After the FDA approves a device, surgeons, ASCs, hospitals and other providers often have to wait months for Medicare coverage decisions because CMS lacks sufficient clinical data to make a decision. This also slows down reimbursement by private payors, who tend to wait for Medicare payment decisions.
In a memorandum of understanding released on July 23, the FDA and CMS are proposing data-sharing and concurrent evaluations that could speed up reimbursement decisions. A 90-day public comment period on the proposed collaboration begins Sept. 17.
However, Mass Device warned the new agreement could have little effect on moving up coverage decisions. The publication stated in a July article, “No matter how free communication becomes between the Food & Drug Administration and the Centers for Medicare and Medicaid Services, it’s still going to require a lot of post-approval data to drive coverage decisions.”
Read the Mass Device report on new medical devices.
Read the FDA-CMS memorandum of understanding on new medical devices.
Read more coverage on medical devices:
– 10 Orthopedic and Spine Devices Recently Launched or Approved
– Orthopedic Implant Device Can Increase Bone Length
– Top 5 Orthopedic Device Companies Based on 2009 Revenues
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