Device Delegation: Don't Get Burned

In New Jersey, only a physician licensed by the New Jersey State Board of Medical Examiners can perform laser procedures. In California, however, such procedures can only be performed by physicians as well as physician assistants, nurse practitioners, and registered nurses who are under a physician’s direct supervision. In some other states, anything (and thus, everything) may go.

“It gets very complicated,” says George J. Hruza, MD MBA, an adjunct professor of dermatology at St. Louis University in MO. “Every state has different rules and there are no national guidelines because the practice of medicine is regulated on a state-by-state basis,” says Dr. Hruza, the American Society for Laser Medicine and Surgery (ASLMS) public policy director.

Groups such as ASLMS, the American Society for Dermatologic Surgery Association (ASDSA), the American Academy of Dermatology (AAD), and the American Med Spa Association (AmSpa) are leading efforts to establish national guidelines on appropriate use and supervision of lasers and other energy-based device procedures, and protect patient safety.

To that end, ASDSA, the advocacy arm of the American Society for Dermatologic Surgery, just launched Patients/Physicians United for Laser Safety and Efficacy (PULSE). The coalition represents a wide range of healthcare stakeholders and affected patients. It aims to advocate for standards that protect patient safety. This group also passed model legislation—The Safe Laser and Energy-Based Device Act—and have provided members with a state-by-state review of laws governing the use of lasers by physicians and non-physicians.

Rhode Island is currently running the new bill, says Kristin A. Hellquist, MS, CAE, Director of Advocacy & Practice Affairs at the ASDSA in Rolling Meadows, IL.

The ASDSA is in favor of direct on-site supervision of non-physician providers, adequate training of providers, and the clear and transparent communication with the patient about who will be providing care. The ASDSA opposes independent practice of non-physician providers outside of a physician-led team and physicians who oversee procedures outside of their scope of practice.

The ASLMS is of the same mind. “A device that can cause tissue injury—or cell death—should be considered medical and regulated as such,” Dr. Hruza says. “Such heavy-duty devices can cause scarring and other complications. Non-invasive laser procedures can be delegated to someone who is properly trained if a physician is on site,” he says. “At least in this model, when a physician extender performs a procedure, they are close to the physician if any problems or complications occur.”

Why Cant We All Just Get Along?

It’s hard to find solid middle ground in the debate about device delegation. “There are some who want to do more with less supervision and others who want this area to be more closely regulated,” Dr. Hruza says. Less supervision may increase profits, but this could be at the expense of patient safety, he adds.

Take Home Messages on Device Delegation

•Know the Rules in Your State

•Think Twice Before Signing On as a Med Spa Director

•Get Involved in Advocacy Efforts at the State Level

•Promote Truth in Advertising

“We certainly need a lot more state-based action so that people have a better idea of what they can and can’t do and who needs to be on site,” says Alex R. Thiersch, JD, the founder and director of the AmSpa. “Every state would have to pass a certain set of regulations. The problem is that the technology is moving so quickly that it is very difficult for state legislators to keep up.”

There are so many laser and energy-based devices currently available with more coming to market seemingly daily. Each device or modality has its own set of benefits, risks, and/or learning curves, he says.

There can also be a disconnect between what a sales person says about a device and what is really and truly OK. “A sales representative may give a doctor advice that is based on regulations in another state within their territory, but may not be OK in their own state.” Among less ethical salespeople, this type of counsel may be solely to help seal a very lucrative deal.

Another issue muddying these waters is patient education and truth in advertising. Often times patients don’t know or ask who is performing the procedure, and when they do ask, they may be met with certificates form private training entities. “Lots of providers show certificates, which are just proof that were trained by a private entity,” Mr. Thiersh says. “This doesn’t mean they can fire a laser in that state.”

It is the responsible physician’s obligation to ensure that the non-physician providers possess knowledge of cutaneous medicine and documented training in the procedure, the ASDSA states.

Sifting Through The Med Spa Milieu

Physicians may be tempted to sign on as a Med Spa advisor as it can seem like easy money and it is, until something goes wrong, Dr. Hruza says.

“Complications do occur when the wrong device is used for the wrong indication in the wrong patient,” he says. “Med Spa director is a real responsibility,” Dr. Hruza says. “If you just come in and check the charts each month, the 100s or 1,000s of patients who you haven’t seen are potential liabilities,” he says. “If something goes bad, this patient will sue you.”

Mr. Thiersch agrees. “Laser burns are the fastest growing source of lawsuits against aesthetic practices. Law firms are actively soliciting laser burn clients,” he says.

“Med Spa director can’t be treated as a part-time job where you float in and out and take a look at charts,” Mr. Thiersch warns. “This has to be seen as an extension of your practice and yes, there are ways to do it where it’s not full time, but it can’t just be a supplement to income.” Protect yourself and your practice by consulting with a lawyer who has knowledge of state laws before signing on as a director of any Med Spa, he says. “Getting involved with state lobbying efforts to establish guidelines on device delegation will also help protect your patients and your practice.” n

NOW PLAYING ON DERMTUBE.COM

Alex Thiersch, JD, founder of the American MedSpa Association (AmSpa), talks to Steve Dayan, MD, about the regulatory challenges of aesthetic medicine on Aesthetics Insider.

Watch it on ModernAesthetics.tv: http://modernaesthetics.com/tv/?f=aesthetics-insider-the-ugly-side-of-regulation