CMS posts final decision on TENS

WASHINGTON - CMS hasn't changed its mind about dropping certain coverage for transcutaneous electrical nerve stimulation (TENS).

Earlier this year, CMS sought comments on a proposed decision memo that outlined its plans to pay for TENS for chronic lower back pain only when the patients using the devices are enrolled in an approved prospective clinical study. On June 8, the agency posted a final decision memo restating its position.

“Despite concerns expressed by seniors, physicians and members of Congress about access to pain therapy, CMS has decided to move ahead with this restrictive TENS policy,” said Tom Hughes, an attorney and executive director of the Neurostimulation Device Alliance, which represents manufacturers and suppliers. “It's a giant step in the wrong direction.”

A 2011 study by the American Academy of Neurology prompted CMS to reevaluate coverage for TENS. It found the devices ineffective for treating chronic lower back pain.

While CMS's decision to drop coverage for chronic lower back pain is a blow to the TENS market, coverage will stand for acute lower back pain (i.e. lasting less than three months) and other uses. There's also a growing cash market for other pain management products like hot/cold packs, stakeholders say.

“We don't have the exact number of people who use TENS for chronic lower back pain—it may be one of the bigger categories of users—but we're still pretty upbeat on the market,” said Paul Guth, president and CEO of Roscoe Medical. “There's no doubt CMS has made the wrong decision, but there are other products and treatments that will continue to be attractive.”

Still unknown: When will the change in coverage go into effect?

“At the end of the day, this is a decision memo, not an NCD,” Hughes said. “The memo informs the public that there will be a future implementation document, so there's more work for them to do.”

Also still unknown: Will the alliance continue to fight CMS's decision?

“Sure, the memo is not good, but will the alliance fold up the tent and go home—we're not sure yet,” Hughes said. “There are some who are hopeful that we will be able to continue to work on this.”