From laser hair removal to vitamin injections, these days, patients are looking beyond traditional medical intervention to achieve “wellness” — and for some providers, offering services to patients who want to boost their vitamin intake and achieve a glowing complexion can be a way to show their patients that health extends beyond treating runny noses and broken bones.

Enter medical spas: bastions of rejuvenation, with a medical twist. Before opening the doors to a new medical spa, there are a few legal points you may want to consider, including new state regulations with which providers have until July 2024 to comply.

What is a medical spa?

Medical spas, also called med spas or medi-spas, are medical clinics that combine spa services, like facials, with medical treatment. Treatment options are typically offered on a walk-in basis and vary from laser hair removal to sun or age spot laser treatment, to intravenous, or IV, hydration and vitamin-boosting therapy. Unlike traditional physician clinics, medical spas typically operate as retail clinics and tend to cater to people who want to improve their overall wellness or seek to enhance their appearances.

How are medical spas in Alabama regulated?

The Alabama Board of Medical Examiners has issued declaratory rulings and regulations related to the regulation of certain services typically found in medical spas, including IV therapy and laser treatment. In both instances, involvement from a physician or an advanced practice practitioner in a person’s diagnosis and treatment is required to comply with state law.

I’m interested in offering IV therapy. What do I need to know?

IV therapy often includes a range of services, from basic administration of saline for the stated purpose of improving hydration, to administration of vitamins, like vitamins B, C and D and calcium, and some prescription medications, like Toradol (an anti-inflammatory) and Zofran (an anti-nausea medication). The IV “cocktails” are typically recommended to patients based on their stated goals and after completion of a general health screening.

The Board of Medical Examiners regulates the prescription of IV therapy as the practice of medicine. Therefore, IV therapy must be performed either by a physician or by a licensed physician assistant (PA), certified registered nurse practitioner (CRNP), or certified nurse midwife (CNM) practicing under the required level of physician supervision. In fact, the Board has advised that the diagnosis of a patient’s condition and subsequent recommendation of IV therapy constitutes the practice of medicine and falls outside the scope of practice for a registered nurse (RN).

The Board of Medical Examiners has also advised that “standing orders” issued by physicians for use by RNs do not satisfy the involvement required by a physician, PA, CRNP or CNM.

Before starting your medical spa business and providing IV therapy, consider the below list of legal dos and don’ts.

• Do: Require the involvement of a licensed physician or a licensed PA, CRNP or CNM working under the supervision of a licensed physician.
• Don’t: Issue standing orders for use by other provider types, like RNs or chiropractors.
• Do: Create a patient-physician relationship with each person seeking IV therapy.
• Don’t: Establish a business in which the physician providing care is unable to act in his or her own independent medical judgment.
• Do: Create a medical record for each patient and document patient information in a manner compliant with state and federal laws and regulations.

I want to open a medical spa that offers a roster of laser treatments. What do I need to know?

New regulations issued by the Alabama Board of Medical Examiners that took effect July 15, 2023, instituted certain practice and training requirements for physicians and advanced practice practitioners who offer surgical, therapeutic and cosmetic services to patients. Providers have until July 17, 2024, to become fully compliant with the Alabama regulations.

Generally, laser treatments that affect living issues are regulated as the practice of medicine (though certain medical professionals, like chiropractors, dentists, occupational and physical therapists, and optometrists, are exempted from the regulations).

The regulations apply to a broad swath of procedures, including: ablative laser skin resurfacing, non-ablative laser photorejuvenation, laser hair removal and vascular procedures, like treatment of varicose veins, rosacea, age and sun spots and other lesions, tattoo removal, liposuction, cryotherapy and certain micro-needling.

Like IV therapy, physicians can delegate certain non-ablative laser treatments to advanced practice practitioners, like PAs, CRNPs and RNs (called Level 1 Delegates under the regulations) and even licensed practicing nurses (LPNS) and medical assistants (called Level 2 Delegates) through the use of written protocols that comply with the regulations. Delegating physicians must supervise all delegated, non-ablative procedures, either on-site or, in certain circumstances, remotely.

Potentially most impactful for physicians and delegates offering laser treatment are the new training requirements. Under the new Alabama regulations, physicians must complete at least 30 hours and delegate 40 hours, of initial training. Of those hours, training must cover topics including the theory and physics of laser procedures, education on skin anatomy, physiology and disease, safety training and training on the Board of Medical Examiners’ rules. The initial training requirements apply to physicians who obtained Board registration to provide laser treatment after January 1, 2024.

In addition, physicians and their delegates may have to comply with certain device-specific training and supervision requirements—even if physicians received training in residency, although the additional training required may be reduced.

The new Alabama regulations cover several other issues, including quality assurance, employment of substitute physicians and registration requirements with the Board of Medical Examiners. The regulations can be found at Ala. Admin. Code § 540-X-11. The Board maintains a guide for physicians providing laser treatments here.

Takeaways

The Board of Medical Examiners is taking an interest in Alabama’s medical spa industry. Before taking a dive into this new business opportunity, consider the legal framework for providing patients with “wellness” services.