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How Will Medtronic Infuse Studies Affect Medicare Coverage?

Jul 11, 2013

There has been a 1,500 percent increase in the number of spinal fusions among Medicare recipients between 2002 and 2007, HealthWorks Collective reports. This dramatic increase is largely attributed to Medtronic Infuse, a product that hit the market in 2002. Infuse uses a genetically engineered protein (rhBMP-2) to stimulate bone growth in the spine. According to recent research findings, however, Infuse may only carry serious risks.

Medtronic was hoping that Infuse would replace traditional bone grafts, which harvest bone from a patient’s own body. Instead, Infuse became shrouded in controversy when a group of spine experts publicly rebuked Infuse studies promoting the product for off-label uses. The review, which was published in the June 2011 edition of the Spine Journal, found that side effects such as male sterility, cancer, infections and leg and back pain were not mentioned in the Medtronic-funded studies. The authors of those studies were also paid millions, the Spine Journal noted.

The Spine Journal publication raised a number concerns, since it is highly unusual for a group of scientists to so publicly criticize another group. Medtronic approached Yale researchers in an attempt to save its reputation, but the recently published reviews have only confirmed suspicions. The studies, published in the Annals of Internal Medicine, found that Infuse didn’t offer benefits compared to traditional bone grafts and is associated with an increased risk of cancer.

Off-label use means that a product is being used in a manner not approved by the FDA. Roughly 85 percent of Infuse procedures are from unapproved uses.

Given this information, experts wonder whether Medicare will continue to provide coverage for a product that has come under fire. Even though the number of Infuse procedures increased, medical literature continues to show that the product can lead to complications such as retrograde ejaculation, cancer, pain and extraneous bone growth.

Medtronic has also been investigated by the Senate Finance Committee, which reported late last year that a number of Medtronic employees had helped write and edit the positive Infuse studies. This so-called “ghostwriting” is considered unethical because it inserts a bias into studies used to make decisions about patients’ health.

Knowing the risks of Infuse and the controversy behind it, the question is whether or not Medicare will continue to provide coverage for this product. Legally, Medicare will not cover any services that are not both “reasonable and necessary for the diagnosis or treatment of injury or illness…” According to the research discussed here, Infuse is more likely to create medical issues than fix them.

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