CMS's new MO: Put codes on the chopping block?

BALTIMORE - An alliance of manufacturers and providers of transcutaneous electrical stimulation (TENS) devices had a pivotal meeting with CMS last month to make its case in person that Medicare should continue paying for the therapy to treat chronic lower back pain.

“We had a good discussion,” said Tom Hughes, an attorney and executive director of the Neurostimulation Device Alliance. “We made some good points, and we agreed that we'll be providing them with more information, as a result of the questions they had.”

CMS is currently reviewing evidence for using TENS devices to treat chronic lower back pain, citing a 2010 American Academy of Neurology study that found the therapy was ineffective for treating the condition.

The alliance submitted evidence for CMS's review by its Oct. 13 deadline, but it also requested a meeting with the agency to provide additional evidence. It brought to the meeting, for example, a statistician who has analyzed the effectiveness of TENS devices from both a treatment and cost perspective.

The alliance will learn if its efforts have paid off in March, when CMS plans to publish a proposed decision on paying for TENS devices to treat chronic lower back pain. CMS expects to have a final decision in June.

Adroit Medical Systems, a manufacturer of heath therapy units, knows all too well what TENS manufacturers are going through. In April of 2010, CMS essentially stopped paying for the units to treat chronic pain. Adroit now plans to offer a unit that's appropriate for retail sale.

“Even though we're primarily an OEM company and Medicare was a small percentage of our business, we've had to re-strategize,” said Scott Gammons, vice president. “It was a blow.”

Adroit Medical blames the demise of heat therapy units on CMS's inability to properly regulate units approved for reimbursement, making it a hotbed for fraud.

“Our product is FDA approved and it wasn't available without prescription,” he said. “But there were other products that were cheaper and lower quality that were getting the same reimbursement, giving a huge incentive for people to put out as many as possible. What has happened proves that the only way Medicare can deal with a code that has been abused is to cut it completely.”

The alliance believes that it has clinical evidence and history on its side.

“TENS has been the standard of practice for chronic lower back pain for decades,” Hughes said.