The medical aesthetics industry is constantly evolving, from ingredients and treatments to business and medical regulations. Most recently, the industry has focused on Intravenous (IV) Therapy, analyzing its benefits and risks and discovering ways to make the process safer and more effective. In some cases, there has been a need to clarify that IV therapy is a medical procedure that must be performed by informed and experienced professionals.
On the business side of medicine, there is a new law going into effect in 2024 that will affect most small business owners, enacted in an effort by the federal government to deter financial crimes, specifically money laundering and tax fraud.
Corporate Transparency Act
In 2024, most small business owners, including medical spas, will have a new annual federal requirement to report beneficial ownership information (BOI) to the Financial Crimes Enforcement Network (FinCEN), which is part of the U.S. Department of the Treasury.
The provision is part of the Corporate Transparency Act signed in 2021 to combat financial crimes. The BOI requirement goes into effect on January 1, 2024, per the American Med Spa Association (AmSpa).
While the eligibility rules can be complex, AmSpa is reporting that the general takeaway of the new requirement is that U.S.-based businesses formed by filing documents with a state may be required to report BOI unless the company meets one of the 23 categories of exemptions.
Many of these exemptions will exclude banks, financial institutions, government entities, insurance companies, non-profits and similar highly regulated industries, but will not apply to medical practices or healthcare entities.
Business owners are encouraged to work with their advisors to review the FinCEN resources to determine their own companies' situations. According to FinCEN, failure to file a report may result in civil fines of up to $500 per day, imprisonment of up to two years and/or a fine of up to $10,000.
IV Therapy Guidelines
IV therapy is popular for its ability to administer various vitamins and nutrients needed by the body. With its growing popularity, state medical boards are discovering a need to provide guidelines and recommendations for IV therapy, including who can perform it.
Alabama first issued a definite ruling that sought to provide the clarity needed for IV therapy in November 2022. The ruling clarified different practitioners’ roles in administering IV therapy. Additionally, the ruling addressed core healthcare compliance issues associated with IV therapy that purportedly concerned the Alabama Board of Medical Examiners (BME). Since then, other states have introduced new recommendations and guidelines for the administration of IV therapy.
AmSpa reports that Alabama's ruling clearly defines IV therapy as the practice of medicine that can only be diagnosed through a good faith exam performed by a licensed physician or physician assistant, certified registered nurse practitioner or certified nurse-midwife legally practicing with a physician. The ruling also requires creating a medical record for the patient and issuing a prescription before administering IV therapy.
The Texas Medical Board temporarily suspended the medical license of Luxe Med Spa's medical director, Michael Gallagher, M.D., following the death of a patient after an IV therapy treatment at the Luxe Med Spa in July. The board noted that Gallagher failed to implement policies and procedures, including having no protocols or standard operating procedures (SOPs) for IV services and only having an unsigned medical director agreement that documents the relationship with Luxe.
The owner of the spa who also personally performed the IV treatment, does not hold any medical or health care license, and no other licensed health professionals were present on site, according to the report.
In North Carolina, the state's medical board published an article that uses a case study to analyze compliance issues in the supervision of physician assistants in the state. The board found issues with the supervisory relationships between physicians and their assistants as well as instances of going beyond the supervising physician's scope of practice. The analysis emphasizes the need for the physician to have practical experience in the specific procedure they are supervising.
The trend of states adding more legislation and requirements to IV therapy dictates the significance of training for providers and medical directors in whatever therapies they plan to offer. AmSpa expects more states to follow suit and address any compliance and licensing issues currently happening in medical aesthetics.