A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices. The OIG also believes the lack of device information on claims data “impedes the ability of FDA and CMS to identify poorly performing devices as early as possible” and interferes with the provision of timely follow-up care. The OIG recommends that CMS:

  1. Continue to work with the Accredited Standards Committee X12 to ensure that the Device Identifier (DI) is included on the next version of claim forms, and then use this data to identify and track the additional health care costs incurred by Medicare for recalled or prematurely failed medical device. CMS stated in reply that it was considering adding the DI to the claim form, but the agency “will carefully evaluate the potential that this policy would impose burden on physicians unnecessarily.”
  2. Require hospitals to use condition codes 49 or 50 (indicating specific product replacements) on claims for reporting a device replacement procedure for all procedures that resulted from a recall or premature failure, regardless of whether the device was provided at no cost or with a credit. CMS concurs with this recommendation in cases where payment is impacted.