Aesthetic medicine is not just for
cosmetic surgeons, dermatologists, or
laser surgeons these days. Just attend
a local laser seminar and you will meet
any number of physicians from
specialties wholly unrelated to
cosmetics, dermatology, or laser
surgery – gastroenterologists,
radiologists, family physicians. Spa
and salon entrepreneurs, looking to
expand their service offerings to
include medical treatments such as
laser hair r
emoval, skin tightening,
and dermal fillers are also trying to get
into the medical spa business.
Whether you’re a physician,
entrepreneur or both, if you plan to
offer aesthetic medical pr
ocedures
such as laser hair removal, Botox
®
injections, or mesotherapy, you must
abide by the same r
egulator
y
guidelines which govern other
healthcare entities. This article will
discuss the main r
egulatory issues of
concern for medical spa owners:
corporate practice of medicine, fee-
splitting prohibitions, and self-referral
conflicts.
CORPORATE PRACTICE OF
MEDICINE PROHIBITIONS
The “corporate practice of
medicine” is simple: it is illegal for a
corporation or business to employ
physicians in such a
way that they may
influence a physician’
s
professional judgment.
The idea is that a lay
entity will make
decisions based on
corporate profit,
which, in turn, can dictate the way in
which a physician practices medicine.
Most states have corporate
practice of medicine prohibitions
which regulate lay ownership of
healthcar
e businesses. Beth Kase, a
healthcare attorney with the firm
Saphier and Heller Law Corp. in
Century City, CA, says that “The issue
arises when the lay owner treats these
medical procedures as an ancillary
service which is offered by a day spa.”
If the lay person has control over the
medical spa services, this could result
in an “unlicensed practice of medicine
violation which could implicate the
physician and non-physician owner.
The physician could then be charged
with unpr
ofessional conduct for aiding
and abetting the unlicensed practice of
medicine. No physician wants to have
pr
oblems with the medical board.”
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.
feb 2006 | www.aesthetictrends.com
29
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legal case of the month
By Mai Pham, Trends Editor
Medical Spa
Ownership
Whether youre a physician, entrepreneur or both, if
you p
lan to offer aesthetic medical procedures such as
laser hair removal, Botox
®
injections, or mesotherapy,
you must abide by the same regulatory guidelines
that g
overn other healthcare entities.
ARE YOU PROTECTED FROM
CORPORATE PRACTICE OF MEDICINE
AND FEE-SPLITTING PROHIBITIONS?
If you don’t know about these
prohibitions, you can easily find
yourself in violation. In many states,
m
edical grade laser hair removal
d
evices can be sold to spa or salon
owners even though laser hair removal
is considered the practice of medicine.
Once the spa or salon owners buy the
machine, they will “hire” a physician
in order to comply with laws
governing medical practice. These
types of arrangements are fairly
common, even in heavily regulated
states. The spa/salon may continue to
operate without regulatory oversight
and without any problems until
something happens. Perhaps a patient
complains to the medical board, a
disgruntled employee files a
complaint, or a competitor complains
to the state agency. Failure to take the
necessary precautions to protect your
business and comply with corporate
practice of medicine laws is most
certain to compromise your long-term
business viability.
Another issue to be concerned
w
ith when dealing with corporate
p
ractice of medicine issues is contract
enforceability. Kase says, “If the
contract is illegal because of the
unauthorized practice of medicine by a
lay entity, this illegality could void the
contract. When an issue arises in
which one of the parties wants to
enforce the contract, the contract may
not be enforceable.”
REFERRAL PROHIBITIONS
Federal Laws
Healthcare self-referral laws and
fee-splitting prohibitions exist at the
state and federal level. Federal self-
referral laws, such as the “Stark
Laws,” prohibit a physician from
referring Medicare and Medicaid
patients to other medical services (e.g.
physical therapy, imaging, diagnostic,
lab, etc.) in which the physician
has ownership interest. The
purpose of this law is to
prevent physicians from
making unnecessary referrals
to ancillary services where they
would directly profit from the
referral. The Federal Anti-
Kickback Statute outlaws direct
r
emuneration for patient
referrals covered by federal
health benefit programs. Since
most medical spa procedures
are not covered by Medicare or
Medicaid, the federal laws may
not be applicable to medical
spas; however, an understanding
of the federal statutes is
important in understanding the
various state laws which
addr
ess these issues.
State Laws
Self-Referral Laws
Many states have self-r
efer
ral
laws similar to the Stark law which
prohibit physician ownership in an
entity where they are directing
referrals. If you are a physician with
undisclosed ownership or a profit-
sharing stake in a medical spa to
which you are referring patients, self-
r
efer
ral pr
ohibitions can be an issue.
Fee Splitting Prohibitions
If you ar
e a medical spa receiving
A statement by the Texas Attorney
General best characterizes the
issue:
Arrangements by which a
corporation formed by non-
physicians employs physicians to
render medical services to the
corporation’s clients consistently
have been held to constitute both
the unlawful practice of medicine
by the corporation and the
violation by the employee-
physician of the prohibitions in
…the Medical Practice Act…on a
physician’s “permitting or
allowing another to use his
license or certificate to practice
medicine in this state,” and …
“aiding or abetting, directly or
indirectly, the practice of
medicine by any person,
partnership, association, or
corporation not duly licensed to
practice medicine.” (Texas
Attorney General Opinion No.
JM-1042, April 24, 1989)
jan
.
feb 2006 | www.aesthetictrends.com
free, unincentivized referrals from
hotels and satisfied customers, you do
not have to worry about fee-splitting
prohibitions and illegal remuneration.
However, if you are a medical spa
owned by lay entity, and the lay entity
wants a 50% cut of the profits from the
procedures performed, you may have
some corporate restructuring about
which to worry.
According to Michael Saphier, a
partner at Saphier and Heller Law
Corp., “The financial arrangements
between the physician and the day
spa owner could cause additional
problems, including illegal
remuneration for the referral of
patients by the day spa owner and
illegal fee-splitting, as well as a
corporate practice of medicine
violation.”
Typical spa procedures such as
facials and massages do not fall within
the regulatory scope of healthcare fee-
splitting regulations. However, in
states such as Califor
nia, any
procedure which requires
administration by a
licensed health
p
rofessional is considered
m
edical. This means that
Botox
®
injections, laser
hair removal, and services
performed using a Class II
medical device are subject
to fee-splitting
prohibitions. California
prohibits remuneration for
referral of medical
services. While the
federal Anti-Kickback
Statute only applies to
federally funded health
programs, the language in
California’s Business and
Professions Code extends to cover all
types of medical services
and different types of
remuneration including
but not limited to rebates,
refunds, commissions, and
other types of inducements.
If you and a physician are in a
partnership whereby profits are
distributed evenly among spa and
medical services, you could be in
violation of anti-kickback and fee-
splitting prohibitions. Lay
persons and entities are
not entitled to
compensation or
other kickbacks
for medical
service
r
efer
rals,
even if
the referrals pertain to aesthetic
medical procedures which are paid for
by cash.
HOW TO PROTECT YOURSELF
To protect yourself from corporate
practice of medicine violations, the lay
entity and physician entity should
consider having a written agreement
which distinguishes the activities of
the lay entity from the medical entity.
Kase recommends the following:
“Spell out the management company
responsibility and professional entity
responsibility. The written agreement
should require that the physician take
responsibility for medical decision
making.”
To protect yourself from self-
referral prohibitions, make sure the
appropriate disclosures are being
made to your patients about your
financial interest in the entity which is
receiving the referral. The patient has
the right to know that you might be
making money from the referral.
jan
.
feb 2006 | www.aesthetictrends.com
Botox
®
injections, laser hair removal, and
services performed using a Class II medical
device are subject to fee-splitting prohibitions.
To protect yourself from fee-
splitting prohibitions, be careful about
monetary distributions, and try not to
f
ashion financial agreements which
d
isburse profits on a per-case or
percentage basis. Make sure that
payments to the lay entity related to
medical services are clearly worded
and are based on fair market value,
monthly salary, or flat fee arrangement
which is not directly connected with
the volume of cases performed or the
volume of referrals received.
If you are concerned about any of
the issues raised in this article, consult
with your healthcare attorney as soon
as possible. Addressing potential
problems before they arise will be
much less costly than waiting until
something happens.
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.
feb 2006 | www.aesthetictrends.com
32
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Disclaimer: This article is presented for
informational purposes only and is not
intended to constitute legal advice.
Mai Pham has a
Master’s Degree
in Public Health.
Most recently, she
built ambulatory
sur
ger
y centers,
ser
ving as
Managing Director for operations,
billing, HR, and regulatory compliance.
For mor
e infor
mation, please contact
832.
752.7772, send an email to
www
.medispainstitute.com. Mai Pham
is the Trends Editor for Aesthetic
T
rends & Technologies and part of the
research team for medical spa
reporting.
SHOULD YOU BE WORRIED?
Here are some typical scenarios which may apply to you:
A nurse or spa owner wants to open a laser clinic and
approaches a physician to ask that physician to be his/her
medical director. In exchange for being medical director,
the physician will receive a percentage of all aesthetic
medical fees collected.
Potential problem: Violating Corporate Practice of Medicine and Fee-
splitting prohibitions
The spouse of a physician with an existing medical
practice decides to open a medical spa with a lay business
par
tner
. The physician regularly refers patients to this
medical spa, and the physician’s spouse receives a 40%
profit distribution from revenues collected at the spa.
Potential problem: Violating Self-Referral laws
A spa r
egularly refers patients to a doctor’s clinic for laser
hair r
emoval. The doctor charges the patient $200 per
treatment and gives the spa a $25 referral fee.
Potential problem: Violating Fee-Splitting Prohibitions
A non-professional lay corporation calls itself a “Medical
Spa,” advertises medical procedures, runs all aspects of
the medical spa business without physician oversight,
purchases medical equipment, and hires and trains
medical personnel.
Potential problem: Violating Corporate Practice of Medicine