The Centers for Medicare & Medicaid Services (CMS) announced on April 27, 2005 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. 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 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.

In the evidence section of the decision memorandum, CMS specifically cited the position statement submitted by the ACFAS. The College strongly opposed the proposed decision to retain the failed prior surgery requirement as it limited the physicians’ ability to prescribe FDA-approved bone stimulator products and thus would severely limit patient care. The ACFAS expressed several areas of concern regarding the CMS proposed decision. Among them, that randomized controlled clinical trials in which patients are randomized to surgery or to ultrasound will be non-reflective of standard protocol and would not provide useful clinical information for decision making which would be highly inappropriate. Such a trial comparing ultrasound to surgery would also be unworkable because patients would drop out if randomized into a treatment group that is not desired.

The ACFAS also pointed out that the current clinical evidence for Exogen’s success in healing nonunions with or without prior surgery is more than adequate. The FDA-reviewed data “clearly demonstrates success healing non-unions in Medicare patients without prior surgery” and a widely-published economic model was cited indicating Exogen is the most cost-effective treatment option. The ACFAS concluded with its strong belief that the use of external bone stimulators can be effective without prior surgery and respectfully requested CMS remove the failed prior surgery requirement currently in place. CMS reviewed this evidence and “concluded that a clinical trial is not necessary and that ultrasound stimulation for the treatment of nonunion fractures without prior surgery is reasonable and necessary.”

The final decision memorandum appears as a PDF on the CMS web site at http://www.cms.hhs.gov/coverage/DM042605.pdf.