The Board of Chiropractic Examiners in California has adopted new regulations for the use of lasers in chiropractic.These regulations regarding chiropractic use of laser machines come out of months of hearings by the California chiropractic board – from San Francisco to Los Angeles and beyond – regarding the way chiropractors use non-FDA-approved machines and therapies in their practice.
One of the questions our attorneys frequently get asked is whether licensed medical doctors, chiropractors, acupuncturists, naturopathic doctors, homeopaths, and others, can use non-FDA-approved drugs and devices in their practice.
The use of lasers has been particularly controversial. We know, for example, that in some states (such as California), the state medical board is cracking down on medical spas and stepping up enforcement efforts targeting unlicensed medical practice, corporate practice of medicine, self-referral and kickback violations, and other violations of law. One legal question our healthcare law attorneys get posed quite often is whether non-medical doctors can use lasers; what kind of MD supervision is legally necessary to operate a laser; whether an esthetician can legally operate a laser (say for a dermatological condition), and so on.
Chiropractors have been using lasers for conditions from obesity (weight loss) to allergies, and that can raise scope of practice concerns. Remember that if a therapy is not within a licensed non-MD’s scope of practice, then it can be considered unlicensed practice of medicine.
In these latest regulations, the chiropractic board has adopted legal rules prohibiting the use of lasers in chiropractic which are not approved by the Food and Drug Administration (FDA) or for treatments that are not consistent with FDA approval. In essence, off-label device use is now considered illegal under state law (California) in this specific context.
As well, the regulation prohibits the use of lasers outside chiropractic scope of practice. Use of lasers by chiropractors to treat allergies is considered medical, outside chiropractic scope of practice, and illegal.
The new legal rules are codified at 116 CCR 302.5 (use of laser) (California Code of Regulations):
(a) A duly licensed chiropractor and any person under their direct or indirect supervision, as defined in section 312, shall:(1) Not use any laser in the practice of chiropractic which has not been properly approved or cleared by the United States Food and Drug Administration (FDA).(2) Not market or advertise the use of a laser or use a laser for purposes other than treatment consistent with section 302 and the product’s FDA approval or clearance.(3) Follow the manufacturer’s specified guidelines for the safe use of laser.
(4) Comply with all state and federal laws governing the use of lasers in clinical settings.
(b) Nothing in this section shall be construed to authorize the use of a laser by a chiropractor outside of the chiropractic scope of practice. This includes, but is not limited to, laser ablation or surgical procedures, and laser treatment of allergies.(c) Any violation of this section may constitute unprofessional conduct and the licensee shall be subject to discipline by the Board.Note: Authority cited: Sections 1000-4(b), 1000-4(e) and 1000-10(a), Business and Professions Code (Chiropractic Initiative Act of California (Stats. 1923 p. lxxxviii)). Reference: Sections 1000-4(b), 1000-7 and 1000-10(a), Business and Professions Code (Chiropractic Initiative Act of California (Stats. 1923 p. lxxxviii)).
If you are any kind of healthcare professional – whether a chiropractor, acupuncturist, naturopathic physician, homeopathy, healer, or even a medical doctor in a medical spa context – contemplating use of a laser, consult with experience legal professionals regarding your legal rights and obligations. Or contact one of our attorneys for a legal consultation today.