The Centers for Medicare & Medicaid Services (CMS) has planned to initiate a national coverage determination (NCD) on ReGen Biologics' Menaflex this week. Menaflex is a collagen scaffold intended to treat of meniscal tears. NCDs are rare, with CMS issuing 18-24 decisions each year, and few of them are associated with orthopedic procedures.
The importance of NCD is it dictates coverage on a national level, rather than allowing local and regional CMS offices to make their own coverage determinations. This review for the early stage device (Menaflex was approved by the FDA in December 2008) may be troublesome for ReGen, as far as the breadth of available data. In a 311-patient study, the data supported patients with average age of 40 years. But CMS looked for whether the device is reasonable and necessary for patients over-65 age group, and while their decision affects only Medicare beneficiaries, private payers tend to follow NCDs. Existing data for Menaflex showed that patients with chronic meniscal disorders (and who had undergone prior meniscal procedures) regained more of their lost activity when compared to control patients who received a meniscectomy and underwent fewer non-protocol re-operations.
Based on what NCD prompted, the CMS website reported that the question of coverage was internally generated. It does follow heavy public scrutiny of the device, which stems from a FDA regulatory decision on which the company may have exerted undue influence. The FDA is reviewing the process currently by which ReGen received 510(k) clearance.