California Medical Board proposes changes to physician supervision rules for elective cosmetic procedures

The California Medical Board, on its page for proposed regulations, has proposed to amend California law to provide regarding physician supervision of elective cosmetic procedures.The proposed rule, entitled “Physician Availability” (to become 16 CCR 1364.50, states:

Whenever an elective cosmetic procedure involving the use of a laser or intense pulse light device is performed by a licensed health care provider acting within the scope of his or her license, a physician with relevant training and expertise shall be immediately available to the provider. For purposes of this section, “immediately available” means contactable by electronic or telephonic means without the delay, interruptible, and able to furnish appropriate assistance and direction throughout the performance of the procedure and to inform the patient of provisions for post procedure care. Such provisions shall be contained in the licensed health care provider’s standardized procedures or protocols.

The proposed regulation cites Sections 2018 and 2023.5(c) of the California Business and Professions Code, which state

2018.  The board may adopt, amend, or repeal, in accordance with the
provisions of the Administrative Procedure Act, those regulations as
may be necessary to enable it to carry into effect the provisions of
law relating to the practice of medicine.
2023.5(c) On or before January 1, 2013, the board shall adopt
regulations regarding the appropriate level of physician availability
needed within clinics or other settings using laser or intense pulse
light devices for elective cosmetic procedures. However, these
regulations shall not apply to laser or intense pulse light devices
approved by the federal Food and Drug Administration for
over-the-counter use by a health care practitioner or by an
unlicensed person on himself or herself.

The proposed rule loosens the requirement of physician supervision and makes it clear that the physician need not be physically present at the time the procedure is performed. However, this does not eviscerate the requirement of a good faith initial exam by the MD or NP.

If you have a medical spa, or a physician aesthetic practice with elective cosmetic procedures, contact our team of healthcare law attorneys who can provide legal and regulatory advice for your medical spa, multidisciplinary clinical practice, or aesthetic and cosmetic medical practice.

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Michael H Cohen Healthcare & FDA Lawyers

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