CMS issued a Medicare National Coverage Determination (NCD) on June 8, 2012 that allows coverage of Transcutaneous Electrical Nerve Stimulation (TENS) for chronic low back pain (CLBP) only when the patient is enrolled in an approved clinical study within three years after the publication of this decision (i.e., June 8, 2015) under coverage with evidence development (CED) that meets the criteria outlined below. 1
- The beneficiary is enrolled in an approved clinical study meeting all of the requirements below. The study must address one or more aspects of the following questions in a randomized, controlled design using validated and reliable instruments. This can include randomized crossover designs when the impact of prior TENS use is appropriately accounted for in the study protocol.
- Does the use of TENS provide clinically meaningful reduction in pain in Medicare beneficiaries with CLBP?
- Does the use of TENS provide a clinically meaningful improvement of function in Medicare beneficiaries with CLBP?
- Does the use of TENS impact the utilization of other medical treatments or services used in the medical management of CLBP?
- These studies must be designed so that the patients in the control and comparison groups receive the same concurrent treatments and either sham (placebo) TENS or active TENS intervention.
The results of additional clinical research may potentially provide sufficient evidence to inform future NCDs on the topic. CMS will maintain a list of all approved studies and post that list on this website.
Currently, no clinical studies involving TENS for the treatment of CLBP have been approved by CMS.
For more details and guidance on the development of a clinical trial for the use of TENS in CLBP, go to /medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=256
1 CLBP, for the purposes of this decision, is defined as an episode of low back pain that has persisted for three months or longer, and is not a manifestation of a clearly defined and generally recognizable primary disease entity (e.g., cancer, multiple sclerosis and rheumatoid arthritis).