Fraud involving medical devices and durable medical equipment (DME) can take a number of forms. Medical equipment and DME fraud can constitute a violation of the False Claims Act. It can also include violations of other federal and state laws.
Types of medical device and DME fraud include:
Kickbacks/Inducements to Prescribe
One common form of medical device/DME fraud involving kickbacks is the provision of financial incentives to healthcare providers in exchange for prescribing a specific medical device. This may involve manufacturers offering excessive consulting fees, extravagant gifts, luxury vacations, or even direct cash payments to doctors who prescribe their products. Such kickbacks create a conflict of interest for healthcare providers, as their decisions become influenced by personal financial gain rather than patient welfare or the best available treatment options. One way that some companies attempt to skirt anti-kickback laws is to pay “consulting fees” to physicians who prescribe their products.
Off Label Promotion
If a company markets or promotes its products for uses and conditions not approved by the FDA or for populations not approved by the FDA they may commit fraud. The FDA regulates medical devices and determines the devices appropriate use
Unnecessary DME Prescribing
Medicare requires that a device or DME be medically necessary for diagnosis or treatment before the government pays for the device. Companies may attempt to skirt these requirements by auto enrolling patients in replacement or refill programs for equipment without determining if the additional equipment is medically necessary.
A supplier may be guilty of fraud if they supply defective medical devices. Fraud can also involve the sale or distribution of substandard or counterfeit medical devices or DME. These devices may not meet safety or quality standards, posing risks to patients. Some individuals or companies may fraudulently market counterfeit devices as legitimate products to exploit the demand for medical equipment.
Prosecuting a claim under the False Claims Act is complex. Those who believe they are aware of pharmaceutical fraud should consult an experienced attorney to determine the steps necessary to protect themselves and file a successful claim.