available at http://www.fda.gov/NewsEvents/Newsroom/Press
Announcements/2008/ucm116857.htm (last visited June 3, 2009).
11
Swain, supra note 3, at 40-41.
12
Id. at 41. An American Society for Dermatologic Surgery (ASDS) survey in 2007 reported that 56
percent of responding physicians “indicated that there had been an increase in the number of patients they
had treated as the result of complications caused by a non-physician.”
13
Id.
In most state, cosmetology involves a licensed individual, among other things, treating
hair using coloring or bleaching solutions, treating a person’s facial skin using creams or
lotions, and offering manicure or pedicure services.14 Aestheticians are licensed skincare
specialists who treat facial skin often disfigured or affected by medical trauma or medical
procedure.15
If laser hair removal is a non-medical cosmetic procedure, then allowing a licensed
cosmetologist or technician to perform the service would be relatively non-controversial.
If there were an agreement that procedures such as laser hair removal involve the practice
of medicine, the debate would then hinge on the exact level of involvement needed from
a physician in terms of supervision and/or delegation. There is, however, no agreement
on which procedures offered by medical spas are in fact medical and which are not.
Dermatologists and plastic surgeons generally state that the procedures are medical in
nature and therefore a high level of physician involvement is required. They cite cases of
burns and improperly-performed procedures that have lead to a 41 percent rise in botched
treatments. The other side largely consists of technicians, cosmetologists, and
aestheticians who have been performing similar services for years and primary care
physicians who have turned to the medical spa industry and its attractive all private pay
clients. They argue that many of the personnel at medical spas have more experience and
more training on lasers and similar devices than the physicians who argue they should
have exclusive rights to use them.16
State Legislatures and regulatory boards are slowly coming to look at this issue. The
Federation of State Medical Boards conducted a 50-state survey on laser use and
delegation by physicians that covers the relevant state laws on many medical spa
procedures.17 Even a quick review of the chart shows the broad disparity in regulatory
schemes on this issue. Some states have long, detailed provisions while others have none
at all. One organization for laser and medical aesthetics has stated, “[a]lthough laser
certification is a natural and profitable component to an aesthetician’s training repertoire,
anyone can become a certified laser technician—soccer moms, secretaries, sales
professionals, teachers, and more.”18
It is important to note that lasers and intense pulsed light devices used for hair removal
and other cosmetic procedures are classified as Class II medical lasers by the FDA, and
thus deemed a prescription device, which, according to federal regulations “is not safe
except under the supervision of a practitioner licensed by law to direct the use of such
14
See Texas Dep’t of Lic. and Reg., Cosmetology Law, available at http://www.license.state.tx.us/cosmet/
cosmetlaw.htm#001 (last visited June 8, 2009).
15
See Kathleen Green, You’re a What? Medical Aesthetician, 48 OCCUP. OUTLOOK QUART. 48 (Spring
2004), available at http://www.bls.gov/opub/ooq/2004/spring/yawhat.htm (last visited June 7, 2009).
16
Sylvia Perez, Medi-Spas, ABC 7 Chicago, (Nov. 15, 2007), available at: http://abclocal.go.com/wls/
story?section+health&id=5764687&ft=print (last visited June 3, 2009).
17
The chart is available at http://www.fsmb.org/pdf/grpol_laser_regulation.pdf.
18
Swain, supra note 3, at 41 (citing Nat’l Laser Inst., Do I Have to Be an Aesthetician or Have Any
Medical Background to Work in the Laser Industry?, available at http://www.nationallaserinstitute.com/
aesthetician.html (last visited June 3, 2009).
device, and … is to be sold only to or on the prescription or other order of such
practitioner for use in the course of his professional practice.”19
Regardless of the presence of state regulation of medical spas, the supervising physician
is ultimately responsible for overseeing patient care, for determining who is qualified to
perform the procedures, and for determining the degree of supervision that is required.20
State Regulation of Medical Spas
The Florida Legislature enacted regulations in 2006 limiting the number of satellite
offices that one physician could supervise, the distance of each from the doctor’s main
office, and other patient safety measures relating to cosmetic procedures.21
New Jersey, a state that has long recognized the use of lasers as a medical procedure,
allows only doctors licensed by the state board of medical examiners to use medical
lasers for cosmetic purposes, and physicians may not delegate the procedures to nonphysicians.22
Following Florida’s lead, a state task force in the Commonwealth of Massachusetts
issued a comprehensive 37-page proposal that recommended medical spas be licensed by
the state Department of Public Health, suggested the implementation of a classification
system for medical aesthetic procedures and those qualified to perform them, and
requiring individuals performing medical spa procedures to be licensed by an appropriate
Board of Registration.23 Based upon the recommendations of the task force, further
legislative action involving medical spa regulation is expected to continue in the state.
Conclusion
It is likely that the scope of practice debate will only increase in the coming months
regarding the appropriate amount of state regulation of medical spas. Until a solid
statutory scheme is in place in a state demarcating the lines of the practice of medicine
and procedures allowable by a non-physician, the lines will continue to be blurred.
Health Law Perspectives (June 2009), available at:
http://www.law.uh.edu/healthlaw/perspectives/homepage.asp
19
See 21 C.F.R. § 878.4810(b)(1) (2009); 21 C.F.R. § 801.109(a)(2) (2009).
Swain, supra note 3, at 41.
21
Id. (citing FLA. STAT. ANN. § 458.348(4) (West 2009); FLA. STAT. ANN. § 459.025(3) (West 2009)).
22
Id. (citing N.J. ADMIN. CODE § 13:35-4A.12(d) (2009)).
23
See Report of the Medical Spa Task Force Established by Chapter 81 of the Acts of 2006, (Jan. 12, 2009),
available at http://www.massmedboard.org/public/pdf/MedSpaFinalReport.pdf (last visited June 3, 2009).
20