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Industry News: State Regs

New Jersey State Board of Medical Examines Proposes New Rules for Lasers, Fillers and More

Monday, June 29, 2015   (0 Comments)
Posted by: Cathy Christensen
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By Allyson Avila, Partner, Wilson Elser, and AmSpa East Coast Partner Attorney

The New Jersey State Board of Medical Examiners has proposed new rules and amendments regarding the delegation of lasers, as well as certain restrictions on who may inject fillers and neuromuscular blockers. They have also proposed certain regulations relating to microdermabrasion and epidermal peels. 

The laws have not yet been approved. However, the proposed rules reflect the New Jersey State Board of Medical Examiners' current thinking and are used as their policy statement on the use of laser, and the administration of Botox and dermal fillers. 

Below is a summary of the proposed regulations: 

1. The Board proposed to delete the requirement that a physician see a patient prior to a subsequent provision of a modality after the initial provision of that modality, because the existing rule requires that a physician be on-site and available in the event of an emergency when treatment orders are being carried out by an assistant. The Board proposes to amend this provision to require that either a physician or other licensed health care provider be on-site while treatment orders are being carried out. If a physician is not on-site, he or she must be available through voice communication. 

2. N.J.A.C. 13:35-6.14A is a proposed new rule, which dictates that the application of lasers, intense pulsed light and infrared to the body is a medical practice.  The rule sets forth specific procedures that a physician may direct a registered professional nurse or licensed physician assistant to perform using lasers, intense pulsed light or infrared, and the education the registered professional nurse or licensed physician assistant has to complete before a physician can direct him or her to perform such procedures. The rule also sets forth the process a physician has to undergo before directing a registered professional nurse or licensed physician assistant to perform such procedures. A physician is prohibited from directing any individual to perform a procedure using radiofrequency.  

According to the proposed regulations, a physician may direct a registered professional nurse or licensed physician assistant who has met certain education and training requirements to perform: 
1.  Hair removal using lasers or intense pulsed light;
2.  Procedures using infrared devices;
3.  Intense pulsed light for pigmentation; and
4.  Intense pulsed light for vascularity.

 A physician who directs a registered professional nurse or licensed physician assistant to perform a procedure with lasers, intense pulsed light or infrared devices shall:

1. Take a medical history, perform a physical examination and develop a treatment plan, which includes the estimated number of treatments for the patient on whom the procedure will be performed prior to the commencement of the procedure. A physician may permit a registered professional nurse or licensed physician assistant to take the medical history and to perform a physical examination, as long as the physician reviews the medical history and the results of the physical examination and personally examines the area that will be treated prior to the initiation of treatment;
2. Maintain the medical history and treatment plan as part of his or her medical records pursuant to N.J.A.C. 13:35-6.5;
3. Ensure that the registered professional nurse or licensed physician assistant knows that he or she is required to notify the physician if the patient experiences complications or adverse events; and
4.  Assess the patient’s progress at the end of the treatments.

 A physician shall only direct a registered professional nurse or a licensed physician assistant to perform a modality if the registered professional nurse or licensed physician assistant has completed a continuing education course, approved pursuant to N.J.A.C. 13:37-5.3 or N.J.A.C. 13:35-2B.8, in that specific modality which includes:

1. Indications for the use of the modality;
2.  Contraindications for the use of the modality;
3.  Potential complications; 
4.  General laser safety and wavelength-specific safety; and
5.  Proper cleaning of devices.

A physician shall not direct any individual to perform a procedure using radiofrequency.

Also,  N.J.A.C. 13:35-6.14B is a proposed new rule that prohibits a physician from directing another person to inject a patient with a filler or neuromuscular blocker.  The rule requires that a physician only inject fillers and neuromuscular blockers that have been approved by the U.S. Food and Drug Administration (FDA) or which are provided as part of an Institutional Review Board approved clinical trial.   

N.J.A.C. 13:35-6.14C is a proposed new rule which dictates that the application of dermabrasion, epidermal peels and microdermabrasion to the body is a medical practice. A physician may direct an individual to perform a superficial epidermal peel, defined as a chemical peel that affects only the epidermis, and microdermabrasion, defined as the use of abrasive material to affect the skin which affects only the epidermis. The rule sets forth the process a physician must go through before directing an individual to perform a superficial epidermal peel or microdermabrasion. The rule dictates that only a physician may perform a medium epidermal peel, deep epidermal peel or dermabrasion.

A physician who directs an individual to perform a superficial epidermal peel or microdermabrasion shall:

1.  Take, or direct a registered professional nurse or licensed physician assistant to take, a medical history for the patient on whom the superficial epidermal peel or microdermabrasion is performed at the initial visit; 
2.  Develop, at the initial visit, a treatment plan, which includes the estimated number of treatments, for the patient on whom the superficial epidermal peel or microdermabrasion is performed;
3.  Maintain the medical history and treatment plan as part of his or her medical records pursuant to N.J.A.C. 13:35-6.5;
4.  Ensure that the individual who will perform the superficial epidermal peel or microdermabrasion knows that he or she is required to notify the physician if the patient experiences complications or adverse events; and 
5. Assess the patient’s progress at the end of the treatments. 

Only a physician shall perform a medium epidermal peel, deep epidermal peel or a dermabrasion.


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