The FDA’s Sentinel Initiative, mandated by Congress two years ago to include and cover medical devices, aims to electronically track the safety of investigational products after they have reached post-market. Recently, however, John Rising of The Pew Charitable Trusts informed a congressional subcommittee that lack of unique device identifiers on insurance claims forms poses a major road block to ensuring the effectiveness of this initiative.
Insurance claims forms serve as a primary source of health data necessary for building the Sentinel Initiative’s electronic database. Unfortunately, because individual medical devices cannot often be identified as part of a claim, tracking these devices can be extremely difficult – a frustrating realization after Congress’s statutory mandate. In an attempt to overcome this hurdle, unique device identifiers, or UDIs, will become a mandatory component of packaging for high-risk devices this September. But until the UDI’s are incorporated into insurance claims their impact may be small.
Pew proposes that a UDI field should be added to all forms that will be used to process reimbursements from Medicare and private insurers. This motion has been recognized and approved by many groups relevant to the medical device realm, including patient groups as well as the FDA. Even insurers themselves have thrown support to Pew’s new form idea. Still, while many support the addition of a new field, the American Hospital Association (AHA) believes that creating an “attachment” form, as opposed to revising hospitals’ entire charge master systems, would be an equally effective but less costly alternative for integrating UDIs into insurance claims. Pew counters that incorporating a field would help to increase standardization of the claim process and therefore ensure more accurate and dependable safety data capture – the main reason for adding UDIs to the forms in the first place.
To help settle this dispute, Rising has called upon Congress in an effort to alleviate a potential on-going debate. At the end of the day, Rising urges medical professionals to keep in mind that “Documenting UDI in claims can…bolster other efforts to utilize date to better understand device performance.”
What do you feel would be a more efficient manner of tracking UDIs? Do you think a separate attachment to insurance claims would be cost-effective and beneficial? Or do you think adding individual fields to claims forms would promote standardization? We at IMARC would be interested to hear your thoughts!
Photo Credit: jonathan mcintosh