MSOs and Compliance Issues for Anti-Aging Aesthetic Clinics

Anti-Aging Aesthetic Clinics offer various health-related services, often through a medical spa. Numerous federal and state healthcare laws regulate several aspects of these clinics, including:

• Who is authorized to provide these services?
• Whether the services provided are classified as medical services.
• Whether those performing the services may breach unauthorized practice of medicine laws.
• Whether ownership interests constitute the corporate practice of medicine.
• Whether FDA approval is required for any drugs, devices, or procedures.
• The legality of referral arrangements between clinic owners and collaborating doctors.
• Many other related issues.

In this article, we delve into the services offered by anti-aging clinics, highlight key legal compliance concerns, and explore how a Managed Service Organization (MSO) can be employed to address some of these compliance issues.

What is Anti-Aging?

As previously discussed, the more medical term for anti-aging medicine is biogerontology. Anti-aging medicine “focuses on diagnosing, understanding, preventing, and attempting to cure certain age-related impairments.”

Many doctors, physician practices, and healthcare companies in the anti-aging field promote their products and services as capable of extending someone’s life. As with all medical practices, federal and state regulations govern the claims made regarding what products and services can achieve for a patient and the accuracy of promises made to patients. This includes regulations from the FDA and FTC, as well as local and state regulations.

What services do anti-aging aesthetic clinics provide?

Anti-aging aesthetic clinics offer a wide range of services encompassing weight and nutrition services, cosmetic procedures, regenerative medicine treatments, body sculpting services, and anti-aging services. Some of these services include:

• Laser and light treatment: Targeting hair follicles to prevent regrowth, used for various body parts, and FDA approval is generally required. Applications include hair removal, skin pigmentation correction, treatment of spider veins, acne, facial rejuvenation, and toenail fungus.
• Cosmetic services: Encompassing Botox, dermal fillers, microdermabrasion, chemical peels, Vampire facials, skin tightening, skin rejuvenation, facials, scar treatments, and various other procedures.
• Waxing: A procedure using strip wax to remove hair from the root, providing patients with hair-free results for several weeks or even months.
• Hormone replacement therapy: Primarily focusing on replacing estrogen lost after menopause, often used to alleviate symptoms such as hot flashes and vaginal discomfort.
• Regenerative medicine therapies: Including platelet-rich-plasma (PRP) treatment, peptide treatment, stem cell therapies, and other innovative treatments.
• Various body sculpting treatments.
• Wellness counseling.
• Lasik eye surgery.
• 3D-printed organs.
• Many other treatments.

One discussed type of anti-aging/regenerative product is a nutraceutical, often classified by the FDA as dietary supplements, functional foods, medical foods, or farmaceuticals.

FDA regulation of nutraceuticals (and cosmeceuticals, which are a hybrid of cosmetics and pharmaceuticals) generally involves focusing on FDA regulations related to the component parts, which may fall into various categories:

• Cosmetic
• Dietary Supplement
• Drug (prescription (Rx) or over-the-counter (OTC))
• Food
• Medical Device
• Medical Food

Certain hybrid nutraceuticals may require multiple types of FDA approval. For example, a product may need approval both as a drug and as a medical food, highlighting the complex regulatory landscape these products often navigate.

Legal issues for anti-aging practitioners

Our healthcare lawyers routinely address a range of legal issues with physicians, medical spas, and anti-aging facilities, including:

• Federal and state self-referral laws, encompassing Stark Law and the Anti-Kickback Statute.
• Telemedicine issues.
• Unauthorized practice of medicine concerns.
• Determining the necessary medical credentials for each type of anti-aging treatment.
• The responsibility of a doctor employed by the anti-aging entity to supervise non-physicians.
• Corporate practice of medicine laws.
• Duty to supervise.
• Legal issues related to concierge legal practice.
• Medical practice management.
• Patient agreements, including subscription and membership agreements.
• Clarification of advertising and marketing rules governing anti-aging healthcare.
• Numerous other legal compliance and contract issues.

It’s noteworthy that many anti-aging procedures necessitate FDA approval or FDA oversight.

Currently, the American Board of Medical Specialties does not officially recognize “anti-aging” as a medical specialty, despite the existence of its dedicated professional society—the American Academy of Anti-Aging Medicine (A4M) society, founded in 1992.

Moreover, laws are in place to regulate the administration of specific anti-aging products such as Botox®, collagen, and other injections. These laws may specify who is authorized to perform these procedures, often designating individuals like physicians, physician assistants, and nurse practitioners or other limited mid-level practitioners, excluding registered nurses, cosmetologists, or estheticians. The laws may also define terms such as “supervision” and distinguish between “direct” and “indirect” supervision.

How can a Managed Service Organization (MSO) be used to help address some of the legal compliance issues for anti-aging aesthetic clinics?

An MSO assists medical practices by handling the administrative and business aspects while healthcare providers concentrate on the medical side of the practice. MSOs can aid an anti-aging practice in several ways:

• Ensuring compliance with appropriate Stark Law exceptions and AKS safe harbors, including arrangements for renting office space and equipment, physician recruitment, bona fide employment relationships, personal service arrangements, certain hospital agreements, and various other business/medical issues.
• Educating and training the medical staff on compliance training, patient relationships, and related issues.
• Managing medical coding for the submission and processing of medical bills, ensuring compliance with the False Claims Act and other federal and state billing laws.
• Facilitating arrangements to rent office space and equipment based on the Stark Law exception.
• Ensuring compliance with healthcare laws and agencies such as HIPAA, OSHA, FMLA, CLIA, and others.
• Reviewing the licensing and other credentials of medical professionals and staff members.
• Hiring administrative staff and managing the enrollment of all employees and staff.
• Selecting, managing, and entering into contracts for the technology needed by the healthcare practice.
• Handling various financial matters, including procurement, auditing, payroll, benefits, and financial statements.
• Conducting audits.
• Managing scheduling.
• Overseeing marketing and sales.
• Maintaining electronic health records.
• Managing many other aspects of the business side of the medical practice.

As the aging population in America grows, there is an increasing demand for anti-aging services, with individuals seeking ways to maintain their youth. To meet this demand, doctors and health professionals are working diligently. However, it is crucial for these professionals to have a comprehensive understanding of federal and state laws regulating anti-aging clinics. This includes compliance with FDA approval for drugs, procedures, and products, corporate practice of medicine laws, unauthorized practice of medicine laws, and anti-referral laws such as Stark and AKS.

An MSO can assist an anti-aging clinic in navigating and addressing various compliance issues. Physicians and medical practices looking for guidance on anti-aging compliance laws and leveraging the expertise of an MSO to separate the medical and business sides of their practice should consider contacting Cohen Healthcare Law Group. Our experienced healthcare attorneys are available to advise physicians and medical practices on healthcare compliance laws and regulations.