Trouble for TENS?

Monday, October 3, 2011

BALTIMORE – Never mind cutting reimbursement. Manufacturers fear CMS may stop paying for transcutaneous electrical nerve stimulation (TENS) for the treatment of a certain condition altogether.

In a recent transmittal, CMS cited a 2010 American Academy of Neurology (AAN) study that found TENS was ineffective for treating chronic lower back pain, and stated that it has decided to review evidence of the use of TENS for that condition.

“TENS has become the standard treatment for chronic pain over the years,” said Tom Hughes, an attorney and executive director of the newly formed Neurostimulation Device Alliance, which represents TENS manufacturers and suppliers. “It’s an effective alternative to prescription drugs, because it’s non-systemic and cost effective. So it’s an important tool in the healthcare provider’s toolkit.”

Interested parties have until Oct. 13 to submit evidence for CMS’s consideration.

CMS stated it was seeking, in particular, “evidence to the health outcomes attributable to the use of TENS in home settings,” and that’s just what manufacturers plan to give the agency.

“There are two other meta-analyses that looked at more studies and found positive benefit from using TENS to treat not only chronic lower back pain but also chronic back pain overall,” said John Velure, vice president of North American operations for Neurotech NA, and a founding member of the alliance. “We’re surprised that they elected to only reference the AAN’s meta-analysis.”

Not only is the evidence there that TENS is an effective treatment for chronic lower back pain, manufacturers say, but so is a “rigorous” review process to make sure TENS is doing its job.

“Medicare pays for an initial rental of a TENS device, but then the patient has to go back to the physician so he can determine whether the patient continues on the device,” Hughes said. “That’s another reason why we’re surprised this came up.”

Manufactures hope the silver lining in CMS’s review will be improved communication.

“We want to work with CMS to make sure we’ve provided them with all the available evidence to make a wise decision about continuing coverage for TENS,” Hughes said.