半月板损伤修复仍无金标准

Dr.LinZhen

CMS Nixes Coverage of Collagen Meniscus Implant

By Todd Neale, Staff Writer, MedPage Today Published: June 02, 2010 WASHINGTON -- Medicare will not cover the collagen meniscus implant for meniscal injuries, according to a decision memo from the Centers for Medicare and Medicaid Services (CMS). Before this national noncoverage determination -- which became effective May 25 -- coverage for the implant procedure was decided by local Medicare contractors. According to Medicare Part B claims data for 2007, over 125,000 meniscectomies were performed on Medicare beneficiaries. But after a review of the literature, which included one randomized controlled trial and six small case series, the CMS concluded that the collagen meniscus implant does not improve health outcomes in the Medicare population and therefore is not "reasonable or necessary" for meniscal injuries or tears. A gold standard for the treatment of meniscal injury has not been established, and there are no published guidelines for treatment. The only FDA-approved collagen meniscus implant, marketed as Menaflex by ReGen Biologics, is designed to fill meniscal defects remaining after a partial meniscectomy. It cannot replace the entire meniscus because it requires a meniscal rim for attachment, serving as a temporary scaffold for tissue ingrowth. The implant, approved in 2008, is placed through an arthroscopic procedure and sutured into place. The only randomized controlled clinical trial compared the Menaflex implant placed after partial meniscectomy with a partial meniscectomy alone. The trial included 311 patients with a mean age of 40. None of the patients were older than 60. The trial found no differences between the implant and control groups on any of the three primary outcomes related to pain, function, and patient satisfaction. There was a benefit found in a subset of patients on the Tegner Index, but the CMS report noted that this was not a prespecified primary or secondary endpoint and therefore has unclear clinical significance. "We do not find this evidence to be compelling to demonstrate that the collagen meniscus implant improves health outcomes," the CMS said in its memo. FDA performed its own analysis of the raw data from the trial, revealing a higher rate of serious adverse events with the implant, which "brings into question possible patient harms related to the collagen meniscus implant," according to the CMS. The FDA review also identified discrepancies between published data from the clinical trial and data presented to the FDA. The CMS called this finding "disconcerting." The CMS acknowledged that none of the studies included in its review involved patients older than 60, and that it had yet to be determined whether the results would apply to older patients. The agency concluded, "There is no evidence of benefit of improved outcomes in the study population for the collagen meniscus implant and this outcome of no benefit is generalizable to the older Medicare population." A statement by Gerald Bisbee Jr., PhD, chairman and CEO of ReGen Biologics, headquartered in Hackensack, N.J., said the CMS decision was inappropriate for two reasons. First, he said, no data exist on the use of the implant in a Medicare population because it is not intended to be used widely in older patients -- which the company had explained to the CMS. "There are companies that have been waiting years to obtain national coverage decisions on products appropriate for the Medicare population," Bisbee said. "We find it curious, at best, that ReGen has been subjected to a national coverage decision that the company did not request which is related to a product that is not intended for a Medicare population." The second reason the CMS decision was inappropriate, according to Bisbee's statement, is that it was "based on a flawed FDA internal review rejected by two FDA advisory panels that found that the device was safe and would reinforce and repair damaged tissue like other surgical meshes."