- In letter to the Accredited Standards Committee X12, the heads of the Centers for Medicare & Medicaid Services (CMS) and Food & Drug Administration have urged the body responsible for developing and maintaining electronic data interchange standards to reconsider how unique device identifiers are captured in medical claims.
"CMS and FDA are hopeful that ASC X12 can complete its work on the next version of the claims form (version 7030) for the relevant transaction standards to permit the DI for implantable devices to be included in the claims form," wrote Acting Administrator Andy Slavitt and Commissioner Robert Califf, MD.
"HHS is committed to improving the quality and safety of health care provided to all American, and believes that monitoring medical device product safety and performance is critical for ensuring public health and safety," they continued. "HHS support adding the DI portion of the UDI to claims for implantable devices if sufficient funding and resources are provided to make the necessary Medicare claims processing system change."
According to Thomas Burton of the Wall Street Journal, the request represents a marked shift toward the capturing of unique device identifiers at CMS. Officials at FDA and other lawmakers have long advocated for tracking the use of medical devices via UDIs. Of the latter, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) and Representatives Nancy Pelosi (D-CA) and Bill Pascrell (D-NJ) support the use of these tracking numbers as part of medical bills and claims.
The CMS-FDA letter lists several benefits associated with using unique device identifiers:
• Allow for evaluation of product performance and identification of safety concerns for devices at the model level;
• Facilitate the collection and analysis of patient data for devices at the model level that would be helpful in surveillance efforts and device innovations;
• Help providers and certain payers to calculate and compare total costs and outcomes based on the device model used; and
• Support program integrity by providing better information to link the patient and implanted device to help track rebates from manufacturers back to the payer of provider.
For its part, CMS acknowledged the complexity that collecting unique device identifiers would introduce, including changes to its own systems to support the activity.
"We recognized that collecting the DI is complex and involves providers changing their workflow and billing systems as well as requiring public and private payers, entities that bill for providers, clearinghouses, and other entities to change their claims processing systems," the letter stated. "CMS also needs to modify legacy computer systems to collect DIs for implantable devices on Medicare claims, which would require additional funding and resources."
An amendment to the 21st Century Cures Act last July introduced by Rep. Mike Fitzpatrick (R-PA) had the purpose of making unique device identifiers a necessary part of EHR technology. At that time, Rep. Pascrell was a vocal supporter of the move.
Back in 2013, FDA updated its plan to require all medical devices to carry a unique device identifier over the coming years. Its plan touted the importance of a unified registry database to ensure patient safety and support innovation relative to medical devices.
“Registries play a unique and prominent role in medical device surveillance because they can provide additional detailed information about patients, procedures, and devices not routinely collected by electronic health records, administrative or claims data,” the federal agency maintained. "For this reason, registries will continue to serve a critical, complementary role in medical device post-market surveillance, even as UDI becomes more routinely incorporated into electronic health information."
ASC X12 is slated to release its update to standards this coming December following a consensus-based review of requests for changes.