Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)

TENS for chronic low back pain (CLBP) is not covered for routine clinical use, but Medicare will cover TENS only when the beneficiary with CLBP (pain >=3 months, not due to a defined primary disease) is enrolled in an approved randomized controlled clinical study that meets specified CMS CED scientific, ethical, registration, and reporting standards. Studies must be registered on ClinicalTrials.gov prior to enrollment, include sham or active TENS comparators with equivalent concurrent care, address pain/function/utilization outcomes, comply with human subjects/FDA regulations, and the CED coverage is time-limited and expires three years after CMS publication of the decision.

"Beneficiary has chronic low back pain (CLBP), defined as low back pain persisting for >= 3 months and not a manifestation of a clearly defined primary disease."

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