- Lack of medical device-specific information in patient claims forms impedes the government’s ability to track Medicare costs related to the replacement of defective or recalled devices, according to a memorandum issued by the HHS Office of Inspector General.
- The OIG reviewed medical records for beneficiaries who received seven faulty cardiac devices and linked them to $1.5 billion in Medicare payments and $140 million in beneficiary copayment and deductibles for device replacements and related procedures.
- To ensure better tracking of such costs, the HHS watchdog urges CMS to include unique device identifiers on health insurance claims forms.
The preliminary results are from an ongoing review of how much faulty and recalled devices cost the Medicare program. The OIG identified 72,710 beneficiaries who received device replacements leading to 8.2 million claims. The total cost to Medicare was $5.1 billion and beneficiaries paid another $501 million out of pocket.
CMS and the FDA recently asked the Accredited Standards Committee X12 to include UDIs for implantable devices on Medicare claims forms. The request followed an appeal by FDA Commissioner Robert Califf and FDA device chief Jeffrey Shuren for more effective tracking of devices from clinical testing to the marketplace.
Including the device identifier in claims would help to identify costs related to device defects and recalls and improve patient safety, the OIG says. The watchdog group urges CMS to work with the committee to include UDI for implantable devices on the next version of the Medicare claims form.
UDIs are made up of two parts: a device identifier and a product identifier. The DI identifies the labeler and specific model of the device. The PI includes information such as lot or batch number, serial number and expiration date, which could help identify patients in need of a replacement if a recall occurs.
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote to HHS Secretary Sylvia Burwell and CMS Acting Administrator Andy Slavitt in March, calling for UDIs to be included in electronic health records and claims forms.
Grassley said Monday that the OIG alert highlights the physical and financial costs to patients when devices fail, as well as the “big expense to taxpayers.”