Category: MIL-OSI

Veloxis Pharmaceuticals Inc. (Veloxis), a drug manufacturer based in Cary, North Carolina, has agreed to pay over $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions and purchases of Envarsus XR (Envarsus), a kidney transplant immunosuppression drug. 

As part of the government’s resolution with Veloxis, the company entered into a deferred prosecution agreement (DPA) in connection with a criminal information filed today in the District of Massachusetts charging Veloxis with conspiracy to commit violations of the federal Anti-Kickback Statute by paying for, among other things, lavish meals, alcohol, and luxury resort stays, to induce healthcare providers to recommend or prescribe Envarsus. As part of the DPA, Veloxis has agreed to pay a criminal penalty of more than $10 million.

“Today’s resolution should serve as a warning to any healthcare company that tries to improperly influence the decisions of healthcare providers,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Kickbacks can erode medical decision-making, result in unnecessary prescriptions of branded drugs, and waste federal healthcare funds.”

“Attempting to improperly influence medical decision-making for financial gain is dangerous, yet it is exactly what Veloxis was doing. Instead of prioritizing patient safety, they were prioritizing profits,” said U.S. Attorney Leah B. Foley for the District of Massachusetts. “Treatment decisions need to be based on what’s best for the patient, not what’s best for the drug manufacturer’s bottom line, or what lavish meal or resort stay they can offer. We remain committed to protecting the integrity of taxpayer-funded health care programs. Drug manufacturers should know that the federal government will use all available enforcement mechanisms to stop the payment of illegal health care kickbacks.”

“Today’s settlement resolves allegations that Veloxis operated with a principal focus on sales, providing kickbacks in the form of luxury resort stays, lavish meals, and payments to induce health care professionals to recommend and prescribe its kidney transplant immunosuppression drug,” said Special Agent in Charge Ted E. Docks of the FBI Boston Field Office. “It’s harmful when pharmaceutical companies prioritize profits over patients. Just know that the FBI and our partners are committed to fighting health care offenses, one case at a time, and seeing perpetrators held accountable.”

“Kickbacks that distort medical decision making put patients at risk and undermine trust in our health care system,” said Acting Deputy Inspector General for Investigations Miranda L. Bennett of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Veloxis used lavish perks and concealed payments to push its drug, and today’s resolution makes clear that this conduct will not be tolerated. HHS OIG will continue working with our law enforcement partners to protect patients, uphold the integrity of federal health care programs, and hold companies accountable when they violate the law.”

Today’s resolution also includes a civil settlement of allegations that Veloxis caused the submission of false claims to federal healthcare programs by paying kickbacks to hospital personnel and specialty pharmacies, in violation of the False Claims Act. Veloxis has agreed to pay $34.45 million to the United States and certain states to resolve those civil allegations. In addition, Veloxis agreed to pay a $1.55 million civil penalty to the Centers for Medicare & Medicaid Services (CMS) to resolve allegations that Veloxis knowingly failed to report to CMS certain payments to physicians under the Open Payments Program (also known as the “Sunshine Act”). This is the largest Sunshine Act recovery since the law was passed in 2010.

As part of the criminal resolution and the Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General, Veloxis has agreed to implement a significant corporate compliance program, including adoption of an enhanced system of policies, procedures, and internal controls designed to deter and detect violations of the Anti-Kickback Statute, and implementation of enhanced oversight, reporting, and enforcement mechanisms.

The Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid, and other federally funded healthcare programs. It seeks to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients. Similarly, Congress created the Open Payments Program to provide greater transparency and protection to consumers by requiring drug manufacturers and others to publicly disclose certain payments and other transfers of value to physicians, with the goal of discouraging the development of inappropriate relationships and potentially unnecessary healthcare costs that can arise from such conflicts.

Veloxis’ Criminal Liability for Conspiring to Pay Kickbacks

According to admissions and court documents filed in the District of Massachusetts, from October 2016 and continuing through in or around June 2023, Veloxis and its employees engaged in a scheme to pay kickbacks to transplant health care providers (HCPs) to induce them to prescribe, order, or recommend or arrange for prescribing or ordering Envarsus for kidney transplant recipients. During the relevant time, Veloxis manufactured and sold a single drug, Envarsus, for use as an immunosuppressant in adult kidney transplant recipients. Envarsus, a drug taken once a day for the life of the kidney transplant recipient, competed against the generic form of the same drug, which was taken only once a day. To gain market share for Envarsus against a cheaper generic drug, Veloxis engaged in an aggressive marketing strategy pursuant to which it promoted Envarsus to HCPs at and tied to transplant centers and hospitals who could influence the placement of Envarsus on the formulary and/or protocol of their respective facilities.

These marketing efforts included various tactics that violated the federal Anti-Kickback Statute, including but not limited to: taking HCPs and at times, their spouses or guests, to lavish dinners and on expensive trips and retreats under the guise of “advisory boards,” providing gifts and expensive alcohol to HCPs, and making purported consulting payments to HCPs for work that was not actually performed. In many of these instances, Veloxis employees submitted falsified company expense reports to conceal their illegal marketing efforts, including by falsely adding names to the list of attendees at dinners and events (to decrease the apparent cost per attendee of the meals) and omitting the names of physicians who attended the meals (to avoid Sunshine Act reporting requirements). This false reporting resulted in Veloxis’ failure to properly report the sums it paid to physicians, which further obscured its illegal activities.

Veloxis admitted that it intended the improper remuneration it provided to HCPs to result in increased Envarsus prescriptions, as demonstrated, in part, by communications between Veloxis employees and certain HCPs. For example, in connection with a surgeon’s request to attend a speaker program, a Veloxis employee told the surgeon that the Veloxis employee “need[ed] scripts. Lots of them.” Several months earlier, the Veloxis employee had told the surgeon that he was “over Sales” and needed the surgeon “more than ever,” and instructed the surgeon that it was “[t]ime to open your Rolodex and make things happen.” The statement of facts filed with the DPA today details additional examples of Veloxis’ kickbacks and related efforts to disguise and conceal its unlawful conduct.

Veloxis’ Civil Liability for False Claims to Federal Healthcare Programs

The resolution announced today also resolves allegations that Veloxis violated the False Claims Act by knowingly causing the submission of claims to Medicare, Medicaid, and TRICARE for Envarsus prescriptions written by HCPs or filled by pharmacies to which Veloxis had knowingly and willfully paid kickbacks in violation of the Anti-Kickback Statute. In connection with the civil settlement agreement, Veloxis admitted that from 2016 to 2023, it paid kickbacks to HCPs in the form of lavish meals, alcoholic beverages, expensive trips, resort stays, gifts, and purported consulting fees to induce prescriptions of Envarsus. Veloxis admitted that it concealed those kickbacks by falsifying company expense reports and business records as to the recipients, amounts, and purpose of the payments; and creating consulting agreements for purported consulting work that was not actually performed.

With respect to Veloxis’ obligation to report physician payments under CMS’s Open Payments Program, Veloxis admitted that because its reports to CMS were based on falsified expense reports, Veloxis underreported, or failed to report, the true amounts of its payments or transfers of value to those physicians. 

In addition, Veloxis admitted that from 2017 to 2023, it paid kickbacks to specialty pharmacies in the form of per-patient and per-month payments to induce those pharmacies to begin or continue purchasing Envarsus instead of competitor drugs, including a cheaper generic drug. Veloxis admitted that it disguised the unlawful purpose of the kickback payments to the pharmacies by falsely describing the payments in written contracts as being for “enhanced services” such as data collection or adherence services. In fact, Veloxis admitted that it paid the pharmacies regardless of whether they provided any data, provided the specified data fields, or provided the data in the specified format, and without confirming whether any adherence services were provided.

Under the civil settlement agreement, Veloxis will pay $21,211,251 to the United States to resolve the False Claims Act allegations and an additional $13,238,749 to certain States for claims settled by certain State Medicaid programs. Veloxis also agreed to pay a civil penalty of $1.55 million to resolve allegations that it knowingly failed to report the amounts of its payments to physicians under the CMS’s Open Payments Program. In connection with the civil settlement, Veloxis entered into a five-year Corporate Integrity Agreement (CIA) with the HHS-OIG. The CIA requires, among other compliance provisions, that Veloxis implement a compliance program to identify and address the Anti-Kickback Statute risks associated with other financial arrangements and retain an independent compliance expert to perform a review of the effectiveness of the compliance program.

Veloxis received credit under the Department of Justice’s guidelines for accounting for disclosure, cooperation, and remediation in False Claims Act cases. Among other things, Veloxis admitted liability and accepted responsibility for the misconduct, proactively disclosed inculpatory evidence not known to the government, and facilitated interviews with current and former employees and the collection of evidence from third parties. Veloxis also received credit for taking timely and remedial measures, including terminating employees responsible for the misconduct, updating and revising policies and procedures related to the Anti-Kickback Statute, adopting enhanced training, reporting, compliance, disciplinary, and internal investigations programs, and terminating agreements and relationships with third parties involved in the offense conduct.

The claims resolved in today’s settlement include certain claims that were brought under the qui tam or whistleblower provisions of the False Claims Act. The qui tam case is captioned United States ex rel. Toulsor1, Inc. v. Veloxis Pharmaceuticals A/S, et al., No. 1:20-cv-11575 (D. Mass.).

The government’s pursuit of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 1-800-HHS-TIPS (800-447-8477).

This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.

The criminal case is being prosecuted by Assistant U.S. Attorneys Leslie A. Wright and Christopher R. Looney for the District of Massachusetts. The civil investigation and resolution were handled by Assistant Director Christopher Terranova of the Civil Division’s Commercial Litigation Branch, Fraud Section, and Assistant U.S. Attorneys Steven T. Sharobem and Lindsey E. Weinstein for the District of Massachusetts. The FBI, HHS-OIG, DCIS, Office of Personnel Management Office of Inspector General, Department of Veterans Affairs Office of Inspector General, and U.S. Postal Service Office of Inspector General investigated the case.