Indivior Solutions Sentenced To Pay $289 Million In Criminal Penalties For Unlawful Marketing Of Opioid Drug

Action Follows Sentencing of Former CEO and Resolutions with Former Corporate Parents

Indivior Solutions was sentenced to pay $289 million in criminal penalties in connection with a previous guilty plea related to the marketing of the opioid-addiction-treatment drug Suboxone, the Department of Justice announced today.

U.S. District Judge James P. Jones of the Western District of Virginia entered the sentence against Indivior Solutions pursuant to a plea agreement. Altogether, Indivior Solutions will pay $600 million to resolve its civil and criminal liability in this matter. In total, the payments made by Indivior Solutions and its parent companies, Indivior Inc. and Indivior plc, along with payments made under a 2019 resolution with Indivior’s former parent, Reckitt Benckiser Group plc, and criminal penalties paid pursuant to plea agreements with two former Indivior executives will exceed $2 billion. That amount represents the second-largest monetary resolution obtained by the Department of Justice in a case involving an opioid drug.

Suboxone, which contains the powerful opioid buprenorphine, is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder. In connection with its guilty plea, Indivior Solutions admitted to making false statements to the Massachusetts Medicaid program (MassHealth) related to the relative safety of Suboxone Film, a version of Suboxone, around children.  

“Combating the opioid epidemic is a top priority for the Department of Justice,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will hold drug manufacturers accountable when they make misrepresentations that could affect consumers’ access to opioid addiction treatments.”

Indivior Solutions, a subsidiary of Indivior Inc., pleaded guilty on July 24, 2020, to a one-count felony criminal information charging false statements relating to health care matters. Indivior Inc. agreed to terms complementing the Indivior Solutions guilty plea and agreed to implement prospective measures that include permanently disbanding Indivior Inc.’s Suboxone sales force and taking steps to prevent promoting Suboxone to health care providers at a high risk of inappropriate prescribing.

On June 30, 2020, Indivior’s former CEO, Shaun Thaxter, pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth. On Oct. 22, 2020, the court sentenced Thaxter to a six-month term of incarceration and $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 Indivior’s false and misleading representations to MassHealth. Baxter’s sentencing hearing is scheduled for Dec. 17, 2020, before Judge Jones in Abingdon, Virginia.

“When a drug manufacturer claims to be part of the solution to the national opioid epidemic, we expect it to make honest representations to government officials, physicians and patients, who have to make crucial treatment decisions,” said Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia. “Instead, Indivior made false statements about Suboxone’s safety to increase its sales.  I’m proud of the close relationship we have with our federal and state partners that led to today’s important result.”

“Pharmaceutical companies that falsely promote their drugs, intended to treat opioid addiction, as superior to other alternatives only worsens the opioid crisis that has touched far too many lives in the U.S. Such actions potentially narrow access to treatment for those who need it,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration. “We will continue to investigate and bring to justice those who devise and participate in these schemes to the detriment of the public health.”

In its guilty plea, Indivior Solutions, which employed marketing and sales personnel for the Indivior group of companies, admitted that in October 2012 it sought to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and sent MassHealth a misleading chart and false data indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (i.e., children taking medication by accident) of all buprenorphine drugs in Massachusetts, when in fact it did not. Indivior Solutions further admitted that sending the false and misleading information occurred in the context of marketing and promotional efforts directed at MassHealth, which were overseen by top executives. MassHealth announced it would provide access to Suboxone Film for patients with children under the age of six shortly after Indivior provided the false and misleading information to agency officials.

The criminal case against Indivior was prosecuted by Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia; Albert P. Mayer and Carol Wallack of the Department of Justice Civil Division’s Commercial Litigation Branch; Charles J. Biro and Matthew J. Lash of the Department of Justice Civil Division’s Consumer Protection Branch; Kristin L. Gray, Joseph S. Hall and Janine M. Myatt of the Virginia Medicaid Fraud Control Unit of the Office of the Attorney General; and Garth W. Huston of the Federal Trade Commission. This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA’s Office of Criminal Investigation; the United States Postal Service Office of Inspector General; and the Department of Health and Human Services Office of Inspector General.

The joint effort advances the goals of the department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully. 

For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva. Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch and http://www. justice.gov/civil/fraud-section. 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 800-HHS-TIPS (800-447-8477).

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    In GAO's opinion, the Internal Revenue Service's (IRS) fiscal years 2020 and 2019 financial statements are fairly presented in all material respects, and although certain controls could be improved, IRS maintained, in all material respects, effective internal control over financial reporting as of September 30, 2020. GAO's tests of IRS's compliance with selected provisions of applicable laws, regulations, contracts, and grant agreements detected no reportable instances of noncompliance in fiscal year 2020. Limitations in the financial systems IRS uses to account for federal taxes receivable and other unpaid assessment balances, as well as other control deficiencies that led to errors in taxpayer accounts, continued to exist during fiscal year 2020.These control deficiencies affect IRS's ability to produce reliable financial statements without using significant compensating procedures. In addition, unresolved information system control deficiencies from prior audits, along with application and general control deficiencies that GAO identified in IRS's information systems in fiscal year 2020, placed IRS systems and financial and taxpayer data at risk of inappropriate and undetected use, modification, or disclosure. IRS continues to take steps to improve internal controls in these areas. However, the remaining deficiencies are significant enough to merit the attention of those charged with governance of IRS and therefore represent continuing significant deficiencies in internal control over financial reporting related to (1) unpaid assessments and (2) financial reporting systems. Continued management attention is essential to fully addressing these significant deficiencies. The CARES Act, enacted in March 2020, and other COVID-19 pandemic relief laws contained a number of tax relief provisions to address financial stress caused by the COVID-19 pandemic. For example, the Economic Impact Payments provisions in the CARES Act provided for direct payments for eligible individuals to be implemented through the tax code. Implementing the provisions related to these Economic Impact Payment required extensive IRS work, and resulted in it issuing approximately $275 billion in payments as of September 30, 2020. IRS faced difficulties in issuing these payments as rapidly as possible, such as in identifying eligible recipients, preventing improper payments, and combating fraud based on identity theft. IRS discusses the challenges in carrying out its responsibilities under the CARES Act in its unaudited Management's Discussion and Analysis, which is included with the financial statements. As part of monitoring and oversight of the federal government's efforts to prepare for, respond to, and recover from the COVID-19 pandemic, GAO has issued a number of reports on federal agencies' implementation of the CARES Act and other COVID-19 pandemic relief laws, including reports providing information on, and recommendations to strengthen, IRS's implementation of the tax-related provisions. In accordance with the authority conferred by the Chief Financial Officers Act of 1990, as amended, GAO annually audits IRS's financial statements to determine whether (1) the financial statements are fairly presented and (2) IRS management maintained effective internal control over financial reporting. GAO also tests IRS's compliance with selected provisions of applicable laws, regulations, contracts, and grant agreements. IRS's tax collection activities are significant to overall federal receipts, and the effectiveness of its financial management is of substantial interest to Congress and the nation's taxpayers. Based on prior financial statement audits, GAO made numerous recommendations to IRS to address internal control deficiencies. GAO will continue to monitor, and will report separately, on IRS's progress in implementing prior recommendations that remain open. Consistent with past practice, GAO will also be separately reporting on the new internal control deficiencies identified in this year's audit and providing IRS recommendations for corrective actions to address them. In commenting on a draft of this report, IRS stated that it continues its efforts to improve its financial systems controls. For more information, contact Cheryl E. Clark at (202) 512-3406 or clarkce@gao.gov.
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  • Macroprudential Oversight: Principles for Evaluating Policies to Assess and Mitigate Risks to Financial System Stability
    In U.S GAO News
    GAO is providing a framework for evaluating macroprudential policy—that is, activities designed to assess and mitigate risks to financial system stability. The framework presents six general components of macroprudential policy and 18 principles (see table), as well as related standards, for establishing the foundation of such policy and putting it into operation. Government actors—such as the Financial Stability Oversight Council (FSOC) and its member agencies—are responsible for meeting or contributing to framework principles as they relate to the actors' individual areas of macroprudential responsibility or authority. GAO refers to government actors with collective macroprudential policy responsibilities as the macroprudential entity. GAO Framework for Evaluating Macroprudential Policy Component Principles The macroprudential entity should: Mandate and scope Have a clear mandate Have a scope of responsibilities that extends across the financial system Establish measurable and specific intermediate objectives reflecting the full scope of its responsibilities Governance Have a governance structure promoting willingness to mitigate risks to financial stability in a timely manner Have authorities promoting ability to act consistent with mandate and scope Have transparency requirements promoting the effectiveness, legitimacy, and predictability of macroprudential policy Risk assessment Establish a risk-assessment program corresponding to the scope of the financial system and the entity’s intermediate objectives Identify and analyze potential sources of systemic risk Develop criteria to evaluate significance of risk Establish policies and procedures to conduct systematic risk assessments Risk mitigation Develop a range of macroprudential tools consistent with mandate and scope of responsibilities Develop policies and procedures for conducting risk-mitigation activities Evaluation Evaluate effectiveness of its efforts Document and communicate evaluation findings and promptly remediate issues Data and information Use quality data Develop useful information for decision-making Document information appropriately Establish policies and procedures for sharing data and information Source: GAO. | GAO 21 230SP The Dodd-Frank Wall Street Reform and Consumer Protection Act established FSOC to identify and respond to threats to financial stability in the United States. Other countries have created similar entities, and a growing body of research has developed around these macroprudential structures and approaches. This report presents a principles-based framework to serve as criteria for assessing the financial stability efforts of FSOC and its member agencies. It is intended as a resource for GAO and other auditors, FSOC and its member agencies, and Congress. It also may be useful to others, both domestically and internationally. In developing this framework, GAO reviewed literature on macroprudential policy, prior GAO reports, relevant laws and regulations, and international risk-management guidelines. GAO also interviewed or held discussion groups with representatives of FSOC and its member agencies; international financial stability entities, supreme audit institutions, and international organizations; public interest and industry groups; former regulators and civil servants; and academic and regulatory experts. For more information, contact Michael E. Clements at (202) 512-8678 or ClementsM@gao.gov.
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  • Defense Health Care: Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective Care
    In U.S GAO News
    The Department of Defense (DOD) has a general expectation that its health care beneficiaries, upon receiving an urgent referral to see a specialist, will access that specialty care in 3 days or less. GAO's analysis of 16,754 urgent referrals at military treatment facilities (MTF) shows that DOD beneficiaries accessed specialty care services in 3 days or less for more than half of the urgent referrals. About 9 percent of the urgent referrals involved beneficiaries waiting 3 weeks or longer to be seen. According to DOD officials, some beneficiaries may have waited longer than 3 days due to factors such as patient preference, appointment availability, or waiting for lab results. Time to access care varied by specialty, with beneficiaries urgently referred to ophthalmology generally seeing a specialist the fastest, and those urgently referred to mental health and oncology generally waiting the longest. According to DOD officials, MTFs are responsible for monitoring beneficiaries' access to specialty care through urgent referrals. GAO found that the monitoring processes used varied by MTF and specialty care clinic at the five selected MTFs that GAO reviewed. For example, officials from one MTF told GAO they centrally manage all urgent referrals using a daily report to address any delays, while officials from another MTF told GAO that individual specialty care clinics are responsible for managing their own urgent referrals. DOD officials acknowledged such variation and MTFs have been directed to centralize their referral management and monitoring processes—an effort that is currently underway. GAO found that DOD monitors the rates at which beneficiaries receive timely and effective care, in part, through 10 outpatient health care quality measures. These measures allow DOD to make comparisons to civilian health care systems, and they are reviewed by various DOD groups at least quarterly. However, DOD officials told GAO that since October 2017, they have been unable to monitor nine of the 10 measures for MTFs using Military Health System (MHS) Genesis, DOD's new electronic health record system. According to the officials, DOD's current data warehouse—a system that stores some MHS Genesis data and can be used by MTFs to create reports on quality measures—is not capable of producing accurate reports for those measures. DOD officials told GAO they expect to implement a new data warehouse by the end of 2020. DOD officials also said they are importing data related to quality measures into another system used for quality monitoring; however, DOD does not have a targeted date for completing these data imports. Until these actions are fully implemented, groups responsible for monitoring quality care will continue to lack the data needed to offer assurance that the growing number of MTFs using MHS Genesis are providing beneficiaries with timely and effective care that will lead to better health outcomes. A draft of this report recommended that DOD establish a timeline to complete importing the quality measure-related data from MHS Genesis into DOD's system used for quality monitoring. In its review of the draft, DOD concurred with the recommendation and established a timeline for importing the data, to be available in DOD's system no later than May 2021. After reviewing the information DOD provided, GAO removed the recommendation from the final report. DOD is responsible for ensuring that beneficiaries have access to specialty care for conditions that, while not life-threatening, require immediate attention, as well as for ensuring that beneficiaries receive timely and effective care for certain routine or other services. A report accompanying the National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to review the quality of health care in the MHS. This report examines (1) the timeliness with which beneficiaries access specialty care at MTFs through urgent referrals and DOD's efforts to monitor access, and (2) DOD's use of quality measures to monitor and improve the rates of timely and effective care received by beneficiaries at MTFs. GAO examined relevant policies, national DOD referral data (a total of 16,754 urgent referrals) for a 1-year period ending August 2019, and the most recent available quality measure data (April 2020). GAO interviewed officials from five MTFs, selected for variation in military services, geography, provision of select specialty services, and use of the electronic health record system. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.
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    In Crime News
    The Justice Department announced today that the Town of Irmo, South Carolina, has agreed to pay $25,000 to a homeowner with a disability as part of a settlement agreement resolving the government’s Fair Housing Act (FHA) lawsuit. 
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    In Crime News
    Johnny Roman Garza, 21, a member of the Neo-Nazi group Atomwaffen Division, was sentenced today to 16 months in prison and three years of supervised release for his role in a plot to threaten and intimidate journalists and advocates who worked to expose anti-Semitism.
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  • Defined Contribution Plans: Federal Guidance Could Help Mitigate Cybersecurity Risks in 401(k) and Other Retirement Plans
    In U.S GAO News
    What GAO Found In their role administering private sector employer-sponsored defined contribution (DC) retirement plans, such as 401(k) plans, plan sponsors and their service providers—record keepers, third party administrators, custodians, and payroll providers—share a variety of personally identifiable information (PII) and plan asset data among them to assist with carrying out their respective functions (see figure). The PII exchanged for DC plans typically include participant name, Social Security number, date of birth, address, username/password; plan asset data typically includes numbers for both retirement and bank accounts. The sharing and storing of this information can lead to significant cybersecurity risks for plan sponsors and their service providers, as well as plan participants. Data Sharing Among Plan Sponsors and Service Providers in Defined Contribution Plans Federal requirements and industry guidance exist that could mitigate cybersecurity risks in DC plans, such as requirements that pertain to entities that directly engage in financial activities involving DC plans. However, not all entities involved in DC plans are considered to have such direct engagement, and other cybersecurity mitigation guidance is voluntary. Federal law nevertheless requires plan fiduciaries to act prudently when administering plans. However, the Department of Labor (DOL) has not clarified fiduciary responsibility for mitigating cybersecurity risks, even though 21 of 22 stakeholders GAO interviewed expressed the view that cybersecurity is a fiduciary duty. Further, DOL has not established minimum expectations for protecting PII and plan assets. DOL officials told GAO that the agency intends to issue guidance addressing cybersecurity-related issues, but they were unsure when it would be issued. Until DOL clarifies responsibilities for fiduciaries and provides minimum cybersecurity expectations, participants' data and assets will remain at risk. Why GAO Did This Study Cyber attacks against information systems (IT) are perpetuated by individuals or groups with malicious intentions, from stealing identities to appropriating money from accounts. DC plans, which allow individuals to accumulate tax-advantaged retirement savings, increasingly rely on the internet and IT systems for their administration. Accordingly, the need to secure these systems has become paramount. Ineffective data security controls can result in significant risks to plan data and assets. In 2018, DC plans enrolled 106 million participants and held nearly $6.3 trillion in assets, according to DOL. This report examines (1) the data that sponsors and providers exchange during the administration of DC plans and their associated cybersecurity risks, and (2) efforts to assist sponsors and providers to mitigate cybersecurity risks during the administration of DC plans. GAO interviewed key entities involved with DC plans, such as sponsors and record keepers, DOL officials and industry stakeholders; and reviewed relevant federal laws, regulations, and guidance.
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    In Crime News
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    A federal court has ordered an individual and 5 companies to stop engaging in a technical-support fraud scheme that is alleged to have defrauded hundreds of elderly and vulnerable U.S. victims, the Department of Justice announced today. 
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