Off Label Prescription Drug Attorney & Off Label Pharmaceuticals Sales 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.
However, many healthcare providers still attempt to collect for off-label drug prescriptions, as well as for the sales of medical equipment for a non-approved use. As an off-label prescription drug lawyer, I invite you to call me to schedule a free consultation if you are aware of fraudulent billing practices for off-label prescription or medical products,
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.
How Do Pharmaceutical & Medical Device Companies Get 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)
If you are aware of any of these practices, it will be helpful to contact an off label medical equipment sales lawyer or off label drug sales attorney to learn how you may be entitled to receive substantial compensation in a False Claims Act lawsuit for reporting fraud. I would invite you to call me to learn how I can help.
Off Label Prescriptions and the False Claims Act – How an Off-Label Drug Sales Lawyer Can Help
If you are aware of the above or other illegal practices involving “off-label” sales, “off-label drug promotion, “off-label” medical equipment sales, or off-label prescription fraud, please call me to learn about the options that are available to exposing this type of 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). As an experienced off-label promotion lawyer, I tenaciously fight for justice for the government and for the compensation rightfully deserved by those blowing the whistle on off-label uses of drugs, medical devices, and pharmaceuticals.
I would look forward to learning about the facts and circumstances of your case, and to answering any questions that you might have.