This article recently ran in the Virginian Pilot. It summarizes that med spas do not have state regulations that govern their operations. The supervision of the med spa is the responsibility of the physician fulfilling that role. As I understand it, the role of the physician/patient relationship has not changed. The physician is responsible for designing a treatment plan and supervising that plan. The injection itself can be provided by another health care personnel within the scope of their professional activities. Nurse practitioners and Physician Assistants have the capacity to order treatments but supervision is still required of the physician. Onsite supervision would be optimal. Below are a copy of the article and the pertinent state regulations.
By Elizabeth Simpson
© June 2, 2013
A trip to the spa used to mean rejuvenating facials and relaxing massages, but in the past decade the industry has grown to encompass treatments that take “skin deep” to a new level.
Medical spas, as many are known, are a hybrid of beauty shops and doctor’s offices. They provide invasive procedures such as Botox injections, liposuction, electrolysis, laser treatments and makeup tattooing.
The marketing firm Marketdata Enterprises released a study in November that tagged the number of medical spas in the United States at 2,100 – up from 224 in 2002. Spa associations place the number even higher, and since most states don’t license them in a single category, statistics are hard to verify.
Several factors are fueling the trend: aging baby boomers trying to turn back the hands of time; people battered by the economy looking for a cheaper alternative to plastic surgery; doctors, frustrated by shrinking insurance reimbursements, looking for a way to expand their pool of self-pay patients.
It’s unfolding in a field with spotty regulation at best, raising concerns about potential hazards such as burns, bruising, infections and even an occasional death.
In light of that, some states have toughened regulation. Mary Broz-Vaughan, spokeswoman for the Virginia Department of Professional and Occupational Regulation, said medical spas in Virginia fall into a no man’s land of sorts.
The Virginia Department of Health doesn’t regulate medical spas as it does hospitals, nursing homes, home-care agencies and abortion clinics. Virginia does regulate “esthetics spas” – where services such as facials and chemical peels are given – and nail and cosmetology salons, but there’s nothing in the code that defines a medical spa.
Some treatments they provide, such as manicures and facials, are regulated by the state and require a license. But doctors are exempt from those regulations, so if a medical spa has a physician directing the facility, the doctor is expected to oversee such treatments.
When procedures go awry, the Virginia Board of Medicine steps in to determine whether a doctor is fulfilling his or her duty, which is spelled out in state code. That’s a complaint-driven system, so enforcement is uneven because there are no regular inspections.
One of the most recent local cases to come before the Board of Medicine involved Dermacare in Chesapeake, a business that advertises laser hair removal, Botox injections and laser “skin tightening.” The board reprimanded the clinic’s medical director, Dr. Michael Keverline, and fined him $4,500 in April for allowing staff members to perform laser surgery, inject dermal fillers and provide facial injections without proper supervision.
He also allowed prescription drugs to be dispensed without a physical examination or medical history. His attorney, Michael Goodman, said that before Keverline opened the Dermacare clinic in 2006, he visited other medical spas and observed an “indirect” supervision model, defined as being available by telephone and within a 30-minute drive.
The interpretation of supervision, though, differs from state to state and even from board to board within the same state, Goodman said. The meaning also differs depending on who is being supervised. A nurse practitioner and physician assistant, for instance, require less oversight than a nurse.
Because of that, it’s difficult for operators to understand all that’s necessary. Goodman said he has represented five to 10 medical directors of spas before the Board of Medicine during the past several years, and it’s not just unhappy customers who turn them in, but also competitors.
He said most of his clients have done a good job training staff but are unaware of the level of supervision required, particularly when it comes to establishing a patient-doctor relationship that includes a medical history, informed consent and examination. He said most are surprised when investigators from the Board of Health Professions arrive asking questions.
“You could knock them over with a feather,” Goodman said.
Keverline has sold the Dermacare facility and returned to full-time practice of ophthalmology. The current owner of Dermacare said the facility is now in compliance.
Two years ago, Peggy Meder was surprised to find health investigators at her spa in Norfolk. The registered nurse owns Skin A Medical Spa on Granby Street.
The medical director of her business, Dr. Barry Clark, was reprimanded and fined $5,000 for allowing unlicensed staff members to inject dermal fillers and local anesthetics and to perform cosmetic laser procedures. He also allowed drugs such as Demerol and Valium to be prescribed and dispensed in his name without documenting that he had examined the patients or taken their medical histories.
Board documents indicate that Clark practiced full time in the Washington area while serving as the spa’s director.
Meder was fined and reprimanded by the Virginia Board of Nursing for giving treatments she wasn’t authorized to perform. Meder’s frustration is that she had worked for other medical spas that operated in the same way.
Since then, though, she has restructured the business. After shutting it down for a week, she hired a nurse practitioner with the authority to write prescriptions, obtain informed consent and medical histories, and do assessments. She also hired a plastic surgeon to oversee the nurse practitioner.
“It’s made us a better business,” she said. “I was running a top shop. I was going over and above what I did anywhere else. And even then, I fell short.”
She said she believes her shop is safer now, and she also works as a consultant helping other medical spas operate within the code. She does question, however, how many medical spas operate outside the law.
It’s a concern for a number of organizations, including the American Society for Aesthetic Plastic Surgery and the American Academy of Dermatology. Both have issued guidelines to help people choose safe treatments.
While severe complications are rare, they do happen. In Maryland, a 59-year-old woman died of an infection last September after a liposuction treatment at a medical spa.
Florida and California, hot spots for medical spas, toughened laws after complaints of complications and deaths. Florida now authorizes the state to inspect any clinic that removes more than 1,000 cubic centimeters of fat during liposuction. California has set up agencies to inspect and accredit outpatient surgery settings, including medical offices and spas.
Dr. Richard Rosenblum, who has a plastic surgery practice and medical spas in Virginia Beach and Norfolk, said patients should educate themselves and become informed, not just about a procedure but who is providing it.
“Every procedure has a risk to it,” he said. “We wish they had zero risk, but there’s always a risk. If you have someone with little to zero cosmetic experience doing it, you may not get the desired effect, and if there’s a problem you don’t have a doctor to correct it.”
Elizabeth Simpson, 757-446-2635, firstname.lastname@example.org
Pertinent Virginia Sate regulations: John:
§ 54.1-2901. Exceptions and exemptions generally.
A. The provisions of this chapter shall not prevent or prohibit:
4. Any registered professional nurse, licensed nurse practitioner, graduate laboratory technician or other technical personnel who have been properly trained from rendering care or services within the scope of their usual professional activities which shall include the taking of blood, the giving of intravenous infusions and intravenous injections, and the insertion of tubes when performed under the orders of a person licensed to practice medicine or osteopathy, a nurse practitioner, or a physician assistant;
6. Any practitioner licensed or certified by the Board from delegating to personnel supervised by him, such activities or functions as are nondiscretionary and do not require the exercise of professional judgment for their performance and which are usually or customarily delegated to such persons by practitioners of the healing arts, if such activities or functions are authorized by and performed for such practitioners of the healing arts and responsibility for such activities or functions is assumed by such practitioners of the healing arts;
§ 54.1-3303. Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only.
A. A prescription for a controlled substance may be issued only by a practitioner of medicine, osteopathy, podiatry, dentistry or veterinary medicine who is authorized to prescribe controlled substances, or by a licensed nurse practitioner pursuant to § 54.1-2957.01, a licensed physician assistant pursuant to § 54.1-2952.1, or a TPA-certified optometrist pursuant to Article 5 (§ 54.1-3222 et seq.) of Chapter 32. The prescription shall be issued for a medicinal or therapeutic purpose and may be issued only to persons or animals with whom the practitioner has a bona fide practitioner-patient relationship.
For purposes of this section, a bona fide practitioner-patient-pharmacist relationship is one in which a practitioner prescribes, and a pharmacist dispenses, controlled substances in good faith to his patient for a medicinal or therapeutic purpose within the course of his professional practice. In addition, a bona fide practitioner-patient relationship means that the practitioner shall (i) ensure that a medical or drug history is obtained; (ii) provide information to the patient about the benefits and risks of the drug being prescribed; (iii) perform or have performed an appropriate examination of the patient, either physically or by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically; except for medical emergencies, the examination of the patient shall have been performed by the practitioner himself, within the group in which he practices, or by a consulting practitioner prior to issuing a prescription; and (iv) initiate additional interventions and follow-up care, if necessary, especially if a prescribed drug may have serious side effects. Any practitioner who prescribes any controlled substance with the knowledge that the controlled substance will be used otherwise than medicinally or for therapeutic purposes shall be subject to the criminal penalties provided in § 18.2-248 for violations of the provisions of law relating to the distribution or possession of controlled substances.