The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services. The board is offering public comment through February 2 on the proposed changes to the existing law.
Under existing law, lasers are broadly defined and the use of a laser is the practice of medicine. Currently, delegation of laser services is limited to three categories: 1) fluorescent lamp phototherapy may be delegated for treatment of psoriasis and similar skin diseases; 2) phototherapy in treatment of hyperbilirubinemia in neonates may also be delegated; and 3) laser hair removal may be delegated only to a physician assistant, registered nurse, licensed practical nurse or cosmetic therapists subject to physician evaluation and assessment standards and dependent upon varying levels of physician supervision.
Proposed New Delegation Authority for Non-Ablative Dermatologic Procedures:
The proposed rule adds a definitional section which includes new regulatory terminology for “ablative” and “non-ablative” “dermatologic procedures,” “phototherapy,” “phototherapy devices” and “photodynamic therapy.”
The added definitions and the distinction between “ablative” and “non-ablative” are significant because the proposed rule adds new authority for physicians to delegate the use of a vascular laser for “non-ablative dermatologic procedures” to a physician assistant, registered nurse or licensed practical nurse subject to robust education and training standards which include eight hours of training, 15 case observations and 20 case direct physical oversight standards per procedure to be delegated. The proposed rule also specifies the physician provide on-site supervision and limits the number of persons supervised to no more than two at any one time.
Proposed Addition to All Delegation Authority:
The proposed rule also adds a new general requirement that any service delegated under the rule must be “within the physician's normal course of practice and expertise.”
Proposed Additions to Laser Hair Removal Delegation:
Regarding the existing authority to delegate laser hair removal services, the proposed rule changes existing law by adding the same robust education and training standards proposed for the new “non-ablative dermatologic procedures” to the delegation requirements for laser hair removal. As a result, the eight hours of training, 15 case observations and 20 case direct physical oversight standards would also apply to laser hair removal services if the proposed rule were adopted as presently written.
Proposed Additions to Delegation of Phototherapy:
Under existing law, a physician's authority to delegate a phototherapy device for the treatment of psoriasis and similar skin diseases or in the treatment of hyperbilirubinemia in neonates was not subject to significant limitations. That changes under the proposed regulations as physicians who wish to delegate phototherapy for the treatment of psoriasis and similar skin conditions or for the treatment of hyperbilirubinemia in neonates, or delegate photodynamic therapy for dermatologic purposes will be required to see and personally evaluate the patient before application of phototherapy, assure the delegate has completed basic training related to the purpose for the phototherapy or photodynamic therapy, and provide on-site supervision. Additionally, while existing law permits delegation to any “appropriate person,” the proposed rule limits delegation of phototherapy for the treatment of psoriasis and similar skin conditions to a physician assistant, registered nurse, licensed practical nurse or qualified certified medical assistant, and limits delegation of phototherapy for the treatment of hyperbilirubinemia in neonates and photodynamic therapy for dermatologic purposes to a physician assistant, registered nurse or licensed practical nurse.
The text of the proposed amendments to Ohio Administrative Code rules 4731-18-01, 4731-18-02, 4731-18-03 4721-18-04, and 4731-25-08 can be found at http://med.ohio.gov/LawsRules/NewlyAdpotedandProposedRules.aspx.
Comments about the proposed updates must be submitted by the end of the business day February 2, 2018. Comments may be sent to Nathan.Smith@med.ohio.gov.