Healthcare fraud and abuse in spine surgery: a review of medicolegal actions brought by the United States federal government.

Abstract

Healthcare fraud and abuse can lead to overutilization, greater care costs, corruption of medical decision-making, and unfair competition. Because of the close relationship between spine surgeons and medical device companies, it is important that spine surgeons understand their legal environment to properly comply with statutory requirements and avoid criminal violations. The aim of this study was to review the major types of healthcare fraud relevant to spine surgery and identify the legal characteristics of cases brought by the US Department of Justice (DOJ). A retrospective review of closed cases brought by the DOJ under five major healthcare fraud and abuse laws, as well as settlements involving healthcare fraud, was performed without time constraints in the legal research database Westlaw Edge. All cases were screened by two independent reviewers, and discrepancies were settled by the first author. Of the 54 cases included in the final analysis, most involved settlements (n = 42, 78%) or guilty pleas (n = 10, 19%). Most cases involved multiple defendants (n = 36, 67%), with medical device companies being named in 48 cases (89%), hospitals in 15 cases (28%), and physicians in 13 cases (24%). An ultimate ruling against the defendant occurred in 52 cases (96%), including 7 criminal convictions resulting in a median total incarceration of 60 months. Most federal indictments were based on the False Claims Act (45 of 87, 52%) or the Anti-Kickback Statute (29 of 87 claims, 33%), but cases involving the Physician Self-Referral Law/Stark Law (2 of 87, 2%) and the Exclusion Authorities Law (11 of 87 claims, 13%) were also represented. The median award for settlements was $4,410,000 (range $177,000-$82,900,000). Spinal implants were involved in 22 cases (41%), and the remaining cases were related to spinal stimulators or intrathecal pain pumps. In cases brought under the qui tam provision of the False Claims Act (n = 25, 46%), the median payout of the entire lawsuit was $5,182,139 (range $228,556-$96,277,279). The median payout for the qui tam relators themselves was $2,786,981 (range $338,649-$15,513,351), representing 17% (range 10%-27%) of the total award payout. Most cases originated in the Northeast region of the US (n = 20, 37%). Most cases of healthcare fraud involving spine surgery resulted in a settlement (78%) or a guilty plea by the defendant (18%). Violations of healthcare fraud and abuse laws in the field of spine surgery can lead to exorbitant fines, exclusion from federal healthcare programs, and even incarceration. These findings can inform spine surgeons and other healthcare providers of the dynamics of healthcare fraud and abuse laws, as well as the consequences of violating such statutes.