Device companies that market transcutaneous electrical nerve stimulation devices will face new CMS coverage limits against using the treatment to address chronic low back pain.
The decision memo, issued by the Centers for Medicare & Medicaid Services, is expected to lead to a final, national coverage decision later in 2012. In essence, CMS has determined that the treatment isn't a "reasonable and necessary" option for chronic low back pain. As a result, the agency says it would limit coverage to patients enrolled in approved clinical studies, exploring whether the treatment helps meaningfully reduce chronic low back pain and improve function for Medicare patients, but doesn't adversely affect their use of other treatments or services used to treat the condition.
RS Medical, a company that produces the technology to treat back pain and other forms of chronic pain, publicized the decision in a formal news release and noted that transcutaneous electrical nerve stimulation, or TENS, will still be covered by Medicare for "painful conditions other than chronic low back pain." But the company also said it disagreed with the CMS conclusion, adding, for example, that 50% of all U.S. workers have experienced some symptoms of back pain.
But many other companies are also likely to be affected by the decision to limit reimbursement for TENS therapies, which have been used to treat various forms of pain since the 1970s. St. Jude Medical ($STJ) and NeuroMetrix ($NEURO) are just two others in the space, both of which either have, or are developing, TENS devices to address immediate pain symptoms or other conditions such as migraines.
- read the CMS decision memo
- here's RS Medical's announcement