On Friday, July 1, 2011, the Centers for Medicare and Medicaid Services (CMS) released a proposed rulemaking (hereinafter “Proposed Rule”) that would have a significant impact on the categorical eligibility of certain types of durable medical equipment (DME) for Medicare coverage. See Proposed Rule. While the relevant provisions are intended to only apply prospectively for new products, the Proposed Rule would, if finalized, present serious problems for manufacturers of certain types of medical devices that do not have a minimum lifetime of three years. CMS is using the Proposed Rule to redefine the term “durable,” presumably in an attempt to address legal vulnerabilities arising from several Medicare contractor determinations made earlier this year. The Proposed Rule will be published in the Federal Register on July 8, 2011. CMS will accept comments regarding the Proposed Rule until August 30, 2011.
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