It appears that a TENS unit, a small electronic device that many doctors prescribe to help patients block low back pain throughout the day, will no longer be covered by Medicare due to conflicting efficacy reports. Is this the Federal government saving money at the patient's expense?

Medicare Says 'No' to TENS for Low Back Pain

By John Gever, Senior Editor, MedPage TodayPublished: March 14, 2012
 

Medicare is set to withdraw most coverage of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, the Centers for Medicare and Medicaid Services indicated Tuesday.

Reimbursements for this indication would be available only when patients are participating in a randomized, controlled trial of the technology's clinical effectiveness, according to a proposed decision memo from CMS.

Currently, Medicare pays for FDA-approved TENS equipment and supplies when prescribed by a physician for chronic intractable pain, and reimburses physicians and physical therapists for evaluating patients' suitability for the treatment, which is typically used at home.

CMS decided on its own to review its coverage of TENS for chronic low back pain in the wake of a 2010 report by an American Academy of Neurology panel that found the treatment was not effective.

The panel had conducted a systematic review of published studies of TENS. "The review concluded that there was conflicting evidence for the use of TENS in the treatment of chronic low back pain and that TENS should be deemed ineffective for this purpose," the CMS memo said.

CMS also cited a series of other reviews that failed to find clear support for the technology's efficacy. On the other hand, some individual studies had shown that it can reduce pain and improve patients' physical function.

The memo also noted that the National Institute of Neurological Disorders and Stroke has listed TENS as a "possible treatment option" for lower back pain that has not responded to conventional therapies.

But in the absence of consistent evidence of TENS's efficacy in this indication, CMS plans to withhold coverage except in the context of randomized trials.

Patients in such trials must have been suffering for low back pain for at least three months, with the pain not resulting from conditions such as inflammatory autoimmune disease or metastatic spinal tumors. The trials must also directly address TENS's clinical efficacy and be designed and powered to yield clear-cut answers. Listing on the Clinicaltrials.gov website is mandatory.

CMS emphasized that Medicare will continue to reimburse for TENS when prescribed for chronic, treatment-refractory pain indications other than low back pain, such as for patients with chronic or severe post-operative pain.

CMS is accepting public comments on the proposed decision through April 12, after which it will issue a final determination.