Three Clermont Labs Agree To Pay $2.45 Million To Settle False Claims Act Liability For Manipulating Diagnosis Codes

Orlando, FL – United States Attorney Roger B. Handberg announces today that Vista Clinical Diagnostics, LLC; Access Dermpath, Inc.; and Advanced Clinical Laboratories, Inc. have agreed to pay the United States, the State of Florida, the State of North Carolina, and the Commonwealth of Virginia $2,450,000 to resolve allegations that they violated the False Claims Act by submitting claims to Medicare and Medicaid that contained manipulated diagnosis codes. 

According to the settlement agreement, Vista Clinical Diagnostics, along with Access Dermpath and Advanced Clinical Laboratories, billed Medicare and Medicaid for clinical laboratory services using diagnosis codes that were generated by a macro and inserted into beneficiaries’ reimbursement submissions. This allegedly occurred during the period from January 1, 2017, through December 31, 2021. According to the allegations, these diagnosis codes were generated by the Defendants and not provided by the beneficiaries’ physicians. 

“My office is committed to investigating and federally prosecuting providers who submit false claims and attempt to cheat the system,” said U.S. Attorney Roger Handberg. “This case exemplifies our dedication to protecting our nation’s taxpayers from fraud.”

“Health care providers who receive Medicaid funds must be responsible stewards of taxpayers’ money,” said North Carolina Attorney General Josh Stein. “When they defraud North Carolinians, we will hold them accountable.”

“Medical providers who participate in federal health care programs must follow the law when billing federally funded health care programs such as Medicare and Medicaid,” said Special Agent in Charge Stephen Mahmood of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “This settlement illustrates HHS-OIG’s commitment to protecting the integrity of these taxpayer-funded programs and the people they serve. Working closely with the United States Attorney’s Office and our other law enforcement partners, we will continue to thoroughly investigate such schemes.”

The settlement concludes a lawsuit originally filed in the United States District Court for the Middle District of Florida by Relator Balbina Castillo, a former employee of Vista Clinical Diagnostics, who sued under the qui tam, or whistleblower, provisions of the False Claims Act permitting private citizens to sue on behalf of the United States for false claims and to share in the recovery. The Act also allows the United States to intervene and prosecute the action. The Relator will receive over $440,000.00 of the proceeds from the settlement with the Defendants.

The settlement agreement was subject to approval the by United States Bankruptcy Court for the Middle District of Florida. Vista Clinical Diagnostics filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code on October 2, 2023. That case is captioned In re: Vista Clinical Diagnostics, LLC, Case No. 6:23-bk-04109. The Bankruptcy Court approved the Settlement Agreement and confirmed Vista Clinical Diagnostic’s bankruptcy plan on July 9, 2024. 

Contemporaneous with the settlement, Vista Clinical Diagnostics, Access Dermpath, and Advanced Clinical Laboratories have entered into a five-year Corporate Integrity Agreement with HHS-OIG, which requires the labs, among other obligations, to establish and maintain a compliance program meeting certain requirements and to submit to an Independent Review Organization’s review of the labs’ Medicare claims to determine whether such claims were medically necessary, appropriately documented, and correctly coded.

This settlement resulted from a coordinated effort by the U.S. Attorney’s Office for the Middle District of Florida, Florida Office of the Attorney General Medicaid Fraud Control Unit (“MFCU”), North Carolina Office of the Attorney General MFCU, Virginia Office of the Attorney General MFCU, and the HHS Office of Inspector General. Assistant United States Attorneys Jeremy R. Bloor and Christopher Emden, Florida MFCU’s Senior Assistant Attorney General Matthew Vitale, North Carolina Special Deputy Attorney General Matthew Petracca, and Virginia Senior Assistant Attorney General Adele M. Neiburg led the investigation.

The government’s action in this matter illustrates the emphasis on combating health care fraud, and one of the most powerful tools in this effort is the False Claims Act. Tips from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).

The False Claims Act case is captioned United States ex rel. Castillo v. Vista Clinical Diagnostics, LLC, et al., Case No. 6:20-cv-617-ORL-WWB. The settlement resolves the United States, the State of Florida, the State of North Carolina, and the Commonwealth of Virginia’s claims in that case. The claims resolved by the settlement are allegations only, and there has been no determination of liability.