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putting the med back in medspa Liposuction

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putting the med back in medspa Liposuction

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									    n advocacy


    putting the “med” back in medspa
    appropriate regulation helps to ensure patient safety is prioritized over financial gain
    Recent high-profile medspa deaths, as well as      with addressing the questions of “Who, What,      legislation, which is currently being considered
    a new framework for addressing the regulation      and Where: who should perform medical spa         by the state legislature, recommended
    of medspas means that 2010 is likely to be         services, what services should be offered and     regulating oversight of medical spas according
    a big year for attempts by policymakers to         how regulated, and the type of environment        to three categories, based on the relative risks
    address these non-traditional settings for         necessary for the safe practice of these          associated with the procedures performed
    medical treatment. Add these to the booming        procedures,” consisted of representatives from    therein. Additionally, the Task Force also
    medspa business numbers and socioeconomic          the Board of Registration in Nursing, the Board   recommended that medical spa facilities should
    indications that these will continue to grow,      of Cosmetology, the Board of Medicine and         be licensed by the DPH in a manner similar to
    and there’s a recipe for much-needed legal         the Board of Professional Licensure, as well as   the way DPH licenses medical clinics. Both
    oversight.                                         State Representative Peter Koutoujian, Senator    of the dermatologic surgeons that served on
                                                       Menard, a member of the general public, a         the Task Force, the ASDSA, the Massachusetts
    According to the International Medspa              registered electrologist, a registered nurse,     Academy of Dermatology, the AADA, and
    Association, the number of medspas has             an internist, a plastic surgeon, dermatologist    others oppose the bill’s exclusion of laser hair
    grown by 85% in the past 2 years, and is           Karen McCoy, MD and current ASDSA President       removal from consideration as the practice of
    currently up to 2,500 nationally. The Aesthetic    Jeffrey Dover, MD, FRCPC.                         medicine and allowance of non-physicians to
    Medicine News reports that annual revenues                                                           perform non-ablative laser procedures without
    from medspas are in excess of $2 billion.          The Task Force met for two years and examined     on-site physician supervision.
    Socioeconomic factors indicate that this           other state laws and regulation of medspas
    growth will continue. According to the AARP,       and cosmetic medical procedures, and heard        Of the thirteen voting members that comprised
    there are 12,000 Americans turning 50 every        presentations from the State Department of        the Task Force, only three members were
    day, or 1 every 8 seconds. An NBC Report from      Public Health (DPH); the National Coalition       physicians (the plastic surgeon was not present
    November 2009 said, “As a result of the need       of Estheticians, Manufacturers/Distributors &     at the vote on the final recommendations).
    to compete longer in the workforce, more men       Associations; Manufacturers of Equipment for      Although ASDSA members deeply value our
    are seeking procedures to keep them looking        Light-Based Aesthetics (MELA); the ASDS and       relationship with physician extenders, it is
    young and fit.”                                    the American Society of Cosmetic Dermatology      worth noting that many of these physician
                                                       and Aesthetic Surgery; as well as an aesthetic    extenders as well as non-medical personnel
    One has only to look at recent news reports        school called the Catherine Hinds Institute;      are seeking scope of practice expansions
    to see the resulting patient injury due to a       and a large day spa, “skin care salon,”           in states across the country. According to
    lack of appropriate regulatory oversight, as       and esthetician school franchise called the       the American Medical Association, last year
    well as enforcement of existing law. This past     Elizabeth Grady Companies, which claims to        nurses sought some form of scope of practice
    September, 37-year-old Rohie Kah-Orukotan          be the largest employer of estheticians in the    expansion in 29 states, including but not
    fell into a coma and ultimately died as a result   country. According to the Task Force’s minutes,   limited to, independent practice, independent
    of complications associated with liposuction       the Elizabeth Grady Companies’ presentation       prescribing rights, authority to perform any
    performed in a Florida tanning salon, which        included a presentation of how estheticians       medical procedure, including but not limited
    was not an appropriately licensed medical          assess patients prior to administering Botox®,    to, interventional pain management, and more.
    facility. The physician performing the procedure   a practice that was praised by the Task Force’s   Given this information, it is not surprising
    learned liposuction at a 3-day cosmetic surgery    internist.                                        that the physicians on the Task Force would
    course. Reports regarding circumstances                                                              be out-voted by nurses, estheticians, and
    surrounding the death are conflicting and the      The MELA representative’s presentation was        cosmetologists on issues regarding appropriate
    tragedy is still under investigation.              also troubling. After stating the products        physician oversight for medical spas.
                                                       manufactured by the companies which belong
    Massachusetts Task Force                           to MELA have a less than one percent adverse      The ASDSA has several policy recommendations
    Recommendation Outcome in the Balance              effect rate, MELA Immediate Past President        that we believe are better models for addressing
    Several states, as well as the Federation of       Josephine Torrente rather inartfully dodged a     patient safety concerns in non-traditional
    State Medical Boards (FSMB), have been             question regarding to whom their members’         medical settings, such as medical spas.
    eyeing a new approach to medspa regulation.        laser devices were sold, saying she “blocks
    As the result of a bill by Senator Joan Menard,    herself from that information.”                   Recommendation: Strengthen Penalties
    the Massachusetts Medical Spa Task Force                                                             and Enforcement of Existing Laws
    was created in 2006. The Task Force, charged       The Task Force’s final report and model           The ASDSA’s experience in California provides

8    january/february 2010
a good picture of how strengthening penalties         kind of lasers or intense pulsed light (‘IPL’).     nurses, passed through the House and Senate
and enforcement of existing corporate practice        Respondent describes himself as self-taught         with only one “no” vote before being vetoed
of medicine prohibitions might assist with            because medical laser training is not available.    by Governor Schwarzenegger, who called the
lessening the incidence of both patient injury        Further, Respondent lacks knowledge about           bill, “redundant.” The ASDSA and CalDerm are
due to treatments and procedures performed            the causes, prevention and treatment of             still in the process of planning our next move
by unsupervised non-physicians and garden             common IPL and laser injuries. Further,             with relation to that legislative proposal. In
variety fraud in the form of systematic under-        Respondent lacks knowledge about the                the meantime, the issue has gained garnered
treatment or inappropriate treatment which            causes, prevention and treatment of injuries        enough visibility to encourage the Medical
results in patients returning to the facility         from injection treatments.” Recently, a young       Board to re-launch “Operation Safe Medicine”
several times for costly procedures which yield       woman in Washington State died as a result          and convene its own task force to address the
little or no result.                                  of complications associated with liposuction in     medical spa issue. The MBC re-established
                                                      a medical spa for which the same Utah-based         its Operation Safe Medicine unit in Southern
The ASDSA and CalDerm’s testimony before              physician served as medical director.               California on July 1. The program, which had
the joint committee of the Medical Board of                                                               previously closed in 2003 due to budget cuts, is
California (MBC) and the Board of Nursing’s           The ASDSA and CalDerm believe a significant         designed to target unlicensed activity, corporate
forum on laser safety demonstrated that several       reason for this lack of enforcement is that the     practice of medicine, and lack of supervision
patients and physicians have filed complaints         MBC has limited resources, which leads to the       violations. The MBC’s Advisory Committee on
on unsafe medical spa practices with either no        need to prioritize complaints by degree of injury   Medspa Supervision will “review the issue of
or very slow follow-up by the MBC. Several of         and level of penalty. In California, which bars     physician availability and adopt the necessary
these unsafe practices occur in large medical         the corporate practice of medicine that arises      regulations to implement changes necessary to
spa and laser chains, which are already in            in the form of corporate entity employment of,      ensure the continued protection of California
violation of the existing corporate practice          or contracting with, “rent-a-docs” to create        consumers who are increasingly using the
of medicine prohibition. This prohibition             the facade of physician-overseen networks           services of medical spas.” ASDSA Board
disallows medical procedures from being               of medispas (if not, necessarily, attention to      Member Suzanne L. Kilmer, MD, will represent
performed within a facility that is less than         patient care) existing law puts the Medical         the ASDSA on the Committee; its first meeting
fifty-one percent physician ownership. Many           Board of California in the awkward case-            will be held on January 28.
of these facilities operate in flagrant disregard     making position of having to “cobble together”
of the law, actively recruiting physicians to         a finding that an M.D. is “aiding and abetting      Recommendation: Crack Down on
serve as “medical directors” by attaching their       (the violation of ) any provision” of the Medical   Consumer Fraud
name to the facility without having to provide        Practice Act (Bus. & Prof. Code Sec. 2234).         As demonstrated in the lack of enforcement
any real oversight. A member forwarded one                                                                of the prohibition of the corporate practice
such solicitation letter to the ASDSA. The letter     Corporations and other artificial legal entities,   of medicine example cited above, other
reads, “…we are very excited to announce our          which have no professional rights, privileges, or   regulatory agencies, even as large as the Food
Medical Director program. This opportunity            powers, are only subject to nominal penalties,      and Drug Administration (FDA), frequently
allows Doctors and Physicians to earn up to           usually reserved for instances of medical           lack the resources to crack down on clear
$400 per month/per spa in their area. We have         malpractice in which there is patient abuse, or     cases of consumer fraud. One prevalent
several DaySpas that anxiously await a Medical        physician substance abuse, of potential “low        problem that is particularly rampant in medspa
Director and we would anticipate a large              misdemeanor” punishment of a fine of not less       settings is the marketing of drugs which are
number of client referrals to your practice.”         than two hundred dollars ($200) nor more than       not-FDA approved, such as the mesotherapy
                                                      one thousand two hundred dollars ($1,200) or        drug Lipodissolve. According to a transcript
One such example of this gross negligence             by imprisonment for a term of not less than         of the FDA Voice radio program entitled,
exists within a complaint which was first             60 days nor more than 180 days, or by both          “Measures Undertaken to Address Concerns
filed with the MBC in September 2007. In              such fine and imprisonment. (Bus. & Prof. Code      about Marketing of Unapproved Drugs,” the
that case, the named physician was licensed           Sec. 2315). To solve this issue, in both 2008       FDA estimates that about 2% of the types of
in California but lived in Utah. This physician       and 2009, the ASDSA and CalDerm proposed            prescribed drug products that are on the market
served as a so-called “medical director” of           bills to strengthen penalties and enforcement       are unapproved. Dr. Jason Woo, the Associate
several medical spa and laser chains up and           of the existing corporate practice of medicine      Director for Scientific and Medical Affairs in the
down the coast of California. Had this medical        prohibition by assigning a penalty of $25,000       Office of Compliance for the Center for Drug
director actually set foot in any of the facilities   for the first offense to facilities violating the   Evaluation and Research of the FDA states,
that he “supervised,” he wouldn’t have had            law. Existing law provides the MBC the ability to   “It’s not that FDA doesn’t allow these drugs
the training to be of any help. According to the      revoke the license for those so-called “medical     to be marketed illegally; we simply don’t have
complaint, which is a matter of public record         directors” who knowingly aid and abet the           the sufficient resources to identify and pursue
available on the MBC’s Web site, “Respondent          unlicensed practice of medicine. In 2009, the       them all at once.”
is a board certified emergency physician…             bill, which was widely endorsed by medical
Respondent has no medical training with any           societies, including physicians assistants and                                continued on next page

                                                                                                                                    january/february 2010 9
     n advocacy

     medspa                                             Recommendation: Ensure Truth in                        (NBME) decision to use questions from the
     contiinued from previous page                      Advertising                                            United States Medical Licensing Examination®
                                                        Patients have a right to know the level of training,   (USMLE) Step 3 Physician Licensing Exam
     The Kansas State Medical Board attempted           licensure, and board certification of the person       for Doctor of Nursing Practice (Dr. NP) has
     to ban the use of Lipodissolve in the state        providing their medical treatment. Too often           prompted a great deal of concern on the part
     in 2007, before a lawsuit by Lipodissolve          consumers are led into non-traditional medical         of the physicians regarding not only the use of
     provider Fig, formerly known as Advanced           facilities, such as spas and salons, by misleading     the title “Dr” to indicate a doctorate of Nursing
     Lipodissolve, blocked its implementation. Later    advertising phony “medical-like” individuals.          Practice, but also the potential ability to
     the same year Fig, abruptly filed for chapter 11                                                          mislead the public that the Dr. NP certification
     bankruptcy, leaving patients that had pre-paid     Florida law requires practitioners to disclose         is equivalent to the training and examination
     for the treatments out in the cold. In 2008,       their level of licensure both in person and            of licensed physicians.
     Nebraska State Senator Rich Pahls introduced       in advertising. Minnesota, Missouri, New
     a bill to attempt to ban Lipodissolve in that      Hampshire, Rhode Island require all personnel          In addition to advocating for transparency
     state, along with the use of any combination of    in hospital facilities and in some cases other         and full disclosure in communicating level of
     phosphatidylcholine or sodium deoxycholate,        licensed medical facilities to wear identification     licensure and training by providers of medical
     by subcutaneous injection for the purposes         displaying their level of licensure. In 2005, the      care, the ASDSA takes the position that
     of eliminating or reducing localized fat           state of Tennessee passed a law requiring              advertisers should be able to document and
     accumulation. Reports of sales of the drug are     all boards of healing arts to create laws              substantiate claims made in ads about safety,
     still widespread; one only has to Google the       governing the use of the professional titles           efficacy, benefits and risks, as well as unique
     drug to find a host of providers offering the      under their jurisdiction, including advertising        skills and remedies.
     treatment.                                         pertaining to board certification and specialty.
                                                        Arizona, California, Massachusetts, and                Recommendation: Include Cosmetic
     A favorite patient recruitment technique of        Pennsylvania proposed legislation relating to          Medical Procedures in Legal Definition
     one very large laser hair removal chain is to      truth in advertising in 2009 While Arizona and         of the Practice of Medicine
     give patients the opportunity the opportunity      California’s bills died with the adjournment of        As has been reported in previous editions of
     to “win” a free consultation. The “winner”         the state legislature and will be re-introduced        Currents, several states do not have an explicit
     is then subjected to high pressure sales to        in 2010, proposals in Massachusetts and                legal definition of the practice of medicine, or
     convince her to sign a nonrefundable contract      Pennsylvania are still active.                         restrict that definition to the treatment of illness
     for several expensive treatments. Lawsuits                                                                or disease. When cosmetic medical procedures
     against that company allege that deceives          In 2010, the ASDSA is providing support to the         are excluded from a state’s definition of the
     customers as to their cancellation rights, and     Pennsylvania Academy of Dermatology and                practice of medicine, they become subject to an
     refuses to allow cancellations and refunds even    Dermatologic Surgery and the Pennsylvania              entrepreneurial environment, where “patients”
     though services have not yet been rendered.        Medical Association in passing House Bill              become “consumers,” and the bottom line is
     One investigative news report on the chain         1482, which would require the Department of            frequently prioritized over the best treatment
     includes the release of the company training       Public Health to “promulgate regulations to            for the patient’s condition.
     manual, which instructs employees to point         require each employee of a home care agency,
     out “imperfections” to potential clients during    home health care agency and hospital to wear           At least fifteen states and the District of
     consultation, and stipulates the company’s         a photo identification tag at all times when the       Columbia do not have definitions of the
     “upselling” requirement.                           employee is working. The photo identification          practice of medicine that extend beyond the
                                                        tag shall include a recent photograph of the           treatment of illness or disease. The states of
     Thankfully, State Attorney Generals have begun     employee, the employee’s name, the name                Georgia, New York, and Virginia explicitly
     to take notice. In December, Illinois Attorney     of the home care agency, home health care              exempt laser hair removal from consideration
     General Lisa Madigan charged the Nu U Medspa       agency or hospital, the certificate or license         as the practice of medicine; however both
     chain with consumer fraud for advertising the      number for the home care agency, home health           Georgia and Virginia law specify training and
     non-FDA approved LipoDissolve mesotherapy          care agency or hospital and the expiration date        physician oversight requirements despite this
     treatment. Additionally, the Attorney General’s    of the certificate or license.”                        exclusion.
     complaint alleges that Nu U Medspa violates
     several state laws, including the including        Laws in Georgia, Oklahoma Oregon ensure                2010: A Hot Year for MedSpa
     the Consumer Fraud and Deceptive Business          that the use of the title “doctor” as it relates       Regulation
     Practices Act for deceptively tricked signing up   to medical training is clearly specified in any        As of this writing, 15 states are projected to
     patients for financing a series of treatments.     advertising, which will be particularly helpful as     have bills, regulatory proposals, or Attorney
     The ASDSA is reaching out to Attorney General      the controversial “Doctor of Nursing Practice”         Generals actions pertaining to medspas in
     Madigan to encourage her to adopt this issue       degree becomes prominent in medical settings.          2010. To see a forecast of these actions, go to
     on a larger scale.                                 The National Board of Medical Education’s              www.asds.net/medspa2010.aspx. n


10      january/february 2010

								
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