The Centers for Medicare & Medicaid Services (CMS) announced today that it intends to expand Medicare coverage of ultrasound stimulation for fractures that are not healing properly, called nonunion fractures. CMS will perform a post-coverage analysis of claims data to examine the net health benefit of ultrasound stimulation for nonunion fractures without prior surgery.
“We are making this bone healing treatment more widely available, while at the same time gaining knowledge that will better inform our coverage decision process,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “And we are doing it without any additional burden to beneficiaries or providers.”
The post-coverage analysis will examine the claims data submitted to CMS for the evaluation of the health benefits of ultrasound treatment. By evaluating this data, CMS will develop better evidence and ensure that Medicare beneficiaries are receiving quality health care.
Ultrasound stimulation, a non-invasive treatment for nonunion fractures, has been covered for Medicare beneficiaries when surgery has failed since 2000. CMS developed this new coverage decision in response to a request by Smith & Nephew, a manufacturer of an ultrasonic bone healing system, to remove the coverage requirement that surgery must have failed before ultrasound can be used as a treatment.
CMS found the new evidence was adequate to conclude that non-invasive ultrasound stimulation for the treatment of nonunion bone fractures prior to surgical intervention is reasonable and necessary. Expanding coverage to include patients without any prior surgical treatments will benefit Medicare beneficiaries and provide another non-surgical treatment option for patients that are not good surgical candidates.
“This decision is part of Medicare’s ongoing commitment to provide new medical technology to its beneficiaries,” said CMS Administrator, Mark B. McClellan, M.D., Ph.D.
CMS is publishing its decision memorandum today in accordance with the coverage decision timeline mandated by the Medicare Modernization Act of 2003 (MMA). The final decision memorandum appears on the CMS web site at http://www.cms.hhs.gov/coverage.