The CMS can't track how much recalled and defective medical devices cost Medicare because of a lack of medical device information on health insurance claims forms, according to HHS' inspector general. Adding a portion of a medical device's unique device identifier could make it easier to count and save costs, he said.
In a letter to acting CMS Administrator Andy Slavitt, HHS Inspector General Daniel Levinson said the CMS should collaborate with the Accredited Standards Committee X12, or ASC X12, to include the device identifier portion of the unique device identifier for implantable medical devices on insurance claims forms. Currently, claims forms do not include UDIs.
Levinson's letter reflects the latest call from governmental agencies to include UDIs on claims forms to improve medical device evaluation and tracking while bolstering patient safety and reducing costs, an effort that has also been supported by the heads of the CMS and the U.S. Food and Drug Administration.
A UDI has two parts: a device identifier, which identifies the device and version, and a production identifier, which identifies the device's batch number, serial number, manufacturing and expiration dates, and other information.
“The inclusion of the DI (device identifier) could assist in identifying the costs to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds,” Levinson wrote in the letter posted Monday to the agency's website.
The Office of Inspector General is reviewing Medicare expenses related to defective medical devices. Preliminary results announced in the letter reveal that seven cardiac medical devices that have been recalled or have high rates of failure have led to $1.5 billion in Medicare payments and $140 million in beneficiary copayments and deductibles for services and procedures.
Because of the missing UDI information on claims forms, the agency said it was unable to identify what specific devices were implanted or whether replacement devices resulted from recalls or failures. So it had to subpoena medical device manufacturers for lists of people who received recalled or failed devices and then review their medical records to determine the replacement costs and cause—a process that Levinson described in the letter as complex and time-consuming.
While claims forms include information about the medical procedures performed and a field for reporting device failures and recalls, hospitals rarely fill out the latter, the letter stated. Including UDI information would help identify the model and manufacturer of an implanted device, reduce Medicare costs by helping to identify failed devices more quickly, reduce medical errors and protect patients.
The OIG isn't the only agency advocating for UDIs. The CMS' Slavitt and Food and Drug Administration Commissioner Dr. Robert Califf are also pushing for health insurance claims forms to include UDIs, which they say would improve post-market surveillance and provide for better value-based reimbursement based on device performance. In July, the two agency heads wrote to the chair of the ASC X12 to ask that the organization add UDIs for implantable medical devices on claims forms. ASC X12, which sets standards for sharing data gathered and used by the insurance industry, will release the next claims form version for public comment in December and the template *is expected to be* released in 2021. *Claims forms are generally updated every 10 years.
Proponents of UDIs say they could identify dangerous devices more quickly before they harm the patient. Having that information on insurance claims would allow them to analyze outcomes data and improve population health, proponents say. Manufacturers and distributors currently are implementing UDIs and electronic health records are being tweaked to allow providers to one day record the identifiers. At the moment, however, few healthcare organizations have the technology that will allow them to take full advantage of the UDI information. Additionally, some critics say the changes required are too costly.
The FDA in 2007 was charged with creating a UDI system, which is intended to better detect devices with adverse events, improve device recalls, and enable better post-market surveillance.