The two new leaders of the Food and Drug Administration and the Medicare program—both recently confirmed by the Senate—have an opportunity to advance a simple policy change with widespread support that can save both money and lives.
Scott Gottlieb, Commissioner of the Food & Drug Administration, and Seema Verma, Administrator of the Centers for Medicare and Medicaid Services, should maintain their agencies' current positions to add unique identifier numbers from medical devices to Medicare claims forms. It may not sound exciting, but this single addition could be a real game changer for patients.
Think about it. When a patient undergoes surgery to get a medical device, such as a pacemaker or artificial hip, they probably assume there is a unique identifier number associated with their device. Then, in theory, if a problem arises with their device, physicians could use that information to quickly detect the problem and any patients at risk could be screened and treated, if necessary. Many other industries have these types of tracking systems already in place.
But despite the fact that the codes have been available on device packages for more than a year, there is no place to record medical device codes on insurance claims or Medicare forms. And even though officials at Medicare and the FDA have said that recording the codes on insurance forms will improve patient safety, the forms have not been changed.
What's the hold up?
In our healthcare system, Medicare can't change its own insurance form. That responsibility falls to a private advisory committee called X12, a group of health industry billing administrators. The committee develops the standard claims form used by Medicare and all private insurers, such as Aetna and Blue Cross.
It would seem to be a common-sense step: when a patient receives an implant the healthcare team would record or scan the code–a number about 14 digits long–into the patient's health record for use in the claims form. That single step would help build a database for manufacturers, doctors and disease specialists to more quickly identify devices that fail or harm patients.
Once the problem had been detected, then devices could be pulled from inventory shelves, and patients who have already received the devices could get screened sooner. It would save lives and spare many seniors from needless surgeries and other risks.
Over time, the database could also help researchers evaluate device performance. In turn, this research would help manufacturers and caregivers determine how to make medical devices safer and more effective for our rapidly aging population.
And, adding device identifiers to claims forms could save taxpayers a lot of money. A federal audit recently found that Medicare spent $1.5 billion on treatment costs associated with seven faulty cardiac devices. Medicare recipients paid an additional $140 million in out-of-pocket costs for treatment they needed as a result. Since Medicare patients receive millions of medical devices every year, the total amount Medicare spends to remediate device failures is far higher.
Where does this stand?
The good news is that the X12 committee recently recommended adding device identifiers to claims forms. This is a major step in the process, but by no means the end. The next step will be a comment period lasting into June, then an advisory committee review process, with the final rulemaking coming from the agency that oversees Medicare. Since the forms are updated infrequently, and the whole process can take years, this might be the last chance to update the forms for a decade or more.
Policymakers at FDA and those that oversee the Medicare program should continue to make this a priority, and members of Congress who have oversight of this issue should help keep pressure on. It's clear that adding device identifiers to claim forms will protect patients, improve public health, and save lives. It is our hope that Dr. Gottlieb and Ms. Verma can now fix this problem.
Dr. H. Vernon Anderson is a cardiologist at the University of Texas Health Science Center in Houston. In 2014 he received the Distinguished Service Award from the American College of Cardiology.
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