Legal Guidelines for Functional Medicine Practices: Navigating Regulations and Compliance

As more individuals pursue personalized, holistic healthcare, the functional medicine field is gaining traction. Yet providing care in this evolving space can come with legal complexities. This is primarily because the laws that govern healthcare in the U.S. are made at both the federal and state levels. While federally set standards, such as those found in the Affordable Care Act, apply to all states, much of the functional medicine legal landscape is painted with the brush of state law. And here the picture can vary widely. Both the laws in different states and the informed consent decisions that different groups of practitioners make can—and do—lead to different legal outcomes.

Understanding Scope of Practice Regulations

Every state has individual laws that define what services healthcare providers can offer based on their credentials. These scope-of-practice laws tell us what kind of procedures and treatments professionals like naturopathic doctors, nurse practitioners, and physicians are allowed to perform. For more information, visit https://www.ama-assn.org/practice-management/scope-practice/what-scope-practice.

It’s essential to work within the legal confines of your license. Practicing outside your authorized scope—like a prescriptive authority, for example—can land you in serious trouble: fines, for one thing; and suspension or even revocation of your license, for another. Even if you’re trying to do the right thing by documenting your qualifications to practice in a “specialty” area, you could still end up with a black mark on your record—like a naturopathic doctor in limited-prescriptive-authority state recently did, when he was found to have prescribed a controlled substance—if you haven’t really got the legal “go ahead” to be doing what you’re doing.

Managing Informed Consent in Functional Medicine

The fundamental legal protection is informed consent, especially in functional medicine, where the treatments may involve therapies that are not traditional. Forms for consent should explain in detail the kinds of treatments that are being proposed. Consent forms should be clear and should help make the patient the primary decision-maker. To that end, AMA’s website nicely summarizes and gives several practical examples of the kinds of things that might be covered in “consent” in this functional medicine space.

When treatments involve experimental or off-label therapies, it’s necessary to tell the patient about these particulars and to obtain consent. Furthermore, because consent is an “up-front” process, it shouldn’t be considered something that’s done once and then forgotten. Patients should be kept in the loop and made aware of any significant changes to their treatment plans. Experimental (and off-label) therapies taken together can amount to what could be seen legally as a large red flag, but if consent is obtained and the reasons (along with the risks) for going this route are well-documented, then the provider in this case has a much better chance of emerging legally unscathed.

Licensing and Multistate Practice Considerations

Numerous functional medicine practitioners provide telemedicine services or treat patients who reside in different states, making it crucial for them to comply with the myriad of state licensing requirements. Some states allow out-of-state telemedicine services, while others require the provider to be in possession of an in-state license before treating any patient remotely. For a detailed rundown of which states require what, check out “Telemedicine Licensure Policies by State,” located on the Federation of State Medical Boards website.

The streamlined process of the Interstate Medical Licensure Compact (IMLC) allows physicians to practice in multiple states. Non-physician providers could have a more strenuous climb to set up a diverse interstate practice.

Why? Because ensuring compliance isn’t just a best practice; it’s a necessity as demanding and obdurate as the interstate highway system itself. And the path to compliance—federal, state, and sector-specific guidelines for licensure and more—that’s where the real work lies. Pave that path successfully, and you can widen your patient base with almost as much accessibility as the telecommunication towers that make FDA-compliant telehealth possible.

Compliance with Dietary Supplement and Off-Label Therapy Regulations

Dietary supplements and off-label therapies are often recommended by functional medicine providers. Both of these categories of health products are regulated by the federal government and by most state governments. However, the regulatory path to the marketplace is very different for supplements and for off-label therapies. Supplements are deemed foods by the federal government. Off-label therapies are deemed drugs. Both are recommended and used by functional medicine providers. So, let’s take a look at the two and their respective regulatory guises in a little more detail.

Practitioners should tell patients when they are recommending therapies that are not used in the way intended—off-label. Patients should know they are using therapies and supplements that are not the usual or typical treatments. The types of information practitioners should tell patients include the following:

• If a supplement has not been shown in studies to work for the condition the patient has.
• Whether the supplement has any shown safety concerns.
• If the clinician has used this supplement with other patients and what happened.

Common Legal Risks and Consequences

Failure to comply with state licensing, scope-of-practice laws, or informed consent standards can lead to disciplinary actions, fines, and complaints from patients. Among the most prevalent legal risks are:

• Violations of the Scope of Practice can result in fines, suspension of licenses, and other disciplinary measures.
• Insufficient Informed Consent: If patients are not adequately informed about their treatment choices, they may lodge complaints or take legal action against their healthcare providers.
• Licensing Problems: Not getting the right licenses can lead to losing licenses or being limited in accessing telemedicine.

Violating FDA supplement regulations occurs when health claims about dietary supplements are made without verification. This problem can result in warning letters and harm to the company’s reputation.

For functional medicine providers to sidestep potential legal trouble and provide top-notch care, they must comply with licensing, scope-of-practice regulations, and informed consent guidelines. These legal frameworks exist not to bind practitioners but to ensure that patients are cared for safely, effectively, and ethically. To be absolutely certain that your practice is operating in compliance and to understand the many nuanced aspects of this area, consult experts in the legal issues that pertain to your practice—like the healthcare and FDA attorneys at Cohen Healthcare Law Group.