July 31, 2021 marks a big day for Ohio Laser Regulations. Starting on this day, physicians may delegate the application of a vascular laser for non-ablative dermatologic procedures according to legal requirements laid out in the Administrative Code. Physicians may also delegate the application of light based medical devices for the purpose of hair removal, the application of phototherapy for the treatment of hyperbilirubinemia in neonates, and the application of phototherapy and photodynamic therapy for dermatologic purposes. This new law affects varying medical professionals, and includes Physician Assistants, Registered Nurses, Nurse Practitioners, and Licensed Practical Nurses, as well as Cosmetic Therapists.
A light based medical device is any device that can be made to produce or amplify electromagnetic radiation wavelengths equal to or greater than one hundred eighty nm, but less than or equal to 1.0 X 10 6nm (ten to the sixth power), and that is manufactured, designed, intended, or promoted for irradiation of any part of the human body for the purpose of affecting the structure or function of the body. (4731-18-01 Ohio Administrative Code).
Non-ablative dermatologic procedure means a dermatologic procedure that is not expected or intended to excise, burn, or vaporize the epidermal surface of the skin. (4731-18-01 Ohio Administrative Code).
Phototherapy means the application of light for the treatment of hyperbilirubinemia in neonates, or the application of ultraviolet light for the treatment of psoriasis and similar skin diseases. (4731-18-01 Ohio Administrative Code).
Photodynamic therapy means light therapy involving the activation of a photosensitizer by visible light in the presence of oxygen, resulting in the creation of reactive oxygen species, which selectively destroy the target tissue. (4731-18-01 Ohio Administrative Code).
For physician delegation of vascular lasers for non-ablative dermatologic procedures, there are a number of conditions that must be met:
- The laser must have been specifically cleared or approved by the US FDA for the specific intended non-ablative dermatologic procedure.
- The use of the laser for the specific procedure must be within the physician’s normal course and scope of practice and expertise.
- The physician has first seen and evaluated the patient to determine whether the proposed laser procedure is appropriate.
- Following the initial application of the laser, the physician must have seen and evaluated the patient prior to continuation of treatment, to determine that the patient responded well to the initial application; and
- The person to whom the physician is making the delegation must be a Physician Assistant, a Registered Nurse, a Nurse Practitioner, or a Licensed Practical Nurse.
Physician Assistants must be licensed and authorized pursuant to the Ohio Revised Code. Registered Nurses, or Licensed Practical Nurses, must be adequately licensed and trained and their level of skill must include eight hours of basic education on the topics listed in Ohio Administrative Code 4731-18-03 (A)(7)(a), observation of at least fifteen procedures for each specific type of vascular non-ablative procedure, that will be delegated to the Registered Nurse of Licensed Practical Nurse, performance of at least twenty procedures under direct physical oversight of the physician on each specific type of procedure delegated, and documentation maintained by the physician of satisfactory completion of such training. The physician must provide on-site supervision at all times when the delegate is applying the vascular laser, and the physician can supervise no more than two persons pursuant to this rule at the same time.
The delegation rules for light based medical devices for the purpose of hair removal require all of the same conditions as well as some additional ones. The delegation may be made to a Physician Assistant who is licensed and the physician has an effective supervision agreement, or a cosmetic therapist who was licensed under the Revised Code as of April 11, 2021 or who has completed a cosmetic therapy course of instruction for a minimum of 750 clock hours and received a passing score on the Certified Laser Hair Removal Professional Examination administered by The Society for Clinical and Medical Hair Removal, or a Registered Nurse or Licensed Practical Nurse. For Cosmetic Therapists, Registered Nurses, and Licensed Practical Nurses, the physician must ensure the person to whom they are delegating the procedure has received adequate training and education to the same standards as required for non-ablative dermatological procedures, and listed above.
Delegates who, prior to the effective date of this new law, have been applying a specific type of light based medical device procedure for hair removal for at least two years through lawful delegation by a physician are exempted from such education and training requirements, provided that they obtain a written certificate from one of their current delegating physicians stating that they have completed sufficient education and training to competently perform the procedure. Such a certificate must be written and signed no more than sixty days after the effective date of this new law, and a copy must be retained by each delegating physician and each delegate.
The physician may also provide off-site supervision when the light based medical device is applied for the purpose of hair removal to an established patient if the person to whom delegation is made is a Cosmetic Therapist meeting all of the following requirements: the Cosmetic Therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the delegating physician, the course consisted of at least fifty hours of training of which at least thirty were clinical experience, and the Cosmetic Therapist has worked under the on-site supervision of the physician making the delegation for a sufficient period of time so that the physician is satisfied that the Cosmetic Therapist is completely capable of competently performing the service with off-site supervision.
Ohio is not issuing any more Cosmetic Therapist Licenses.
Cosmetic Therapists, Physician Assistants, Registered Nurses, and Licensed Practical Nurses must immediately report any clinically significant side effects following the procedure to the delegating physician. Any failure of the treatment to progress as expected must also be reported. The physician must then personally see and evaluate the patient as soon as practicable.