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Why Would Medicare Reimburse for Infuse Bone Graft Stimulator, Which Lacks Benefits, Offers Myriad Potential Side Effects

Jul 5, 2013

Spinal fusions jumped 1,500% among Medicare patients between 2002 and 2007, according to published reports, which also revealed that this explosive growth was tightly associated with the introduction of Medtronic’s Infuse bone growth stimulator.

The findings of recently released independent studies, however, have cast a shadow over Medtronic’s Infuse. These studies have revealed that the product, essentially, offers no new benefits aside from traditional forms of treatment that have been on the market. Even worse, the drug is known to raise the risk for a host of negative side effects, some of which are quite major, such as cancer and male infertility/sterility.

Furthermore, the growing popularity of off-label use of the product – which was approved for only one procedure – has added to the list a wide range of additional side effects, makes the patient’s requirement for additional treatment, such as revision surgery, that much more likely.

Medicare has a "reasonable and necessary" requirement as part of it. Notably, no items or services will be covered by Medicare that are not both "reasonable and necessary for the diagnosis or treatment of injury or illness...," according to 42 U.S.C. Section 1395y(a)(i)(A).

Given the limited possible benefit of Medtronic’s Infuse, and the large number of potential adverse reactions, it remains to be seen how much longer Medicare – and presumably Medicaid – will continue to reimburse Infuse-related procedures. The U.S. Food and Drug Administration (FDA) having the product pulled from the market one day does not seem to be beyond the realm of the possible, either.

Infuse was approved by the U.S. Food and Drug Administration (FDA) in 2002, but only for one type of surgery: spinal fusions of the lumbar (lower) spine, with the surgeon reaching the spine via a frontal approach. Soon after the FDA approved the product, however, surgeons began using it for other kinds of lumbar fusions such as cervical (neck) fusions, where it has been widely used, according to a Bloomberg Businessweek report.

This follows the FDA’s 2008 notification regarding the hazards of off-label usage. In this alert, the agency revealed that the Infuse bone graft had been associated with serious complications – including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage – when used in cervical spinal fusions. Specifically, the FDA noted that it had received reports of “life-threatening complications associated with” Infuse when it was used off-label, in the cervical spine. The agency reiterated that “these products are not approved by FDA for this use.”

Most recently, Medtronic was knocked by the results of two independent clinical studies overseen by Yale University. These studies offer strong evidence that Infuse not only does not work better than a traditional bone graft, but that it also seems to raise the risk of cancer, among other medical problems.

Published in mid-June in the medical journal Annals of Internal Medicine, the studies offer several key findings, namely that there is little difference between using Infuse and a traditional bone graft. In addition, there is a small, increased risk of developing cancer, and with men, retrograde ejaculation, a cause of male infertility.

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