When a pacemaker gets recalled: Defective heart devices cost Medicare a fortune

If you own a vehicle, you’ve likely received a recall notice about a potentially defective part. You can schedule an appointment with a mechanic who will replace everything from an airbag to a sun visor at no cost to you. Nearly 900 vehicle recalls affected 51 million vehicles in 2015. 

Contrast this with a recall on a medical device implanted in your chest. You may not be notified of a problem. The medical costs associated with replacing it are not covered by the manufacturer. And you'll need to do more than spend a half hour sipping coffee in a car dealership waiting room. 

Replacing a recalled medical device means another trip to the hospital. Another surgical procedure. Another opportunity to contract a staph infection. And more costs to consumers and health insurers. 

A September report from the Health and Human Services Office of Inspector General estimated Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices in 73,000 patients. These included pacemakers and implantable defibrillators — small devices placed under the skin to help treat irregular heartbeats.

The inspector general noted more must be done to track costly product failures and protect patients. Among the recommendations: The Centers for Medicare and Medicaid Services should require hospitals and doctors to submit detailed information identifying failed devices, such as serial and batch numbers, during the billing process. 

“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report states. 

The federal government should most certainly require more detailed reporting by health providers.

Currently, patients and health insurers may not even know the serial number of an implanted device. That can make it impossible for consumers to check for recall notices on the U.S. Food and Drug Administration's website. And Medicare may not be able to notify patients.

In 2005 Guidant Corp. recalled thousands of pacemakers because excess moisture could seep into the devices and ruin them. The Government Accountability Office later reported 1,732 of those devices were never recovered because there was "no implant record available." Medicare had no way of tracking which patients may have gotten them. 

And why aren't device manufacturers required to pick up all the costs related to a recall, the same way vehicle manufacturers are? Hospitals that replace a device covered under a warranty may receive a no-cost replacement or credit. But most devices do not carry a warranty, according to the inspector general report. 

Health insurance, including Medicare and Medicaid, pay the medical bills for a replacement. So do patients. Consumers' out-of-pocket expenses related to heart implant recalls in the 10-year-period studied totaled $140 million.

While the inspector general’s report largely focused on costs to Medicare and the need for better reporting, it should prompt serious concern about apparently rampant problems with pacemakers and defibrillators. Are devices being subjected to adequate scrutiny prior to approval? 

In the past five to six years, more than 200 cardiac devices have been recalled. In most cases, manufacturers withdraw their products voluntarily after reports surface of injuries or malfunctions. In other words, after health providers reported problems. 

But it is patients — including 73,000 Medicare beneficiaries over a decade — whose lives are put at risk. Washington officials should care as much about this as a defective car-door latch.