CMS Makes Policy Waves With Pullback Of Longstanding TENS Coverage

Article preview from "The Gray Sheet"-  June 18, 2012

The new finalized coverage policy for transcutaneous electrical nerve stimulation for treating chronic back pain is a rare decision by the agency to reverse coverage on an established technology, and is a new direction for the coverage-with-evidence-development program, observers say.

 

CMS Makes Policy Waves With Pullback Of Longstanding TENS Coverage

Article preview from "The Gray Sheet"-  June 18, 2012

CMS moved ahead with a restrictive coverage-with-evidence-development policy for a long-used chronic back pain therapy over the protests of product stakeholders and broader device industry interests who worry about the precedent it sets.

The agency issued its final national coverage decision memo for transcutaneous electrical nerve stimulation for treating chronic back pain June 8, sticking with the basic approach laid out in a proposal earlier this year.

CMS says TENS “is not reasonable and necessary for the treatment of chronic low-back pain.” But it has decided to allow limited coverage for the treatment in the context of randomized, controlled trials that seek to answer specific, pre-specified questions about the clinical impact of TENS. Under the final decision, the trials must be completed within three years, when coverage for the treatment will expire unless new data can be used to convince CMS to re-open a coverage analysis.

While it is not unusual for impacted product makers and clinicians to cry foul in reaction to Medicare coverage limitations, this case has attracted additional attention because TENS is an established treatment. Until now, it has had relatively broad coverage under a national Medicare policy for more than 20 years to treat low-back pain.

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