TENS is not reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Social Security Act

Medicare Set-Aside Blog on June 11, 2012 | Posted by


In an amazing moment of clarity, CMS announced today that the use of Transcutaneous Electrical Nerve Stimulation for the treatment of Chronic Low Back Pain has not proven effective enough to warrant Medicare coverage. Because TENS treatment was marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, it was grandfathered and has never been FDA approved to have a reasonable assurance of safety and effectiveness – i.e., not FDA approved to be effective or have clinical benefit for pain relief. Despite 359 comments received in the initial public comment period last fall and another 275 comments on the proposed decision memo, CMS still decided that, with the exception of certain clinical trials during the next three years, TENS shall not be covered by Medicare.

So how long until CMS/WCRC allows us to stop projecting for them in WCMSAs???