Prescribing weight loss drugs? Better make sure it's covered by your malpractice policy

A considerable rise in the public demand for weight loss drugs such as Ozempic and Wegovy has created a supply shortage, prompting many physicians to prescribe generic compounded semaglutide, which contains the active ingredient found in the brand-name versions. These non-FDA-approved alternatives are not covered by medical malpractice insurance and pose a great liability risk for the prescribers.

As a specialized medical malpractice broker, I am focused on protecting my physician and surgeon clients from the imminent surge of weight loss drug-related malpractice claims. In this article, we will explore liability risks related to glucagon-like peptide-1 (GLP-1) medications like Ozempic and present an action plan for surgeons to protect themselves against malpractice litigation.

What are the liability risks associated with GLP-1s?

The use of GLP-1 semaglutide can lead to side effects and adverse drug events for patients, including gallbladder disease and permanent conditions like gastroparesis. The risk profile tied to weight loss drugs is clearer as details emerge from the class action suit against the manufacturer. This lawsuit claims that the manufacturer failed to honor its legal obligation to adequately inform consumers about the potential health risks associated with the drug.

Physicians who prescribe weight loss drugs are also vulnerable to legal action.

Healthcare providers have a legal responsibility to exercise due diligence and adhere to the standards of care before recommending a drug to patients. A prescribing physician could face liability if they fail to adequately collect a patient's medical history or accurately assess their personalized risk of experiencing adverse reactions to the medication. Also, a patient would have grounds for a claim if the physician failed to effectively communicate the benefits and risks of the drug before obtaining consent for the treatment plan.

Widespread off-label drug use (OLDU) of semaglutide complicates risk factors.

While OLDU is quite common across most fields of medicine, the practice carries a certain degree of built-in risk for physicians since OLDU treatment plans deviate from the FDA-approved usage model. GLP-1 medications like Ozempic only have FDA approval for the treatment of diabetes, so prescribing semaglutide to help patients achieve weight loss is considered off-label drug use (OLDU). A recent report found that only 50% of patients who take Ozempic have diabetes indicating that the other half of prescriptions are used to treat off-label indications such as obesity.

How does the popularity of GLP-1 medications affect specialty surgeons?

Specialty surgeons often address medical conditions for which obesity is a contributing factor or comorbidity. In an obstetrics and gynecology setting, 90% of OBGYN surgeons regularly counsel patients on obesity to help address common fertility and pregnancy complications. GLP-1s provide surgeons with a viable option for treating obesity and potentially enhancing the safety and efficacy of surgical care.

According to the American Academy of Orthopaedic Surgeons, obesity increases a person’s risk of experiencing surgical complications and difficulty during recovery. In 2023, roughly 16% of bariatric surgery patients were prescribed GLP-1 medications as an adjunctive treatment alongside surgery, demonstrating its effectiveness in improving the long-term results of these surgical procedures.

How can surgeons reduce the liability risk of prescribing GLP-1s?

• Understand the exact terms of your insurance policy.
  Consult with your broker to confirm that your malpractice insurance provides coverage for GLP-1s. In most cases, any FDA-approved medications are covered, but some policies exclude weight loss services by default. This distinction becomes especially important for off-label treatment plans when there is no patient history of diabetes, the only FDA-approved indication for semaglutide.
• Determine how patient Body Mass Index (BMI) affects coverage.
  Some insurance carriers only cover weight loss medication for patients with qualifying BMIs. It’s also possible to lose coverage once the patient’s BMI falls below the overweight or obese threshold. Before starting treatment, understand how changes to the patient’s BMI during treatment will affect coverage status.
• Maintain meticulous patient records.
  Rigorous documentation can deter lawyers from submitting a malpractice claim whereas minimal documentation will undermine a physician’s ability to defend a treatment plan. Inaccurate or insufficient records play a role in 10-20% of medical malpractice suits.
  
  To minimize liability and fulfill the legal obligation of due diligence:
  • Outline the decision-making process for prescribing a GLP-1.
  • Demonstrate the process of obtaining informed consent from the patient.
  • Explain the methods used to ascertain a comprehensive medical history.
  • Discuss alternative treatment plans or lifestyle recommendations
• Err on the side of overcommunication.
  Provide thorough patient communication before, during, and after prescribing semaglutide to reduce the risk of being named in a malpractice claim. Insufficient or unclear provider-to-patient communication frequently causes malpractice claims. Conversely, strong patient rapport decreases the possibility of malpractice claims.
• Ensure proper training for yourself and your staff.
  Stay up-to-date on weight loss medication data and evidence-based best practices to maintain due care. Make sure that anyone on your team with prescribing privileges, such as NPs and PAs, practices within the scope of their training and follows medication-related processes to safeguard against the delivery of substandard care.

Minimize risk through patient referrals.

Making the recommendation for a patient to seek weight management care from a more specialized provider demonstrates strong due diligence and can effectively mitigate risk. Staying within your area of expertise is usually the safest route. Clear referral protocols and proactive communication during the handoff phase can help surgeons maintain a claims-free record.

In conclusion

GLP-1 drugs like Ozempic and Saxenda provide surgeons with an operational method to treat patients with obesity, a leading cause of preventable death in our country. Following the strategies outlined in this article can help limit a surgeon’s degree of liability when prescribing semaglutide. Communicating with your medical malpractice broker and carefully reviewing your insurance policy can help mitigate the liability risk for medication-related malpractice.

Max Schloemann is the founder of MEDPLI Professional Liability Insurance