Unique Issues for Licensed Clinicians Prescribing Compounded Peptides

By: Jeff Cohen

The use of compounded peptides, particularly GLPs (glucagon-like peptides), presents a complex and nuanced landscape for licensed clinicians. While these treatments offer potential benefits, they are not without risks. Clinicians must navigate a web of regulatory, legal, and ethical challenges, including:

  1. FDA Shortage Declarations and Reversals
    The FDA’s declared shortage of GLPs initially opened the door for the compounded GLP industry. However, in the fall of 2024, the FDA announced the shortage had ended, signaling its intent to curtail the use of compounded GLPs.
  2. Regulatory Pushback on Specific Compounded Peptides
    The FDA has actively urged state medical boards to restrict clinicians from using compounded peptides like retratrutide and cargrilintide.
  3. Legal Actions by Pharmaceutical Giants
    Major pharmaceutical companies, including Eli Lilly and Novo Nordisk, have filed lawsuits against clinical enterprises utilizing compounded GLPs, further complicating the legal landscape.
  4. FDA Category 2 Bulk Drug Substances
    Many popular compounded peptides, such as AOD, BPC-157, and Epitalon, are listed on the FDA’s Category 2 bulk drug substances list, marking them as “suspect” chemicals.
  5. State-Level Regulatory Scrutiny
    Some state regulators are actively investigating and pursuing clinicians who use or recommend compounded peptides, adding another layer of risk.

Licensed clinicians face heightened exposure to these issues simply by virtue of their professional licensure. To navigate this challenging environment, they must take proactive steps to understand and mitigate their risks. Key measures include:

A. Understanding the Legal and Regulatory Landscape
Clinicians should engage in thorough discussions to fully grasp the laws, options, and risks—not just those related to the FDA but also state-level regulations and broader legal implications.

B. Ensuring Comprehensive Professional Liability Coverage
It’s critical to confirm that professional liability insurance includes regulatory defense, not just medical malpractice coverage. The use of compounded peptides can attract scrutiny from both state and federal regulators.

C. Utilizing Tailored Informed Consent
Clinicians should employ highly specific, well-crafted informed consent documents tailored to the peptides they recommend. These documents should clearly outline the risks and regulatory status of the treatments.

D. Verifying Product Quality
Unlike FDA-approved branded products, compounded peptides lack the same level of regulatory oversight. Clinicians must ensure the quality of the products they use and be prepared to counter the perception that their use of compounded products is driven by financial motives.

E. Maintaining Clinical Leadership
Above all, clinicians must apply the same rigorous clinical leadership to the use of compounded peptides as they do to every patient encounter. This includes proper diagnosis, prescribing, treatment, and documentation.

Clinicians interested in prescribing compounded peptides must dedicate the time and effort to thoroughly investigate the associated liability and regulatory nuances. By doing so, they can make informed decisions and implement strategies to mitigate risks. As the old adage goes: Measure twice, cut once.

Informed Consent and Amalgam Restoration Use

By: Carlos Arce

On August 25th, the State Surgeon General issued a statement highlighting the risks associated with the use of dental amalgam in routine fillings, specifically mercury exposure. While this is not a prohibition, it is a clear signal from the state’s top medical authority that dentists should take additional care in how they approach these restorations.

For Florida dentists, this statement has two key implications:

1. Heightened Duty of Disclosure
Patients should be made aware of the potential risks tied to amalgam use. This means engaging in a clear, documented discussion about mercury exposure, alternatives, and the rationale for selecting a specific restorative material. The Surgeon General’s acknowledgment of these risks raises the expectation that providers address them directly.

2. Risk Management and Liability
The best tool to demonstrate that you have fulfilled this duty is a well-drafted informed consent form. While such documents will not shield you from malpractice or negligence claims, they provide critical evidence of disclosure and communication. A consent form should outline the risks of amalgam, note available alternatives, and confirm that the patient had an opportunity to ask questions.

Practical Guidance

  • Review and, if necessary, update your existing consent forms to specifically reference amalgam risks.
  • Incorporate the Surgeon General’s findings into patient conversations, both verbally and in writing.
  • Train staff to reinforce these disclosures consistently across the practice.

Working with an informed consent document is not just a compliance step, it is the gold standard of risk management. It protects the provider by showing proactive disclosure, while also fostering openness and trust with patients.

Breaking Up with Your Employer: What Physicians Need to Know About Terminating Employment Agreements

By: Michelle Caputi

Ending a physician employment agreement is a significant decision that requires careful planning and attention to detail. Whether you’re moving on to a new opportunity, stepping away from clinical practice, or simply seeking a better fit, the way you handle your termination can have lasting effects on your career, reputation, and relationships within the medical community.

Step 1: Review the Termination Provisions

The first step in terminating your physician employment agreement is to carefully review the termination provisions in your contract. These provisions outline the rules and requirements for ending the agreement, including:

· Termination for Cause vs. Without Cause: Most physician contracts allow for termination either “for cause” or “without cause.” Terminating for cause typically involves specific reasons outlined in the contract, such as misconduct or breach of duties. However, this can have serious implications for your future employment and references. Terminating without cause is often the safer route, but it’s important to consult with a healthcare attorney to determine the best approach for your situation.

· Notice Period: Many contracts require a specific notice period before termination. This could range from 30 to 120 days or more. Failing to provide proper notice could result in financial penalties or legal disputes.

Step 2: Understand the Notice Requirements

Once you’ve reviewed the termination provisions, it’s time to focus on the notice requirements. Pay close attention to:

· How to Provide Notice: Your contract may specify how notice must be given—whether it’s in writing, via certified mail, or through another method. Following these instructions to the letter is critical to ensure your termination is valid.

· Timing: Make sure you provide notice within the required timeframe. If you’re planning to terminate without cause, giving ample notice can help maintain goodwill and ensure a smoother transition.

Step 3: Check for Non-Compete Provisions

Non-compete provisions, also known as restrictive covenants, are common in physician employment agreements. These clauses may limit your ability to practice within a certain

geographic area or timeframe after leaving your current employer. Before terminating your agreement, review the non-compete language carefully to understand:

· Scope and Duration: How far does the restriction extend, and for how long? Are there exceptions for certain types of practice or locations?

· Enforceability: Non-compete clauses are subject to state laws, and their enforceability can vary widely. A healthcare attorney can help you assess whether your non-compete is likely to hold up in court.

Step 4: Evaluate Tail Coverage

Tail coverage is a critical consideration when terminating a physician employment agreement. This type of insurance provides protection against malpractice claims that arise after you leave your employer but are related to incidents that occurred during your employment. Key questions to ask include:

· Who Pays for Tail Coverage? Some contracts require the employer to cover the cost, while others place the responsibility on the physician.

· What Are the Costs? Tail coverage can be expensive, so it’s important to budget for this expense if you’re responsible for it.

Step 5: Review Indemnification Language

Indemnification clauses outline how liability is handled during your employment. Before terminating your agreement, review this language to understand:

· Your Coverage: Were you adequately protected during the course of your employment? Are there any lingering liabilities you need to address?

· Post-Termination Obligations: Does the indemnification clause impose any obligations on you after you leave?

Step 6: Consider the Impact of Termination

Terminating your employment agreement is not just a legal and financial decision—it’s also a professional and relational one. Consider the following:

· Future Employment and References: Terminating for cause can raise red flags for future employers and may impact your ability to secure positive references. Whenever possible, lean toward terminating without cause to preserve your professional reputation.

· Community Relationships: Maintaining positive relationships with facilities, medical staff, and colleagues is essential, especially if you plan to continue practicing in the same area. A respectful and professional approach to termination can go a long way in preserving these connections.

Step 7: Consult with a Healthcare Attorney

Terminating a physician employment agreement is a complex process with significant legal and professional implications. Consulting with a healthcare attorney can help you:

· Understand your rights and obligations under the contract.

· Navigate the termination process smoothly and avoid potential disputes.

· Protect your career, reputation, and financial interests.

Ending a physician employment agreement is never a decision to take lightly, but with careful planning and the right guidance, it can be a positive step forward in your career. By reviewing your contract, understanding your obligations, and seeking legal advice, you can ensure a smooth transition and set yourself up for success in your next chapter.

Who can buy into a Dental Practice?

By: Ben Cook Jr., Esq.

The field of dentistry can be a lucrative medical field for those who find a passion in oral health. However, it is also a very highly regulated field of practice, which includes who can and cannot legally own or buy into a dental practice.

In Florida, the law is very clear that only licensed Florida dentists—or business entities made up entirely of licensed Florida dentists—are allowed to own or operate a dental practice. A non-dentist cannot legally buy into or own a dental practice. This prohibition is explicitly laid down by law and can carry serious criminal consequences if violated; violating this law is a third-degree felony that can lead to both professional discipline and criminal charges.

This isn’t just about having your name on the door; it also means that non-dentists are not allowed to have any say in the clinical side of the business. That includes decisions like hiring dentists, deciding how treatment is provided, managing patient records, setting prices, making staffing choices, or even controlling how the practice is marketed.

So, what can a non-dentist do?

Florida does provide legal ways for a non-dentist to be involved in the business side of a dental practice without violating the state’s strict ownership rules; this is done through a structure known as a Practice Management Agreement (PMA), which is commonly used by Dental Service Organizations (DSOs), practice management companies, and similar entities. You may hear these called “Management Service Organizations” (MSOs) and Management Service Agreements (MSAs) in other medical practices, but they essentially do the same thing.

Under a PMA, the licensed dentist remains the sole owner of the dental practice and keeps full control over all clinical decision-making. The non-dentist entity does not touch the clinical side but can provide a range of non-clinical support services. These can include office management, billing, marketing, staffing, accounting, facility logistics, and compliance work. Florida law, specifically the Florida Administrative Code 64B5-17.013(4) and Florida Statute § 466.0285(1), even defines these as “Practice Management Services.”

The key is in how the arrangement is set up. The contract must be carefully drafted to make it clear that only the dentist has authority over professional, medical judgments and clinical operations. If the language is sloppy or gives the non-dentist any real influence over the clinical side, the arrangement can cross into noncompliance.

To put it simply:

· Owning any part of the dental practice itself—even 1%—is not allowed for a non-dentist. The practice must be fully owned and controlled by licensed Florida dentists.

· Providing non-clinical services through a PMA is allowed, but only if the dentist retains full clinical control and the agreement makes that explicit.

If you or your client want to be involved financially or operationally, the safest route is to (1) have the PMA or DSO agreement drafted by an expert attorney who understands Florida dental law, (2) ensure the practice entity is owned exclusively by licensed Florida dentists, (3) state in writing that only the dentist controls all clinical matters, and (4) review the contract regularly to ensure it stays within the legal limits. This is an area where a small misstep can lead to a serious legal problem, and the attorneys at the Florida Healthcare Law Firm can help you through this difficult area of law.