What is off-label use of medicine?

The federal government carefully regulates the use of pharmaceutical drugs to ensure that people safely use them and that pharmaceutical companies and other health care providers do not defraud government benefit programs like Medicaid. Unfortunately, many forms of pharmaceutical fraud exist. One kind of fraud involves making off-label use of medication. 

According to the Centers for Medicare & Medicaid Services, off-label use is when someone uses a pharmaceutical drug in a way that is not medically accepted. This can include using a drug for unauthorized health problems or symptoms, using it in unauthorized dosages, or using it when you are not part of an approved patient group. In some instances, pharmaceutical companies may defraud Medicaid through the promotion of off-label drug use. 

Off-label promotion as fraud

State Medicaid programs have rules about how pharmacies and manufacturers can claim reimbursement for pharmaceutical drugs. Among these rules is that Medicaid does not cover pharmaceutical drugs used for unaccepted medical purposes. If a pharmacy dispenses medicine for off-label usage, it may do nothing to help the condition of the person who receives it. This amounts to a waste of Medicaid funds. 

Off-label use is not a small matter. In fact, the Department of Justice and the states have encountered many different schemes that promote off-label prescription drug use. The government may levy penalties that rise three times higher than the amount of damages, in addition to monetary penalties for every false claim. 

Off-label use may harm patients

The government also criminalizes off-label use because of the harm it may inflict on people who take the medication. Some people are allergic to certain medicines. Patients may have existing medicines in their systems that do not mix well with other prescription drugs. Some outcomes of taking the wrong medication could include hospitalization, disability, passing on birth defects, or even death. 

Forms of off-label promotion

Understanding different ways people promote off-label use may help you to avoid becoming caught up in an off-label use scheme. Some perpetrators pay off doctors to engage in efforts like advocating for off-label use to other health care workers or to serve on so-called advisory boards that campaign for off-label use. A doctor might also claim to have written an article that addresses off-label use when in reality the agent of a manufacturer had written it. 

Some forms of off-label use promotion involve other forms of deception. Corrupted doctors may promote studies that claim to support off-label use of a prescription drug while suppressing literature that counters such claims. A person may also make false claims to Medicaid about a drug to secure coverage while intending the drug for off-label use purposes.