Frier Levitt has recently become aware that healthcare providers have received warning letters from insurance companies questioning the legality of “off-label” prescribing of specific diabetes medications that are now being prescribed regularly for weight-loss. These warning letters from insurers include threats to report suspected inappropriate or fraudulent activity to federal or state law enforcement agencies or a provider’s state licensing board for further action against the provider.
To be clear – prescribing medication for an off-label use is not inherently illegal or unethical, and is a common occurrence in the practice of medicine, generally providing immense benefits for patients who may not otherwise have available treatment options. However, providers who regularly prescribe medications for off-label use must be vigilant in two key areas:
- Navigating Insurance Coverage Restrictions: While an off-label use of a medication may be beneficial to a patient, insurers may restrict coverage of certain medications to their “on-label” use. Healthcare providers frequently communicate patient’s diagnostic criteria for the use of the prescribed medications to insurers. These representations are made on an insurer’s pre-authorization form, on claims/billing forms, or even in a provider or staff member’s conversation with an insurance company representative. Any representation that a patient meets criteria for on-label use of a medication, if untrue or unsupported, exposes that provider to potential claims of insurance fraud which can lead to civil and criminal penalties under state or federal laws.
- Complying with State Licensing Regulations: In some states, state licensing board laws or regulations place additional requirements on providers when prescribing certain medications for off-label use. These regulations may encompass general requirements or targeted requirements for particular medications. Non-adherence to these regulations by the provider can result in a violation of state licensure requirements and potential action against the provider’s license.
For example, the New Jersey Board of Medical Examiners has long-standing regulations – New Jersey Administrative Code (N.J.A.C.) §13:35-7.5A – requiring physicians to take certain actions prior to or in concert with the prescribing of obesity medications. Under the state Board of Medical Examiners regulations, any licensed provider must prescribe, order, dispense, or administer obesity medications in accordance with specific requirements, including:
- Taking a complete history of the patient, conducting a comprehensive physical examination, and ordering or performing any laboratory and/or diagnostic tests as indicated by the clinical evaluation to determine the existence of any co-morbidities and if the use of any prescription medication is contraindicated. This process should include the assessment of the possible existence of any psychiatric or psychological condition;
- Providing nutritional counseling, recommendations for behavior modification, and appropriate exercise for weight loss;
- Obtaining informed consent from the patient before prescribing, ordering, dispensing, administering any such medications and indicating the risks associated with such use; and
- Monitoring the progress of the patient’s weight loss or gain via follow-up visits by conducting a physical examination, performing laboratory tests as indicated by the clinical evaluation, and documenting all findings of the physical examination in the patient record.
Importantly, the required actions taken by the provider pursuant to N.J.A.C. 13:35-7.5A must be contained in the patient’s medical record.
Healthcare providers who prescribe medications for off-label weight loss purposes should be mindful of the recent actions by insurers, and have a thorough understanding of any state licensing regulations, such as those exemplified in New Jersey.
Frier Levitt is a national healthcare law firm providing regulatory guidance and defense across all aspects of a healthcare provider’s practice. We are well-equipped to guide your practice in proactively addressing any regulatory requirements while ensuring compliance. Frier Levitt has vast experience in providing counsel and defending providers against any actions pursued by insurers or state enforcement bodies. Please contact Frier Levitt for a consultation.
