Ashley Moody Helps Secure $300 Million Following Investigation into Improper Marketing, Sale of Suboxone

State Attorney General Ashley Moody, working with state and federal partners, helped secure $300 million following a nationwide investigation.

Moody’s Medicaid Fraud Control Unit (MFCU) worked with the U.S. Department of Justice and other state MFCUs to investigate allegations that Indivior plc. and Indivior Inc., d/b/a Indivior, falsely and aggressively marketed and otherwise promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds. Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.

“The opioid epidemic is claiming the lives of Floridians every day. It is reprehensible that these companies would prey on those recovering from opioid addiction to earn a dishonest dollar. Even more disturbing, they exploited the taxpayer-funded Medicaid program to get the job done. Thanks to my Medicaid Fraud Control Unit and the Department of Justice, these companies are being held accountable and relief will go to the government health care programs affected by these aggressive and predatory tactics,” Moody said.

As a result of the investigation, Indivior will pay a total sum of $300 million to resolve various civil-fraud allegations impacting Medicaid and other government health care programs—with more than $203 million going to Medicaid. Florida’s Medicaid share of the nationwide recovery is approximately $1.3 million.

The investigation arose from six separate qui tam actions filed in the U.S. District Courts for the Western District of Virginia and the District of New Jersey. The agreement resolves allegations that Indivior directly or through its subsidiaries:

Promoted the sale and use of Suboxone to physicians who were writing prescriptions that were not for a medically accepted indication in that they lacked a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, medically unnecessary and often diverted;

Knowingly promoted the sale or use of Suboxone Sublingual Film (SSF) based on false and misleading claims that SSF was less subject to diversion and abuse than other buprenorphine products and that SSF was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets; and

Submitted a petition to the Food and Drug Administration, fraudulently claiming that Suboxone Tablet had been discontinued due to safety concerns about the tablet formulation of the drug and took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone, including pricing to the states’ Medicaid programs.

Regarding the federal criminal case against Indivior on July 24, 2020, Indivior Solutions pleaded guilty to a one-count felony information and, together with its parent companies Indivior Inc. and Indivior plc., agreed to pay a total of $289 million to resolve criminal liability associated with the marketing of Suboxone. In its guilty plea, Indivior Solutions admitted to making false statements to promote Suboxone Film to the Massachusetts Medicaid program relating to the safety of Suboxone Film around children.

On Nov. 12, 2020, U.S. District Judge James P. Jones of the Western District of Virginia sentenced Indivior Solutions to pay $289 million in criminal fines, forfeiture and restitution. In addition to the criminal and civil resolutions, Indivior executed a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services—Office of Inspector General, requiring Indivior to implement numerous accountability and auditing provisions.

On June 30, 2020, Indivior plc.’s former CEO Shaun Thaxton pleaded guilty to a one-count misdemeanor information related to the same conduct. On Oct. 22, 2020, the court sentenced Thaxton to a six-month term of incarceration and to pay $600,000 in criminal fines and forfeiture. On Aug. 26, 2020, Indivior’s former medical director, Tim Baxter, pleaded guilty to a one-count misdemeanor information related to the same conduct, conduct for which Baxter was sentenced on Dec. 17, 2020 to six months home detention, 100 hours of community service, and a $100,000 criminal fine.

This present agreement follows the Reckitt Benckiser Group plc. $1.4 billion agreement with the federal government and the states in 2019, which resolved Reckitt’s potential criminal and civil liability related to substantially similar allegations involving Suboxone. The 2019 agreement resulted in a total civil agreement of $700 million—with $400 million paid to the federal and state governments to resolve Medicaid fraud allegations resolved in the agreement.

The Florida Attorney General’s Medicaid Fraud Control Unit investigates and prosecutes providers that intentionally defraud the state’s Medicaid program through fraudulent billing practices. Medicaid fraud essentially steals from Florida’s taxpayers. From January 2019 to the present, Moody’s MFCU has obtained more than $68 million in settlements and judgments. Additionally, the MFCU investigates allegations of patient abuse, neglect and exploitation in facilities receiving payments under the Medicaid program.

The Florida MFCU is funded through a grant totaling $26,329,510, for Federal Fiscal Year 2021, from the U.S. Department of Health and Human Services—Office of Inspector General. The Federal Share of these funds is 75 percent totaling $19,747,136. The State Matching Share of these funds is 25 percent totaling $6,582,374 and is funded by Florida.

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