Medical Spa Lawyers
Medical spa legal issues have come into focus as a distinct set of liability and regulatory enforcement concerns, as the health, wellness, and beauty driven culture has resulted in an explosion of opportunity for med-spa businesses. Consult with our med spa lawyers today!
Legal Issues Unique to Medical Spas
Medical spas are unique in the way they combine aspects of aesthetic medicine and cosmetic medicine with the non-medical modalities of the traditional day spa. As such, medical spas tend to attract strong, heavy-hitting regulatory enforcement, and the physicians who work with medical spas can easily come under scrutiny.
In The Bottom Line: The Business of Medicine – Medical Spas, the California Medical Board warns:
There has been an explosion of cosmetic medicine over the past few years, and many physicians are being approached to “increase their bottom line” by entering into this lucrative field….
This business is offering the opportunity for physicians, for a fee, to rent their license to a business so that the business may engage in the practice of medicine — a profession for which it has no license or qualifications. Is what this business proposes legal? Can physician s simply sign-on, lend their names on paper to a salon or spa, collect “up to” $400 a month, and escape any liability or responsibility for the patients treated by the business? NO!
Like integrative clinical care centers and multi-disciplinary clinical practices (for example, practices utilizing a medical doctor and a chiropractor), medical spas raise unique legal issues when different healthcare providers are under a common umbrella.
Legal concerns include:
- Corporate practice of medicine
- Informed Consent Practices
- Laws governing advertising and marketing
- Law of unfair competition and unfair business practices
- Laws relating to the use of lasers and laser therapies
- Legal rules governing prescription of controlled substances
- Negligence (Malpractice)
- Physician assistant scope of practice
- Prescriptive devices
- Standardized procedures and regulatory requirements for documentation
- Supervision and delegation of procedures to allied health professionals
- The “good faith exam” (or appropriate prior exam)
Medical spa arrangements typically require regulatory review to ensure compliance with relevant legal rules.
As the Medical Board of California states:
The current environment gives rise to violations of the laws governing the business of medical practices, including violations of the corporate practice prohibitions, as well as fee-splitting and payment for referrals. The illegal business models give rise to the use of unlicensed or inappropriately licensed personnel, paper-only supervision (“rent-a-license”) of allied health professionals, consumer confusion over the medical nature of the procedures, and confusion over who is responsible for the patient. Patients are not fully informed of the risks and often do not know the medical nature of the treatments or who is responsible for their care.
Medical boards—in California and other states—as well as other prosecutorial authorities have stepped up enforcement activities against medical spas.
While most of our clients come to us for preventative advice, we have assisted clients who were raised by enforcement agents, on the weekend – and heard stories of computers being carted away, medical spas being shut down, and even of staff being handcuffed and told lay face-down on the floor. Medical spas require legal advice and a compliance review as the regulatory environment can be treacherous.
In addition, medical spas can face liability risk from a variety of fronts. One of our clients, for example, received a cease-and-desist letter from a former employer. The demand letter from the attorney cited not only the usual misappropriation claims, but also alleged that our client had been operating illegally, including by engaging in the unlicensed practice of medicine. Many medical spa owners are lured by the profitability of medical spa treatments and less than fully informed about the attendant legal and regulatory risks they have to monitor and manage.
Transactional Documents & Legal Issues for the Medical Spa
In addition to a regulatory compliance review and counsel, our medical spa lawyers can draft or review:
- Board of Equalization or Sales Tax Issues
- Clinical Protocols
- DEA Issues (Controlled Substances)
- Delegation of Services Agreement (to the Physician Assistant)
- Financing and Financial Responsibility Forms
- HIPAA and HITECH
- Business Associate Agreement
- Notice of Privacy Practices
- Other Compliant Forms
- Informed Consent
- Aesthetic Medicine Informed Consent
- Botox Informed Consent
- Microdermabrasion Informed Consent
- Cosmetic Laser Informed Consent
- Management Agreement
- Medical Director Arrangement
- Medical Records
- Nurse Practitioner Written Collaboration Agreement
- Nutrition Notice
- Practice Forms and Disclosures
- Other Legal Documents for a Medi-Spa
Informed Consent Forms
Whether we represent the medical spa that is gathering work product on behalf of the physician, or the physician who will be working with the medical spa, our lawyers can draft informed consent forms for the client’s practice.
Our informed consent forms typically will address:
- Benefits of Therapeutic Modality
- Regarding Level of Medical Acceptance
- Regarding Necessary Supplemental Approaches (for example, diet and exercise as part of a weight loss program)
- FDA Approval (devices; supplements; approaches)
- Distinction Between Primary Care and Specialist (CAM) Care
- Assumption of Risk Language
- Risks and Complications
- Claims; Guarantees
The informed consent form represents one item in a checklist of medical spa compliance action steps.
Medical Spas Are Under Legal and Regulatory Fire
As mentioned, medical spas are under legal and regulatory fire and medical spa owners often underestimate the dangers.
Quoting the California Medical Board again, from Medical Spas – What You Need to Know:
Medical spa. It sounds so soothing. It evokes images of candles, beautiful music, warmth and pampering. Spahhhh! The words alone can make one relax.
Medical spas are marketing vehicles for medical procedures. If they are offering medical procedures, they must be owned by physicians. The use of the term “medical spa” is for advertising purposes to make the procedures seem more appealing. In reality, however, it is the practice of medicine.
There is no harm in seeking pampering or in wanting to look better. A visit to a spa may provide a needed respite from our stressful lives, and treatments that make us look better often make us feel better. The Medical Board, however, is concerned when medicine is being marketed like a pedicure, and consumers are led to believe that being injected, lasered, and resurfaced requires no more thought than changing hair color.
Medical treatments should be performed by medical professionals only. There is risk to any procedure, however minor, and consumers should be aware of those risks. While it is illegal for unlicensed personnel to provide these types of treatments, consumers should be aware that some persons and firms are operating illegally. Cosmetologists, while licensed professionals and highly qualified in superficial treatments such as facials and microdermabrasion, may never inject the skin, use lasers, or perform medical-level dermabrasion or skin peels. Those types of treatments must be performed by qualified medical personnel. In California, that means a physician, or a registered nurse or physician assistant under the supervision of a physician.
The medical board, in Bottom Line, also emphasizes issues of ownership and control of the medical spa business:
California law prohibits the corporate practice of medicine. Laypersons or lay entities may not own any part of a medical practice. (Business & Professions Code Section 2400). Physicians must either own the practice, or must be employed or contracted by a physician-owned practice or a medical corporation. (The majority of stock in a medical corporation must be owned by California licensed physicians, with no more than 49% owned by other licensed health care professionals, such as nurses, physician assistants, nurse practitioners, etc. No stock in a medical corporation may be owned by a lay-person. (Corporation Code Section 13401.5(a)) In an attempt to circumvent this legal prohibition, some creative business and management schemes have emerged that violate the law. Businesses that provide management services, franchises or other models that result in any unlicensed person or entity influencing or making medical decisions are in violation of the law.
Our medical spa lawyers have counseled many medical spa owners, and physicians contracting with medical spas, with a keen awareness of medical board enforcement. Many medical doctors get into business owners, without understanding the legal and regulatory dangers; and likewise medical spa owners insufficiently appreciate some of the legal barriers relating to business arrangements with medical doctors.
We understand the interlocking layers of law and levels of legal protection that can help lessen the prospect of enforcement dangers. Our med spa lawyers help clients—whether physicians or medical spa entrepreneurs—sort through their legal options so they can secure their intellectual property rights, make proper agreements, reduce the possibility of unnecessary investigation, and mitigate enforcement and liability risk in the medical spa enterprise.
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Medical spas and integrative care centers can often benefit from management services models to structure arrangements in light of Stark, anti-kickback and fee-splitting legal rules.
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