Tuesday, June 12, 2012 CMS Retains Clinical Study Requirement in Final TENS Decision Memo Despite APTA's urging for continued Medicare coverage of TENS for chronic low back pain (CLBP) and additional research regarding the circumstances when the use of TENS for CLBP is effective, the Centers for Medicare and Medicaid Services (CMS) finalized the requirement of enrollment in an approved clinical study to receive coverage for TENS for CLBP. In its final decision memo, CMS said that the clinical study requirement is to support additional research on the use of TENS for CLBP, and this requirement will expire in 3 years. CMS says in the memo that based on its review of the evidence, "… we have determined that TENS is not reasonable and necessary for CLBP under 1862(a)(1)(A) of the Act. Neither the comments we received, nor the discussions that we have had with industry and investigators, have provided us with the persuasive scientific evidence to reach a different conclusion." Thus, at the expiration of the 3-year clinical study requirement, TENS for CLBP will not be covered, as it will be considered not reasonable and necessary. Links to APTA's comments and summary on the National Coverage Analysis Tracking Sheet for TENS for Chronic Low Back Pain can be found on APTA's Medicare Coverage Issues webpage. APTA members commented extensively on CMS's proposal memo in News Now coverage posted March 14 and April 3.