Identification numbers are key in tracking Medicare spending on recalled medical devices and protecting consumer health.
According to auditors with Medicare’s financial watchdog office, the federal Medicare program is spending billions of dollars on failed medical devices. Currently, the government lacks a reliable way to track public spending on the thousands of recalled or defective medical devices. The U.S. Health and Human Services Office of Inspector General (OIG) reports that this is the result of Medicare claim forms lacking important information that would let the government track expenses. This includes devices that were recalled or failed earlier than expected. The absence of this important information also threatens the health of consumers and medical device recipients.
What are the OIG Findings and Recommendations?
Medicare costs related to the replacement of recalled or prematurely failed medical devices could not be identified and tracked using claim data only. As such, OIG recommends the following for the Centers for Medicare & Medicaid Services (CMS):
- Continue working with the Accredited Standards Committee to ensure that a device identifier is included on the next version of claim forms.
- Require hospitals to use condition codes on claims for reporting a device replacement for all procedures resulting from a recall or premature failure.
How to Track Medical Devices
In 2007, CMS expressed concern about spending on recalled medical devices. Almost eleven years later, the Medicare agency is just now considering a proposal to include part of the device-identifier on claim forms.
Just like a vehicle identification number (VIN), a device identifier (DI) for medical devices would identify them by make, model, and lot number. The OIG audit concluded that “the lack of information on the claim forms prevents [Medicare] from being able to fully understand and address the Medicare costs related to recalled or prematurely failed medical devices.” In Addition, there is also an issue in identifying poorly performing devices as early as possible. This alone puts public health at risk by delaying urgent replacement surgery and follow-up care for medical device recipients.
By including medical device-specific information on the claim forms, CMS could more effectively identify and track Medicare’s aggregate costs related to recalled or prematurely failed devices, such as defective hernia mesh and faulty metal-on-metal hip implants. This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly.
Medical Devices in Today’s Society
The implantation of medical devices to cure common ailments and basic aging has become commonplace in today’s society. Unfortunately, each year, the United States Food and Drug Administration (FDA) is deluged with more than 200,000 reports of medical devices that have malfunctioned or been involved in an injury. In addition, over 2,000 device-related deaths are reported annually.
Recalls of medical devices nearly doubled from 2003 through 2012. Independent studies have shown that recalled or prematurely failed devices have likely cost Medicare billions of dollars in monitoring, hospitalization, surgeries, imaging, post-acute care, physician services, and other costs. Furthermore, beneficiaries affected by recalled or prematurely failed devices, like IVC blood clot filters and transvaginal mesh, may incur adverse health events and additional costs in the form of deductibles and coinsurance. There is no reliable up-to-date estimate of the Medicare costs associated with recalled or prematurely failed medical devices at this point.
How Waters Kraus & Paul Helps Victims of Medical Device Injuries?
Waters Kraus & Paul is a mid-sized plaintiffs’ firm with a history of success in the field of medical device injury. A partner oversees each medical device lawsuit and the litigation team employs the firm’s extensive medicolegal database and other resources to reinforce your case. If you or a loved one has suffered an injury from hernia mesh or another type of medical device, the experienced medical device injury attorneys at Waters Kraus & Paul are ready to fight for the justice you deserve. Contact the attorneys at Waters Kraus & Paul at 800.226.9880 to discuss your potential medical device injury lawsuit.