In 2015, the United States Department of Justice reached 70 settlements involving 457 hospitals in 43 states for more than $250 million related to cardiac devices that were implanted in Medicare patients in violation of Medicare National Coverage Determinations (NCDs). The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. The medical purposes of waiting periods are to give the heart an opportunity to improve function on its own to the point that an ICD may not be medically necessary, as well as to avoid the cost of implanting an expensive ICD into a patient that may not survive either the heart attack or treatment. The NCD expressly prohibits implantation of ICDs during the waiting periods. The False Claims Act (FCA) relator studied MEDPAR claims from from 2003 to 2010 to identify the 457 hospitals. This was the first FCA case to have settled using administrative claims to identify the violators.

Methodology: PurpleLab further examined Medicare Fee-For-Service administrative claims during subsequent periods 2010 to 2014 using CMS Limited Data Sets (LDS). PurpleLab identified ICD implantation using a number of relevant ICD9 procedure codes. Each ICD implantation observed within the period of study was identified as an “indexing event”. Using the date of the claim for the “indexing event”, queries were executed to scan for “predicate events” within a 90-day window for Percutaneous Coronary Interventions (PCIs) and within a 40-day window for Coronary artery Bypass Grafts (CABGs) using additional relevant ICD9 procedure and diagnosis codes to identify cases that appear to violate the NCDs established by Medicare around the appropriateness of ICDs. PurpleLab identified additional HCOs that appear to have provided inappropriate care and improper billing in addition to those previously identified by the Department of Justice.