Medical spas

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ISSUE SUMMARY

The number of medical spas in the United States has grown rapidly in recent years, and while there exists no specific information on the number of medical spas within the state of Kansas, it is apparent the facilities are becoming increasingly common, especially in our state's urban areas.

There is not widely accepted consensus on the definition of what constitutes a "medical spa," however they can best be viewed as business entities that are not the primary office of a licensed physician, but with the following characteristics:

• They are operated for the purpose of providing an array of elective, aesthetic enhancement procedures–usually including medical therapeutic procedures such as light-based, chemical and injectible therapies.
• While some services provided in a medical spa may also be available within a physician office, medical spa facilities are often free-standing entities which differentiate themselves by offering treatments in a "spa-like" setting.

Currently, there exists no regulation of medical spas, nor any limitations on or definitions of the types of services which may be performed at a medical spa, no required inspections of medical spa facilities, and limited regulations addressing the specific responsibilities of physicians who serve as spa medical directors. In an effort to raise awareness of these issues, the Kansas Medical Society convened a task force to study medical spas in Kansas and make recommendations on the appropriate strategies to promote quality and patient safety in such facilities.

ADOPTED ACTION OR POLICY

KMS endorses the three broad, consensus principles which emerged from Medical Spa Task Forces' discussion of the medical spa issue:

1. Many of the services available at medical spas carry inherent risk, and constitute the practice of medicine and/or surgery, and such facilities should be regulated.
2. In order to ensure the highest levels of quality and patient safety, all medical spas which provide any services which constitute the practice of medicine and surgery must have a medical director who is licensed by the Healing Arts Board, and all medical services should be provided in a physician-directed, safe, sanitary environment.
3. Physicians who serve as medical directors of spa facilities have a responsibility to ensure they adhere to all applicable laws, rules and regulations relating to the delegation of medical acts and supervision of non-physician staff. They may only supervise or delegate to other persons, those acts and functions which are within the physician's normal and customary specialty, competence and lawful practice; and the physician may only delegate to such persons those acts and functions which the physician knows can be competently performed by such person, and is not in violation of any other statute or regulation.

Because medical spas offer services provided by several different professions, each regulated by different agencies, and because many medical spa treatments carry risk of harm to patients, KMS believes that state oversight of medical spas is necessary to protect the public and promote patient safety. The Task Force makes the following recommendations:

1. Medical spa facilities should be licensed and regulated by the state; licensure requirements should be tiered to reflect differences in the complexity of services offered or the risk to patients represented by those services.
2. Medical spa facilities should be regularly inspected and required to ensure compliance with sanitation and safety requirements.
3. The responsibility for regulating medical spas should be vested with the Kansas Department of Health and Environment (KDHE), and should include a regulatory board; the medical spa regulatory board should, at a minimum, include representation from the Kansas State Board of Healing Arts and physicians from medical specialties with experience, training and competence providing the services offered in medical spas.
4. The entity established to regulate medical spas should identify and maintain a comprehensive inventory of the aesthetic services and treatments provided by medical spas in the state of Kansas. Working with the Kansas State Board of Healing Arts, the medical spa regulatory agency should identify and develop a classification list of those aesthetic services which are medical in nature, or otherwise constitute the practice of medicine and surgery.
5. KDHE and the medical spas themselves should clearly identify a process through which consumers may register complaints or concerns regarding quality, safety and/or treatments provided within a facility.
6. Every medical spa at which services are provided which constitute the practice of medicine and surgery must have a Kansas-licensed physician as its medical director. The requirements for the presence on-site and/or availability of the medical director should reflect the level of regulation of the facility, the complexity of services offered and the potential risk to patients represented by those services.
7. All clinical personnel in the medical spa should have appropriate licensure or certification, and the necessary training, skills and supervision to deliver the services they provide. The type of professional licensure of all clinical personnel must be clearly identified to patients.
8. Prior to any aesthetic medical procedure which alters or causes biologic change to living tissue (including injections, laser or other light-based treatments) patients must be assessed by a physician. Patient assessment for non-medical procedures may be done by a physician assistant, advanced registered nurse practitioner, or a registered nurse working pursuant to the direction of, supervision of, or collaboration with a physician.
9. Physicians who serve as medical directors of medical spa facilities must adhere to all applicable laws relating to the delegation of medical acts, including supervising and delegating only those acts and functions which are within the normal and customary specialty, training, competence and lawful practice of the physician.
10. Medical spas should be required to have written protocols in place for the timely and safe transfer to an alternate care facility such as a physician's office or hospital when emergency or other medical services are necessary.
11. Medical spas should establish an internal quality assurance program, including requirements for continuing education of all clinical personnel.
12. Medical spas should be required to carry an appropriate level of liability insurance.
13. In order to advertise as a medical spa, a facility must be licensed as such by the state.

KMS should work with relevant stakeholders to develop the above principles and objectives into bill form, introduce the legislation in the Kansas Legislature and advocate for its passage.

Adopted by the KMS House of Delegates on May 1, 2010.

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