Opioid Manufacturer Purdue Pharma Pleads Guilty to Fraud and Kickback Conspiracies

Opioid manufacturer Purdue Pharma LP (Purdue) pleaded guilty today in federal court in Newark, New Jersey, to conspiracies to defraud the United States and violate the anti-kickback statute.

Purdue pleaded guilty to an information charging it with three felony offenses: one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute. 

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,”  said Deputy Attorney General Jeffrey A. Rosen.  “Today’s guilty pleas to three felony charges send a strong message to the pharmaceutical industry that illegal behavior will have serious consequences.  Further, today’s convictions underscore the department’s commitment to its multi-pronged strategy for defeating the opioid crisis.”

“Purdue admitted that it marketed and sold its dangerous opioid products to healthcare providers, even though it had reason to believe those providers were diverting them to abusers,”  said Rachael A. Honig, First Assistant U.S. Attorney for the District of New Jersey.  “The company lied to the Drug Enforcement Administration about steps it had taken to prevent such diversion, fraudulently increasing the amount of its products it was permitted to sell. Purdue also paid kickbacks to providers to encourage them to prescribe even more of its products.”

“As today’s plea to felony charges shows, Purdue put opioid profits ahead of people and corrupted the sacred doctor-patient relationship,” said Christina Nolan, U.S Attorney for the District of Vermont.  “We hope the company’s guilty plea sends a message that the Justice Department will not allow big pharma and big tech to engage in illegal profit-generating schemes that interfere with sound medicine.  We hope, also, that this guilty plea will bring some sense of justice to those who have suffered from opioid addictions involving oxycodone and some vindication for families and loved ones of those who did not survive such addiction.”

“This case makes clear that no company, including Purdue Pharma, whose actions harm the health and safety of the American public, is beyond the reach of law enforcement,”  said Assistant Director Calvin Shivers of the FBI’s Criminal Investigative Division.  “The opioid epidemic continues to spread across the United States impacting countless Americans and harming communities. Together with our law enforcement partners, the FBI is committed to investigating and holding criminals accountable for the roles they play in fueling this crisis.”

As part of today’s guilty plea, Purdue admitted that from May 2007 through at least March 2017, it conspired to defraud the United States by impeding the lawful function of the Drug Enforcement Administration (DEA).  Purdue represented to the DEA that it maintained an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids.  Purdue also reported misleading information to the DEA to boost Purdue’s manufacturing quotas.  The misleading information comprised prescription data that included prescriptions written by doctors that Purdue had good reason to believe were engaged in diversion.  The conspiracy also involved aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions.

Purdue also admitted it conspired to violate the federal Anti-Kickback Statute. Between June 2009 and March 2017, Purdue made payments to two doctors through Purdue’s doctor speaker program to induce those doctors to write more prescriptions of Purdue’s opioid products.  Also, from April 2016 through December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue’s extended release opioid products – OxyContin, Butrans, and Hysingla.

Under the terms of the plea agreement, Purdue agreed to the imposition of the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. For the $2 billion forfeiture, the company will pay $225 million within three business days following the entry of a judgment of conviction in accordance with the Plea Agreement.  The department is willing to credit the value conferred by the company to state and local governments under the department’s anti-piling on and coordination policy if certain conditions are met.

Purdue has also agreed to a civil settlement that provides the United States with an allowed, unsubordinated, general unsecured bankruptcy claim for recovery of $2.8 billion to resolve its civil liability under the False Claims Act.  Separately, the Sackler family has agreed to pay $225 million in damages to resolve its civil False Claims Act liability.

The criminal and civil resolutions, which were announced on Oct. 21, 2020, do not include the criminal release of any individuals, including members of the Sackler family, nor are any of the company’s executives or employees receiving civil releases.

On Nov. 17, 2020, the bankruptcy court in the Southern District of New York approved the financial terms of the global resolution with the company.  The resolution includes the condition that the company cease to operate in its current form and instead emerge from bankruptcy as a public benefit company (PBC) or entity with a similar mission designed for the benefit of the American public.  The proceeds of the PBC will be directed toward state and local opioid abatement programs.  Based on the value that would be conferred to state and local governments through the PBC, the department is willing to credit up to $1.775 billion against the agreed $2 billion forfeiture amount.  The department looks forward to working with the creditor groups in the bankruptcy in charting the path forward for this PBC to best accomplish public health goals.

The global resolution does not resolve claims that states may have against Purdue or members of the Sackler family, nor does it impede the debtors’ or other third parties’ ability to recover any fraudulent transfers.

Except to the extent of Purdue’s admissions as part of its criminal resolution, the claims resolved by the civil settlements are allegations only.  There has been no determination of liability in the civil matters.

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    Agencies compiled a variety of data on time and attendance misconduct and fraud. Specifically, 22 of the 24 agencies covered by the Chief Financial Officers Act of 1990 (CFO Act) had some data on instances of time and attendance misconduct—including potential fraud—from fiscal years 2015 through 2019. However, because agencies tracked data differently, the data could not be aggregated across the 22 agencies (see table). The remaining two agencies reported that they did not compile misconduct data agency-wide but began using systems to collect this data in fiscal year 2020. Scope of Agency Data on Time and Attendance Misconduct for Fiscal Years 2015–2019 Level of data compiled; number of years included Number of agencies Data compiled 22 Agency-wide data; all 5 years included 13 Agency-wide data; less than 5 years of data 5 Component-level data; all 5 years included 4 Data not compiled 2 Source: GAO analysis of agency data. | GAO-20-640 Most (19 of 24) agency Inspectors General (IG) reported that they substantiated five or fewer allegations of time and attendance misconduct or fraud over the 5-year period. In total, these IGs substantiated 100 allegations, ranging from zero substantiated allegations at six agencies to more than 10 at four agencies. IGs stated that they might not investigate allegations for several reasons, including resource constraints and limited financial impact. In addition, 20 of 24 agencies reported that they considered fraud risks in payroll or time and attendance, either through assessments of these functions, or as part of a broader agency risk management process, including their annual agency financial reports. Also, 14 of 15 agencies that reported a risk level determined that time and attendance fraud risk was low once they accounted for existing controls. Agencies reported using various internal controls, including technologies, to monitor time and attendance, which can also prevent and detect misconduct. According to agencies and IGs, first-line supervisors have primary responsibility for monitoring employee time and attendance. Additional internal controls include policies, procedures, guidance, and training. Agencies also reported using controls built into their timekeeping system to provide reasonable assurance that time and attendance information is recorded completely and accurately. These controls include requiring supervisory approval of timecards, and using time and attendance system reports to review abnormal reporting. According to agencies and stakeholders GAO spoke with, technology for monitoring time and attendance can help prevent and detect fraud, but may not help when an employee is intent on circumventing controls. Technology alone, they said, cannot prevent fraud. Agencies and IGs also reported using a mix of other technologies to assess allegations of time and attendance misconduct, such as badge-in and -out data, video surveillance, network login information, and government-issued routers. However, agency and IG officials also stated that these technologies have limitations. For example, many of the technologies may not account for when an employee is in training or at an off-site meeting. The federal government is the nation's biggest employer, with about 2.1 million non-postal civilian employees. Misconduct is generally considered an action by an employee that impedes the efficiency of the agency's service or mission. Fraud involves obtaining something of value through willful misrepresentation. In 2018, GAO reported that, on average, less than 1 percent of the federal workforce each year is formally disciplined for misconduct—of which time and attendance misconduct is a subcomponent. Misconduct can hinder an agency's efforts to achieve its mission, and fraud poses a significant risk to the integrity of federal programs and erodes public trust in government. GAO was asked to review agencies' efforts to prevent and address time and attendance misconduct, including fraud. This report describes 1) what is known about the extent of time and attendance misconduct and potential fraud across the 24 CFO Act agencies, and 2) controls and technologies these agencies reported using to monitor employee time and attendance. GAO collected misconduct data from the 24 CFO Act agencies and their IGs. GAO also collected information on fraud risk reporting but did not independently assess agencies' fraud risk. Using a semi-structured questionnaire, GAO obtained information on controls and technologies that agencies reported using to monitor time and attendance and any challenges associated with their use. For more information, contact Chelsa Kenney Gurkin at (202) 512-2964 or gurkinc@gao.gov, or Vijay A. D'Souza at (202) 512-6240 or dsouzav@gao.gov.
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    In U.S GAO News
    Critical technologies—such as elements of artificial intelligence and biotechnology—are those necessary to maintain U.S. technological superiority. As such, they are frequently the target of theft, espionage, and illegal export by adversaries. The Department of Defense (DOD) has outlined a revised process (see figure) to better identify and protect its critical technologies including those associated with acquisition programs throughout their lifecycle or those early in development. Prior DOD efforts to identify these technologies were considered by some military officials to be too broad to adequately guide protection. The revised process is expected to address this by offering more specificity about what elements of an acquisition program or technology need to be protected and the protection measures DOD is expected to implement. It is also expected to support DOD's annual input to the National Strategy for Critical and Emerging Technologies, which was first published in October 2020. Overview of DOD's Revised Process to Identify and Protect Critical Acquisition Programs and Technologies DOD began implementing this process in February 2020, and officials expect to complete all steps for the first time by September 2021. DOD has focused on identifying critical acquisition programs and technologies that need to be protected and how they should be protected. It has not yet determined how it will communicate the list internally and to other agencies, which metrics it will use to assess protection measures, and which organization will oversee future protection efforts. By determining the approach for completing these tasks, DOD can better ensure its revised process will support the protection of critical acquisition programs and technologies consistently across the department. Once completed, the revised process should also inform DOD and other federal agencies' protection efforts. Military officials stated they could use the list of critical acquisition programs and technologies to better direct resources. Officials from the Departments of State, Commerce, and the Treasury stated that they could use the list, if it is effectively communicated, to better understand what is important to DOD to help ensure protection through their respective programs. The federal government spends billions annually to develop and acquire advanced technologies. It permits the sale and transfer of some of these technologies to allies to promote U.S. national security, foreign policy, and economic interests. However, the technologies can be targets for adversaries. The John S. McCain National Defense Authorization Act for Fiscal Year 2019 requires the Secretary of Defense to develop and maintain a list of acquisition programs, technologies, manufacturing capabilities, and research areas that are critical for preserving U.S. national security advantages. Ensuring effective protection of critical technologies has been included on GAO's high-risk list since 2007. This report examines (1) DOD's efforts to identify and protect its critical technologies, and (2) opportunities for these efforts to inform government protection activities. GAO analyzed DOD critical acquisition program and technologies documentation, and held interviews with senior officials at DOD and other federal agencies responsible for protecting critical technologies. GAO is recommending that DOD specify how it will communicate its critical programs and technologies list, develop metrics to assess protection measures, and select the DOD organization that will oversee protection efforts beyond 2020. DOD concurred with the first recommendation and partially concurred with the second and third. GAO maintains the importance of all recommendations in this report. For more information, contact William Russell at (202) 512-4841 or russellw@gao.gov.
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    Why This Matters The Department of Education gives grants to schools and organizations that provide disadvantaged students with services to help them attend college. These eight grant programs are collectively known as “TRIO”, named for the original three programs. Congress provides over $1 billion each year to these programs, but Education could do more to understand how well these grants work to help students. Key Takeaways Education could improve the information it has about TRIO programs in two areas: (1) grantee performance data, and (2) program assessments. Schools and organizations report data to Education to show how the TRIO grants they receive have been working. For example, organizations that receive grants to encourage students to complete college report on the numbers and percentages of students who received services and earned degrees.  Education evaluates grantees’ performance using the self-reported data, but has done little to verify the data. Accurate performance data are important because returning grantees can earn points for past performance in the next grant competition—increasing the likelihood that they will receive new grants. Almost 80 percent of recent TRIO grants went to returning grantees.  Therefore, grantees may have an incentive to report a more positive picture than warranted. Officials from an organization representing TRIO grantees told us there is a risk that some grantees may report inaccurate information.  As for assessing the individual TRIO programs, studies of some programs are outdated. In addition, Education has never assessed the effectiveness of three of the seven TRIO programs that serve students, and did not have any new assessments planned as of August 2020. How GAO Did This Study We analyzed data from Education about TRIO grantees and applicants. We also reviewed relevant federal laws and regulations and agency documents, and interviewed Education officials and other TRIO stakeholders. Education should take additional steps to ensure the reliability of grantees' performance data and develop a plan for assessing the effectiveness of the TRIO programs that serve students. Education generally agreed with our recommendations. For more information, contact Melissa Emrey-Arras at (617) 788-0534 or emreyarrasm@gao.gov.
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    GAO found that the completeness and accuracy of Transformed Medicaid Statistical Information System (T-MSIS) data have improved. Over the past decade, the Centers for Medicare & Medicaid Services (CMS) has been implementing T-MSIS, which is the agency's initiative to improve state-reported data available for overseeing Medicaid. CMS's assessment of two key T-MSIS data sources reflect these improvements. I. Priority items. Priority items are areas of data CMS identified as critical for program oversight, such as beneficiary eligibility and managed care. CMS's assessment of states' data submissions for the first 12 priority items identified significant improvement in meeting CMS data standards over a 22-month period. CMS's assessments of additional priority items similarly indicate improved completeness and accuracy. Improvements in the Number of States Meeting CMS Standards for Transformed Medicaid Statistical Information System Priority Items One through 12 Number of priority items that met standards Number of states as of October 2018 Number of states as of August 2020 10 or more 6 41 7 to 9 26 10 6 or less 18 0 Source: GAO analysis of the Centers for Medicare & Medicaid Services (CMS) priority item data. │ GAO-21-196 Note: CMS assessed data from all 50 states and the District of Columbia. CMS excluded Wisconsin from its October 2018 assessment, because the state had not submitted sufficient data. II. Analytic files. Analytic files are publicly available, research-ready T-MSIS data. GAO's review of CMS's assessments found that all states submitted some data for 67 of the 69        topics relevant to their Medicaid programs. This is an improvement from what GAO found in 2017, when none of the six states reviewed submitted all T-MSIS data applicable to their programs. GAO also found that states' data for 52 of the 69 topics were acceptable—meaning that CMS determined most states' data did not have significant problems that would affect their usability. While CMS's assessments of priority item and analytic file data indicate improvement in the completeness and accuracy of T-MSIS data, GAO also found that these assessments highlight areas where data do not meet the agency's standards. For example, 30 states did not submit acceptable data for inpatient managed care encounters. Accurate encounter data are critical to ensuring that Medicaid managed care beneficiaries obtain covered services and that payments to managed care organizations are appropriate. GAO has made at least 13 recommendations related to improving T-MSIS data and expediting their use for program oversight. CMS has addressed five of these recommendations, and has not fully addressed eight—including recommendations to improve data for overseeing payments to providers and managed care organizations. Implementing these recommendations would help CMS strengthen program oversight through improved T-MSIS data. Since adding Medicaid to its High Risk List in 2003, GAO has identified multiple limitations in program data affecting CMS's ability to ensure beneficiaries' access to care and proper payments to health care providers. CMS intends T-MSIS be a national repository of data to manage and oversee Medicaid, which served approximately 77 million individuals at an estimated cost of $673 billion in fiscal year 2020. Prior GAO work found issues with the completeness and accuracy of T-MSIS data and recommended that CMS expedite efforts to improve T-MSIS data and to use them for program oversight. CMS has taken steps to improve T-MSIS data and has made some T-MSIS data publicly available. Yet, questions remain about the usability of T-MSIS data for program oversight. Under the Comptroller General's authority, GAO initiated this review to examine what is known about the completeness and accuracy of T-MSIS data. GAO reviewed CMS's assessments of two T-MSIS data sources: (1) states' submissions of T-MSIS priority items; and (2) the 2016 T-MSIS analytic files, which was the most recent analytic file data available when GAO began this work. GAO also reviewed CMS documents, prior GAO reports, and reports published by others examining T-MSIS data. GAO interviewed officials from CMS and seven states selected based on variation in their progress submitting complete and accurate priority item data, among other factors. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov.
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    The Department of Veterans Affairs (VA) has faced challenges in its efforts to accomplish three critical information technology (IT) modernization initiatives: the department's health information system, known as the Veterans Health Information Systems and Technology Architecture (VistA); a system for the Family Caregiver Program, which is to support family caregivers of seriously injured post-9/11 veterans; and the Veterans Benefits Management System (VBMS) that collects and stores information and is used for processing disability benefit claims. Specifically, GAO has reported on the challenges in the department's three previous unsuccessful attempts to modernize VistA over the past 20 years. However, VA has recently deployed a new scheduling system as part of its fourth effort to modernize VistA and the next deployment of the system, including additional capabilities, is planned in October 2020. VA had taken steps to address GAO's recommendations from its 2014 report to implement a replacement system for the Family Caregiver Program. However, in September 2019, GAO reported that VA had yet to implement a new IT system that fully supports the Family Caregiver Program and that it had not yet fully committed to a date by which it will certify that the new IT system fully supports the program. In September 2015, GAO reported that VA had made progress in developing and implementing VBMS, but also noted that additional actions could improve efforts to develop and use the system. For example, VBMS was not able to fully support disability and pension claims, as well as appeals processing. GAO made five recommendations aimed at improving VA's efforts to effectively complete the development and implementation of VBMS; however, as of September 2020, VA implemented only one recommendation. VA's progress in implementing key provisions of the Federal Information Technology Acquisition Reform Act (commonly referred to as FITARA) has been uneven. Specifically, VA has made progress toward improving its licensing of software and achieving its goals for closing unneeded data centers. However, the department has made limited progress toward addressing requirements related to IT investment risk management and Chief Information Officer authority enhancement. Until the department implements the act's provisions, Congress' ability to effectively monitor VA's progress and hold it fully accountable for reducing duplication and achieving cost savings will be hindered. In addition, since fiscal year 2016, GAO has reported that VA faces challenges related to effectively implementing the federal approach to, and strategy for, securing information systems; effectively implementing information security controls and mitigating known security deficiencies; and establishing elements of its cybersecurity risk management program. GAO's work stressed the need for VA to address these challenges as well as manage IT supply chain risks. As VA continues to pursue modernization efforts, it is critical that the department take steps to adequately secure its systems. The use of IT is crucial to helping VA effectively serve the nation's veterans. The department annually spends billions of dollars on its information systems and assets—VA's budget for IT now exceeds $4 billion annually. However, over many years, VA has experienced challenges in managing its IT projects and programs, which could jeopardize its ability to effectively support key programs such as the Forever GI Bill. GAO has previously reported on these IT management challenges at VA. GAO was asked to testify on its prior IT work at VA. Specifically, this testimony summarizes results and recommendations from GAO's issued reports that examined VA's efforts in (1) modernizing VistA, a system for the Family Caregiver Program, and VBMS; (2) implementing FITARA; and (3) addressing cybersecurity issues. In developing this testimony, GAO reviewed its recently issued reports that addressed IT management issues at VA and GAO's biannual high-risk series. GAO also incorporated information on the department's actions in response to recommendations. GAO has made numerous recommendations in recent years aimed at improving VA's IT system modernization efforts, implementation of key FITARA provisions, and cybersecurity program. VA has generally agreed with the recommendations and has begun to address them. For more information, contact Carol C. Harris at (202) 512-4456 or harriscc@gao.gov.
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