By Patrick O’Brien, JD, General Counsel, American Med Spa Association (AmSpa)

With the great popularity of weight loss treatments using GLP-1 receptor agonists such as semaglutide, AmSpa has received a number of questions regarding what rules to follow in offering these treatments. Although a few states do have rules on appropriate practice for weight loss treatments, for the most part, states do not have special rules on policies and procedures for specific medications (controlled substances being the major exception). However, that doesn’t mean that there aren’t any rules involved. These are still FDA-approved drugs requiring a prescription to provide to a patient, and licensed prescribers—such as physicians, physician assistants (PAs) and advanced practice registered nurses (APRNs)—must still adhere to their professional ethical obligations and the standard of practice for their profession. Here is the basic framework for providing weight loss medical treatments.

In general, a prescriber-patient relationship must be established, the prescriber must perform an appropriate examination of the patient (commonly called a good faith exam), and then the prescriber must develop a diagnosis of the patient’s condition and order an appropriate treatment. After the patient has given their informed consent to the treatment, the actual provision of the treatment can usually be delegated to others.

Licensed health care professionals owe a special duty to those they have undertaken to treat. This special duty applies when certain elements are met and a prescriber-patient relationship is established. The rules on what elements are needed vary between states, but, in general, there needs to be a person seeking health care and a health care provider who agrees to treat the person. This may seem obvious, but it is critical to understand that if the physician, APRN or PA has never met or interacted with the person in a sufficient way, they can’t prescribe them treatments or medication.

We next have to consider the good faith exam. It is important to understand that “good faith exam” is jargon; it’s a term for the larger patient assessment/examination concept that is present in all states. At this step, the practitioner owes this special duty to the patient and must gather pertinent data and evidence about the patient’s condition. This can and should include taking a medical history and assessing the patient’s current physical state. It also should include any tests or diagnostic procedures, including blood work, that are appropriate to get a more complete picture of the patient’s condition. Again, this may seem obvious, but is also critical to the treatment process. If the patient is seeking treatment for obesity, the methods selected to treat them could be different if they also have liver, kidney or other endocrine issues, or if their body composition warrants a certain treatment. To put it another way, would it be appropriate to give penicillin to someone without first checking to see if they had an allergy?

Most states allow physicians and other health professionals to provide services remotely via telehealth or telemedicine. Of course, requirements differ between states, but most require that telehealth services meet the same standard of care as in-person services. So, if there is a test or measurement or observation that is appropriate if the patient was being seen in-office, it is likely that will need to be adequately replicated when using an audio/video telehealth system.

Now that evidence and data about the patient and their symptoms have been gathered, the practitioners bring their professional training, knowledge and judgement to bear by diagnosing the patient’s condition and considering appropriate methods of treatment. While conceptually this is a discrete step, it is often overlooked or lumped in with other parts of the process. In practice, this makes complete sense, as we naturally form an early hypothesis and then refine and test that hypothesis through the observation and testing stage before drawing a conclusion (the diagnosis).

For weight loss treatments, the patient may come in with an expressed desire to start semaglutide treatment to lose weight, and that may initially appear like a viable option. But, at this point, this is just a theory or hunch—not enough to base a professional judgement on. However, with a review of their medical history, examination of their current state of health, and search for indications and contraindications, there is a concrete basis to determine what the patient’s condition is and if they may be helped by this semaglutide treatment. With that, the practitioner can discuss the risks of the treatment with the patient and obtain their informed consent.

Once all the above steps have been taken. the actual rendering of the treatment—i.e., injecting the medicine—can likely be delegated to a trained staff member. State rules vary on what licensing and training is needed for this person and the rules under which they may perform the task. Some states limit administering medications to only licensed registered nurses (RNs) or practical/vocational nurses (LPNs/LVNs), but many states allow unlicensed medical assistants to perform this task, as well. All states require that the delegated person act under the supervision of the prescribing practitioner and may additionally need to be guided by standardized procedures or protocols if the practitioner is not present. Additionally, many states require that prescribers provide the option of issuing a written or electronic prescription as an alternative to directly administering the medication. State rules usually favor patient choice on filling prescriptions and dislike requiring they be locked into any one source.

While specific state rules governing these treatments are rare, they do exist and are important for practitioners to be aware of. For example, the Florida Board of Medicine has rules on prescription obesity treatments. Under these, the physician, PA or APRN must perform an initial evaluation that includes a physical and complete history, tests related to medical treatment for weight loss, and medical referrals as indicated by the physical examination, history and testing. Re-evaluations are needed every three months. Practitioners may only prescribe medication for weight loss if the patient has a body mass index (BMI) over 30 or a BMI of 27 or above and at least one comorbidity. The patient’s informed consent must be obtained prior to prescribing treatment. There are additional rules about what types of drugs are permitted, advertising standards, and notices and documentation.

In essence, offering medication-assisted weight loss, such as semaglutide, is not all that different from treating a patient’s condition with any other prescription medication. Likewise, it is important not to skip over the requirements, steps and standards needed in prescribing these medications. This is especially true because of the ubiquity of the symptoms. Nearly everyone wishes they could lose a few pounds or be slimmer. But, even with extremely common conditions the physicians, PAs, and APRNs must still adhere to their professional duties and responsibilities when treating patients.

Compliance issues such as these are covered in detail at AmSpa’s Medical Spa Boot Camps. Make plans to attend one today.

Discover more about compounding pharmacies, legal issues at play and prescriber perspectives when you visit AmSpa’s Medical Aesthetic Semaglutide Resource Center at https://americanmedspa.org/med-spa-semaglutides.