Patients who have been implanted with St. Jude Medical’s now-recalled Riata defibrillator leads will likely face some hefty medical bills. According to a report from The Wall Street Journal, doctors are increasingly removing St. Jude Riata leads, a procedure that is not only risky, but expensive.
As we’ve reported previously, St. Jude stopped selling the Riata and Riata ST defibrillator leads in late 2010, and warned doctors not to use them because they were poking through their insulation. Such a defect can cause a defibrillator to emit unnecessary shocks to a patient’s heart, and even worse, fail to emit a life-saving electrical impulse to the heart when it’s needed. In December 2011, the U.S. Food & Drug Administration (FDA) deemed St. Jude’s action a Class I medical device recall, its most serious type of recall.
According to the Journal, it is expected that one in five Riata lead patient will experience lead abrasion. St. Jude has estimated that about 128,000 patients worldwide still have a Riata lead implanted in their body. Earlier this month, the FDA recommended that patients with Riata leads undergo regular x-rays or other imaging tests to check for abnormalities in the insulation surrounding the wire. However, the FDA is not recommending that patients automatically have the wires removed if their imaging tests indicate problems. Instead, the agency says each patient should be evaluated individually to determine if the benefits of lead removal outweigh its risks.
Medicare pays surgeons around $873 to remove defective leads, but hospital bills for difficult where patients suffer complications can cost as much as $18,000. According to The Wall Street Journal, St. Jude’s warranty on the Riata wires does cover some costs for lead removal if they are replaced with another of the company’s devices, the Durata lead. However, the Durata has recently been the subject of safety concerns, leaving some doctors wary of using them. The surgeries to replace the leads are covered by insurance companies, but patients often must spend thousands on co-payments and other out-of-pocket costs. For example, doctors are being encouraged to refer patients to experts in extracting leads, which means large travel bills for some.
While St. Jude has started paying some of those expenses, many doctors aren’t aware, as the company isn’t advertising this program. A company spokesperson told the Journal that additional reimbursement is decided on a case-by-case basis, but wouldn’t say how many claims it’s approved. The spokesperson also declined to comment on what steps it’s taking to let patients know they could be eligible for reimbursement. At least one patient who recently had a Riata lead removed told the Journal he was never informed that he could seek reimbursement beyond the warranty’s terms.
The FDA, it seems, isn’t too interested in the methods medical device companies use to reimburse patients with recalled products. According to the Journal, the agency “does not generally evaluate how refunds of recalled products are handled.”