Health Plan Data Can Help Track Issues With Medical Devices

Patients, health care providers, and insurers all benefit when potentially problematic drugs or medical devices can be identified promptly and accurately.

Today, when a patient receives a medication, the drug’s unique identifier—a number that provides specific information, such as its manufacturer and dosage amount—is routinely entered on claim forms submitted to private insurers and public payers such as Medicare and Medicaid. Given the large volume of claims filed daily, the population-level data these numbers provide can help determine whether a specific drug may be causing unintended harm, even for rare events.

The same approach should be used with medical devices, such as pacemakers or artificial hips, which have their own unique device identifiers. However, these numbers are currently not included on insurance claims.

Without this information, it can be hard to determine whether a certain type of device isn’t working correctly. And the longer it takes to discover a faulty device, the more patients may receive it before the problem is detected. Any delays can expose more people to harm—and prove costly. For example, one study found as much as $1.5 billion in costs to Medicare linked to just a few types of faulty cardiac devices.

Preliminary research findings published by the Journal of Patient Safety reveal that claims data could be used to supplement and backstop data on device safety from patients’ electronic health records (EHRs). These data could provide a more comprehensive perspective than EHRs alone. For example, if a patient had sought treatment initially through a different health care system, the EHR would not capture that information. Because insurance claims can include data from multiple hospitals or offices, researchers could use them to find records of additional problems they might otherwise have missed.

Examining data from nearly 5,000 patients who received stents and more than 2,200 who had total hip replacements, researchers from Brigham and Women’s Hospital in Boston, Geisinger Health System in Pennsylvania, and Blue Cross Blue Shield of Massachusetts attempted to track medical events—such as admissions to emergency rooms or diagnoses of related medical problems—within 90 days after those procedures occurred. To do this, they examined data collected by Geisinger. Researchers first used data solely from EHRs and then compared the results to analyses that also used claims data.

Among the patients who had a stent inserted, researchers found a nearly fourfold increase in those readmitted with a possible stroke when they could factor claims data into their analysis. Among patients who received a hip replacement, researchers found a 72 percent increase in the number readmitted to a hospital for any reason when claims data were included.

While this comparison included data from only one health system, the results are promising and highlight the importance of using claims data to coordinate care. Although the readmissions may not have been related to device failures, the data show that insurance claims are a crucial source of information and can help reveal more widespread problems or trends. And this information, if used to evaluate medical device safety, could help determine whether certain types of products lead to higher risks of hospital readmissions, surgeries to revise an implant, or other complications. Claims data, though, still do not include details on the specific products implanted and therefore are limited in their ability to help evaluate whether certain brands or models may be more likely to lead to adverse outcomes.

In some settings, analysts may have access to both EHR and claims data for a patient, but the claims are often used independently to examine broader trends and may not be linked to a particular EHR.

In 2017, the team behind this study examined how to capture and transmit device identifiers using the insurance claims form. The analysis found that it would likely be straightforward and could be done without an undue burden. The new work bolsters the evidence that insurance claims can play an important role in tracking the performance of medical implants and in assisting in the recognition and remediation of problems.

Efforts are already underway to secure the benefits expected from adding device identifiers to insurance claims. The panel of experts that governs the content of these claims has issued draft recommendations to do so. Once the changes are finalized, the Centers for Medicare & Medicaid Services would need to adopt them before they take effect. The Journal of Patient Safety study shows why the agency should act.

Ben Moscovitch directs The Pew Charitable Trusts’ health information technology initiative.