Use of Lasers and Other Modalities
The use of lasers/pulsed light devices, or any energy source, chemical, or other modality that affects living tissue (when referring to the skin, anything below the stratum corneum), whether applied for surgical, therapeutic, or cosmetic purposes, is the practice of medicine.
The Board has developed guidelines for the use of these devices and requires registration of physicians using them in their medical practices.
- Provide guidelines for the use of lasers and other modalities affecting living tissue.
- Provide for delegation of non-ablative procedures (ablative procedures may only be performed by a physician and may not be delegated).
- Require physician registration with the Board (registration form). There is no fee for this registration.
- Require reporting of adverse events (reporting form).
- Persons licensed to practice chiropractic, dentistry, occupational therapy, optometry or physical therapy if the device that affects living tissue is used exclusively for the practice of those branches of the healing arts.
- Persons practicing "body art" as defined by the Department of Public Health.
- Persons using these devices in hospitals.
- "Lasers and other modalities": lasers, pulsed light devices, or any energy source, chemical or other modality that affects living tissue (for skin, anything below the stratum corneum), whether applied for surgical, therapeutic or cosmetic purposes.
- "Non-ablative": includes any laser/intense pulsed light treatment or another energy source, chemical or modality that is not expected or intended to remove, burn, or vaporize tissue. This includes treatments related to laser hair removal.
- "Physician registration": required of physicians who use or offer to use a laser/pulsed light device in any facility other than a hospital. (registration form)
- "Reporting of adverse events": all events related to a procedure that resulted in hospitalization or third-degree dermal injury must be reported to the Board. (reporting form)
- "Level 1 Delegate": a licensed Physician Assistant, Nurse Practitioner, or Nurse Midwife who is authorized in a written job description or collaborative protocol to use a specific laser/another device for non-ablative procedures, as designated in the written job description or collaborative protocol and who has met the educational requirements for a Level 1 Delegate.
- "Level 2 Delegate": any person, other than a Level 1 Delegate, who has met the educational requirements for Level 2 Delegates.
What is required of physicians using lasers/other devices?
Supervision, written protocols, educational requirements, quality assurance, equipment safety, safe use of lasers, registration and adverse event reporting requirements.
Are there any forms provided by the Board for the required written protocols and/or quality assurance program?
No, each practice is expected to develop its own protocol and quality assurance program.
To whom may a physician delegate laser/other devices procedures?
A Level 1 Delegate (authorized Certified Registered Nurse Practitioners or Physician Assistants) or a Level 2 Delegate (non-licensed individual).
What training is required for physicians and Level 1 Delegates?
Sixteen hours of basic training, maintenance of competence.
What training is required for Level 2 Delegates?
Academic training, sixteen hours of documented initial training, completion of at least ten procedures of preceptee training.
What if the delegating physician is unavailable to supervise a delegate?
Arrangements should be made for an alternate physician to provide the supervision. The alternate physician must have the same training as the primary supervising physician and must affirm in writing to the Board that the physician is familiar with the protocols in use at the site and will be accountable for adequate supervision.
Can a physician petition the Board to allow delegates to use lasers/other devices for ablative procedures?
No. Only physicians may use these devices for ablative procedures.
What's the difference between "ablative" and "non-ablative"?
The terms "ablative" and "non-ablative" are distinctions commonly used by the American College of Surgeons and other medical specialties when referring to lasers/pulsed light treatments. According to ACOS: "An ablative treatment is expected to excise, burn, or vaporize the skin below the dermo-epidermal junction. Non-ablative treatments are those that are not expected or intended to excise, burn, or vaporize the epidermal surface of the skin. Any procedures that can damage the eye (cornea to retina) are ablative and should only be performed by a licensed physician." Source: American College of Surgeons.
Can the initial examination take place via telemedicine?
If a physician is capable of conducting a proper and sufficient examination via telemedicine while adhering to the same standard of care as an in-person examination, and a proper collaborative or supervisory practice agreement, pursuant to Board rules, is in place with the mid-level provider who will be with the client/patient at the time of the examination, then such examination via telemedicine would be permissible for the purpose of satisfying Rule 540-X-11-.04(2).
Is electrocautery covered under these rules?
Yes, electrocautery may be used by a Level 1 or Level 2 delegate under direct physician supervision.
Is the use of pulsed and thermocoagulation radiofrequency lesioning governed under the rules?
Yes. Pulsed and thermocoagulation radiofrequency lesioning is a modality that affects living tissue, and as such, a physician using it is required to register with the Board.
Is the use of hyfrecators, thermage or cryotherapy governed under the rules?
No. A physician utilizing hyfrecators, thermage and cryotherapy, as these modalities currently exist, is not required to register with the Board.
Is the use of radiofrequency endovascular procedures governed under the rules?
Yes. Radiofrequency endovascular procedures are ablative and the physician is required to register with the Board; however, because the procedure cannot be delegated, there is no requirement for written protocols or quality assurance.
Is the use of microwave machines (Urologix, Theramatrix and Prolieve) governed under the rules?
Yes. Procedures using these machines are considered "other modalities affecting living tissue," and all rules apply.
Is the use of the Series 12 Elite, invisa-RED Technology governed under the rules?
Yes. Procedures using this device are considered "other modalities affecting living tissue," and all rules apply.
Is laser tattoo removal governed under these rules?
Yes, non-ablative lasers are approved for use under the supervision of a qualified physician who is appropriately registered with the Board.