Medical Spa Regulation

Who can perform various medical spa procedures? Is physician supervision necessary, or physician delegation to an unlicensed assistant or to a nurse possible? Regulation differs by state. In all states, medical boards control the practice of medicine through the licensure process. State medical practice acts define the "pratice of medicine" and prohibit unlicensed practice. In some states, either statutes establish rules, or medical boards have created rules, governing who can provide different spa procedures, and whether these procedures are considered "medical" or not. Sometimes medical boards will respond to written inquiries with a ruling, providing guidance. Sometimes there are other statutes and boards at work--for example, the Board of Cosmetology, or a statute on tatooing (in the case of one inquiry in Alabama).

The Massachusetts Board of Registration convenened a Medical Spa Task Force in 2007 and made written inquiries to various regulatory boards around the country concerning regulation of physician delivery of medical spa therapies. Some of the responses received are reproduced below.

ALABAMA STATE BOARD OF MEDICAL EXAMINERS OPINION

November 16, 2005

(Response to a Request for Clarification from Marc Yeanvood, Genesis Laser Services, LLC)

The Alabama Board of Medical Examiners (hereinafter "the Board") has been asked for a clarification concerningthe Board's Declaratory Ruling No. 97-002 and aBoard opinion issued on October 20,2004, to Ms. Karen Gipson, Fountain of Youth. In Declaratory Ruling No. 97-002, the Board stated:

The use of laser hair removal devices in the State of Alabama is declared to be the practice of medicine and such use shall be limited to physicians and those directly supervised by physicians, such that a physician is on the premises and would be directly involved in the laser treatment immediately if required.

On September 21,2005, the Board issued an opinion reaffirming Declaratory RulingNo. 97-002 and determining that general use of laser devices is also the practice of medicine. Additionally, the Board opined that licensed mid-level practitioners must have prior approval from the Board to use laser devices and, as new types of lasersare introduced, prior approval for use by licensed mid-level practitioners must be obtained from the Board.

In response to Mr. Yeawood's request for further clarification, the Board issues the following opinion:

The Board reaffirms the original Declaratory Ruling No. 97-002. Additionally, the Board considers the use of lasers to be the practice ofmedicine, and lasers should be utilized only by licensed physiciansand by licensed physician assistants and certified registered nurse practitioners whose approved duties include use of a specitic laser device. Additionally, the Board reaffirms its opinion that the Board considers procedures using Botox, Restylane and collagen and procedures involved in mesotherapy to be the practice of medicine and that such procedures should be performed only by a licensed physician. The Board finds no conflict or inconsistency between its ruling concerning use of lasers and its ruling concerning Botox, Restylane, collagen and mesotherapy.

Medical Board of California Memo (CA)

California has passed no specific law or regulation relating to medical spas.* As I tell physicians inquiring about entering into such a business, a medical practice is a medical practice, and all laws relating to medicine relate to the medical procedures done, even if they're done in a spa setting. Botox and other Injections, laser hair removal, laser resurfacing, spider vein removal, pulse light procedures and the like are all the practice of medicine, and therefore must be done by the physician, or a licensed registered nurse or physician assistant under the physician's supervision. Unlicensed personnel, or medical assistants, may not perform these procedures.

Chemical peels, depending on their level,'must either be performed by medical personnel or licensed estheticians. I f the peel is at a medical level, then only licensed medical personnel may perform them. If superficial, then they must be performed by licensed estheticians. The same holds true for dermabrasion. .. if irs "micro" then it is an esthetic procedure; if any stronger, then it's medical. Thermage, or other radio frequency devices are generally the practice of medicine. (There might be some of these devices that are not medical, but I'm not familiar with any.) a he problems in California with these "medical spas" generally revolve around supervision and ownership.

Registered nurses and physician assistants may perform ~otoxin jections, laser hair removal, and just about anything else without a physician being physically present under what our law calls "standardized procedures."

(They're basically written protocols) Because of this, a number of nurses have established private practices and hire a "supervising physician," which is not legal. The issue of ownership, either by nurses or lay personnel continue to vex us, as California law does not allow physicians to be employed by non-physicians. Uder California law, nurses may be part-owner of a medical corporation, the physician must be the majority stockholder. Under no circumstances may an unlicensed personbe a stockholder in a medical corporation. Other business related problems also exist. Ownership poses problems, but also the establishment of contracts that basically are fee-splitting arrangements. More and more lay-owned companies are trying to own the medical practices and set up paper corporations that comply with the law by having a physician own the practice, and the lay corporation own the facility and equipment. On the surface, that would be legal, however, the compensation ratesor rent or advertising arrangements amount to fee splitting or payment for patient referrals. (Rent tied to number of patients, discounts that are not legal, etc.) Franchises are also usually illegal. (Under some limited circumstances, if you.twist the law hard enough, you can make them semi-legal.)....



From Florida re osteopathic physicians:

(2) PROTOCOLS REQUIRING DIRECT SUPERVISION.--All protocols relating to electrolysis or electrology using laser or light-based hair removal or reduction by persons other than osteopathic physicians licensed under this chapter or chapter 458 shall require the person performing such service to be appropriately trained and to work only under the direct supervision and responsibility of an osteopathic physician licensed under this chapter or chapter 458.

(3) SUPERVISORY RELATIONSHIPS IN MEDICAL OFFICE SElTlNGS.--An osteopathic physician who supervises an advanced registered nurse practitioner or physician assistant at a medical office other than the osteopathic physician's primary practice location, where the advanced registered nurse practitioner or physician assistant is not under'the onsite supervision of a supervising osteopathic physician, must comply with the standards set forth in this subsection.....

(a) An osteopathic physician who is engaged in providing primary health care services may not supervise more than four offices in addition to the osteopathic physician's primary practice location. For the purpose of this subsection, "primary health care" means health care services that are commonly provided to patients without referral from another practitioner, including obstetrical and gynecological services, and excludes practices providing primarily dermatologic and skin care services, which inciude aesthetic skin care services.

(b) An osteopathic physician who is engaged in providing specialty health care services may not supervise more than two offices in addition to the osteopathic physician's primary practice location. For the purpose of this subsection, "specialty health care' means health care services that are commonly provided to patients with a referral from another practitioner and excludes practices providing primarily dermatologic and skin care services, which include aesthetic skin care services.

(c) An osteopathic physician who supervises an advanced registered nurse practitioner or physician assistant at a medical office other than the osteopathic physician's primary practice location, where the advanced registered nurse practitioner or physician assistant is not under the onsite supervision of a supervising osteopathic physician and the services offered at the office are primarily dermatologic or skin care services, which include aesthetic skin care services other than plastic surgery, must comply a with the standards listed in subparagraphs 1-4.

From Idaho, 2006:

"With respect to regulating so-called medical spas and the procedures being performed in them," the ldaho State Board of Medicine has initiated proposed rulemaking procedures for IDAPA 22.01.04 - Rules of the Board of Medicine for Registration of Supervising and Directing Physicians. These proposed rules add a new section for the registration of those physicians who are responsible for and supervise the provision of cosmetic treatments using res~ri~tivemedica~cosmetic devices and ~roducttsh at are exclusivelv non-incisive or non-ablative bv medical oersonnel. The o.r ooosed rules add definitions, provide for the duties and responsibilities of supervising physicians of medical personnel providing such cosmetic treatments, including at those locations that are remote or non-medical, describes training requirements and outlines scope of cosmetic treahnentsif medical personnel.



While some of the rules place limits on supervision and delegation, or more creatively, even limit the number of offices in which a physician / entrepreneur can multiply himself or herself as a spa medical director, many simply go back to the definition of "medicine" in the statute and provide that designated therapies simply cannot be delivered by anyone other than an MD, period. Louisiana drew the conclusions this way:

Accordingly, it is the position of the Board, equally as an interpretation of applicable law and as a matter of safe practice of medicine, that:

Whether used or applied for surgical, therapeutic or cosmetic purposes on human beings the use of lasers or chemical treatments constitute the practice of medicine under Louisiana law.

Such treatments may be performed or undertaken only by a physician currently licensed to practice medicine by the Board or by a non-physician who acts under the direct supervision of a Louisiana licensed physician who mutually observe the following conditions:

( I ) A physician must insure that any non-physician acting under his supervision is appropriately trained and qualified to perform the tasks or treatments that are delegated;

(2) All treatments and procedures must be performed under the licensed physician's direction and immediate personal supervision-ie., where the physician is physically present on the premises and immediately available at all times that the non-physician is on duty and retains full responsibility to patients and the Board for the manner and results of all services rendered.

(3) A non-physician serving in such a position could not-and may not under any circumstances be permitted tcb-act independently or in the absence of a Louisiana licensed physician or exercise independent medical judgment in implementing any procedure or modality of treatment.

(4) In the context of this Statement, an "appropriately trained and qualified" nonphysician who assists a physician in the performance of laser. or chemical treatments should possess, ai a minimum, haining in safety, application of each system, cutaneous medicine, indicationslcontraindications for such procedures, preoperative and post-operative care,. potential complicitions and infecti. o. us disease control involved with each treatment.

(5) As is the case with any medical procedure or treatment the standard of care requires that such treatments be preceded by a history, an appropriate physical examination conducted by a physician, a diagnosis which confirms that any treatment recommended is appropriate for the patient's condition, informed consent, availability and instructions for emergency and follow-up care and the preparation of an appropriate medical record.

Non-physicians who perform laser or chemical treatments in contravention to the manner expressed herein will necessarily be engaged in the unauthorized practice of medicine as defmed by Louisiana law.

Such conduct is a crime punishable by incarceration' for up to five (5) months and a criminal fine of up to $500.00jor each such offense.' The Board is constrained to refer individuals engaged in such activities to the Louisiana Attorney General and/or the local district attorney for criminal prosecution, file a civil injunction against any continued practice and seek civil penalties and attorney's fees associated therewith.' A physician who participates in such a relationship or acts inconsistent with this Statement in any respect will be subject to disciplinary action by the Board, which may include revocation or suspension of lioensure, a fine of up to $5,000 and imposition of all costs of the Board's proceedings, including attorney's fees: as a resultof engaging in medical practice which failsto satisfy the prevailing and usually accepted standards of medical practice in this state; assisting a non-physician practice medicine; and having professional connection with, or lending one's name to, an illegal practitioner.

Bottom line: each state has different rules. Be sure to seek legal counsel who can do the research and determine what law will apply to the MD or DO (physician medical director), to the medical spa, and to the other practitioners.
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