In 2016, a whistleblower recently received nearly a million dollar whistleblower award for blowing the whistle on the emerging, but controversial medical injection practice. Viscosupplements are a frequent target of False Claims Act (FCA) investigations and lawsuits on the basis of medical necessity and off-label use. If your medical practice or clinic prescribes and/or administers Viscosupplements, you may have a potential FCA claim.
Viscosupplements are injections used to treat osteoarthritis joint pain. The manufacturing, marketing, and labelling of such drugs are strictly regulated by the FDA. Among other things, drugs that are purposed for export outside the United States may not be FDA-approved for sale domestically, and thus “reimportation” of exported drugs back into the United States can be illegal.
The Government and the FDA have cracked down on similar violations on the sale, marketing, and reimportation of unapproved drugs. In relation to Viscosupplements, the Government has argued that “providers knowingly purchase Viscosupplements reimported from foreign countries that are then billed to state and federal health-care programs.” These acts often lead to false claims to Medicare, Medicaid and other Government insurance programs because such re-imported, non-FDA-approved Viscosupplements are not reimbursable by federal healthcare programs.
Generally speaking, a drug needs to be approved by the FDA before it will be covered by Medicare and other insurance carriers. In some instances, even unapproved drugs are reimbursable if a physician deems it medically necessary. But this is the exception rather than the rule, because there is usually a plethora of approved drugs that can be used instead of the unapproved drug. For example, in a 2016 case, the Government settled for $4.4 million an FCA lawsuit alleging that an orthopedic surgery practice billed for injections that were not medically necessary.
Today, there are many investigations across the United States focused on getting to the bottom of this issue. Whistleblowers play a crucial role in prosecuting these cases, by alerting the Government of unapproved and off-label drug use and guiding the Government’s investigation.
When the Government unwittingly pays for prohibited, re-imported drugs, it is massive fraud on the Taxpayer. Moreover, every time a doctor or medical practice thinks they can save a few bucks by using reimported drugs, they are placing patients’ health and safety at risk. The False Claims Act tackles both problems: it allows the Government, through whistleblowers, to recover millions in fraudulent payments, and protects patient safety. If you have questions regarding the use of Viscosupplements at your and you would like a free confidential consultation regarding your rights as a whistleblower, you should speak with the top whistleblower law firm Brown, LLC for a free, confidential case evaluation. It’s critical to understand how to approach the government the RIGHT way. Our qui tam law firm can give you the right assistance with the right team of attorneys who can help you get through a whistleblower lawsuit from start to finish. Our whistleblower lawyers are led by a Former FBI Special Agent and Legal Advisor. Our experience, strength and the methodical approach to win cases have resulted in aggregate recoveries well over 100 million dollars (although past results don’t guarantee future success). Call us today at 1 (877) 561-0000 for a free whistleblower consultation.