CMS Nixes TENS for Back Pain
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: June 11, 2012
WASHINGTON — Medicare will no longer cover most uses of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, according to a memo issued by the Centers for Medicare and Medicaid Services (CMS).
Reimbursement for TENS for low back pain will be available only when patients are participating in a randomized, controlled trial of the technology’s clinical effectiveness, CMS officials wrote in the final decision, which was released Friday and is effective immediately.
“TENS is not reasonable and necessary for the treatment of [chronic low back pain],” they wrote.
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.
TENS units are usually small, portable battery operated devices that deliver electrical currents to the skin through electrodes.
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.That panel had conducted a systematic review of published studies of TENS and concluded 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.”
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.
CMS has been accepting comments on its proposal to stop paying for TENS since September 2011 and has received 275 comments on the issue, including many from individuals and groups urging CMS to not cut reimbursement for TENS for low-back pain. One commenter worried that CMS would eliminate other long-standing treatments in the future.
To which CMS responded: “Long-standing use of a medical treatment is unfortunately no guarantee that it is in fact clinically appropriate or necessary.”
Others accused CMS of interfering with the physician-patient relationship, and some doctors told CMS of patients they’ve treated who have achieved lasting pain relief from use of TENS and were able to reduce the amount of medication and avoid surgery.
“While we acknowledge that some individuals are sincerely conveying their personal experiences with TENS, we must point out that evidence from formal clinical studies is more persuasive to draw confident conclusions about the impact of medical technologies,” CMS wrote it its decision memo.
CMS plans to withhold coverage, but it will continue to fund randomized clinical trials of TENS for 3 years. Patients in such trials must have been suffering for low back pain for at least 3 months, with the pain not resulting from conditions such as inflammatory autoimmune disease or metastatic spinal tumors. The trials also must directly address TENS’ clinical efficacy and be designed and powered to yield clear-cut answers.
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 postoperative pain.
Low back pain is the fifth most common medical complaint for which people seek medical treatment, and between 75% and 80% of individuals in the U.S. will experience an episode of low back pain at some point in their lifetime, according to the agency. For most people, low-back pain is a short-lived condition, but for a small proportion of people, it can be disabling.