Public Health Committee

JOINT FAVORABLE REPORT

Bill No.:

SB-418

Title:

AN ACT CONCERNING THE DEPARTMENT OF PUBLIC HEALTH'S RECOMMENDATIONS CONCERNING MEDICAL SPAS.

Vote Date:

3/21/2014

Vote Action:

Joint Favorable Substitute

PH Date:

3/14/2014

File No.:

SPONSORS OF BILL:

Public Health Committee

REASONS FOR BILL:

This bill will implement the Department of Public Health's (DPH) recommendations concerning medical spas.

RESPONSE FROM ADMINISTRATION/AGENCY:

Dr. Jewel Mullen, Commissioner, Department of Public Health (DPH): Dr. Mullen provided testimony in support of SB 418. The bill was developed with input from all stakeholders who provided their valuable expertise to the Department. DPH believes that SB 418 provides significant protection to the public by explicitly defining cosmetic medical procedures and clarifying that these procedures must be performed by, or under the direction of, licensed healthcare practitioners as applicable under their scope of practice.

“Cosmetic medical procedure” is defined to include procedures that are directed at improving a person's appearance, rather than a procedure that promotes the proper functioning of the body including the treatment of illness or disease. This definition was carefully drafted to include cosmetic procedures that should be directly performed by a licensed healthcare practitioner or delegated by such practitioner to a person qualified to perform the procedure.

The bill defines “medical spa” as a place where cosmetic medical procedures are performed. The legislation requires each medical spa to contract with a physician, an advanced practice registered nurse (APRN) or a physician's assistant (PA) that is currently licensed in this state. The physician, APRN, or PA is responsible for performing an assessment of each person undergoing a cosmetic medical procedure and is responsible for the care rendered under his or her supervision as required by each profession's current statues.

Each medical spa is required to post the names and any specialty areas of any licensed health care practitioner performing medical procedures. This information is to be posted in a conspicuous place at the medical spa and on any internet site maintained by the medical spa. This information is also required to be included in any advertising and contained in any written information provided to a medical spa client.

The Department requests deleting the word “facility” in lines 3, 18, and 41. DPH is concerned that the use of “medical spa facility” rather than simply “medical spa” could create confusion for the public who may have expectations that such spa is licensed by the Department. The term “facility” has a specific meaning within the definition of “institution” for purposes of the DPH licensure statues. Adding “facility” to medical spa could be read to imply that such a spa is licensed or requires a license.

The Department also requests the following changes to lines 18-26 to ensure there is no confusion about the need for practitioners to have both a current license and additional training experience: (b) Each medical spa facility shall employ or contract for the services of: (1) A physician licensed pursuant to chapter 370 of the general statues; (2) a physician assistant licensed pursuant to chapter 370 of the general statues; or (3) an advanced practice registered nurse licensed pursuant to chapter 378 of the general statues. Each such physician, PA, or APRN shall:[who] (A) [is] be actively practicing in the state, and (B) [has] have received education or training from an institution of higher education or professional organization to perform cosmetic medical procedures and has experience performing such procedures.

Lastly, the Department requests deleting language in lines 26-35 starting with “each such physician” and replace it with: “Any cosmetic medical procedure performed at a medical spa shall be performed by a physician licensed pursuant to chapter 370 of the general statues, a physician assistant licensed pursuant to chapter 370 of the general statues, or an advanced practice registered nurse licensed pursuant to chapter 378 of the general statues in accordance with applicable authority.”

NATURE AND SOURCES OF SUPPORT:

C. Drew Morten, Chairman of Legislative Committee, Connecticut Academy of Physician Assistants (ConnAPA): Provided testimony in support of SB 418 on behalf of the Connecticut Academy of Physician Assistant (ConnAPA), the only state organization representing the 1,988 licensed Connecticut PAs and the third profession authorized to practice medicine in Connecticut. ConnAPA participated as a member of the ad hoc work group convened by the governor and led by the Office of Policy and Management and the Department of Public Health. The compromises in language reached during the group meetings create the right balance of both insuring public safety and improving access to care.

Nikki Rasmussen, RN: As an owner of a “medical spa”, I strongly support SB 418. The bill clearly defines what procedures are medical procedures, who can perform them, and the oversight required, while remaining conscious of current scope of practice for Registered Nurses, Nurse Practitioners, Physician Assistants, and Medical Doctors. The bill strengthens the focus of public safety by defining what unlicensed personnel, such as estheticians are allowed to perform.

Lynn Rapsilber, APRN & Chair, Connecticut Coalition of Advanced Practice Nurses: Provided testimony in support of SB 418 on behalf of the Connecticut Coalition of Advanced Practice Nurses. APRNs practice independently without MD oversight, supervision or co-signature for 15 years. APRNs own medical spas and as small business owners contribute to the tax base in Connecticut. The bill protects the public by defining cosmetic medical procedures and who can practice those procedures. The proposed legislation does not infringe on the APRN Practice Act and would allow APRN owned medical spas to continue providing quality care that is both safe and cost effective.

Dr. Donna Aiudi, President, Connecticut Dermatology and Dermatologic Surgery Society: Provided testimony in support of SB 418 on behalf of the Connecticut Dermatology and Dermatologic Surgery, an organization representing 90% of dermatologists practicing in Connecticut. The testimony provided was referenced by the American Society for Dermatologic Surgery Association (ASDSA) submission by Dr. Philip Kerr and Dr. Mitchel P. Goldman.

Connecticut Society of Dermatology Surgery (CDS) & American Society for Dermatologic Surgery Association (ASDSA): Members of the ASDSA and the CDS are treating numerous patients with horrific complications who have received a cosmetic medical procedure in a spa, beauty salon, or some other facility where onsite physician supervision does not exist. Many patients are lured into these facilities by false, deceptive, and misleading advertising. These practices are not concerned with patient safety, but rather are interested only in financial gain. The problem lies not with the medical spa model, itself, but with non-physician-owned medical spas that do not provide adequate physician supervision and oversight. There are many legitimate, safe physician-owned medical spas that operate with a high standard of patient care. The lack of regulation and enforcement has enabled a large number of med-spas to offer cosmetic medical procedures by inadequately trained or supervised persons to an unsuspecting public.

There is an increasing concern with regards to the proliferation of non-physicians practicing medicine and its impact on patient safety. Recent studies conducted by the ASDSA have shown an increase in patient complications resulting from this trend. A 2005 study of laser complications by non-physicians published in Skin and Aging Magazine found that, “Eighty-two percent of all complications occurred in facilities that had no direct physician supervision. Of these, 57 percent were in facilities with a 'medical director' who had limited training in dermatologic procedures and laser/light-based therapy. Of all the complications, 78 percent occurred in non-traditional medical facilities, such as free-standing medical spas and laser centers in shopping malls”. Another study published in the Journal of the American Medical Association Dermatology in October 2013, shows that despite only one-third of laser hair removal procedures being performed by non-physicians- including registered nurses, nurse practitioners, aestheticians or “technicians”- they accounted for about 76 percent of injury lawsuits from 2004 to 2012. That number jumped to 85.7 percent in the time period from 2008 to 2012, with 64 percent of procedures being performed outside a traditional medical setting.

The CDS and ASDSA holds the position that the practice of medicine involves diagnosis, treatment, or correction of human conditions, ailments, diseases, injuries , or infirmities whether physical or mental, by any means, methods, devices, or instruments. The practice of medicine includes, but is not limited to undertaking to perform any surgical operation upon any person; performing any act or procedure that uses a biological or synthetic material, or chemical application of any kind if it alters or damages or is capable of altering or damaging living tissue; and performing any act or procedure using a mechanical device, or displaced energy form of any kind if it damages or is capable of damaging living tissue. These acts and/or procedures include the use of all lasers, light sources, microwave energy, electrical impulses, chemical application, particle sanding, the injection or insertion of foreign/natural substances, or soft tissue augmentation.

Donna Montesi-Enters, DNP, APRN, WCC: The new definition of what constitutes a cosmetic medical procedure would provide overall safer practices in Connecticut's med-spas. It is now necessary for each client to have an initial physical assessment performed by properly licensed personnel before undergoing a cosmetic medical procedure as defined in law. This bill would allow for current APRN owned medical spas to remain open and gives the

APRNs the ability to maintain full scope of practice in accordance with the existing Practice Act.

Dr. David J. Goodkind, Plastic Surgeon & Medical Director, Fuzion Medical Aesthetic Boutique: Medical spas are facilities that perform surgical and non-surgical procedures, and currently have no Connecticut licensure requirements, which means there is no regulatory oversight from the Department of Public Health (DPH). The lack of regulation from DPH means that there are no inspections, no infection control requirements, or other guidelines/services which would be made available to patients in a formal hospital. The existence of medical spas allows patients to have procedures performed without the physician supervision which would otherwise be a required in a properly functioning medical environment.

A mutual consensus among many of the State's practicing physicians is that a physician, certified physician assistant, or an advance practice registered nurse is capable of running a stand-alone medical spa with an MD supervising the PA-C or APRN on an intermittent or PRN (pro re nata) basis. A registered nurse could provide services at a spa, but only with full time physician supervision. This compromise, having a full time credentialed physician working with the registered nurse, would allow for the production of unified medical care services.

Mary Jane M. Williams, RN & chairperson of Government Relations Committee, Connecticut Nurses' Association (CNA): In the Fall of 2013 a Task Force, under the direction of Anne Foley (Under Secretary of Office of Policy & Management) , was established to construct language related to medical spas. The task force membership included representation from the Connecticut Society of Plastic and Reconstructive Surgery, the Department of Public Health, the Connecticut Dermatology and Dermatologic Surgery Society, the Connecticut Academy of Physician Assistants, the Connecticut Medical Society, the Connecticut Coalition of Advanced practice Nurses, the managing partner of Radiance Med Spa, and the Connecticut Nurses' Association. The Task Force addressed the issues raised by each invited group and crafted language that thoroughly defined Cosmetic Medical Procedures, i.e. clearly lists the individuals who would be employed for services and their responsibility in delegating appropriately with monitoring outcomes. There is also a clear identification with regards to the necessity of performing a Complete Physical Assessment prior to any med spa treatment.

The legislation calls for complete transparency in advertising so that all potential clients are aware of the individuals employed in each med spa and their qualifications. The goal of this bill is to protect the public and allow the providers in medical spas to continue to provide services in accordance with their scope of practice. It also does not infringe on any of the providers practices, allows individuals to continue providing services in their respective settings, and makes each provider individually accountable for the services they provide.

Also Providing Similar Testimony in Support of SB 418:

Dr. Felice, President, Connecticut Society of Plastic Surgeons

Christine Zarb, APRN-BC, MPH, MedSpa Owner/Operator

Donna Sanchez, CRNA, Connecticut Association of Nurse Anesthetists (CANA)

NATURE AND SOURCES OF OPPOSITION:

None

Reported by: Francesco Sandillo

Date: 4/1/14