Over the past decade Medicare has spent more than $1.5 billion to replace defective heart devices for 73,000 patients.
That’s according to a report from the Health and Human Services (HHS) Office of Inspector General (OIG).
The OIG is an organization mandated to protect the integrity of HHS programs, including Medicare and the U.S. Food and Drug Administration (FDA).
Some of the costs for removing faulty heart devices has also fallen to consumers, however.
Out-of-pocket expenses related to device recalls totaled $140 million during the same period, according to the report.
The inspector general’s report focuses on the costs associated with the recalls of seven heart devices, including pacemakers and implantable defibrillators for treating irregular heartbeats, that had serious flaws or had failed prematurely.
The report includes recommendations to make hospitals and healthcare providers submit detailed information identifying failed devices during the billing process to better identify poorly performing devices more quickly.
It also recommends better coding on recalled device-related procedures.
“There’s a code in Medicare billing that indicates evidence of a recalled device,” Dr. Rita Redberg, a University of California San Francisco (UCSF) cardiologist who advises Medicare, told Healthline. “But the hospitals aren’t using it. Using that code could shift the billing to the device manufacturers. They should be paying instead of Medicare and the patient.”
Even when the billing code for device recall is used, Medicare isn’t typically reimbursed for the costs of replacement.
“There a few percent of cases where that code is used, but the manufacturer gives the money to the hospital and not to Medicare,” Redberg explained.
The problems with the devices
Recalls of heart devices have been ordered for problems such as failing batteries, fragmented wiring, and disintegrating components.
In one instance, St. Jude Medical (now owned by Abbott Pharmaceuticals) notified doctors of a defective battery in 400,000 cardiac resynchronization therapy defibrillators (CRT-Ds) in October 2016.
That was five years after St. Jude learned of battery problems with the devices, according to a letter the FDA sent the company in April.
More recently, Abbott issued a warning this summer about cybersecurity vulnerabilities in its implantable cardiac pacemakers, making them potentially hackable.
“A lot of these devices end up getting recalled,” Redberg said. “Besides the costs, it’s risky and dangerous to have a procedure for the replacement of a faulty device.”
Difficulties with testing
The recall of so many heart devices demonstrates the difficulty inherent in adequate testing.
Although the FDA requires vigorous testing of pharmaceuticals, heart devices undergo a different scrutiny.
When contacted by Healthline, the FDA press office responded to questions raised by the OIG report via email.
According to the FDA, heart devices need the agency’s approval based on the type of device it is.
An implantable pulse generator for a pacemaker, for instance, would be subject to premarket approval as a Class III (high-risk) device.
Premarket approval involves a determination of “probable benefit to health from the use of the device weighed against any probable injury or illness from such use” and “the reliability of the device.”
New processes introduced
The spate of recalls in the past decade might indicate that additional testing measures should be implemented to ensure device reliability.
The FDA, however, suggests that the increase in recalls between 2003 and 2012 mentioned in the OIG report are the result of increased awareness of recall notices — not an increase in faulty devices.
“Moreover, these interactions,” or recalls, “triggered efforts within industry to improve safety of devices, which are expected to improve device performance over time,” the agency told Healthline.
The FDA also told Healthline that it is working to develop the National Evaluation System for Health Technology (NEST) for medical devices, to improve the quality of real-world evidence for patients and healthcare providers to make better informed treatment decisions.
The agency said it has already invested $20 million in the effort.
And on October 24, the FDA Commissioner Scott Gottlieb announced steps the organization is implementing to encourage an even speedier to-market process for new heart devices.
Citing the development of more modern measurement tools that would aid in regulatory decisions, the FDA expects to minimize the use of animal studies, reduce the duration of testing, and require fewer patients in clinical studies.
These steps incentivize innovation but could also increase the risk of faulty or defective heart devices being implanted in patients due to limited testing.