CMS: One step closer to dropping certain TENS coverage

BALTIMORE - Transcutaneous electrical nerve stimulation (TENS) for chronic lower back pain now has two strikes against it.

Strike 2: CMS in March issued a proposed NCD that essentially eliminates Medicare coverage for TENS for chronic lower back pain unless the patients using the devices are enrolled in an approved prospective clinical study, something called "coverage with evidence development." It will accept comments on the proposed NCD until April 12.

"Obviously, we're disappointed, but we're not demoralized," said Tom Hughes, an attorney and executive director of the Neurostimulation Device Alliance, which represents manufacturers and suppliers, in March.

Strike 1: Late last year, CMS announced it would review evidence of the use of TENS for chronic lower back pain, citing a 2010 American Academy of Neurology study that found the devices ineffective for treating that condition.

The alliance is concerned that CMS wants to apply "coverage with evidence development"—a policy often used with new technology—to TENS, a technology that's been in regular use for decades, Hughes said.

"That's unreasonable," he said.

The proposed NCD does not seek to eliminate coverage for TENS for acute lower back pain (i.e. lasting less than three months) or for other uses. But that's not much comfort to the alliance, Hughes said.

"There's a large number of patients who use TENS and a significant number of those patients use it for chronic lower back pain," he said.

Roscoe Medical, a member of the alliance that recently increased its presence in the TENS market significantly by acquiring another manufacturer of the devices, believes there's "still a very good chance" the proposed NCD will not become a final NCD, a decision CMS expects to make in June.

"CMS is always throwing things out to the industry and saying, 'Prove it wrong,'" said Paul Guth, president and CEO. "We're saying, 'Here's the evidence; it should continue to be a treatment method.'"