Bottom Line: A U.S. Department of Justice investigation into the placement of implantable cardioverter-defibrillators (ICDs) in Medicare patients who didn't qualify for them based upon Medicare coverage criteria was associated with significant decreases in the use of the devices that shock the heart to restore normal rhythm and in the proportion of devices not meeting these established criteria.
Why The Research Is Interesting: The Department of Justice (DOJ) announced in 2010 it was investigating hospitals under the False Claims Act for overusing ICDs in patients who didn't meet criteria for Medicare reimbursement. The DOJ concluded its investigation in 2016 and reached settlements with more than 500 hospitals for more than $280 million.
Who and When: 300,151 ICDs implanted to prevent arrhythmia and sudden cardiac death in Medicare beneficiaries from 2007-2015 at 1,809 U.S. hospitals, of which 452 hospitals subsequently reached settlements with the DOJ.
What (Study Measures and Outcomes): DOJ investigation announcement in 2010 (exposure); proportion of ICDs not meeting Medicare coverage criteria (outcomes).
How (Study Design): This was an observational study. Researchers were not intervening for purposes of the study and cannot control for all the natural differences that could explain the study results.
Authors: Jeptha P. Curtis, M.D., Yale School of Medicine, New Haven, Connecticut, and coauthors
Results: The volume of ICDs and the proportion of devices not meeting Medicare coverage criteria decreased overall, and larger decreases were observed at hospitals that reached settlements with the DOJ.
Study Limitations: Analysis may not reflect all cases among non-Medicare beneficiaries and no public listing identifies all hospitals investigated by the DOJ.
Study Conclusions: The DOJ investigation was associated with significant declines in ICDs placed outside the National Coverage Determination at all hospitals, including patient populations that were not the focus of the investigation. The potential unintended consequences of the DOJ investigation warrant further study.
Related material: The editorial, "US Department of Justice Investigations of Implantable Cardioverter-Defibrillators and Quality Improvement in Health Care," by Paul A. Heidenreich, M.D., M.S., Stanford University School of Medicine, Palo Alto, California, is also available on the For The Media website.
To Learn More: The full study is available on the For The Media website.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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