How states regulate medical spas

Back in April, we shared with you our thoughts on what to consider before opening or investing in a medical spa, thinking about corporate structure, scope of practice, licensing and registration, referral restrictions, HIPAA and data privacy, and more.

This month, we’re focusing on how states are starting to regulate this area so that owners and operators can start ensuring compliance right away or relax and take a deep breath knowing they’re ahead of schedule.

In March 2024, Rhode Island introduced S 2870, the Medical Spa Safety Act, providing (under the definition of “aesthetic medical procedure”) that:

• The provision of aesthetic medicine services is the practice of medicine and surgery; AND
• Cosmetic medical services may be provided by a qualified, licensed, or certified non-physician physician only when the services have been delegated by the medical director, supervising physician, supervising physician assistant (PA), or advanced practice nurse practitioner (APRN) who is responsible for on-site supervision of services performed.

Rhode Island legislation, which would add Chapter 100 to Title 23 of the General Laws entitled Health and Safety, would require that all cosmetic medical procedures – defined as medical procedures or treatments that alter or transform normal body structures or remove/remove living organisms from tissues in to improve physical appearance – can only be performed in a licensed medical spa. The regulations also state that some of these procedures (e.g., using ablative lasers) can only be performed by physicians or by others under the direction of the local medical director.

23-100-2 Patient protection in a medical spa: specifics

Protections under Rhode Island law include provisions relating to:

Medical Directors. Each health resort appoints a medical director, who is:

• Trained in the indications and performance of aesthetic medicine treatments, including all medical devices or instruments that may alter or cause biological changes or damage to the skin or subcutaneous tissue;
• Responsible for implementing policies and procedures to ensure quality of patient care;
• Responsible for delegating and supervising cosmetic treatments;
• Responsible for developing and maintaining written office protocols for each cosmetic medical procedure (protocols must be maintained on-site at the medical spa for review and/or inspection by the Rhode Island Department of Health);
• Responsible for the supervision of all cosmetic medical procedures performed by physicians, PARNs, APRNs and non-physician practitioners; AND
• Responsible for ensuring that supervising physicians, PAs, APRNs and others are appropriately trained to safely and effectively perform all cosmetic and medical procedures performed at the medical spa.
• The medical director is also responsible for reporting any complications to the Rhode Island Department of Health.

Supervising Physicians, PA, APRN. Those who perform aesthetic medicine procedures or supervise aesthetic medicine procedures ordered and performed by a non-physician, non-PA or non-APRN should be trained in the indications and method of performing the aesthetic medicine procedure. An APRN performing or supervising aesthetic medicine procedures should be accredited by the State Chamber of Nursing. Supervising physicians, paying agencies, or APRNs should:

• Perform an initial patient assessment;
• Prepare a written treatment plan for each patient that includes, where appropriate, the diagnosis, course of treatment and specifications of each device used;
• Obtain patient consent if aesthetic procedures are performed by a non-physician, non-PA, or non-APRN, documenting credentials and names; AND
• Creating and maintaining medical records in a manner consistent with applicable laws and regulations and accepted medical practice.

Non-physicians, non-PAs, and non-APRNs. He only performs aesthetic medicine treatments:

• For this they have the necessary training; AND
• That have been assigned to them by their attending physician, PA or APRN.

All suppliers. When performing your duties in the field of aesthetic medicine treatments:

• Review and follow written protocols for each assigned cosmetic medical procedure;
• Verify that the attending physician, PA, or APRN has evaluated the patient and provided written treatment instructions;
• Discuss the cosmetic medical procedure with each patient;
• Notify the medical director, supervising physician, PA, or APRN before leaving the hospital or after the patient becomes aware of any adverse events or complications, monitoring the patient after the procedure as appropriate;
• Document all relevant details of the cosmetic procedure performed;
• Meet all licensing authority requirements.

To go

State regulations in this area remain sparse, but these issues remain a focus of attention for state regulators. Connecticut’s Medical Spa Act, CGSA § 19a-903c, requires a licensed physician, PA or APRN, whether employed or contracted, with education, training and experience to perform aesthetic medicine treatments; these people must complete an in-person physical assessment at the spa prior to treatment. Other requirements apply to posting information/notices regarding individuals and their qualifications.

The Tennessee Board of Medical Examiners maintains an online registry of medical spas in accordance with the requirements of TCA § 63-6-105 – including any medical offices that advertise or hold themselves out to be medical spas, or medical offices that are primarily engaged in the provision of elective medical spas. services in the field of aesthetic medicine. Tennessee also has a Cosmetic Medical Procedures Patient Safety Act, TCA § 63-1-153, which is mainly limited to labeling; the law requires any entity conducting business or advertising itself as a medical spa to include the name of its medical director or attending physician along with its certificates (or lack thereof).

Even Rhode Island’s S 2870 may not succeed. On April 23, the state Health and Human Services Commission recommended the measure be retained for further study, and the state’s regular session ends on June 30. However, Rhode Island legislation shows an increase in states’ interest in overseeing medical spas.

However, as we mentioned in our last post, laws and regulations surrounding the healthcare industry, including medical spas, are constantly evolving. The applicability of these laws and regulations to medical spas should be analyzed on a case-by-case basis. If you are considering opening or investing in a spa practice, you should consult with a health care attorney to ensure compliance with state regulations.

Read Part I here