Off-Label Audits
Serving Clients Nationwide
An important tool in investigating illegal off-label prescription drug marketing is auditing pharmacy claims received by healthcare payers, both from private insurers and government healthcare programs. Pharmacy claims provide nearly real-time information from the point of purchase for prescription drugs. Based on the FDA-approved indications for each drug, an “inferred diagnosis” can be made in many cases, which can later be compared to medical claims and records to determine the prevalence of off-label use. While it is both permissible and common for physicians to prescribe medications for off-label indications, audits using pharmacy claims can provide important evidence in cases of illegal off-label marketing by pharmaceutical companies.
Off-Label Audit Process
To find evidence of off-label use of a given prescription drug, investigators will create a query for that drug in the relevant payer database or data warehouse. For each patient linked to the drug in the query, investigators then search for medical claims, which include diagnosis codes, from the past 30-45 days. If a patient’s medical claim does not include a diagnosis code for one of the FDA-approved indications for the drug, it is generally safe to assume an instance of off-label prescription. This assumption can then be verified by more thorough evaluation of the patient’s charts and medical records.
Because physicians are allowed to prescribe medications for off-label use, audits do not directly uncover illegal activity such as off-label marketing. However, the data from off-label audits can be combined with other evidence to show a correlation between off-label promotion to physicians or pharmaceutical kickback payments with increased off-label prescriptions. This correlation can then be crucial in pursuing litigation or enforcement action against the drug manufacturer or marketer.
Off-Label Marketing and Whistleblowers
Even with off-label audits and other tools, off-label marketing cases can be difficult to prove without the help of whistleblowers who are aware of illegal off-label promotion by pharmaceutical companies. Under legal protection from retaliation and with the help of a qui tam attorney, whistleblowers can initiate a qui tam lawsuit to recover money paid in fraudulent claims for illegally marketed drugs under the False Claims Act.
If you have knowledge of inappropriate off-label marketing or promotion of a prescription drug by a pharmaceutical company, you can become a whistleblower and assist the government in uncovering pharmaceutical fraud.
The qui tam law firm of Kenney & McCafferty can help you build your case while ensuring complete whistleblower protection. With over fifteen years of experience representing whistleblowers, Kenney & McCafferty’s dedicated qui tam lawyers are intimately familiar with the qui tam process, and we have the detailed, real-world knowledge to maximize your whistleblower compensation.
If you have knowledge of a fraud or false claim against the government, please contact our qui tam lawyers today. Kenney & McCafferty attorneys will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys during these consultation services are confidential and protected by the attorney-client privilege.
