On June 20, the United States Attorney’s Office for the District of Delaware announced that it filed a civil complaint against a pain management provider, the Center for Interventional Pain and Spine (CIPS) and its principal owner, Dr. Chee Woo.

The lawsuit against CIPS and Dr. Woo alleges violations of the federal False Claims Act (FCA).  Specifically, the government alleges that the defendants violated the FCA by submitting claims for “thousands of” medically unnecessary diagnostic tests and services, some of which were allegedly never performed.

Much of the government’s complaint focuses on a common topic for FCA investigations and litigation – urine drug testing.  The complaint alleges that Dr. Woo and his practice “developed and implemented a urine drug testing protocol that required all CIPS’ patients to submit to urine drug tests every three months, regardless of whether the testing was supported by individual or clinical need.”  According to the complaint, the practice’s providers did not order the urine drug tests and, in many cases, were not even aware that the tests had been ordered.  Moreover, according to the government, the test results were not used to inform the diagnosis or treatment of the practice’s patients and, therefore, were medically unnecessary.

In addition to submitting false claims for urine drug tests, the complaint alleges that Dr. Woo and his practice also submitted thousands of false claims for psychological and neuropsychological tests that were not performed.  In particular, the complaint alleges that CIPS asked patients to self-complete health screening questionnaires that were ineligible for reimbursement, and then failed to use the results of these questionnaires to treat patients, even when the results indicated that medical interventions were warranted.

Significantly, this matter was not the result of a whistleblower lawsuit, but instead resulted from “a proactive analysis of Medicare claims data.”

This filing of this lawsuit demonstrates that the DOJ’s long-time focus on pain management, and in particular the frequency and appropriateness of urine drug screening, continues.  Pain management providers must be careful in crafting its UDS policies to ensure that such tests are billed only when medically necessary based upon the patient’s specific circumstances.  It is also imperative that the results of the tests are reviewed and incorporated, where appropriate, into the patient’s plan of care.  And, of course, providers must be sure to maintain detailed documentation to support their medical decision-making should they ever be questioned later.

This case also serves as a reminder that while the majority of FCA recovery comes as a result of whistleblower cases filed under the qui tam provisions (in FY2023, nearly 87% of total FCA settlements and judgments were the result of a qui tam lawsuit), proactive data analysis continues to become a powerful investigative tool, allowing the government to uncover instances of potential fraud without relying on a whistleblower, and without the necessity of sharing the eventual recovery with the whistleblower and the whistleblower’s lawyer.

The attorneys at Chilivis Grubman represent businesses of all types and sizes in connection with False Claims Act investigations and litigation.  If you need assistance with such a matter, please feel free to contact us today.