REGULATORY INTELLIGENCE YEAR-END REPORT - 2021 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Business Practices This Issue Brief was written by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/20/2021 I. Introduction Ohio Attorney General Dave Yost recently announced that the state has reached an $808 million agreement with three large opioid distributors: Cardinal Health, McKesson, and AmerisourceBergen. Connecticut Attorney General William Tong recently filed formal notice with the United States Bankruptcy Court in the Southern District of New York that Connecticut will appeal a controversial decision that would extinguish Connecticut's claims against both Purdue Pharma and the Sackler family. The U.S. Department of Justice recently announced that three generic pharmaceutical manufacturers have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from alleged conspiracies to fix the price of various generic drugs. Texas Attorney General Ken Paxton recently announced a $290 million statewide opioid settlement agreement with Johnson & Johnson to resolve opioid-related claims. The agreement is consistent with the terms of the Global Prescription Opioid Litigation Settlement Agreement that was announced July 23, 2021. Arizona Attorney General Mark Brnovich recently announced that his office obtained a consent judgment involving a $400,000 settlement with a Scottsdale-based pain management doctor. Arthrex Inc., a Florida-based medical device company, has agreed to resolve allegations that it violated the False Claims Act by paying kickbacks that caused the submission of false claims to the Medicare program. The Justice Department recently announced that, kal?o Inc., a Virginia-based pharmaceutical manufacturer, has agreed to pay the United States $12.7 million to resolve allegations that the company caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. ll. General News Congresswoman Porter Releases Report Documenting Negative Effects of Big Pharma Mergers Congresswoman Katie Porter (CA-45) recent released a report documenting the alleged negative effects of large mergers and acquisitions of pharmaceutical companies. The report includes a case study of the 2002 takeover of Immunex, a small biotechnology firm, by Amgen, which at the time was the largest biotechnology company in the world. Through first-hand accounts, the report highlights how such consolidations can limit scientific innovation at the expense of patients. According to Porter, 'What we learned from the Immunex/Amgen researchers we spoke with was deeply upsetting: this incredible collaborative culture, focused on innovative new ideas to treat chronically ill patients, was completely gutted. Research that could have led to new treatments or cures was dropped because it was too risky, and therefore, too "expensive." Congresswoman Porter further noted that, 'The statistics from researchers show a similar story, but hearing this from scientists on the ground helps people understand what's going on. That's why we wanted to present this as a staff report for the public." Key findings of the report include: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. ¢ Big pharmaceutical companies are not responsible for most major breakthroughs in new drugs. Rather, innovation is driven in small firms, which are often spun off of taxpayer-funded academic research. These small labs are then purchased by giant firms after they've assumed the risk needed to develop a blockbuster drug. ¢ Instead of producing lifesaving drugs for diseases with few or no cures, large pharmaceutical companies often focus on small, incremental changes to existing drugs in order to kill off generic threats to their government-granted monopoly patents. * Mergers in the pharmaceutical industry have had an overall negative effect on innovation, taking what little competition existed in the industry and completely destroying it. The report suggests the need for comprehensive and urgent reform. Congresswoman Porter specifically recommends: « Removing incentives that prioritize investors and Wall Street over patients. Companies should not tie bonuses to financial metrics, but instead link bonuses to either 1) measures of health outcomes such as reduced mortality, or 2) revenue reinvested for research and development of new drugs. If companies will not take these actions on their own, legislators should consider tying requirements for this to merger conditions, patent exclusivity, or some other mechanism. ¢ Reevaluating the standards used by the Federal Trade Commission (FTC) for healthcare mergers. The FTC should incorporate into merger review previous anticompetitive conduct as part of the assessment as part of whether or not the merger should be considered anticompetitive behavior. * Altering the presumption that most mergers and acquisitions are legal unless contested by an individual or group. Legislation can and should be passed to require health care companies to demonstrate that any merger or acquisition is more likely than not to result in improved health care quality and cost for consumers. * Lowering the cost of prescription drugs. Congress should pass legislation that reins in skyrocketing costs. This can begin with drug price negotiation legislation, such as the Elijah E. Cummings Lower Drug Costs Now Act, but must extend to include a larger class of drugs and cover all payers and the uninsured. ¢ Preventing anti-competitive abuses of the drug patenting system. Congress should pass legislation, such as the Preserve Access to Affordable Generics and Biosimilars Act, the Affordable Prescriptions for Patients Through Promoting Competition Act, and the Stop STALLING Act, to stop abuses of the regulatory process. During Porter's questioning in an October 2020 Oversight Committee hearing, the current CEO of Amgen, Robert Bradway, downplayed the role of small firm Immunex in the development of Enbrel, a lifesaving drug. This testimony allegedly prompted a former Immunex, and later Amgen, Principal Scientist to contact Porter's office to provide clarification on Bradway's testimony, as well as the transformation he witnessed the company undergo after the acquisition. Representative Porter's office subsequently interviewed this scientist and several other former employees of Immunex/Amgen. Porter also noted that, 'Competition is central to capitalism. As our report shows, Big Pharma has little incentive to invest in new, critically needed drugs. Instead, pharmaceutical giants are free to devote their resources to acquiring smaller companies that might otherwise force them to compete. Lives are on the line; it's clear the federal government needs to reform how it evaluates health care merges and patent abuses." At one point, the report refers to the COVID-19 vaccine development and drug company behavior. The report notes that, 'The rapid breakthroughs that we have seen in response to the COVID-19 pandemic highlight that innovation is possible. But without taxpayer funded research, we likely would not see these signs of hope." The report also states that, 'Companies with billions in profits have relied on our dollars to support research, unwilling to assume risk themselves. It's no different in the rest of the market, where Big Pharma relies on the creativity of academic researchers and small biotechnology firms, only to acquire them after they've discovered a blockbuster drug" IFN2] FTC Announces International Working Group to Build New Approach to Pharmaceutical Mergers The Federal Trade Commission and its counterpart competition enforcement agencies in the U.S. and abroad recently announced that they are launching a working group to update their approach to analyzing the effects of pharmaceutical mergers. Initiated by the FTC, the working group will include the Canadian Competition Bureau, the European Commission Directorate General for Competition, the U.K.'s Competition and Markets Authority, the U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General. This joint project taps expertise from competition authorities with whom the FTC cooperates frequently, as well as others with relevant experience, to ensure the most effective enforcement in these crucial markets. The goal of this initiative is to identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers. This project will ensure that FTC investigations include fresh approaches that fully analyze and address the varied competitive concerns that these mergers and acquisitions raise. According to FTC Acting Chair Rebecca Kelly Slaughter, 'Given the high volume of pharmaceutical mergers in recent years, amid skyrocketing drug prices and ongoing concerns about anticompetitive conduct in the industry, it is imperative that we rethink our approach toward pharmaceutical merger review." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Ms. Slaughter further noted that, 'Working hand in hand with international and domestic enforcement partners, we intend to take an aggressive approach to tackling anticompetitive pharmaceutical mergers." Included in the questions to be considered by this working group are: ¢ How can current theories of harm be expanded and refreshed? ¢ What is the full range of a pharmaceutical merger's effects on innovation? ¢ In merger review, how should we consider pharmaceutical conduct such as price fixing, reverse payments, and other regulatory abuses? ¢ What evidence would be needed to challenge a transaction based on any new or expanded theories of harm? « What types of remedies would work in the cases to which those theories are applied? « What have we learned about the scope of assets and characteristics of firms that make successful divestiture buyers? [FNS] Activist Investor Group Demands Equitable Access to COVID-19 Vaccines and Therapeutics Proposals sponsored by members of the Interfaith Center on Corporate Responsibility (ICCR) recently submitted to three drug companies in receipt of public funding for COVID medicines are set to go to votes at Johnson & Johnson, Merck & Co., and Pfizer. The proposals ask whether and how government financial support is being, or will be, considered by these companies in developing their access strategies, including pricing. Given that taxpayer monies and government contracts significantly supported the R&D, manufacturing, and distribution of COVID-19 medicines, and that the public assumed most of the risk, the investors claim the proposals are intended as an accountability mechanism to ensure broad and equitable access to them. ICCR is a coalition of shareholder advocates who view the management of their investments as a catalyst for social change. Its 300- plus member organizations are made up of faith communities, socially responsible asset managers, unions, pensions, NGOs, and other socially responsible investors with combined assets of over $US 2 trillion. CCR members engage hundreds of corporations annually in an effort to foster greater corporate accountability. According to a press release from ICCR, 'As the world first began to grapple with the COVID-19 pandemic, many public health officials foresaw it would not be an equal opportunity virus; in fact, COVID-19 has been quite efficient in exacerbating the systemic inequities that have long plagued marginalized communities, often people of color, where structural racism, discrimination, and the negative impact of the both corporate and social influencers of health have put them at an extreme disadvantage." At a news briefing of the World Health Organization in January, Director-General Tedros Adhanom Ghebreyesus called the growing inequities in the distribution of COVID 19 vaccines 'grotesque" and 'another brick in the wall for inequality between the world's haves and have-nots". He further said the world was on the verge of 'a moral catastrophe[i]'. Christopher Cox of Seventh Generation Interfaith Coalition for Responsible Investment also noted that, 'As faith and values investors who have engaged pharma companies for decades to press for greater access and affordability of medicines, this pandemic has underscored how disparities in the delivery of healthcare further drive poverty and suffering. Without a vaccine, the global cost associated with COVID-19 and its economic impact was initially projected to be $3.4 trillion a year. If the vaccines aren't distributed equitably, that projection jumps to a loss of $9 trillion dollars in wealth{[ii]." [FN4] House Select Subcommittee on the Coronavirus Crisis Releases Initial Findings Relating to Investigation Into Emergent BioSolutions, Inc. and COVID-19 Vaccine Manufacturing Failures Rep. James E. Clyburm, Chairman of the Select Subcommittee on the Coronavirus Crisis, and Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, recently released a staff memo identifying initial findings and releasing new documents obtained in the Committees' ongoing investigation into Emergent BioSolutions, Inc. On April 19, 2021, the Select Subcommittee and the Committee on Oversight and Reform opened a joint investigation into Emergent. Documents released by the Committees illustrate contracts awarded by the Trump Administration in 2020 and provide additional details on the extent of manufacturing failures that led to the destruction of millions of coronavirus vaccines since October 2020. The memo states in part that, 'The Committees' investigation raises troubling new questions about the lucrative contract Emergent received under the Trump Administration, the company's failure to address manufacturing problems that led to the destruction of millions of desperately needed coronavirus vaccine doses, and large bonuses paid to top executives despite these failures." Findings from the joint investigation include: The Trump Administration agreed to pay Emergent millions despite its failure to produce vaccines. * Under the May 2020 contract issued by the Trump Administration, Emergent has charged the federal government $27 million per month in reservation fees to maintain its 'readiness" to manufacture vaccines pursuant to 'current good manufacturing practices" whether or not the company was producing vaccines. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. * Under these terms, taxpayers have already paid Emergent more than $271 million. Emergent executives have acknowledged that the reservation fees were among the 'primary drivers" of the company's high profit margins last year. The Biden Administration reduced monthly payments to Emergent by more than half of the fee after the contamination came to light. Emergent's systemic failure to address serious deficiencies at its facility led to the destruction of millions of vaccine doses. ¢ From June 9 through June 18, 2020, Janssen Pharmaceuticals conducted a virtual audit of Emergent's Bayview facility. On July 24, Janssen sent Emergent a report with its audit findings, which concluded that Emergent's 'quality systems may have weaknesses or gaps that require CAPA [Corrective and Preventive Actions]."The report also stated:'The site virus contamination control strategy is deficient," noting that 'There is not a formal Bayview contamination control strategy for the site' and 'the disinfectant program used in the facility is deficient." ¢ On June 17, 2020, Carlo de Notaristefani, the lead manufacturing advisor for Operation Warp Speed, issued a private report on Emergent. The report identified multiple 'risks" at the Bayview facility, noting:'Most of the large scale existing equipment is not suitable for the new processes, and will be either removed or mothballed," and 'staffing plans presented seem inadequate to the level of current activities required for full scale production of 3 programs."The report also raises other concerns about facility readiness, personnel, and compliance. ¢ Despite the serious nature of these findings, Emergent failed to remediate the problems at the facility. Ultimately, this led to the contamination of millions of vaccine doses in separate incidents in October 2020, December 2020, and February 2021. Emergent has privately admitted to serious manufacturing problems. * In its response to an April 2021 Food and Drug Administration (FDA) inspection report, Emergent admitted that the 'sudden scale- up to full-scale manufacturing activities for two different Covid-19 vaccine drug substances" contributed to 'a dramatic increase in storage and staging demands" and 'strained the capacity" of Emergent's equipment as the facility 'operated at full capacity for the first time."Emergent also acknowledged FDA's finding that Emergent employees were not adequately trained. Key official who awarded contracts had previously been paid by Emergent. « New documents released by the Committees show that Dr. Robert Kadlec-a former consultant to Emergent who later became a senior Trump Administration official-received at least $360,000 in consulting fees from Emergent prior to joining the Department of Health and Human Services (HHS) and awarding Emergent billions of dollars in contracts. The awards included a $261 million order for anthrax vaccines in 2019; a ten-year, $2 billion contract for smallpox vaccines in 2019; and $650 million in coronavirus vaccine manufacturing agreements from 2020, which Dr. Kadlec later acknowledged were a risky decision. Company executives reaped a windfall as vaccines were destroyed. ¢ In February 2021, Emergent awarded millions in raises and bonuses to its senior executives, praising them for their 'exceptional leadership" and 'exemplary" performance in 2020-despite the dysfunction at the Bayview plant. ¢ Emergent even awarded the executive vice president responsible for manufacturing a 'special bonus award" of $100,000 for 'significant CDMO [Contract Development and Manufacturing] expansion related to COVID-19" and in recognition of 'his exceptional performance in 2020." The report also found that Emergent's response to the FDA's April 20, 2021 inspection report (a previously undisclosed document) shows that the company admitted to some of the failures and committed to remediation. However, according to the report, 'the company's troubling history raises questions regarding whether Emergent will ever be able to comply fully with FDA standards and produce safe and effective vaccines." [FNS] AmerisourceBergen Acquires Alliance Healthcare Businesses AmerisourceBergen Corporation announced the completion of its acquisition of the majority of Walgreens Boots Alliance's Alliance Healthcare businesses for $6.275 billion in cash, subject to a customary working capital and net debt adjustment, and two million shares of AmerisourceBergen common stock. According to Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen, 'We are excited to complete the acquisition and extend a warm welcome to the talented team at Alliance Healthcare. The acquisition of Alliance Healthcare expands our reach and solutions in pharmaceutical distribution and adds to AmerisourceBergen's breadth and depth of global manufacturer services." Mr. Collins also noted that, 'With Alliance Healthcare, we will advance our ability to provide innovative and global healthcare solutions and further our purpose of being united in our responsibility to create healthier futures." 'This transaction provides great benefit for both companies and is a logical step following the continued success of our long-term strategic relationship," said Ornella Barra, Chief Operating Officer, International, Walgreens Boots Alliance, Inc. Ms. Barra also stated that, 'The Alliance Healthcare teams are joining a global pharmaceutical distribution leader and trusted partner in AmerisourceBergen, and we look forward to continuing to work together as strategic partners." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. AmerisourceBergen and Walgreens Boots Alliance will also execute on the expansion and extension of commercial agreements in an attempt to drive incremental growth and synergies. AmerisourceBergen describes itself as 'a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies and providers, we create unparalleled access, efficiency and reliability for human and animal health. Our 41,000 global team members power our purpose-* [FN6] FDA Issues Warning Letter To Amgen Over Advertising Of Onpro Pegfilgrastim Wearable Injector Kit The FDA has recently issued a warning to Amgen, instructing it to discontinue what the agency contends are misleading claims about its Onpro pegfilgrastim wearable injector kit. The warning was issued after the FDA received several complaints about these claims through its 'Bad Ad" program. The letter, sent to David Shechter, Ph.D., the company's Senior Manager, Regulatory Affairs, notes that, 'The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a professional animated banner (USA003-80637) for NEULASTA? (pegfilgrastim) injection, for subcutaneous use (Neulasta), submitted by Amgen Inc. (Amgen) under cover of Form FDA 2253." The FDA's letter also states that, 'The FDA Bad Ad Program also received complaints regarding promotional communications with similar claims and presentations as the ones discussed in this letter. The banner makes false or misleading claims and representations about the benefit of Neulasta. Thus, the banner misbrands Neulasta within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(3)(i); 202.1(e)(5). These violations are concerning from a public health perspective because this promotional communication's misleading claims could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector (OBI) is more effective than Neulasta delivered via prefilled syringe (PFS) or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS." The FDA then listed the indications and summary of the most serious and most common risks associated with the use of Neulasta. According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (Pl) (in pertinent part), 'Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia . . ." The Limitations of Use for Neulasta state that, 'Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation." According to the FTC, Neulasta is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony- stimulating factors such as pegfilgrastim or filgrastim. The PI for Neulasta includes warnings and precautions regarding splenic rupture, acute respiratory distress syndrome, serious allergic reactions, allergies to acrylics, use in patients with sickle cell disorders, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulatory effects on malignant cells, myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer in conjunction with chemotherapy and/or radiotherapy, potential device failures, and aortitis. The most common adverse reactions reported with use of Neulasta include bone pain and pain in extremity. Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to benefits. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication. The banner at issue includes the following claims and presentations: - 'In a Real-World Study with nearly 11,000 patients Pegfilgrastim PFS resulted in a significantly higher risk of FN vs. Onpro?" - 'Across all cycles of chemotherapy, the incidence of FN associated with prefilled syringe (PFS) was 1.7% (n = 455) vs 1.3% (n = 126) for Neulasta? Onpro?" - A large presentation of an upward arrow containing the claim, '31%* *p = 0.01" - 'With PFS, FN incidence increased by 31% vs Onpro?" The FDA's position is that these claims and presentations create a misleading impression regarding the benefit of the product by stating that there is a statistically significant higher risk of febrile neutropenia (FN) when pegfilgrastim is administered via the prefilled syringe THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. (PFS) compared to the Onpro on-body injector (OBI). However, the multiple limitations of the cited study2 preclude the drawing of such conclusions regarding the comparative risk of febrile neutropenia (FN) in patients taking pegfilgrastim depending on delivery method. The study, however, was not designed to ensure that patients with FN were appropriately identified for inclusion in the analysis. Specifically, the study uses an unvalidated algorithm to identify study participants. This algorithm retrospectively identified patients who had FN by selecting inpatient and outpatient encounters with diagnosis codes for neutropenia and fever or infection. The data on file that Amgen provided to OPDP included no information about the performance characteristics (e.g., sensitivity, positive predictive value) of the algorithm or the diagnostic codes that were used. The use of an unvalidated algorithm with unknown performance characteristics is a significant limitation because of the potential for misclassification of patients at the onset of the study. The FDA also noted that the data on file does not describe any measures taken to ensure the quality and accuracy of the results generated by the algorithm. As a result, the extent of FN in this study population may be overestimated or underestimated. Furthermore, according to the FDA, the study was not designed to ensure that the PFS and OBI patient populations were adequately balanced or controlled for potential bias. Specifically, the study did not control for factors other than the delivery device that may influence the incidence of FN in the compared groups. Eligible patients for the study had highly diverse clinical characteristics, and the study report did not include any information on the baseline comorbidity or risk factors for FN of the two exposure groups or on design or analytic strategies to minimize the risk of selection bias. Selection bias is a key concern for this study because even slight differences in populations (e.g., risk factors for FN, age, chemotherapy regimen and dosing, etc.) could substantially impact the incidence of FN and the conclusions stemming from the analysis. We note that while the size of the relative effect in this study is large (31% increased incidence of FN with PFS vs. OBI), the absolute difference is much smaller in magnitude (0.4%; 1.7% PFS vs 1.3% OBI). It cannot be ruled out that selection bias is entirely responsible for the observed risk difference. As such, according to the agency, 'reporting a p-value for the claims and presentations in frames one and two of the banner is misleading." Therefore, the FDA concluded that, 'due to multiple limitations of design and analytic strategy, the study does not support the claims and presentations regarding the comparative FN risk when pegfilgrastim is administered via PFS compared to the OBI. We note that two limitations to the study are presented in frames seven and eight under the header 'Real-World Study Limitations. "" [FN7] Senator Durbin Gives Speech Criticizing Drug Industry For Its Role In Opioid Crisis U.S. Senate Majority Whip Dick Durbin (D-IL) recently delivered a speech on the Senate floor criticizing the pharmaceutical industry for allegedly igniting the opioid overdose epidemic and profiting off the suffering of Americans. In his remarks, Durbin spoke about his efforts to reduce opioid overproduction after drug companies distributed 100 billion painkillers in the United States between 2006 and 2014. In 2018, Durbin helped pass a bipartisan bill to strengthen the Drug Enforcement Administration's (DEA) oversight of the opioid production levels for drug manufacturers, which has led DEA to lower opioid quotas by an average of 60 percent over the last five years. Senator Durbin noted that, 'In Illinois [in 2020], 3,500 of our neighbors died of an overdose ? a 27 percent spike from the year before. How did we get here? And who's is responsible for this? There is one clear culprit: the pharmaceutical industry. For years, opioid manufacturers deliberately mischaracterized the risks of their drugs-This epidemic wasn't created by some infectious virus. It was created by corporate greed. In the words of Richard Sackler, of Purdue Pharma, his company chose to flood our streets with "a blizzard of prescriptions that will bury the competition.' It ended up [with] - 500,000 American families burying their loved ones." Durbin also discussed the importance of holding drug companies accountable for allegedly fueling the crisis. He acknowledged the bipartisan group of state attorneys general who announced a framework of a litigation settlement last month involving Johnson & Johnson and the nation's three largest drug distributers. The framework proposes that the companies would pay a total of $26 billion over 18 years to resolve the suits, in addition to certain changes to their business practices. Durbin also highlighted the importance of learning from the diversion of funds from the 1998 tobacco master settlement, by dedicating any opioid settlement funding to addressing the current overdose crisis and fortifying our public health system for the future. Durbin further spoke about his co-sponsorship of a new bill with Senator Elizabeth Warren (D-MA), the Nondebtor Release Prohibition Act, which would ensure that those who engaged in malfeasance cannot escape liability by going through bankruptcy proceedings. He noted that, 'Legal proceedings continue for several other key industry stakeholders that have yet to be held accountable-that includes the Sackler Family of Purdue and Oxycontin infamy. The Sacklers are trying to engineer a legal scheme to escape liability through the bankruptcy court-avoiding future lawsuits while paying $4.5 billion while protecting their vast fortunes estimated at over THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. $11 billion. That's why Senator Warren and | recently teamed up to introduce the Nondebtor Release Prohibition Act, which would prevent the non-consensual release of liability through bankruptcy proceedings-We must demand that the worst corporate actors are held accountable for their role in this crisis." TN®! Ill. Legal Actions and settlements Justice Department announces $22 million False Claims Act settlement with Biogen Biogen Inc., a Cambridge, Massachusetts-based pharmaceutical manufacturer, has agreed to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations, Chronic Disease Fund (CDF) and The Assistance Fund (TAF), as conduits to pay the Medicare co-pays for patients taking Biogen's multiple sclerosis (MS) drugs, Avonex and Tysabri. Advanced Care Scripts (ACS), a specialty pharmacy that performed services for Biogen, has agreed to pay $1.4 million to resolve allegations that it conspired with Biogen to enable Biogen to use CDF and TAF as conduits for Biogen to pay Medicare co-pays for Avonex and Tysabri patients. In separate settlements in late 2019, CDF paid $2 million and TAF paid $4 million to resolve allegations concerning their respective roles in enabling certain pharmaceutical companies to pay kickbacks to Medicare patients. As part of the recent settlements, the government alleged that Biogen, acting with ACS's help, used CDF and TAF, each of which claimed status as a nonprofit organization for tax purposes, as conduits to pay the co-pay obligations of thousands of Medicare patients taking Avonex and Tysabri. According to the government's allegations, Biogen used CDF and TAF, which Biogen paid, to cover Avonex and Tysabri patients' co-pays to induce those patients' Medicare-reimbursed purchases of the drugs. When a Medicare beneficiary obtains a prescription drug covered by Medicare Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (referred to as 'co-pays"). Congress included co-pay requirements in these programs to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. According to First Assistant United States Attorney Nathaniel R. Mendell, 'Biogen coordinated with ACS to game the system, time its payments, and direct its money to cover co-pay costs for patients using its drugs. By using co-pay foundations this way ? as a conduit to pay for co-pays for Biogen patients ? Biogen violated the anti-kickback statute and undermined Medicare's co-pay structure, which Congress designed to safeguard against inflated drug prices. We commend ACS for resolving this matter expeditiously and Biogen for resolving this matter on a cooperative basis." The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration (which involves money or any other thing of value) to induce Medicare patients to purchase the companies' drugs. The False Claims Act settlements resolve allegations first brought in lawsuits filed by whistleblowers under the qui tam provisions of the False Claims Act, which allow private parties to bring suit on behalf of the government and to share in any recovery. The initial whistleblower in this case will receive approximately $3.96 million of the recovery. The government specifically claims that in 2011, Biogen identified Medicare-eligible Avonex patients in Biogen's free drug program, and arranged for ACS to transfer those patients from the Biogen free drug program to CDF, so that CDF could cover those patients' Medicare co-pays and the patients' purchases of Avonex would generate Medicare revenue for Biogen. Biogen then allegedly paid CDF, and ACS promptly sent CDF batch files of co-pay assistance applications for Medicare-eligible Avonex patients who had been receiving the free drug from Biogen. CDF subsequently approved most of those applications and covered the costs of those patients' Medicare co-pays for Avonex. The government also alleges that, in 2012, Biogen identified Medicare-eligible Tysabri patients in Biogen's free drug program, and arranged for ACS to transfer those patients from the Biogen free drug program to TAF, so that TAF could cover those patients' Medicare co-pays and the patients' purchases of Tysabri would generate Medicare revenue for Biogen. Biogen allegedly made payments to TAF in the second and third quarters of 2012, and each time ACS then transferred to TAF batch files of co-pay assistance applications for Medicare-eligible patients who had been receiving the free drug from Biogen. TAF subsequently paid most or all those patients' Medicare co-pays for Tysabri. The government also alleges that, in 2013, Biogen worked with ACS again to transition Medicare-eligible Tysabri patients out of Biogen's free drug program to CDF, which Biogen paid so that CDF would cover those patients' Medicare co-pays for Tysabri and Biogen would receive the resulting Medicare reimbursement revenue. Acting Assistant Attorney Jeffrey Bossert Clark of the Department of Justice's Civil Division commented on the settlement, noting that, 'The resolution announced today, like prior settlements concerning similar misconduct, demonstrates the government's commitment to hold accountable companies that pay kickbacks to undermine important constraints on rising drug costs. Drug companies that illegally manipulate charitable patient assistance programs to subsidize copays for their own products will be held accountable." According to Phillip Coyne, Special Agent in Charge, Office of the Inspector General of the Department of Health and Human Service's Boston Regional Office, 'Kickback schemes can undermine our healthcare system and lead to higher costs for the Medicare program. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. We will continue to hold pharmaceutical companies and specialty pharmacies accountable if they work together to subvert the charitable donation process and violate the prohibition on the payment of kickbacks." The U.S. Attomey's Office, since 2017, has collected over $1 billion from eleven pharmaceutical companies that allegedly used third- party foundations as conduits to pay kickbacks. The Department also has reached settlements with four foundations, as well with ACS concerning its relationship with a different pharmaceutical company. Joseph R. Bonavolonta, Special Agent in Charge of the FBI Boston Division, noted that, 'Biogen tried to unfairly boost its bottom line by working with Advanced Care Scripts to bill Medicare for those who were already receiving their drug for free, undermining Medicare's co-pay structure which was set up to safeguard against inflated drug prices. Kickback schemes like this one undermine our healthcare system, can compromise medical decisions, and waste taxpayer dollars. The FBI will continue to work with our partners to hold accountable those who conspire to disguise kickbacks as charitable contributions, at the expense of the Medicare program." [FNS] New Jersey AG Announces Multi-Million Dollar Settlement with Insys Therapeutics Founder Relating to Marketing of Fentanyl Spray New Jersey Attorney General Gurbir S. Grewal recently announced an anticipated $5 million settlement with Insys Therapeutics, Inc. founder John N. Kapoor to resolve allegations that Kapoor unlawfully orchestrated the payment of bribes to New Jersey doctors as part of a nationwide kickback scheme to boost sales of the company's flagship opioid drug Subsys. After the State is reimbursed costs from the lawsuit, most of the recovery will be used to fund the State's efforts to combat the opioid epidemic. The remainder will be divided among state agencies affected by the alleged fraudulent scheme, as required by law. The settlement resolves a civil lawsuit filed by the Attorney General and the Division of Consumer Affairs against Kapoor in 2017, asserting violations of the New Jersey Consumer Fraud Act and False Claims Act. The Kapoor settlement is the first settlement in any of the State's civil lawsuits against corporations and executives involved in manufacturing and fraudulently marketing opioid drugs. The settlement does not resolve the State's claims against Insys itself, which has declared bankruptcy and filed a plan of liquidation, or the State's claims against other companies that engaged in misconduct involving the sale of opioids. According to Attorney General Grewal, 'We are committed to holding accountable anyone whose bad conduct has helped fuel the opioid epidemic, whether they pushed drugs from a board room, an exam room, or a street corner." Grewal further noted that, 'With today's settlement, we've recovered a substantial sum from one individual who used his perch in a corporate board room to sell addictive drugs through bribes and fraud. We are looking forward to additional recoveries from other opioid manufacturers and distributors, who also are responsible for helping New Jersey overcome and heal from the epidemic they unleashed." The State's 2017 complaint alleged that Mr. Kapoor directed and approved a campaign to fraudulently market Subsys, which is a sublingual fentanyl spray that is approximately fifty times stronger than heroin and one hundred times more potent than morphine. This marketing campaign was intended to increase sales in New Jersey and elsewhere. Although the U.S. Food and Drug Administration approved Subsys only for the narrow purpose of treating breakthrough pain in opioid- tolerant cancer patients, the State alleged that Kapoor arranged for Insys to bribe healthcare professionals to write Subsys prescriptions for other purposes and at higher doses than appropriate. The State also alleged that Kapoor directed and approved a scheme to lie to insurance carriers and pharmacy benefit managers about patients' diagnoses and treatment histories to secure payment for unwarranted prescriptions. According to the State's complaint against Kapoor, Kapoor's conduct contributed to a flood of improper Subsys prescriptions, many of which resulted in payments from the State's public employees' health benefit and workers compensation insurance programs. In May 2019, a federal jury in Boston convicted Kapoor and four other Insys executives of racketeering conspiracy in connection with the nationwide Insys bribery scheme. In January 2020, Kapoor was sentenced to five-and-a-half years in federal prison. As part of his sentencing, a multi-million dollar monetary obligation was imposed on Kapoor, which he owes jointly and severally with his co- defendants. Under the terms of the Final Consent Judgment filed in Superior Court in Middlesex County today, Kapoor agreed to make an upfront, lump sum payment of $1 million within ten days, followed by an additional payment of an anticipated $4 million following satisfaction of the monetary obligation imposed in the criminal case. Mr. Kapoor is obligated to pay the State a lump sum equal to 30 percent of any amount of the criminal obligation not paid by him, up to $4 million. The settlement also permanently bars Kapoor from managing or owning any business organization within New Jersey and from serving as an officer, director, trustee, member of an executive board or similar governing body, principal, manager, or stockholder owning 10 percent or more of the aggregate outstanding capital stock of all classes of any corporation doing business in New Jersey. Since 2018, the State also has taken action against several doctors who prescribed Subsys to non-cancer patients after receiving monetary payments from Insys, which disguised its payments as compensation for sham speaking and consulting work. The State THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Board of Medical Examiners has barred five of those doctors from practice in New Jersey, and administrative actions are pending against four more. Those doctors' patients collectively suffered at least two overdoses and one overdose-related death, while other patients were placed at heightened risk of addiction, overdose, and death. Sharon M. Joyce, Director of the Office of the New Jersey Coordinator for Addiction Responses and Enforcement Strategies (NJ CARES), commented on the settlement. Ms. Joyce noted that, 'As we continue to hold individual doctors accountable for their part in this egregious abuse of New Jersey patients, we are pleased that a central figure in this scheme is answering for his conduct." Ms. Joyce further stated that, 'We cannot begin to measure the pain and suffering caused by John Kapoor's callous greed, but we know it will plague our communities for years to come. This settlement rightly makes him responsible for providing financial resources needed to combat the long-lasting and destructive ripple effects of his unlawful actions." Section Chief and Deputy Attorney General (DAG) Lara Fogel, and DAsG Eric Boden, Brian DeVito and Dana Vasers, all from the Government & Healthcare Fraud Section in the Division of Law's Affirmative Civil Enforcement Practice Group represented the State in the litigation. They consulted with Assistant Attorneys General Janine Matton and Brian McDonough of the Affirmative Civil Enforcement Practice Group. [FN 10] New York and Other States Settle Opioid Marketing Claims With McKinsey & Company for Over $573 Million New York Attorney General Letitia James, along with a coalition of several attorneys general across the country, recently announced a $573 million settlement agreement and consent judgment with McKinsey & Company relating to the company's alleged role in role in working for opioid companies, helping those companies promote their drugs, and profiting millions of dollars from the opioid epidemic. The funds from the agreement, over $32 million of which will go to New York state, will be used towards abating the effects of excessive opioid use in the participating states. This is the first multistate opioid agreement to result in substantial payment to states to address the crisis. According to Attorney General James, 'McKinsey's cynical and calculated marketing tactics helped fuel the opioid crisis by helping Purdue Pharma target those doctors they knew would overprescribe opioids. They knew where the money was coming from and zeroed in on it. Under the terms of today's agreement, the company will finally end its illegal conduct, deliver more than half a billion dollars into communities across the nation, and will never be able to help perpetrate this type of fraud and deception again." James further noted that, 'While no amount of money will ever compensate for the pain of the hundreds of thousands dead, the millions addicted, and the countless families torn apart from opioid addiction, we can ensure that those responsible for the crisis help to fund prevention, education, and treatment programs to stop additional New Yorkers and Americans across the country from becoming addicted to opioids in the first place. This is just the beginning of our fight for justice for victims, and we will continue to do everything in our power to prevent the industry from hooking more patients and causing yet additional harm." In addition to providing more than $573 million, minus payment of costs, to address the opioid crisis, the agreement (filed simultaneously by 47 states, the District of Columbia, and five U.S. territories) calls for McKinsey to release tens of thousands of its internal documents detailing its work for OxyContin manufacturer Purdue Pharma, as well as other opioid manufacturers, for public disclosure online. McKinsey also agreed to adopt a strict document retention plan, continue its investigation into allegations that two of its partners tried to destroy documents in response to investigations of Purdue Pharma, implement a strict ethics code that all partners must certify each year, and stop advising companies on potentially dangerous opioid-based Schedule II and III narcotics. The recent filing of settlement documents describes how McKinsey allegedly contributed to the opioid crisis by promoting marketing schemes and consulting services to opioid manufacturers, including Purdue Pharma, for over a decade. A complaint describing McKinsey's marketing tactics that detail how the company advised Purdue and members of the Sackler family (who control Purdue) on how to maximize profits from its opioid products, including targeting high-volume opioid prescribers, using specific messaging to get physicians to prescribe more OxyContin to more patients, and circumventing pharmacy restrictions in order to deliver high-dose prescriptions. Acting in concert, McKinsey, Purdue, and the Sacklers sold millions of doses of Purdue's opioids in New York in violation of New York law. When states began to sue Purdue's directors for their implementation of McKinsey's marketing schemes, McKinsey partners began emailing about deleting documents and emails related to their work for Purdue. Attorney General James contends that the opioid epidemic has caused massive harm to individuals and communities in New York and in states across the nation over the last 20 years. During this time, nearly 500,000 Americans have died from an opioid overdose, including more than 20,000 New Yorkers. These deaths, as well as impacts on New Yorkers who have struggled with opioid use, have created significant costs to New York in the form of health care, child welfare, criminal justice, and many other programs needed to lessen the epidemic. It has also resulted in lost economic opportunity and productivity. A press release from Attorney General James also noted that, 'On the social level, opioid addiction, abuse, and overdose deaths have torn families apart, damaged relationships, and eroded the social fabric of communities." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Attorneys general of the following jurisdictions joined Attorney General James in leading the executive committee that reached today's agreement: California, Colorado, Connecticut, Massachusetts, North Carolina, Oklahoma, Oregon, Tennessee, and Vermont. Attorney General James and the other executive committee members are joined by the attomeys general of Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, lowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, Wyoming, the District of Columbia, and the territories of American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands. [FN11] California Attorney General Xavier Becerra noted that the opioid epidemic has led to considerable harm to individuals and California's communities. In 2019, the California Department of Public Health reported 3,244 deaths related to an opioid overdose. The epidemic has resulted in considerable costs to the state in the form of healthcare, child welfare, criminal justice, and many other programmatic costs. On the societal level, opioid addiction, abuse, and overdose deaths have torn families apart, damaged relationships, and eroded the social fabric of communities. Furthermore, according to Becerra, the uncertainty and stress caused by the COVID-19 pandemic continues to feed the increase in opioid overdose deaths. The Overdose Detection Mapping Application Program reports that national suspected overdoses in 2020 rose 18 percent in March, 29 percent in April, and 42 percent in May compared to the same months in 2019. Attorney General Becerra also noted that, 'The abuse of opioids, not just by those who consumed these drugs, but by those who produced, marketed, distributed and dispensed them, has left much of America in mouming. We can't bring back lost lives, but we can hold ringleaders accountable. McKinsey & Company was a player in this unfolding opioids tragedy. Today's settlement holds McKinsey to account." [FN Ohio Sues Multiple Centene Entities for Breach of Medicaid Contracts Relating to Use of Layers of Pharmacy Benefit Managers The state of Ohio has sued insurer Centene Corp., alleging an elaborate scheme to maximize company profits at the expense of the Ohio Department of Medicaid (ODM) and the state of Ohio, Attorney General Dave Yost recently announced. The lawsuit alleges that Centene subsidiary Buckeye Health Plan used a web of subcontractors for the provision of pharmacy benefits in order to misrepresent pharmacy costs, resulting in millions of dollars of overpayments by ODM. According to Attorney General Yost, 'Corporate greed has led Centene and its wholly owned subsidiaries to fleece taxpayers out of millions. This conspiracy to obtain Medicaid payments through deceptive means stops now. My office has worked tirelessly to untangle this complex scheme, and we are confident that Centene and its affiliates have materially breached their obligations both to the Department of Medicaid and the state of Ohio." The Department of Medicaid administers a medical assistance plan that provides coverage to about 2.9 million Ohioans, and it does so using Managed Care Organizations (MCOs). One such MCO, Centene's Buckeye Health Plan, administered its pharmacy benefit via sister companies Envolve Health Solutions and Health Net Pharmacy Solutions. The practice of subcontracting to more than one Pharmacy Benefit Manager (PBM) raised questions about Buckeye Health Plan's business practices and, ultimately, Centene's. The Office of the Attorney General, through outside counsel, conducted a thorough investigation of these practices, finding significant breaches of contract. Notably, these include: * Filing reimbursement requests for amounts already paid by third parties; ¢ Failing to accurately disclose to ODM the true cost of pharmacy services, including the disclosure of discounts received; and ¢ Artificially inflating dispensing fees. Yost noted that, 'Centene's actions are deeply concerning and have a direct effect on the most vulnerable Ohioans. Centene has broken trust with the state of Ohio, and | intend to hold this company accountable for its deceptive practices. Today's lawsuit is a message to corporations nationwide that Ohio will not allow them to impermissibly profit at the expense of our taxpayers," Yost said. The lawsuit, filed on March 11th in the Franklin County Court of Common Pleas, was filed under seal due to a confidentiality and nondisclosure agreement. [FN13] $834 Million Judgment Entered Against Bristol-Myers Squibb and Sanofi Subsidiaries in Hawall State Court Hawall Attorney General Clare E. Connors recently announced the entry of an $834 million state court order against Bristol-Myers Squibb Company and three U.S.-based subsidiaries of the French pharmaceutical company Sanofi for violating the State of Hawaii's unfair and deceptive practices laws. The amount of the judgment reflects the profits earned by the defendants while engaged in deceptive conduct that spanned more than a decade. The order arises out of Defendants' acts in developing, marketing and promoting Plavix, a prescription drug designed to reduce the risk of serious cardiovascular events such as heart attacks, strokes, and blood clots. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -10- According to evidence presented in court, the defendants began marketing the drug to Hawall physicians and consumers in 1998, knowing that it was not effective for many patients, including Asian and Pacific Island patients. Defendants only began warning Hawall physicians and consumers about this issue in March 2010, when the U.S. Food and Drug Administration (FDA) required them to place a 'black box" warning on the label accompanying the drug. After a four-week trial that ended on November 20, 2020, Hawall Circuit Court Judge Dean E. Ochiai concluded that Defendants deliberately withheld vital information about Plavix's efficacy from the FDA, the greater medical community and Hawall consumers. The Court found that, between December 1998 and March 12, 2010, when the FDA required Defendants to disclose the waming, the defendants sold 834,012 prescriptions, refills, and non-retail units in Hawall without including important information about the large percentage of patients who received less benefit or no benefit from Plavix due to their race and genetic makeup. Based on this evidence, the court determined the Defendants 'knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits." The Court further found that the Defendants engaged in 'immoral, unethical, oppressive or unscrupulous" acts, by choosing not to warn about the risks and benefits of Plavix and instead 'burying their heads in the sand." Finally, the Court found that Defendants' acts deprived consumers of the right to make informed choices about the use of Plavix, and found that each distribution of Plavix with its misleading package label constituted a violation of Hawall law. Noting that Defendants' acts were 'unfair and deceptive," the Court imposed a penalty of $1,000 per violation, for a total of the $834,012,000 awarded as penalties. Attorney General Connors commented on the settlement, noting that, 'Today's order vindicates seven long years of work by this Department and its attorneys to ensure that companies marketing and selling their products in Hawall keep the safety and welfare our people at the forefront of their business decisions. The order entered by the Court today puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety." The Court's order highlights Defendants' 'seemingly blind refusal to accept the reality of Plavix's limitations." The Court further determined that '[t]hose limitations could potentially contribute to very significant harm, including death, to large groups of patients unable to bioactivate it, or only able to activate it partially. " IFN14] New York Pharmacist Indicted Over Alleged Health Care Fraud Kickbacks and Bribes Relating to Over $4 Million in Medicare and Medicaid Reimbursements The Department of Justice recently announced that a New York man was arrested today for his role in a conspiracy to commit health care fraud and to pay kickbacks and bribes to customers for expensive prescription orders in connection with more than $4 million in Medicare and Medicaid reimbursements. According to an indictment returned by a federal grand jury in the Eastern District of New York, Robert John Sabet, 44, of Brooklyn, was the owner of Brooklyn Chemists in Gravesend, Brooklyn, and Lucky Care Pharmacy in Flushing, Queens. Since September 2016, Sabet allegedly conspired to bill Medicare and Medicaid for expensive prescription drugs that were not eligible for reimbursement because, among other reasons, they were not needed or not dispensed. Sabet also allegedly conspired to pay kickbacks and bribes to customers to convince them to fill prescriptions at his pharmacies, and to pay customers cash in exchange for the ability to bill Medicare and Medicaid for over-the-counter health care-related products on their behalf. In December 2020, Sabet allegedly wired nearly $100,000 from Lucky Care's bank accounts to an automobile dealership to pay for a luxury car. Investigators conducted a search warrant at Sabet's home at the time of his arrest and seized a 2020 Porsche Taycan worth over $250,000, as well as cash and luxury goods. Sabet is charged with conspiracy to commit health care fraud, conspiracy to defraud the United States by paying kickbacks and bribes in connection with the provision of health care services, and unlawfully spending the proceeds of his fraud. The defendant is scheduled for his initial court appearance today before U.S. Magistrate Judge Ramon E. Reyes, Jr. of the U.S. District Court for the Eastern District of New York. If convicted, he faces a maximum penalty of 10 years in prison for conspiracy to commit health care fraud, five years in prison for conspiracy to pay kickbacks and bribes, and 10 years in prison for unlawful spending. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. HHS-OIG, IRS-Cl, and OMIG are investigating the case. [FN15] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -11- Bristol-Myers Squibb to Pay $75 Million to Resolve False Claims Act Allegations of Underpayment of Medicaid Drug Rebates Deputy United States Attorney Louis D. Lappen of the Eastern District of Pennsylvania recently announced that Bristol-Myers Squibb ('BMS") has agreed to pay the United States and participating states a total of $75 Million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program. Of that total amount, BMS will pay approximately $41 million, plus interest, to the United States, and the remainder to states participating in the settlement. Pursuant to the Medicaid Drug Rebate Program ('MDRP'), drug manufacturers are required to pay quarterly rebates to state Medicaid programs in exchange for Medicaid's coverage of the manufacturers' drugs. The quarterly rebates are based, in part, on the Average Manufacturer Prices (AMPs) that the manufacturers report to the government for each of their covered drugs. Generally, the higher the reported AMP for a drug, the greater the rebate the manufacturer pays to state Medicaid programs for the drug. This settlement resolves allegations that BMS underreported AMPs for a number of its drugs by improperly reducing the reported AMPs for service fees paid to wholesalers, and by improperly excluding from the reported AMPs additional value it received pursuant to price appreciation provisions in its contracts with wholesalers. As a result, BMS allegedly underpaid quarterly rebates owed to the states and caused the United States to be overcharged for its payments to the states for the Medicaid program. Deputy United States Attorney Lappen commented on the settlement, noting that, 'The Department of Justice is committed to ensuring that pharmaceutical manufacturers comply with the requirements of programs such as the Medicaid Drug Rebate Program. It is critical that these companies report accurate pricing information used in the rebate calculations so that the government and taxpayers benefit from the program as Congress intended." This settlement resolves a lawsuit filed by Ronald J. Streck under the whistleblower provisions of the False Claims Act, which permit private parties, called relators, to file suit on behalf of the United States for false claims and share in a portion of the government's recovery. The civil lawsuit was filed in the Eastern District of Pennsylvania and is captioned United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa.). The government declined intervention of this matter, and the relator and his counsel proceeded with the case. Relator Streck is represented by Dan Miller of Walden Macht & Haran LLP, Joy Clairmont of Berger & Montague, PC, Robert Jackson Martin of Martin Law, PC, and Peter Kohn of Faruqi and Farudai. Deputy U.S. Attorney Lappen further noted that, 'We thank Mr. Streck and his counsel for their efforts, which were critical to the favorable resolution of this case." The settlement was a coordinated effort among the Department of Justice Civil Division's Commercial Litigation Branch, the United States Attorney's Office for the Eastern District of Pennsylvania, and the National Association of Medicaid Fraud Control Units. For the U.S. Attorney's Office, the investigation and settlement were handled by Assistant United States Attorney Eric D. Gill and Assistant United States Attorney Charlene Keller Fullmer, Deputy Chief of the Civil Division. "4 Incyte Settles False Claims Act Allegations for $12.6 Million; Allegations Include Misuse of Foundation The Justice Department recently announced that Delaware-based pharmaceutical company Incyte Corporation has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks. The settlement resolves allegations that, from November 2011 through December 2014, Incyte allegedly used an independent foundation as a conduit to pay the copays of certain federal beneficiaries taking Incyte's drug Jakafi, which was approved to treat myleofibrosis in 2011. Specifically, Incyte was the sole donor to a fund that opened in November 2011 to assist only myleofibrosis patients. After the fund opened, the government alleges that Incyte used the fund to pay the copays of federal beneficiaries taking Jakafi who were ineligible for assistance from the fund because they did not have myleofibrosis. Incyte managers allegedly pressured the foundation, through phone calls and emails, to provide economic assistance to these ineligible patients, and Incyte's contractor helped ineligible patients to complete applications submitted to the fund for assistance. The government alleges that through this conduct, Incyte caused false claims for Jakafi to be submitted to Medicare and TRICARE. When a beneficiary obtains a prescription drug covered by Medicare or TRICARE, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance or a deductible (collectively 'copays"). Congress included copay requirements in these federal programs, in part, to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. Under the Anti-Kickback Statute, a pharmaceutical company is prohibited from offering or paying, directly or indirectly, any remuneration (which includes money or any other thing of value) to induce federal beneficiaries to purchase the company's drugs. This prohibition extends to the payment of patients' copay obligations. Acting Assistant Attorney General Brian M. Boynton of the Justice Department's Civil Division commented on the settlement, noting that, 'Drug companies undermine the integrity of federal health care programs and contribute to rising drug costs when they illegally THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -12- use foundations to cover patients' costs for their own drugs. This resolution reflects the government's continuing commitment to hold pharmaceutical companies accountable for this conduct." Acting U.S. Attorney Jennifer Arbittier Williams for the Eastern District of Pennsylvania also commented on the settlement, stating that, 'Pharmaceutical companies cannot skirt the anti-kickback rules by disguising their inducements to federally-insured patients as charitable donations. This resolution shows our office's continuing commitment to holding drug companies accountable for this conduct." The civil settlement includes the resolution of claims brought under the qui tam (or whistleblower) provisions of the False Claims Act by a former compliance executive at Incyte. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned U.S. ex rel. Dillon v. Incyte Corp., No. 2:18 -cv-2642 (E.D. Pa.). The former employee will receive approximately $3.59 million of the recovery. Special Agent in Charge Patrick J. Hegarty of the DCIS Northeast Field Office stated that, 'Protecting TRICARE, the health care system for U.S. military members and their dependents, is a top priority for the Defense Criminal Investigative Service (DCIS). Submitting false claims for ineligible patients compromises the integrity of the TRICARE program. Today's settlement is the result of a joint effort with the U.S. Attorney's Office, DOJCivil Frauds, and HHS-OIG, and it demonstrates our ongoing commitment to work with our law enforcement partners to investigate those who engage in health care fraud." [FN17] Indivior Settles Suboxone Marketing Case With Several States for $300 million Missouri Attorney General Eric Schmitt recently announced that Missouri and several other states have reached an agreement with Indivior plc and Indivior Inc. ('Indivior') to settle allegations that Indivior falsely and aggressively marketed and promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds. Suboxone is a drug approved for use by patients recovering from opioid addiction to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful opioids. Indivior will pay a total of $300 million to the collective states to resolve the civil fraud allegations impacting Medicaid and other government healthcare programs, of which approximately $204 million will go to Medicaid. The states will receive a total of nearly $91 million as their share of the Medicaid recovery, with the remaining paid to the federal government. As part of the settlement, the state of Missouri will receive $712,107.57 in restitution and damages. The Attorney General's Medicaid Fraud Control Unit handled this case. Attorney General Schmitt noted that, 'Indivior and its executives were falsely and aggressively marketing Suboxone, a powerful opioid, in order to game the Medicaid system and fraudulently receive Medicaid payouts. Suboxone is used to aid in recovery from opioid addiction, and Indivior's actions preyed on that vulnerable population. As a result of the efforts of my Office's Medicaid Fraud Control Unit, Missouri will receive $712,000 in restitution and damages." Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals, Inc.) is a Delaware corporation headquartered in Richmond, Virginia, and is a wholly owned subsidiary of Indivior plc. The civil settlement resolves allegations that, from 2010 through 2015, Indivior, directly or through its subsidiaries: ¢ Promoted the sale and use of Suboxone to physicians who were writing prescriptions that were not for a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted; ¢ Knowingly promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that the Film was less subject to diversion and abuse than other buprenorphine products and that the Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets; and ¢ Submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that Suboxone Tablet had been discontinued 'due to safety concerns'. Indivior also made efforts to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone. As part of the settlement, Indivior was also required to execute 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. [FN18] Kentucky Sues CVS Health For Its Alleged Role In Opioid Epidemic; Claims CVS Had Dual Role In Supply Chain Kentucky Attorney General Daniel Cameron recently filed a lawsuit against CVS Health (CVS) for the company's alleged role in Kentucky's opioid epidemic. The lawsuit, filed in Franklin Circuit Court, alleges the company engaged in unlawful business practices and failed to guard against the diversion of opioids. It is the latest action by Attorney General Cameron to attempt to hold companies accountable for their role in the Commonwealth's opioid crisis. Attorney General Cameron noted that, 'During the height of the opioid epidemic, CVS allowed millions of dosage units of opioids to flood Kentucky's borders, fueling the crisis and devastating thousands of families and communities across the Commonwealth." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -13- Cameron further stated that, 'As both distributor and pharmacy, CVS was in a unique position to monitor and stop the peddling of these highly-addictive drugs from their stores, yet they ignored their own safeguard systems. By bringing this lawsuit on behalf of the people of Kentucky, we are holding CVS accountable for these decisions and for contributing to a man-made crisis that tragically led to the loss of life of thousands of Kentuckians." CVS maintained over 100 separate license numbers in the Commonwealth as a 'wholesaler," 'out-of-state pharmacy," and 'retail pharmacy."Between 2006 and 2014, CVS pharmacies in Kentucky purchased more than 151 million dosage units of oxycodone and hydrocodone from its own distribution centers and third-party distributors, accounting for nearly 6.1 percent of the total dosage units in the Commonwealth during this time. One CVS store, located in Perry County, purchased over 6.8 million dosage units of oxycodone and hydrocodone from 2006 to 2014, which was enough opioids for every man, woman, and child in the county to have over 26 pills every year during the same period. A CVS in Crittenden County bought over 2.8 million dosage units of the drugs, enough to supply everyone in the county with over 34 pills every year. The lawsuit claims that, because CVS had a dual role in the opioid supply chain as a distributor and pharmacy, the company's compliance with the law 'was vital to safeguard consumers and control the rate of addiction, abuse, and diversion of opioids."CVS had access to prescription opioid dispensing data for all of the company's Kentucky pharmacies, including information revealing the size, frequency, dose, and combinations of prescriptions filled by each pharmacy. Despite supplying significant quantities of opioids in Kentucky, CVS reported zero suspicious orders for its Kentucky stores from 2007 to 2014. The next year, in 2015, the CDC identified Kentucky as having a statistically significant drug overdose death rate increase from 2014 to 2015. In 2015, drug overdoses accounted for more than 59 percent of Kentucky's statewide accidental deaths, which is more than motor vehicle accidents, fire, drowning, and gunshot wounds combined. Leading up to and during the height of the opioid epidemic, CVS also participated in the marketing, advertising, and promotion of opioid products, working with manufacturers like Purdue Pharma and Endo Pharmaceuticals. The lawsuit alleges that CVS improperly normalized the widespread use of opioids by participating in these efforts. The lawsuit includes seven claims against CVS for its role in the opioid epidemic. Attorney General Cameron continues to pursue litigation against Walgreens, Endo Pharmaceuticals, and Teva Pharmaceuticals Industries Inc. for each company's alleged role in the opioid crisis. Settlement discussions are ongoing with Johnson & Johnson, McKesson Corporation, Cardinal Health, and AmerisourceBergen for allegedly failing to maintain effective control over their narcotics. Claims against two other opioid producers in bankruptcy, Purdue Pharma, and Mallinckrodt Pharmaceuticals, are expected to reach a resolution at some point in 2021. [FN19] NY Attorney General Reaches $230 Million Settlement With Johnson & Johnson for Treatment and Prevention of Opioid Crisis in New York; Company Ends Sale of Opioids New York Attorney General Letitia James recently announced an agreement with Johnson & Johnson (J&J), the parent company of Janssen Pharmaceuticals, Inc., that will provide up to $230 million to New York state, in the largest monetary settlement ever secured by Attorney General James. The agreement resolves claims made by the state for the company's role in helping to fuel the opioid epidemic and would allocate payments over nine years, with substantial payments made upfront. The agreement also requires J&J to pay $30 million more in payments in the first year if the New York state executive chamber signs into law new legislation that creates an opioid settlement fund, and other criteria are met. If that legislation, which passed the state Legislature unanimously, becomes law and all litigating subdivisions within New York sign on to the settlement, New York would be eligible to receive more than half of total payments, or more than $130 million, as soon as February 2022. The agreement also makes enforceable a ban stopping J&J and all of its subsidiaries, predecessors, and successors from manufacturing or selling opioids anywhere in New York, and acknowledges Johnson & Johnson's exit from the opioid business nationally. According to Attorney General James, 'The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids. Johnson & Johnson helped fuel this fire, but today they're committing to leaving the opioid business - not only in New York, but across the entire country. Opioids will no longer be manufactured or sold in the United States by J&J. We are also delivering up to $230 million to fund opioid prevention, treatment, and education efforts across New York state." James further noted that, 'While no amount of money will ever compensate for the thousands who lost their lives or became addicted to opioids across our state or provide solace to the countless families tom apart by this crisis, these funds will be used to prevent any future devastation. Our trial against the remaining defendants will commence this coming week, where we will lay bare the callous and THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -14- deadly pattern of misconduct these companies perpetrated as they dealt dangerous and addictive opioids across our state. As always, our goal remains getting funds to those devastated by opioids as quickly as possible." In March 2019, Attorney General James filed the lawsuit, which attempted to hold accountable the various manufacturers and distributors allegedly responsible for the opioid epidemic. In addition to J&J, the manufacturers named in the complaint included Purdue Pharma and its affiliates, as well as members of the Sackler Family (owners of Purdue) and trusts they control; Mallinckrodt LLC and its affiliates; Endo Health Solutions and its affiliates; Teva Pharmaceuticals USA, Inc. and its affiliates; and Allergan Finance, LLC and its affiliates. The distributors named in the complaint were McKesson Corporation, Cardinal Health Inc., Amerisource Bergen Drug Corporation, and Rochester Drug Cooperative Inc. The cases against Purdue Pharma (and subsequently the Sackler family), Mallinckrodt, and Rochester Drug Cooperative are all now moving separately through U.S. Bankruptcy Court. The trial against all other defendants is set to begin this summer. As part of the agreement, J&J will pay New York state a total of up to $229,862,769.25, with payments made over the course of nine years. The schedule of those payments will depend on a number of circumstances, including how many of the state's political subdivisions accept and choose to participate in today's agreement. It will also depend on whether the state's executive chamber signs legislation that creates an opioid settlement fund, which would ensure that payments for New York state under any opioid settlement or through litigation would be earmarked towards prevention, treatment, education, and other forms of abatement, instead of towards the state's general fund. Under the most aggressive schedule, where this new legislation is signed into law and all subdivisions accept the terms of the settlement, the first three years of payments - totaling $134,330,271.65 (over half of the total settlement) will be accelerated and paid as soon as February of 2022. In addition to negotiating a monetary component, Attorney General James negotiated injunctive relief securing the end of J&J's manufacturing of opioids and their distribution across New York and the rest of the nation. J&J has committed to ending the manufacture and sale of all opioids and opioid products for distribution in the state of New York, as well as to no longer ship these products anywhere within the United States. The company will also provide the Office of the Attorney General with details of when the last of the inventory of opioids it has already shipped expires. J&J will also be prohibited from promoting opioids or opioid products through sales representatives, sponsorships, financial support, or any other means; will not be allowed to provide financial incentives to its sales and marketing employees for the sale of these products; and will not, directly or indirectly, provide financial support or in-kind support to any third party that primarily engages in conduct that promotes opioids, opioid products, or products for the treatment of opioid-induced side effects. J&J will also be forbidden from disciplining its sales and marketing employees for not hitting opioids sales quotas, which was allegedly one of the key motivators J&J and other companies had in marketing opioids so heavily to the American public. The company will also be prohibited from using, assisting, or employing any third party to engage in any activity that J&J itself would be prohibited from engaging in pursuant to the recent agreement. J&J will also be prohibited from lobbying federal, state, or local legislative or regulatory authorities about opioids or opioid products. Lastly, J&J will have to make additional information about opioids and opioid products more accessible to the public, including to patients, health care providers, and others. Part of how J&J will fulfill this provision is by sharing clinical trial data under the Yale University Open Data Access (YODA) Project to allow researchers qualified under the program to access the company's propriety data under the terms of the project. The agreement would also resolve lawsuits against J&J by Nassau and Suffolk counties if the county legislatures approve it. IFN20] New York AG Announces Tentative $26 Billion Multi-State Opioid Settlement New York Attorney General Letitia James recently announced a proposed $26 billion agreement that will resolve claims against three of the nation's largest drug distributors: McKesson Corporation, Cardinal Health Inc., and Amerisource Bergen Drug Corporation, as well as one of the nation's largest drug manufacturers (Johnson & Johnson (J&J)), over the companies' alleged roles in creating and fueling the opioid epidemic. New York communities affected by opioids will specifically receive up to $1.25 billion to fund prevention, treatment, and recovery programs (the terms of New York's specific settlements were previously announced with both the three distributors and with J&J). Furthermore, the proposed agreement requires significant industry changes that are intended to end the opioid epidemic and prevent this type of crisis from occurring again. According to Attorney General James, 'The numerous companies that manufactured and distributed opioids across the nation did so without regard to life or even the national crisis they were helping to fuel. Johnson & Johnson, McKesson, Cardinal Health, and Amerisource Bergen not only helped light the match, but continued to fuel the fire of opioid addiction for more than two decades. Today, we are holding these companies accountable and infusing tens of billions of dollars into communities across the nation, while taking significant steps to hold these companies accountable. Johnson & Johnson will stop the sale of opioids nationwide, and McKesson, Cardinal Health, and Amerisource Bergen are finally agreeing to coordinate and share their data with an independent monitor to ensure this wildfire does not continue to spread any further." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -15- James further noted that, 'While no amount of money nor any action can ever make up for the hundreds of thousands of lives lost or the millions more addicted to opioids, we can take every action possible to avoid any future devastation." The proposed global agreement, if approved by a substantial number of states and local governments across the country, would resolve the claims of nearly 4,000 entities that have filed lawsuits in federal and state courts against the four companies. New York has already signed on to the agreement, while other states have 30 days to sign onto the deal. Local governments in the participating states will have up to 150 days to join. States and their local governments will receive maximum payments if each state and its local governments join together in support of the agreement. Highlights of the proposed agreement include: Global Funding - The three distributors collectively will pay up to $21 billion over the next 18 years. - Johnson & Johnson will pay up to $5 billion over nine years, with up to $3.7 billion paid during the first three years. - The total funding distributed will be determined by the overall degree of participation by both litigating and non-litigating state and local governments. - Nationwide, the substantial majority of the money is to be spent on opioid treatment and prevention. - Each state's share of the funding has been determined by an agreement among the states using a formula that takes into account the impact of the crisis on the state - specifically, the number of overdose deaths, the number of residents with substance use disorder, and the number of opioids prescribed - and the population of the state. Global Injunctive Relief - The 10-year proposed agreement will result in court orders requiring McKesson, Cardinal, and Amerisource Bergen to: - Establish a centralized independent clearinghouse to provide all three distributors and state regulators with aggregated data and analytics about where drugs are going and how often, eliminating blind spots in the current systems used by distributors. - Use data-driven systems to detect suspicious opioid orders from customer pharmacies. - Terminate customer pharmacies' ability to receive shipments, and report those companies to state regulators, when they show certain signs of diversion. - Prohibit shipping of and report suspicious opioid orders. - Prohibit sales staff from influencing decisions related to identifying suspicious opioid orders. - Require senior corporate officials to engage in regular oversight of anti-diversion efforts. - The 10-year proposed agreement will result in court orders requiring Johnson & Johnson to: - Stop selling opioids. - Not fund or provide grants to third parties for promoting opioids. - Not lobby on activities related to opioids. - Share clinical trial data under the Yale University Open Data Access Project. This proposed settlement is a result of investigations by state attorneys general into whether the three distributors fulfilled their legal duty to refuse to ship opioids to pharmacies that submitted suspicious drug orders and whether Johnson & Johnson misled patients and doctors about the addictive nature of opioid drugs. In March 2019, Attorney General James filed an extensive lawsuit to hold accountable the various manufacturers and distributors allegedly responsible for the opioid epidemic. The manufacturers named in the complaint included Purdue Pharma and its affiliates, as well as members of the Sackler Family (owners of Purdue) and trusts they control; Janssen Pharmaceuticals and its affiliates (including its parent company Johnson & Johnson); Mallinckrodt LLC and its affiliates; Endo Health Solutions and its affiliates; Teva Pharmaceuticals USA, Inc. and its affiliates; and Allergan Finance, LLC and its affiliates. The distributors named in the complaint were McKesson Corporation, Cardinal Health Inc., Amerisource Bergen Drug Corporation, and Rochester Drug Cooperative Inc. The cases against Mallinckrodt and Rochester Drug Cooperative are now moving separately through U.S. Bankruptcy Court. The case against Purdue and the Sacklers is also moving through U.S. Bankruptcy Court. However, Attorney General James and a majority of states recently announced their approval of an agreement that would force the Sacklers and entities they control to pay more than $4.5 billion for opioid abatement, as well as shut down Purdue, and ban the Sacklers from ever selling opioids again. The agreement is pending court approval. The trial against the three remaining defendants (Endo Health Solutions, Teva Pharmaceuticals USA, and Allergan Finance) is currently underway and will continue in state court. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -16- Joining Attorney General James in leading the state negotiations for this settlement were the attorneys general of California, Colorado, Connecticut, Delaware, Florida, Georgia, Louisiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Tennessee, and Texas. [FN21] Connecticut Attorney General Announces $75 Million Settlement With Bristol-Myers Squibb Connecticut Attorney General William Tong recently announced a $75 million settlement between states and the federal government resolving allegations that Bristol-Myers Squibb Company overcharged the state Medicaid programs for drugs. The investigation resulted from a qui tam action filed in the United States District Court for the Eastern District of Pennsylvania under the federal False Claims Act and various state false claims statutes. Bristol-Myers Squibb is a New York-based pharmaceutical manufacturer. The Connecticut Medicaid program will receive $1.3 million through the settlement. According to Attorney General Tong, 'Bristol-Myers-Squibb wrongly withheld millions of dollars in rebates owed to state Medicaid programs. This national settlement will return $75 million back to the states and federal government, and should serve as a strong deterrent to any company seeking to unlawfully shortchange our public healthcare programs." These settlements resolve allegations that Bristol-Myers Squibb underpaid drug rebates owed to the states. Under a federal law known as the Medicaid Drug Rebate Program, drug manufacturers must periodically return a portion of the amount paid by state Medicaid programs for the manufacturers' drugs. The rebate program is designed to ensure that states pay competitive prices for drugs, and the rebates for a manufacturer's drugs are calculated based on a percentage of the average prices drug wholesalers pay for each of the drugs. This average price, which the manufacturer reports to the federal government, is known as the Average Manufacturer's Price or 'AMP". The greater the AMP reported by the manufacturer, the greater the rebate the manufacturer must pay for that drug. The whistleblower's complaint alleged that Bristol-Myers Squibb improperly treated certain fees paid to wholesalers as 'discounts," and improperly failed to include certain 'price appreciation" amounts it received from wholesalers in its AMP calculations. The complaint also claimed that the effect of these accounting practices was to falsely decrease the AMP the companies reported to the federal government and improperly decrease the rebates paid to the states. The claims resolved by the settlement are allegations only, and there has been no determination of liability. A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and conducted the settlement negotiations with Bristol-Myers Squibb on behalf of the states and included representatives from the Offices of the Attorneys General for the states of California, Florida, New York, North Carolina, and Texas. Department of Social Services Commissioner Deidre S. Gifford, whose agency administers Medicaid in the state, noted that, 'This $75 million national settlement shines a light on how taxpayer-financed Medicaid programs, by federal law, are supposed to receive significant rebates from drug manufacturers. The settlement is a positive development for Connecticut and other states, and a reminder that manufacturers need to scrupulously observe the protocols and processes governing the rebate amounts." Chief State's Attorney Richard J. Colangelo, Jr. also commented on the settlement, noting that, 'Bristol Myers Squibb's actions resulted in the company improperly withholding Medicaid Funds needed by our most vulnerable state residents. This collaborative investigative effort between the Attorney General's office, the Division of Criminal Justice and federal agencies sends a clear message that the improper diversion of Connecticut Medicaid funds will not be tolerated and will result in serious consequences from civil fines, as shown in this case, up to and including possible criminal charges." [FN22] Ohio AG Announces Opioid Settlement With Cardinal Health, McKesson, and AmerisourceBergen; Claims Terms Are Better Than Similar Federal Settlement Ohio Attorney General Dave Yost recently announced that the state has reached an $808 million agreement with three large opioid distributors: Cardinal Health, McKesson, and AmerisourceBergen. According to Yost, 'This is a historic day for Ohio-we have $800 million coming to Ohio to fix this mess ? what lawyers call "abatement." Attorney General Yost claims that the settlement is better than the national settlement with these three companies, stating that, 'We were able to get the companies to agree to pay the state's attorney fees on top of the settlement - so the settlement amount will not be reduced by legal fees." Under the agreement, Ohio cities and counties will begin receiving compensation as early as November 2021, and the money is guaranteed even if the national agreement does not move forward. The settlement, which is scheduled to be paid over 18 years, also calls for a continuous annual flow of settlement money, meaning that the distributors can pay extra in a given year, but that additional money will come off the back end so that there is no disruption of payments. Ohio was among the first states to sue opioid distributors and manufacturers over their allegedly unlawful practices of marketing these drugs. Yost and Governor Mike DeWine has developed the OneOhio plan, a mechanism to ensure that any money from a negotiated THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -17- settlement is distributed fairly to the communities hit hardest by the opioid crisis. The settlement was supported by 99% of those 'litigating subdivisions." OneOhio has been incorporated into the settlement, with 85 percent of the settlement money targeted for local distribution: « 55% goes to a foundation created to disburse the money and fund programs that benefit Ohioans affected by opioids and/or prevent addiction. * 30% is earmarked for community recovery programs at the local level. ¢ 15% goes to the state of Ohio. In addition to the monetary settlement, Cardinal, McKesson, and AmerisourceBergen must also make significant internal changes to help prevent a similar crisis. The three companies must: * Establish a centralized independent clearinghouse to provide all three distributors and state regulators with aggregated data and analytics about where drugs are going and how often, eliminating blind spots in the current systems used by distributors. ¢ Use data-driven systems to detect suspicious opioid orders from customer pharmacies. ¢ Terminate customer pharmacies' ability to receive shipments, and report those companies to state regulators when they show certain signs of diversion. ¢ Prohibit shipping of suspicious opioid orders and report such suspicious orders. ¢ Prohibit sales staff from influencing decisions related to identifying suspicious opioid orders. From 2010 to 2019, over 23,700 Ohioans died of opioid overdoses. During the second quarter of 2020 in Ohio, 11 of every 100,000 people died of an opioid overdose, the state's highest mortality rate at any point during the epidemic. Yost also commented that, 'With this resolution, we have some important controls and monitoring provisions in place to help protect Ohioans and its communities from the reckless distribution and over-prescriptions that we have seen in previous years." [FN23] Connecticut AG Appeals Bankruptcy Plan For Purdue Pharma and Sackler Family; Claims Sacklers 'Are Not Bankrupt" Connecticut Attorney General William Tong recently filed formal notice with the United States Bankruptcy Court in the Southern District of New York that Connecticut will appeal a controversial decision that would extinguish Connecticut's claims against both Purdue Pharma and the Sackler family. According to Tong, 'The Sacklers are not bankrupt. We cannot allow our bankruptcy laws to be abused and misused as a loophole for the rich and powerful to avoid justice and accountability. This decision was an unprecedented and unacceptable overreach by the bankruptcy court. Connecticut has filed notice that we will appeal and will continue to fight on behalf of the victims and families of the opioid epidemic until we see justice." Judge Robert Drain ruled earlier this month that he will approve a bankruptcy plan for Purdue Pharma that grants a lifetime legal shield to the Sackler family for civil opioid-related claims. Purdue's bankruptcy plan requires the Sackler family to pay $4.3 billion (though they are worth multiple times that amount) over nine years to help abate the opioid crisis they allegedly fueled. A press release by Tong claims that, by the time they are finished paying this settlement, the Sacklers will be wealthier than they were when they started. Attorney General Tong joined eight other attorneys general filing objections in the U.S. Bankruptcy Court for the Southern District of New York. The objections note that the Sackler family made at least $11 billion in profits from producing and deceptively marketing OxyContin, a major driver in the rise of the opioid crisis. The objections also claim that the Sacker family is not bankrupt or even claiming bankruptcy, and that the crisis has cost the nation millions of lives and more than $2 trillion in damage. [FN24] Three Drug Makers Settle False Claims Act Allegations For $447 Million; Companies Previously Entered Into Deferred Prosecution Agreements For Same Conduct The U.S. Department of Justice recently announced that three generic pharmaceutical manufacturers (Taro Pharmaceuticals USA, Inc., Sandoz Inc., and Apotex Corporation) have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from alleged conspiracies to fix the price of various generic drugs. These conspiracies allegedly resulted in higher drug prices for federal health care programs and beneficiaries, according to the Justice Department. The government alleges that between 2013 and 2015, all three companies paid and received compensation prohibited by the Anti- Kickback Statute through arrangements on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs manufactured by the companies. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -18- New York-based Taro Pharmaceuticals USA, Inc., has agreed to pay $213.2 million. The Taro drugs allegedly implicated in this scheme address a variety of health conditions, and include etodolac (a nonsteroidal anti-inflammatory drug used to treat pain and arthritis), and nystatin-triamcinolone cream and ointment (a combination of an antifungal medicine and steroid used to treat certain kinds of skin infections). New Jersey-based Sandoz Inc. has agreed to pay $185 million. The Sandoz drugs at issue include benazepril HCTZ (used to treat hypertension) and clobetasol (a corticosteroid used to treat skin conditions). Florida-bases Apotex Corporation has agreed to pay $49 million in connection with its sale of pravastatin, a drug used to treat high cholesterol and triglyceride levels. Acting Assistant Attorney General Brian M. Boynton of the Justice Department's Civil Division commented on the settlement, noting that, 'Illegal collaboration on the price or supply of drugs increases costs both to federal health care programs and beneficiaries. The department will use every tool at its disposal to prevent such conduct and to protect these taxpayer-funded programs." Acting U.S. Attorney Jennifer Arbittier Williams for the Eastem District of Pennsylvania stated that, 'These civil settlements are another achievement in my office's efforts to hold generic drug companies accountable for the consequences arising from price-fixing schemes, including the harm to federal health care programs. We will continue to aggressively pursue these violations of the Anti-Kickback Statute and the False Claims Act and obtain significant recoveries." The Anti-Kickback Statute prohibits companies from receiving or making payments in return for arranging the sale or purchase of items such as drugs for which payment may be made by a federal health care program. These provisions are designed to ensure that the supply and price of health care items are not compromised by improper financial incentives. As part of the settlement agreements, each company also entered a five-year corporate integrity agreement (CIA) with OIG. The CIAs include unique internal monitoring and price transparency provisions. They also require the companies to implement compliance measures including risk assessment programs, executive recoupment provisions, and compliance-related certifications from company executives and board members. All three companies previously entered into deferred prosecution agreements with the Antitrust Division to resolve related criminal charges. Taro paid a criminal penalty of $205.6 million and admitted to conspiring with two other generic drug companies to fix prices on certain generic drugs. Sandoz paid a criminal penalty of $195 million and admitted to conspiring with four other generic drug companies to fix prices on certain generic drugs. Apotex paid a criminal penalty of $24.1 million and admitted to conspiring to increase and maintain the price on pravasiatin. The recently announced civil settlement payments are in addition to the criminal penalties paid by the companies. Except for those facts admitted to in the deferred prosecution agreements, the claims resolved by the civil settlements are allegations only, and there has been no determination of liability. 'Conspiring to raise prices on generic medications is illegal and could prevent patients from being able to afford their needed prescription drugs. Americans have the right to purchase generic drugs set by fair and open competition, not collusion," said Special Agent in Charge Maureen R. Dixon of the Philadelphia Regional Office of the Inspector General, Department of Health and Human Services (HHS-OIG). 'HHS-OIG along with our law enforcement partners will continue to investigate allegations of companies engaging in actions that put the public and the Medicare program at risk." Chief Counsel Gregory E. Demske for the Inspector General at HHS also commented on the settlement, stating that, 'These kickback schemes harm Medicare, Medicaid and patients. The CIAs promote transparency and accountability by requiring the companies to report price-related information to OIG and mandating individual certifications by key executives involved in pricing and contracting functions." 'Protecting TRICARE, the healthcare system for U.S. military members and their dependents, is a top priority for the Department of Defense, Office of Inspector General, Defense Criminal Investigative Service (DCIS)," said Special Agent in Charge Patrick J. Hegarty, DCIS Northeast Field Office. "When pharmaceutical corporations artificially inflate prices, they undermine the integrity of TRICARE and place an unnecessary financial burden on the program. The settlement agreements announced today are the result of a joint effort and demonstrate the ongoing commitment of DCIS to work with our law enforcement partners, DOJ Civil Frauds and the USAO-EDPA, to investigate healthcare fraud." These recently announced settlements are the third, fourth, and fifth arising from this investigation and were handled by the Civil Division's Commercial Litigation Branch (Fraud Section) and the U.S. Attorney's Office for the Eastern District of Pennsylvania with support from the Office of Inspector General for the Department of Health and Human Services, the Defense Health Agency Program Integrity Office, DCIS and the Office of Inspector General for the Department of Veterans Affairs. [FN25] Arizona AG Announces Settlement With Pain Management Doctor Accused Of Accepting Sham Speaker Fees From Opioid Manufacturer Arizona Attorney General Mark Brnovich recently announced that his office obtained a consent judgment involving a $400,000 settlement with Dr. Steve Fanto, a Scottsdale-based pain management doctor. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -19- The settlement resolves the State's claims that Dr. Fanto took hundreds of thousands of dollars in sham educational 'speaker fees" from Chandler, Arizona-based Insys Therapeutics in exchange for prescribing Subsys, a highly addictive opioid prescription drug that contains fentanyl. According to Attorney General Brnovich, 'Doctors have a primary obligation to protect the health and well-being of their patients and must exercise caution when accepting payments from pharmaceutical companies to promote opioids. We will hold accountable those who improperly profited from Arizona's opioid crisis." Under the settlement, Dr. Fanto must forfeit all of the money he collected from Insys for alleged sham speaker fees, and pay an additional $152,000 in civil penalties to the State. Dr. Fanto is also barred from receiving any money or substantial gifts from any pharmaceutical companies while holding a license to practice medicine in the State of Arizona. This settlement is the latest development in the multi-defendant lawsuits filed by the state's attorney general's office related to Insys's allegedly illegal and unethical opioid sales practices. Previous settlements included a $9.5 million settlement with Insys's former Vice President of Sales, a $2 million settlement with the former CEO of Insys, and over $500,000 in combined settlements with two other Arizona doctors who accepted speaker fees from Insys Therapeutics. Insys pleaded guilty to federal charges, declared bankruptcy, and ceased to exist. Attorney General Brnovich' consumer fraud lawsuit continues against John Kapoor, the founder and former President of Insys. [FN26] Texas AG Announces $290 Million Statewide Opioid Settlement Agreement With Johnson & Johnson; State Also Expecting To Receive Up To $1.2 Billion From Three Distributors Texas Attorney General Ken Paxton recently announced a $290 million statewide opioid settlement agreement with Johnson & Johnson to resolve opioid-related claims. The agreement is consistent with the terms of the Global Prescription Opioid Litigation Settlement Agreement that was announced July 23, 2021. According to the settlement, Johnson & Johnson has agreed to pay $291,841,754.89 into the Qualified Settlement Fund, representing Texas's allocation of the Global Abatement Settlement. Attorney General Paxton commented on the settlement, noting that, '| am pleased that all parties have reached final agreement on this monumental settlement. This is the next step to bring much-needed funding for Texans who have fallen victim to the irresponsible and deceptive marketing practices from opioid manufacturers that spurred this epidemic." Paxton further stated that, 'My office will continue to aggressively work to hold those accountable for causing this crisis. These funds will bring life-changing resources to those victimized by this tragic crisis." In addition to the funds from Johnson & Johnson, Texas is also expecting to receive up to $1.2 billion from the three distributors, which will total approximately $1.5 billion in funding for statewide opioid abatement efforts. Smith County Judge Nathanial Moran also commented on the settlement, stating that, 'With genuine appreciation to General Paxton and the Office of the Attorney General, and on behalf of the citizens of Smith County, | am deeply appreciative for the coordination of state and local resources to reach this first monumental opioid settlement." Judge Moran furhter commented that, 'The funds from this settlement, which will be disbursed at the state, regional, and local levels in a manner and method specifically designed to fight the opioid epidemic and mitigate the harm it has caused, are appropriate and will bring much needed relief and treatment to citizens in rural East Texas, including Smith County." Bexar County Judge Nelson Wolff stated that, 'Bexar County has the second trial setting in the Texas opioid litigation efforts, and sadly has the highest rate of babies being born addicted to opioids in the State of Texas." Judge Wolff also noted that, 'The ability to put the money from this settlement to work for families in the county and to address opioid use disorder across the state right away is an important part of why | support General Paxton and Texas political subdivisions in moving this historic settlement forward." Lastly, Dallas County Judge Clay Jenkins observed that, 'Dallas County, like so many communities throughout Texas, has been hard hit by an opioid epidemic that was caused and fueled by drug company misconduct. Through this settlement, which is the best of its kind in the nation, one of those companies, Johnson & Johnson, has been held to financially account for its role in this crisis." Judge Jenkins also stated that, 'Dallas County, its trial counsel, and the Office of the Attorney General have worked together to achieve this historic result that benefits tens of millions of Texans by promptly putting monies for opioid harm reduction into communities that sorely need it." IFN27] Maker Of Naloxone Settles False Claims Act Allegations With Government For $12.7 Million The Justice Department recently announced that, kal?o Inc., a Virginia-based pharmaceutical manufacturer, has agreed to pay the United States $12.7 million to resolve allegations that the company caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -20- Evzio was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio. The United States alleged that, between March 14, 2017, and April 30, 2020, kal?o directed prescribing doctors to send Evzio prescriptions to certain preferred pharmacies that in turn: (1) submitted false prior authorization requests for Evzio that misrepresented to insurers that the prescribing physicians submitted the request when the pharmacies did so and/or contained false or misleading assertions about the patients' medical histories, such as false statements that patients had previously tried and failed less costly alternatives to Evzio; and (2) dispensed Evzio without collecting or attempting to collect co-payment obligations from government beneficiaries. The United States contends that kal?o knew of or deliberately ignored this pharmacy misconduct, but nevertheless kept directing business to these pharmacies. The United States also alleged that kal?o provided illegal remuneration to prescribing physicians and their office staff in violation of the Anti-Kickback Statute to induce and reward their prescribing of Evzio. 'Truthful and accurate documentation is essential to the integrity of federal health care programs," said Acting Assistant Attorney General Brian M. Boynton of the Justice Department's Civil Division. 'Today's settlement demonstrates that the department will hold to account those who undermine these programs by causing false claims to be submitted to the government." The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Rebecca Socol, a former employee of kal?o0. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of the resolution with kal?0, Ms. Socol will receive $2,548,600 of the settlement amount. The qui tam case is captioned United States ex rel. Socol v. kal?o, Inc., 18-cv010050-RGS (D. Mass.) 'When a pharmaceutical manufacturer knowingly engages with bad actors, they hurt the federal health care system - and they can expect us to see it," said Acting U.S. Attorney Nathaniel R. Mendell for the District of Massachusetts. 'Today's settlement is our latest signal to pharmaceutical manufacturers that my office does not tolerate health care fraud and will continue to pursue enforcement." The resolution obtained in this matter was the result of an effort between the Justice Department's Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney's Office for the District of Massachusetts, with assistance from the HHS OIG; DCIS; OPM OIG; the FBI; and the U.S. Postal Service Office of Inspector General. 'The American people, as both taxpayers and consumers, expect pharmaceutical companies like kal?o to abide by relevant laws and regulations," said Special Agent in Charge Phillip M. Coyne of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS OIG). 'When a pharmaceutical company participates in fraud in order to boost profits, it erodes public confidence in the health care system, can compromise the patient-physician relationship and wastes valuable government health care program funds. We will continue to investigate allegations of fraud in close cooperation with our law enforcement partners." 'Today's settlement resolves allegations that kal?o used gifts to incentivize and reward providers for prescribing the company's pricey anti-overdose drug, while turning a blind eye to pharmacies' fraudulent practices that fleeced taxpayer-funded health care programs - programs that all of us pay for and depend on," said Special Agent in Charge Joseph R. Bonavolonta of the FBI Boston Division. 'These unsavory tactics only fuel the FBI's and our law enforcement partners' commitment to aggressively root out those who seek to boost their bottom line at the expense of hard-working taxpayers." 'False claims undermine the integrity of the Federal Employees Health Benefits Program," said Deputy Inspector General Performing the Duties of the Inspector General Norbert E. Vint of the U.S. Office of Personnel Management, Office of the Inspector General (OPM OIG). 'The OPM OIG is committed to protecting the federal health care programs from deceptive schemes that increase the cost of medical care and waste taxpayer dollars." 'Protecting TRICARE, the health care system for military members and their dependents, is a top priority for the Department of Defense Office of Inspector General Defense Criminal Investigative Service (DCIS)," said Special Agent in Charge Patrick J. Hegarty of DCIS, Northeast Field Office. 'When companies submit false authorizations for high-priced medical goods and services, they undermine the integrity of TRICARE and place an unnecessary financial burden on the program. The settlement agreement announced today is the result of a joint effort and demonstrates the DCIS' ongoing commitment to work with our law enforcement partners to investigate health care fraud." The claims resolved by the settlement are allegations only and there has been no determination of liability. [FN28] Medical Device Company Settles False Claims Act Allegations With Government For $16 Million Arthrex Inc., a Florida-based medical device company, has agreed to resolve allegations that it violated the False Claims Act by paying kickbacks that caused the submission of false claims to the Medicare program. According to the settlement, Arthrex Inc., which specializes in orthopedic products, has agreed to pay $16 million for allegedly paying kickbacks to a Colorado-based orthopedic surgeon. The settlement resolves allegations that Arthrex agreed to provide remuneration to the surgeon in the form of royalty payments purportedly for the surgeon's contributions to Arthrex's SutureBridge and SpeedBridge products when the remuneration was in fact intended to induce the surgeon's use and recommendation of Arthrex's products. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24- The United States alleged that Arthrex's participation in this arrangement violated the Federal Anti-Kickback statute and, in turn, the False Claims Act by causing the submission of false or fraudulent Medicare claims. In connection with the settlement, Arthrex entered into a five-year corporate integrity agreement with HHS-OIG, setting forth requirements for future compliance. The claims resolved by the settlement are allegations only, and there has been no determination of liability. The settlement resolves claims brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act by Joseph Shea. The lawsuit was filed in the U.S. District Court for the District of Massachusetts and is captioned United States ex rel. Shea v. Arthrex Inc. et al., No. 20-cv-10210-ADB (D. Mass.). Mr. Shea will receive $2.5 million of the False Claims Act settlement. "N79 © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . 'We've Lost Our Soul," "It Felt Like Death By a Thousand Cuts": Rep. Porter Report Details the Devastation of Pharma Mergers, January 29, 2021, available at: https://porter.house.gov/news/documentsingle.aspx?DocumentID=276. [FN3] . "FTC Announces Multilateral Working Group to Build a New Approach to Pharmaceutical Mergers," March 16, 2021, available at: https://Awww .ftc.gov/news-events/press-releases/202 1/03/ftc-announces-multilateral-working-group-build-new-approach [FN4] . "Shareholder Proposals Seek to Prevent 'Vaccine Apartheid' via Disparate Access to Life-Saving Covid Medicines," April 19th 2021, available at: https:/Awww.iccr.org/shareholder-proposals-seek-prevent-vaccine-apartheid-disparate-access-life-saving-covid-medicines [FNS] . "Clyburn and Maloney Release Initial Findings from Investigation into Emergent BioSolutions," May 19, 2021, available at: https:// oversight.house.gov/news/press-releases/clyburn-and-maloney-release-initial-findings-from-investigation-into-emergent [FN6] . 'AmerisourceBergen Completes Acquisition of Alliance Healthcare Businesses," June 2, 2021, available at: https:// www.businesswire.com/news/home/20210602005219/en/AmerisourceBergen-Completes-Acquisition-of-Alliance-Healthcare- Businesses [FN7] . FDA Letter to David Shechter, Ph.D, July 7, 2021, available at: https://www.fda.gov/media/150751/download [FN8] . 'Durbin: Big Pharma Must Be Held Accountable For Fueling The Opioid Crisis," August 10, 2021, available at: https:// www.durbin.senate.gov/newsroom/press-releases/durbin-big-pharma-must-be-held-accountable-for-fueling-the-opioid-crisis [FN9] . "Biogen Agrees to Pay $22 Million to Resolve Allegations that it Paid Kickbacks Through Two Co-Pay Foundations," December 17, 2021, available at: https:/Awww.justice.gov/usao-ma/pr/biogen-agrees-pay-22-million-resolve-allegations-it-paid-kickbacks-through-two- co-pay. [FN10] . 'AG Grewal Announces Multi-Million Dollar Settlement with Insys Therapeutics Founder John Kapoor over His Role in Fueling the Opioid Epidemic," January 21, 2021, available at: https:/Awww.njoag.gov/ag-grewal-announces-multi-million-dollar-settlement-with- insys-therapeutics-founder-john-kapoor-over-his-role-in-fueling-the-opioid-epidemic/. [FN11] . "Attorney General James Delivers More Than $573 Million to Communities Across the Nation to Fight Opioid Crisis," February 4, 2021, available at: https://ag.ny.gov/press-release/2021/attorney-general-james-delivers-more-573-million-communities-across-nation- fight [FN12] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -29- . "Attorney General Becerra Announces $573 Million Nationwide Settlement with McKinsey & Company for its Role in the Opioid Epidemic," February 4, 2021, available at: https://oag.ca.gov/news/press-releases/attorney-general-becerra-announces-573-million- nationwide-settlement-mckinsey [FN13] . "Ohio Sues Multiple Centene Entities for Breach of Medicaid Contracts: Centene Corp. used layers of Pharmacy Benefit Managers to jack up prices for tax payer-financed care, Yost says," March 11, 2021, available at: https://Awww.ohioattorneygeneral.gov/Media/News- Releases/March-202 1/Ohio-Sues-Multiple-Centene-Entities-for-Breach-of [FN14] . "$834 Million Order Entered in Hawai?i State Court Against Bristol-Myers Squibb and Sanofi For Failing to Investigate and Disclose Ineffectiveness of Plavix," February 15, 2021, available at: https://ag.hawaii.gov/wp-content/uploads/2021/02/News- Release-2021-13.pdf [FN15] . "Pharmacist Charged in $4 Million Health Care Fraud and Kickback Scheme," March 17, 2021, available at: https:/Awww.justice.gov/ opa/pr/pharmacist-charged-4-million-health-care-fraud-and-kickback-scheme [FN16] . 'Bristol-Myers Squibb to Pay $75 Million to Resolve False Claims Act Allegations of Underpayment of Drug Rebates Owed Through Medicaid, April 1, 2021, available at: https:/Avww.justice.gov/usao-edpa/pr/bristol-myers-squibb-pay-75-million-resolve-false-claims-act- allegations-underpayment. [FN17] . "Incyte Corporation to Pay $12.6 Million to Resolve False Claims Act Allegations for Paying Kickbacks," May 4, 2021, available at: https:/Avww justice.gov/opa/pr/incyte-corporation-pay-126-million-resolve-false-claims-act-allegations-paying-kickbacks [FN18] . "Attorney General Schmitt Announces Settlement with Indivior Over False Marketing Related to Suboxone," May 6, 2021, available at: https://ago.mo.gov/home/news/2021/05/06/attorney-general-schmitt-announces-settlement-with-indivior-over-false-marketing-related- to-suboxone [FN19] . 'Attorney General Cameron Sues CVS for Company's Role in Opioid Epidemic," June 2, 2021, available at: https://kentucky.gov/ Pages/Activity-stream.aspx?n=AttorneyGeneral&prild=1069 [FN20] . 'Attorney General James Reaches $230 Million Settlement for Treatment and Prevention of Opioid Crisis in New York, Johnson & Johnson Ends Sale of Opioids," June 26, 2021, available at: https://ag.ny.gov/press-release/2021/attorney-general-james-reaches-230- million-settlement-treatment-and-prevention [FN21] . 'Attomey General James Announces Proposed $26 Billion Global Agreement with Opioid Distributors/Manufacturer," July 21, 2021, available at: https://ag.ny.gov/press-release/2021/attorney-general-james-announces-proposed-26-billion-global-agreement-opioid [FN22] . "Attorney General Tong Announces $75 Million Settlement with Bristol Myers Squibb over Medicaid Charges," August 17, 2021, available at: https://portal.ct.gov/AG/Press-Releases/2021-Press-Releases/AG-Tong-Announces-75-Million-Settlement-with-Bristol- Myers-Squibb-over-Medicaid-Charges [FN23] . "AG Yost Announces Ohio's Historic $808 Million Settlement with Opioid Distributors," September 16, 2021, available at: https:// www.chioattorneygeneral.gov/Media/News-Releases/September-2021/AG-Yost-Announces-Ohio-s-Historic-$808-Million-Set [FN24] . "Connecticut to Appeal Purdue Bankruptcy Plan," September 17, 2021, available at: https://portal.ct.gov/AG/Press-Releases/202 1 - Press-Releases/Connecticut-to-Appeal-Purdue-Bankruptcy-Plan THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -23- [FN25] . "Pharmaceutical Companies Pay Over $400 Million to Resolve Alleged False Claims Act Liability for Price-Fixing of Generic Drugs," October 1, 2021, available at: https://Awww.justice.gov/opa/pr/pharmaceutical-companies-pay-over-400-million-resolve-alleged-false- claims-act-liability [FN26] . 'Attomey General Bmovich Obtains Over $400,000 from Scottsdale Doctor for Opioid Prescriptions," October 27, 2021, available at: https:/Avww.azag.gov/press-release/attorney-general-brnovich-obtains-over-400000-scottsdale-doctor-opioid-prescriptions [FN27] . 'Paxton Announces Details of $290 Mil?lion Opi?oid Settlement," October 26, 2021, available at: https:// www.texasattorneygeneral.gov/news/releases/paxton-announces-details-290-million-opioid-settlement [FN28] . "Kal?o Inc. Agrees to Pay $12.7 Million to Resolve Allegations of False Claims for Anti-Overdose Drug," November 9, 2021, available at: https:/Avww.justice.gov/opa/pr/kal-o-inc-agrees-pay-127-million-resolve-allegations-false-claims-anti-overdose-drug [FN29] . 'Medical Device Company Arthrex to Pay $16 Million to Resolve Kickback Allegations," November 8, 2021, available at: https:// www .justice.gov/opa/pr/medical-device-company-arthrex-pay-16-million-resolve-kickback-allegations Produced by Thomson Reuters Accelus Regulatory Intelligence 24-Jan-2022 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24-