Off Label Prescription Drug Attorney for False Claims Act Case

The Food and Drug Administration (the “FDA”) is in charge of approving all prescription drugs sold in the United States. As part of this process, prescription drugs are not only approved for sale, but they are also approved for sale in connection with the treatment for specific medical issues.

In some cases, in addition to the approved use, a physician may believe that a drug approved for one use may also be helpful in treating another condition. There are often medical research papers or doctors who claim the drug is effective for another condition. The physician may legally prescribe such drug for the other condition, which is referred to as an “off-label” prescription, but while a physician may be entitled to write an “off-label” prescription, under US law the federal government (under Medicare and Medicare reimbursement programs) cannot be billed for the cost of “off-label” prescriptions.

Why Aren’t Off-Label Prescriptions Covered Under Medicaid and Medicare?

The simple reason is that Medicare and Medicaid are not authorized to pay for the cost of prescription drugs to treat conditions unless and until the FDA has approved such treatment.  As an example, the government believes that it should not have to pay the cost when a drug approved by the FDA for hair loss treatment is prescribed for the treatment of cancer (which use has not been approved by the FDA).

If reimbursement for “off-label” prescriptions were allowed, the federal government could potentially be responsible for paying millions (or billions) of dollars for prescriptions that have not been proven effective for the “off-label” medical conditions.

Pharmaceutical Incentives to Getting Physicians to Prescribe Drugs for Off-Label Uses

“Big Pharma” (the major pharmaceutical companies) will have a strong incentive for their drugs to be prescribed to help or cure as many conditions as possible, since increased prescriptions drive up profits.  As a result, these companies may actively engage in practices to promote “off-label” prescriptions, including engaging in tactics such as:

  • Encouraging sales reps to actively market such off-label uses to physicians and providers,
  • Improperly promoting off label drugs through marketing materials or inappropriate use of physicians as salespeople.
  • Paying commissions and kickbacks based upon off-label prescriptions (which might be paid to both sales reps and physician/provider offices), and
  • Engaging in illegal tactics to mask off-label uses through deceptive coding (which can include sales reps showing physicians/providers and their staff how to bill for off label use in a way that Medicare and Medicaid may not notice, or otherwise use such deceptive coding practices)

Off-Label Prescriptions and the False Claims Act

If you are aware of the above or other illegal practices involving “off-label” sales or off label prescription fraud, please call me to learn about the options that are available to exposing this fraud against the federal government.  If a False Claim Act case is initiated, as the whistleblower or “relator” (the person exposing the fraud) you may be entitled to compensation of up to 30% of the funds recovered for illegal wrongdoing.

I provide a free consultation, and there is no fee to you to initiate a False Claims Act case, as I and my firm are only entitled to a fee if money is recovered (in which case our fee will also be based upon a percentage of the recovery).

I would look forward to learning about the facts and circumstances of your case, and to answering any questions that you might have.