Use of lasers for body sculpting raises legal issues

Medical spas represent a cash cow for many medical doctors and other health professionals, but medispas are raising legal issues.

Medical spa legal issues include not only licensing and scope of practice, but also bring in concerns under state advertising laws as well as Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issues.

A recent online article is revealing entitled, State board struggles to define what can chiropractors legally do: some treat diabetes, use lasers to 'melt away' body fat.

The article begins:

Dr. Genene Prado of Georgetown runs full-page newspaper ads claiming that she does laser treatments in which her patients "lose inches of fat" with "no surgery, no dieting, no exercise and no sweat." In other ads, she touts her expertise at helping diabetics whom she says may have been mishandled by other doctors.

Prado is a chiropractor.

Chiropractors are increasingly seizing on two trends in health care: new technology such as lasers and the obesity epidemic, which is fueling a growing number of Americans with type 2 diabetes, a chronic condition commonly seen in overweight people. But in expanding their range of treatment, some of them are coming into conflict with doctors, who consider those areas their turf — leaving state regulatory boards, courts and lawmakers to referee who is allowed to do what to a patient.

In Texas, the state board that regulates chiropractors is embroiled in a lawsuit with the Texas Medical Board and the state's largest doctors' organization, the Texas Medical Association, over other treatments done by chiropractors that the doctors' groups say cross into their domain.

Separately, the chiropractic board — aware of ads by Prado and other chiropractors — recently began looking into whether a chiropractor should be allowed to treat diabetes and use lasers for body shaping. Board staffers are investigating and will report to the full board later this year, said Glenn Parker, the executive director.

Chiropractors in Texas can use lasers and treat painful conditions as long as the care relates back to the musculoskeletal system, the spine or its nerves, Parker said. The law forbids them from doing surgery, using radiation to treat patients or prescribing drugs.

Using a laser for weight loss or trimming fat "seems to be cosmetic in nature," Parker said, "... but I have to see what they're saying to the patient."

Prado uses the Zerona laser to break down fat cells in the body, which are then absorbed into the bloodstream. The Zerona is called a "cold laser" because it does not cut through the skin. Her ads include the headline, "I lost 14½ Inches With The Zerona Laser!"

Prado initially agreed to be interviewed for this article but did not call back after repeated phone messages, an e-mail and a visit to her office.

About 600 Zerona lasers are being used in the U.S., and an estimated 6,000 people have been treated by them, according to Ryan Maloney, medical director for Erchonia Medical, the McKinney-based company that makes the device. He estimated that 70 to 80 Zerona lasers were being used for body sculpting in Texas, including perhaps as many as 30 in the Austin area. The laser is mostly used by cosmetic surgeons and plastic surgeons, although some chiropractors have followed suit, Maloney said.

A 2009 study of the laser's effectiveness published in the peer-reviewed journal Lasers in Surgery and Medicine says the average loss is 3½ inches from waist, hips and thighs combined. After two weeks, patients regained a third of an inch overall, the study said.

Understand that:

  • Scope of practice is a huge issue in health care law.  Licensing laws for allied health and CAM practitioners are more limited than for medical doctors.
  • MDs can supervise allied health professionals but the notion of supervision between MDs and DCs is illogical.  Chiropractors are independent not dependent practitioners.
  • The corporate practice of medicine doctrine complicates ownership of medical spas.
  • Kickbacks or referral-based inducements are illegal as is fee-splitting.
  • Some regulators may see management services arrangements as disguised kickbacks.
  • Compensation arrangements must be structured carefully for legal compliance.
  • Corporate attorneys do not necessarily know health care law.
  • Stark and self-referral legal issues lurk.
  • Enforcement agencies are coordinating efforts.
  • State advertising laws must be complied with as well.

 

Recently, the Chief Research Officer for Erchonia testified before the California Chiropractic Board Examiners Scope of Practice Subcommittee on February 24, 2011. The video of this testimony meeting (which is available on the Board’s website and in short form on You Tube), shows the Committee asking pointed questions about whether use of the Zerchona laser for body contouring is truly within chiropractic scope of practice. Although the Board of Chiropractors has not yet finalized rules, the video does showcase a good deal of concern by the Board as to whether use of these devices is truly part of chiropractic scope of practice.

Another expressed concern of the Board is the use of advertisements to “lure a person in for a weight loss program.”

If you are opening or operating a medical spa or advertising body sculpting procedures, consult and experienced health care attorney who understands medical spa law and laws governing body sculpting, weight loss, and health care claims.

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Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Mr. Cohen represents conscious business leaders in a transformational era.

Clients seek Mr. Cohen’s specialized expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas.  Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges.

Mr. Cohen is admitted to practice in California, Massachusetts New York, and Washington, D.C.  Contact our attorneys at our Beverly Hills, California law firm today.