Medical Device Fraud Explained By a New York City Criminal Lawyer
Each year, $110 billion is spent in the medical device industry. Private insurers and government insurers, like Medicaid and Medicare
Sometimes, however, accusations of medical device fraud arise. These allegations of fraud can be made against individuals and businesses who manufacture, sell, or prescribe medical devices, as well as against patients and those who make claims for insurance to cover devices. Fraud accusations can lead to civil lawsuits to recoup funds that were allegedly paid out improperly. Criminal prosecution is also possible, both by state prosecutors and by federal authorities.
What is Medical Device Fraud
Violating Good Manufacturing Practices in the design and production of medical devices.
- Illegal kickbacks, including accepting, offering, or soliciting kickbacks to encourage care providers to prescribe medical devices to patients.
- Off-label marketing, or advertising medical devices for any purpose other than what the device has been approved for by the Food and Drug Administration (FDA).
- Failure to report adverse events associated with medical devices.
- Marketing medical devices, despite knowledge or reasonable cause to believe that the medical device is defective or dangerous.
- Billing the government or private insurers for medical devices which are not medically necessary for a patient and/or which should not be covered by insurance.
- Billing for medical devices which are not provided, or billing for medical devices which are more expensive than the devices which are actually provided to patients.
Any misleading statements which are made in connection with insurance claims to the federal government or to private insurers can be considered illegal health insurance fraud. Misleading statements to the FDA, to other regulators, or to patients, is also against the law. Fraud charges can arise not just because of making false material statements, but also when you omit essential information- such as when providers tell a patient a medical device is free but then subsequently bill Medicare or Medicaid for the device.
Penalties for Medical Device Fraud
Penalties for medical device fraud vary based on many factors. Defendants will face different criminal charges for improperly billing insurers than they would face for marketing drugs off label or for paying or accepting illegal kickbacks. In many cases, defendants are charged with criminal acts on the federal level, especially when false claims are made to government insurance programs or when misleading information is provided to the FDA or other federal regulators. State prosecutors can also pursue fraud charges in cases where dishonest behavior occurs.
Criminal charges are the most serious consequences, because prison time and/or crippling fines and penalties may be imposed. However, there are also other consequences associated with medical device fraud as well. For example, the False Claims Act allows civil lawsuits to recover penalties when the government is defrauded of money. These civil lawsuits can even be filed by private citizens who are whistleblowers and who become aware of wrongdoing. Whistleblowers who file Qui Tam lawsuits can earn millions of dollars because they get to keep part of the money which the government is able to recover in a civil lawsuit.
How a NY Criminal Lawyer Helps Defendants in Healthcare
A NY criminal defense lawyer at Bukh Law Firm, PLLC can provide you with legal representation if you have been accused of any type of medical device fraud. Call our legal team as soon as possible so we can get started developing your case and helping you craft your response to all charges.
