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Chart: Should Medicare Cover Menaflex?

This article was originally published in The Gray Sheet

Executive Summary

When CMS began a coverage review for ReGen Biologics' Menaflex collagen meniscus implant on Aug. 27, it declined to say whether the internally generated action was related to the FDA controversy over the product ("The Gray Sheet" Aug. 31, 2009). Numerous commenters expressed surprise that CMS would consider Medicare coverage for a product not intended for and never studied in patients age 65 and older, and point out that a negative coverage decision could influence other insurers not to cover younger patients who might benefit from the device. Key comments, which were due Sept. 26, are excerpted below.

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