A key advisory committee today recommended changes to enable the standard health insurance claim form to record the identifying codes for implanted medical devices—something long sought by hospitals, providers, health plans, and patient organizations. The X12 committee, made up of hospital and health plan billing administrators, proposed the revisions to the routine claims forms that hospitals submit to Medicare and private insurance companies, such as Aetna. If the recommendation is fully implemented, the resulting data would help the U.S. Food and Drug Administration, clinicians, hospitals, and patients better understand the long-term safety of artificial hips, cardiac stents, and other life-changing medical implants.
Millions of devices are implanted in the United States each year, and while failures are rare, they can lead to serious health risks and even death. They can also present enormous financial costs for patients and taxpayers. The Office of the Inspector General in the U.S. Department of Health and Human Services recently studied a handful of cardiac devices that failed or were recalled and found that Medicare spent $1.5 billion to treat patients who were harmed and that the patients themselves faced $140 million in out-of-pocket medical costs.
Insurance claims forms feed information into a range of databases, which can be used to evaluate the safety of pharmaceuticals and to study many other aspects of health care. However, these resources presently lack key data on medical device brands and models.
The committee’s recommendation is a critical first step, but many more remain to be taken before the changes can be implemented. X12 must finalize its recommendations, which will then be reviewed by other advisory committees and eventually presented to the Centers for Medicare & Medicaid Services to develop the final rules. That process could take a year or more.
The health insurance claims form is updated infrequently—the last changes took place in 2012, and the new proposed modifications from X12 may not be fully implemented until about 2021. Missing this window to update the form could delay the addition of device codes and the collection of better patient safety data for a decade or more.
Given the urgency of this change, members of Congress have also weighed in, with support coming from Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) and Representative Bill Pascrell (D-NJ). The American Academy of Orthopaedic Surgeons, the American College of Cardiology, the Alliance of Community Health Plans, Intermountain Healthcare, Mercy, Geisinger Health System, and Aetna, among other firms and organizations, also support the change.
Ben Moscovitch manages health information technology at The Pew Charitable Trusts.