Ozempic, Wegovy, and the New Compliance Risks for Providers



Looking for the latest podcast? Scroll down below to find Episode 4, “Drug Sample Precautions & Safeguards.”

Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for Ozempic, Wegovy, and similar drugs in the last three months of 2022, with prescriptions rising 300% between 2020 and 2022. The report also noted that just over half of patients taking these medications have a history of type 2 diabetes, meaning almost half of users are likely taking the medications for weight loss.

Demand for both Ozempic and Wegovy has outpaced supply, resulting in both medications being increasingly difficult for patients to access, especially patients who have not previously taken them. Patient access is also often limited by cost. The list prices for these medications range from between $900 and $1300 per month, making health insurance coverage of the medications critical for most patients.

The blockbuster popularity of these medications, coupled with these access issues, creates new compliance risks for providers prescribing these medications, warranting increased education, monitoring, and vigilance. As these medications become more popular, pressure from patients for prescriptions will likely increase, as may the pressure for complete documentation of medical necessity and other criteria required by insurers. Practitioners should ensure they examine a patient before writing a prescription, the patient is under their care for the condition, they appropriately document the diagnosis and treatment plan, and the prescription is medically necessary and appropriate for the patient’s condition. If a patient’s insurer limits coverage for these prescriptions, practitioners should consider the insurance coverage requirements and whether patients meet the criteria for coverage. 

If a patient does not satisfy the coverage criteria but states he/she intends to pay out of pocket for the medication, the practitioner should discuss alternatives with the patient and make sure to document these discussions. Practitioners must ensure any documentation they complete or provide to an insurer to assist the patient in obtaining coverage for the medication is accurate and supported by the patient’s medical record. Practitioners who prescribe medications without examining and diagnosing patients, prescribe medications that aren’t medically necessary, or submit false or misleading documentation to insurers to support coverage face licensing ramifications, potential insurance fraud allegations, and could lose their credentials with the applicable third-party payor.

To help reduce an organization’s risk associated with these medications, compliance officers should consider:

  • Providing increased education to practitioners on these medications and insurance coverage requirements, including keeping practitioners up to date on the latest information regarding supply shortages and insurer requirements for coverage;
  • Implementing processes to track and keep practitioners informed of the organization’s most prevalent insurers’ coverage criteria for these medications to help ensure the criteria are appropriately documented in the patient’s medical record, such as utilizing checklists by medication and insurer so practitioners can review them before writing a prescription and inform patients of alternatives if the medication is unlikely to be covered; 
  • Implementing processes to review and respond to insurer requests for documentation relating to coverage determinations that ensure the information provided by the practitioner is accurate and supported by the medical record documentation;
  • Monitoring the prescribing of these medications by the organization’s practitioners to identify any potential outliers or unusual prescribing habits, such as prescribing these medications much more often than peers or the medications are for conditions outside the provider’s specialty; and
  • If monitoring reveals an outlier, coordinate a more in-depth review of the issue with the appropriate individuals internally, such as a peer review committee, based on the nature of the issues involved.

Another risk associated with these medications is drug diversion and theft. Unfortunately, as access to medications becomes difficult and people become more desperate to obtain them, they may take more drastic measures, such as stealing or diverting medications or writing fake prescriptions. Healthcare providers who stock these medications should be mindful that these medicines may be at higher risk for diversion and ensure they are properly safeguarded. This includes drug samples and drug sample closets, which can be particularly susceptible to diversion and theft. 

Please Podcast see here.

Our podcast this week dives into drug samples. We talk about the various laws that regulate drug samples, why drug samples are particularly susceptible to abuse and compliance issues, and ways to reduce your organization’s risk.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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