TranS1 Inc. has reached a tentative agreement to settle a federal investigation for $6 million.
TranS1 Settles Fed Investigation for $6 Million
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Secondary
The U.S. Department of Justice, on behalf of the Department of Health and Human Services, Office of Inspector General, issued a subpoena against the company in October 2011. The subpoena was issued under the authority of the federal healthcare fraud and false claims statutes and sought documents for the period January 1, 2008 through October 6, 2011. Industry insiders speculated the investigation was related to coding issues.
Coding
On November 2, 2012, the company announced that the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services, approved and released the valuation of the Category I Current Procedure Terminology (CPT) code 22586 for pre-sacral interbody single level spinal fusion at L5-S1 to be effective January 1, 2013.
CPT code 22586, which applies to the company’s AxiaLIF 1L+ device, is a bundled lumbar arthrodesis procedure that includes bone graft, posterior instrumentation, and fixation which has been assigned a work Relative Value Unit (RVU) of 28.12 for calendar year 2013.
The December 24 announcement of agreement is subject to completion and approval of a written settlement with the government. A final agreement is expected in the first few months of 2013. The company admitted no wrongdoing.
“TranS1 has cooperated fully with this investigation and the proposed settlement is consistent with our efforts to instill a culture of compliance throughout the company, ” stated Ken Reali, TranS1’s president and CEO. “We believe that resolving this issue and reducing the related financial uncertainty is in the best interests of the company and its shareholders.”
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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