This article was co-authored by Julia Cantu of Marti Law Group.
The patient journey into any medical practice begins with an initial exam, more commonly known as the “Good Faith Exam” (or “GFE”). This is the initial consultation a person will have with their medical provider to establish the provider-patient relationship before treatment begins, and unsurprisingly, it is a critical first step to ensuring compliance within your practice. During this examination, a medical professional gathers information from a patient about their medical history, pre-existing conditions, lifestyle, and expectations for the procedure(s) to be performed. Generally, this initial consultation must be conducted by a physician, nurse practitioner (NP) or physician assistant (PA). Knowing the “who,” “what," “when” and “where” of a proper GFE is essential to patient safety, minimizing risk of complications, and ensuring legal compliance. In this article we explore the factors that contribute to confusion around GFE requirements and how to mitigate your exposure.
Increase in Demand for Medical Aesthetics Visits
The exponential rise in annual visits for minimally invasive facial enhancements in recent years is unprecedented. From the years 2000 to 2010, dermatology, plastic surgery and aesthetic practices saw approximately 140,000 annual visits for dermal fillers and 440,000 annual visits for neurotoxins.[1] This number skyrocketed to over 2.7 million visits annually for dermal fillers and 7.7 million visits annually for botulinum toxin in 2019 alone.[2] The industry saw another marked increase after the Covid-19 pandemic, when the world sat staring at itself on Zoom, forcing millions of people to seek revitalizing facial treatment.
While the spike in demand for aesthetic services created an expanded marketplace for new patients, products and techniques, these developments also meant an increased risk of complications. As a slew of new providers entered the aesthetics space, an increase in the occurrence of adverse events resulted. Compounding the issue was strenuous time constraints placed upon providers to squeeze in more and more patients. This shortening of appointment time meant that the GFE went from a thorough one-on-one evaluation to merely popping into the room to say hello and running to the next patient. This was a recipe for disaster, as board complaints exploded, causing some states to initiate a witch hunt for non-compliant practices.
Ambiguity of Regulations
It probably goes without saying, but regulations in the aesthetics space vary widely across the country and are constantly evolving, thus contributing to the risk of non-compliance. As noted above, the option of who can perform the GFE will vary by state. In some instances, the physician/NP/PA may be able to delegate certain tasks to registered nurses (RNs), aestheticians or medical assistants. But it is important to remember that the spirit of the initial consultation is for the lead provider to establish the patient’s candidacy for treatments. Whether resulting from a patient complaint or an anonymous call from a disgruntled employee or competitor, almost every medical board investigation will begin with an analysis of the GFE protocols. Oftentimes, an aesthetics practice that can show compliance with GFE requirements can escape major scrutiny from medical boards or at least minimize penalties.
Setting Restrictions and Telehealth
In healthcare, a “setting” refers to the physical space where treatment is rendered (think: hospitals, medspa treatment rooms, etc). In the context of GFEs, setting requirements again vary by state. Though “telemedicine” or “telehealth” existed prior to the global pandemic, Covid-19 opened the floodgates for telehealth treatment, including the potential for a provider to perform a "virtual" GFE. During the pandemic, forty-one states permitted waivers of telehealth regulations, though most were rescinded after the public health emergency ended.[3] However, during that time, many providers took advantage of the loosened regulations and obtained licenses in most or all fifty states. This undoubtedly left its mark on the operations of medical spas, as patients and providers alike experienced the convenience of virtual appointments for the GFE.
While many states still allow for a form of virtual GFE, like anything else in medical aesthetics law, the devil is in the details. Some jurisdictions restrict the setting in which a patient or provider (or both) must be located in order to establish the patient-physician relationship. At the time of publication of this article, Alabama, Mississippi, Missouri, South Carolina and Georgia require the physician to be located within state lines to act as a Medical Director, which generally includes administering the GFE. Other states hone in on the modalities that can be used to establish such a relationship (e.g., telephone versus two-way audio and video technology).[4] While virtual appointments have transformed the patient capacity a practice can sustain, practice owners must always keep an eye towards compliance to ensure that that GFEs are being given the proper attention they require.
So, What Must You Do?
Regardless of your particular practice’s approach and your geographic location, the key is to err on the side of caution (sorry, but we’re lawyers after all!). Having clearly articulated protocols for the GFE, including treatment and telehealth (if applicable) consent is key to passing the medical board GFE smell test. At a minimum, your GFE protocols must ensure: (i) the proper medical provider is conducting the GFE, (ii) a reasonable amount of time is allocated to the visit so that the patient feels thoroughly informed and the practice can fully understand pre-existing conditions and analyze potential contraindications, (iii) intake and consent forms are complete, and (iv) chart notes reflect medical conditions and the patient’s eligibilty to receive treatment.[5] A thorough GFE must generally occur only at the initial visit unless the patient’s health status has changed. However, in many states, an existing patient with no changes in health status must still receive an updated GFE at least annually.
Much the same way that a Medical Director holds the ultimate liability for failure for non-compliance (on behalf of themselves or any of the allied health professionals in which they oversee), so too does the lead provider who is responsible for fulfilling the GFE duties. As the old adage states, the best defense is a good offense. In other words, arming yourself with ample malpractice insurance and more consent forms than you know what to do with will help to minimize exposure. Our law firm has rolled out a robust Membership Plan to help medspas and aesthetic practices chip away at the many segments of an aesthetics business that could result in exposure. A deep review of your intake processes and procedures will help to ensure long-term success with (hopefully) minimal headaches. Give us a call at (860) 552-7770 or email info@martilawgroup.com to learn more about how we can help keep you protected and legally-compliant.
[1] American Society of Plastic Surgeons (2020). [2] American Society of Plastic Surgeons (2020). [3] Federation of State Medical Boards, U.S. States and Territories Modifying Requirements for Telehealth in Response to COVID-19 (last updated May 24, 2023) [4] Id. [5] Note that this is not an exhaustive list and you must consult your state regulations to ensure total compliance.
コメント