A High-Risk Medical Device Didn’t Meet Federal Standards. The US Govt Paid Millions for More.
Neil Bedi (ProPublica) 13 January 2022
This story was originally published by ProPublica.
For years after federal inspectors found serious problems with the HeartWare heart pump, agencies like the Department of Veterans Affairs and Centers for Medicare & Medicaid Services continued paying to implant it in patients.
In 2014, when the Food and Drug Administration found serious problems with a life-sustaining heart pump, its warning letter to the manufacturer threatened to notify other federal health agencies about the inspection’s findings.
But for years, no such alert ever went out. Instead, the agency added the warning letter to an online database alongside thousands of others, following its typical procedures, an FDA spokesperson said.
Agencies such as the Centers for Medicare & Medicaid Services and the U.S. Department of Veterans Affairs went on paying to implant the HeartWare Ventricular Assist Device, or HVAD, in new patients even though federal inspectors had found problems with the device linked to patient deaths and injuries.
Taxpayer dollars continued to flow to the original device maker, HeartWare, and then to the company that acquired it in 2016, Medtronic, for seven years while the issues raised in the warning letter remained unresolved.
If crucial safety information in FDA warning letters doesn’t make it to other arms of the government responsible for deciding which medical devices to pay for, experts said patients are the ones put at risk.
“It’s clearly a breakdown of communication,” said Dr. Rita Redberg, a cardiologist at the University of California San Francisco who researches medical device safety and regulation. “It’s not just the money, obviously. It’s people’s lives.”
The FDA acknowledged that it doesn’t directly notify other agencies when it issues warning letters, pointing instead to its online database, which is accessible to both government officials and the public. “The FDA’s decisions are intended to be patient-centric with the health and safety of device users as our highest priority,” the agency spokesperson said in an email.
The HeartWare letter was removed from the public database about two years ago, even though the problems remained unresolved and patients were still receiving implants. The database clears out letters that are more than five years old.
CMS, which oversees the Medicare and Medicaid programs, would not say why it continued paying for a device that didn’t meet government standards.
It directed questions about the HeartWare warning letter to the FDA. “CMS does not have oversight of the manufacturing and related safety assessments of a medical device manufacturer,” a spokesperson said in an email.
The spokesperson noted that CMS requires heart pump patients to have specialized medical teams managing their care, which should monitor FDA communications regarding safety of devices.
CMS doesn’t track data on devices by manufacturer, so it’s essentially impossible to calculate its total spending on HVADs. One 2018 medical journal study found that Medicare and Medicaid paid for more than half the cost of all heart pump implants from 2009 to 2014. If that rate of spending continued, CMS may have spent more than $400 million on implanting HVADs since 2014.
A spokesperson for the VA said his agency was never notified about the HeartWare warning letter. The VA paid HeartWare and Medtronic more than $3 million after the FDA issued the letter in 2014. It offered this explanation for why: “It’s important to note that FDA Warning Letters are notifications issued to manufacturers found to be in significant violation of federal regulations. They are not product recalls.”
In the case of the HVAD, the FDA’s failure to make sure its warning reached beyond the manufacturer may have had life-and-death consequences. Continue Reading… 
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