After years of defrauding the U.S. government and taxpayers, Mylan, the maker of EpiPen, last week resolved allegations that it profited at the expense of Medicaid.

On August 17, Mylan and its subsidiaries agreed to pay $465 million to resolve claims they violated the False Claims Act (“FCA”) for knowingly misclassifying its lifesaving EpiPen product as a generic drug to avoid paying rebates owed to the U.S. government.  In a press release, the Department of Justice (“DOJ”) stated, “this settlement demonstrates the DOJ’s unwavering commitment to hold pharmaceutical companies accountable for schemes to overbill Medicaid, a taxpayer-funded program whose purpose is to help the poor and disabled.”

The settlement was first announced in October 2016, amidst fierce public criticism of Mylan’s triple-digit price hikes for the EpiPen, but the settlement agreement, and the fact that Sanofi was the whistleblower, was just released last week.  It is rare for one health care company to blow the fraud whistle on another health care company.

Sanofi’s Qui Tam Suit

Inquiries into Mylan’s misconduct started when rival Sanofi-Aventis US LLC (“Sanofi”) filed a qui tam lawsuit against Mylan under seal in 2016, in the District of Massachusetts, under the whistleblower provisions of the FCA.  The government then intervened in the case.

Sanofi, which had been selling a competing product to Mylan’s EpiPen, alleged that Mylan knowingly misclassified EpiPen as a generic drug, or “non-innovator” product, even though it was marketed and priced as a brand-name product.  Under the Medicaid program, manufacturers must pay higher rebates for brand-name drugs, i.e. drugs only available through a single source.  To avoid price gouging, Medicaid receives a 23 percent discount on brand-name drugs but only a 13 percent discount on generics.  The intentional misclassification of the EpiPen as a generic allowed Mylan to underpay hundreds of millions of dollars in rebates to Medicaid sold through its health coverage program from 2010 to 2016.  During that timeframe, the company increased the price of the EpiPen by 400% but paid the lesser rebate for generic drugs.

Mylan’s $465 Million Settlement

Mylan’s August 17 settlement agreement with DOJ and the Office of the Inspector General of Health and Human Services (“OIG-HHS”) resolves Sanofi and the government’s allegations that Mylan knowingly skirted its rebate obligations under the FCA.

Without admitting any wrongdoing, effective retroactive to April 1, 2017 Mylan reclassified EpiPen as a brand-name product for rebate purposes and Mylan entered into a corporate integrity agreement.  The company’s five year corporate integrity agreement with OIG-HHS requires that Mylan fulfill numerous obligations, including: (1) retain an independent review organization to assess annually whether Mylan is complying with the Medicaid program, and (2) hold executives and board members individually accountable for the company’s compliance with the corporate integrity agreement and federal health care programs.

As the whistleblower, Sanofi was awarded $38.7 million as its share of the federal recovery for alerting the government about Mylan’s misconduct.  Sanofi also stands to recover some money state Medicaid programs will receive under the settlement.

Public Outcry – Mylan’s Settlement “Shortchanges” Taxpayers

Both Republican and Democratic Senators have issued statements showing disapproval with Mylan’s settlement with DOJ.  Senator Chuck Grassley (R-IA) spoke out against the settlement, calling it a “disappointment.”  Senator Grassley continued, “the government’s own watchdog said the taxpayers may have overpaid for EpiPen by as much as $1.27 billion over 10 years.  Did the Justice Department consider the inspector general estimate?  If not, why not?”  Senator Richard Blumenthal (D-CT) also issued a fiery response, saying, “quite simply, the Department of Justice is letting this deceptive pharmaceutical behemoth off the hook.  Absolving Mylan from a finding of wrongdoing has cleared the way for the company to pocket the money it embezzled from an American public in desperate need of lifesaving and affordable medications.”

Mylan is not completely off the hook, at least to other private actions – it still faces Sanofi’s separate antitrust suit in New Jersey federal court.  There, Sanofi alleges that Mylan, to preserve its monopoly over EpiPen-like injectors, offered large rebates to insurers that did not cover competing products.

In early July, and with little fanfare, Attorney General Jeff Sessions and the Department of Justice (DOJ) all but gutted the Health Care Corporate Fraud Strike Force – stripping it of several key personnel.  Nevertheless, the investigation and prosecution of health care fraud will likely continue, and the Department will remain vigorous in its pursuit of health care fraud, perhaps with a more individual focus.  In a May 2017 speech at the Annual Institute on Health Care Fraud, Deputy Assistant Attorney General Kenneth Blanco said, “health care fraud is a priority for the Department of Justice.  Attorney General Sessions feels very strongly about this.  I can tell you that he has expressed this to me personally.”

Anonymous sources close to DOJ reported that three of five full-time attorneys had been removed from the Corporate Fraud Strike Force.[1]  Asked for comment on the new-look Corporate Fraud Strike Force, a DOJ spokesperson stated, “the Health Care [Corporate Fraud] Strike Force, as with the entire health care fraud unit, is going strong under steady leadership—continuing to vigorously investigate and hold accountable individuals and companies that engage in fraud, including tackling an opioid epidemic that claimed 60,000 American lives last year.”[2]  Interestingly, AG Sessions did not cut positions within other strike forces, such as the Medicare Fraud Strike Force and the Organized Crime Drug Enforcement Task Forces Program.  In distinction to the Medicare Fraud Strike Force, the DOJ’s Health Care Corporate Fraud Strike Force focuses on complex corporate health care fraud.

Gutting the Corporate Fraud Strike Force Aligns with AG Sessions’ Priorities

On the surface, it may appear that the dismantling of the Corporate Fraud Strike Force comes as the Department of Justice shifts resources to combat new priorities.  AG Sessions has repeatedly announced his commitment to combating health care fraud, as well as cracking down on drugs, violent crime, and illegal immigration.  However, a deeper dive into AG Sessions’ priorities signals a clear shift: corporate health care fraud investigations will take a back seat to the focus of DOJ headquarters on the prescription drug epidemic ravaging America.  Indeed, the appointment of Kenneth Blanco as Deputy Assistant Attorney General fits Sessions’ priority commitment to tackling the opioid crisis—Blanco brings experience from several narcotics-focused roles throughout his career, including Acting Chief of Narcotics in the United States Attorney’s Office for the Southern District of Florida and Chief of the Narcotic and Dangerous Drug Section at DOJ.

While acknowledging extensive health care corruption at the corporate and grass roots levels, the Sessions-led DOJ has put the opioid crisis at the top of its list and will divert resources to components better positioned to tackle drug abuse.  For example, in July 2017 Sessions announced that 412 defendants in over 20 states were charged with orchestrating health care fraud schemes totaling $1.3 billion in false claims.  Importantly, over 120 of the defendants were charged for their roles in the unlawful distribution of opioids and other prescription narcotics.

Caution: Corporate Health Care Fraud Prosecutions Are Not Dead

The DOJ established the Medicare Fraud Strike Force during the George W. Bush administration to coordinate and staff the investigation and prosecution of health care fraud cases in “hot spots” around the country, identified by data analysis.  Those hot spots were originally Miami and Los Angeles.  The Obama Administration expanded the Medicare Fraud Strike Force to seven more “hot spot” cities: Detroit, Houston, Tampa, Baton Rouge, Brooklyn, Dallas, and Chicago.  As DOJ and the Medicare Fraud Strike Force took on more cases – and as complex Medicare fraud cases involving large corporates became even more common – the Department identified a need for dedicated attorneys to oversee the most complicated corporate health care fraud cases.

As a result, in 2015, Attorney General Eric Holder formally established the Health Care Corporate Fraud Strike Force, separate and apart from the Medicare Fraud Strike Force.  With a staff of five experienced trial attorneys, the Corporate Fraud Strike Force had one mission: to detect, investigate, and prosecute complex corporate health care fraud matters.  Notably, in October 2016 the Corporate Fraud Strike Force orchestrated the Justice Department’s $516 million settlement with Tenet Healthcare Corporation to resolve civil and criminal allegations that Tenet received kickbacks in exchange for patient referrals.  John Holland, a former senior vice president at Tenet, was also charged in connection with the fraud.

Even though the Corporate Fraud Strike Force has been effectively dismantled, private and public companies must realize that corporate health care fraud prosecutions are not dead.  Because expertise in complex health care fraud investigations and prosecutions has been developed over the past decade, the need to augment expertise in the field from Main Justice has diminished.  U.S. Attorney’s Offices around the country now have a well-trained, sophisticated staff to continue the Department’s work in combating corporate health care fraud.  While the Department of Justice continues its re-positioning of resources to focus on Sessions’ priorities – drugs, violent crime, and illegal immigration – don’t expect to see a reduction in interest from U.S. Attorney’s Offices, given past successes and the Department’s overall commitment to health care fraud.  Sessions has expressed no soft spot for corporate fraud, saying, “I was taught if [companies] violated a law, you charge them.  If they didn’t violate the law, you don’t charge them.”

Additionally, the President’s proposed FY2018 budget request would increase spending in Health and Human Services’ Health Care Fraud and Abuse Control (HCFAC) program by $70 million, to $751 million.  Money allocated to the HCFAC is shared among the Centers for Medicare and Medicaid Services, DOJ, and Health and Human Services Office of Inspector General.  The takeaway for the health care sector is that the federal focus on health care fraud will continue.  Stay tuned.

[1] Sue Reisinger & Kristen Rasmussen, As Priorities Shift at DOJ, Health Care Corporate Fraud Strike Force Gutted, The National Law Journal (July 10, 2017), http://www.nationallawjournal.com/id=1202792591440/As-Priorities-Shift-at-DOJ-Health-Care-Corporate-Fraud-Strike-Force-Gutted.
[2] Id.

In a February blog post, we detailed the summary judgment rulings in a False Claims Act case involving Lance Armstrong: United States ex rel. Landis v. Tailwind Sports Corporation, et al.  The federal government alleges that Lance Armstrong, his Tailwind Sports team, and its manager, Johan Bruyneel, submitted false claims to the United States Postal Service (“USPS”) and violated sponsorship agreements by using and then denying the use of banned performance enhancing drugs.

In June 2017, in anticipation of a November 2017 trial, the government and Armstrong filed Motions in Limine (“MIL”) to exclude evidence from being introduced before the court.  The parties’ MIL, specifically those motions aimed at barring expert economic testimony via Daubert challenges, could have a significant impact on the government’s ability to meet its burden of proof with respect to damages.  Likewise, Armstrong could suffer a similar misfortune on the MIL as his expert testimony may be critical to combat the government’s claims.  In addition, two  of the MIL, which essentially argue that “everybody does it” and that the “first to come clean benefits,” could have far-reaching implications for FCA cases in the future.  Regardless of the outcome of the MIL, such posturing suggests that this matter is almost certainly headed for trial. Continue Reading Lance Armstrong False Claims Act Suit Cycles Through Motions on Way to Trial

cheatsheetIn February, to little fanfare, the Department of Justice (DOJ) Criminal Division Fraud Section issued detailed criteria for evaluating corporate compliance programs.  The guidance, entitled Evaluation of Corporate Compliance Programs (“Evaluation Guidance” or “Guidance”) comes two years after DOJ hired Hui Chen as Compliance Counsel in the Fraud Section.  When her position was announced, the DOJ said that Chen would “help prosecutors develop appropriate benchmarks for evaluating corporate compliance and remediation measures” and would “communicat(e) with stakeholders in setting those benchmarks.”  The Evaluation Guidance provides those benchmarks used by the DOJ to evaluate the effectiveness of corporate compliance programs. It covers 11 key compliance program evaluation topics, along with a list of specific questions that DOJ considers important in evaluating compliance programs as part of a criminal investigation. Continue Reading DOJ Compliance Cheat Sheet

USDCSDNYEarlier this month, the Southern District of New York dismissed the remaining claim in United States ex rel. Kolchinsky v. Moody’s Corp., ruling that Moody’s alleged “false claim” was not material under the standards set in Universal Health Services, Inc. v. United States ex rel. Escobar. The analysis of this case is instructive for other FCA cases, including health care fraud, for the court’s analysis on dismissal of FCA claims on materiality grounds. The court had previously dismissed the Relator’s claims in February but gave leave for him to amend his complaint with respect to claims about certain inaccuracies in Moody’s Ratings Delivery Service. The Relator filed an amended and somewhat more specific complaint thereafter, alleging that Moody’s provided ratings it knew to be inaccurate directly to its subscribers, which included the federal government. Continue Reading FCA Case Dismissed on Materiality Standard

bikersIn a case with important considerations for False Claims Act cases, Lance Armstrong will face claims at trial that he fraudulently obtained funds from the United States Postal Service because of alleged violations of his sponsorship contract. On February 13, 2017, a D.C. federal judge ruled on competing motions for summary judgment setting the stage for a trial on the issues of implied certification and potential damages.

Armstrong argued that because the invoices sent to the Postal Service did not contain representations about the services rendered, the implied certification theory outlined in the Supreme Court case Universal Health Services, Inc. v. United States, ex rel. Julio Escobar and Carmen Correa (“Escobar”) was inapplicable.  Specifically, Armstrong argued that the Escobar implied certification test was inapplicable because Armstrong’s invoices did not make “specific representations about the goods or services provided . . . ” The D.C. district court agreed that the invoices merely requested payment and made no other representations, but held that the lack of a representation of the services in Armstrong’s invoices was not dispositive of the implied certification issue at summary judgment. Whereas the Supreme Court limited the holding in Escobar to its facts and expressly declined to “resolve whether all claims for payment implicitly represent that the billing party is legally entitled to payment,” the  D.C. Circuit had already explicitly addressed such omissions in United States v. Scientific Applications International Corp. In that case, the D.C. Circuit said that a claim for payment “need not include ‘express contractual language specifically linking compliance to eligibility for payment,’ . . . [but] ‘[r]ather, all the government must show is ‘that the [claimant] withheld information about its noncompliance with material contractual requirements.’”  In other words, Armstrong’s material omission that he was using performance enhancing drugs when he signed the sponsorship agreements was sufficient to allege implied certification, even though the invoices or demands for payment themselves did not make any representations. Continue Reading Federal Judge Ruling in United States ex rel. Landis v. Tailwind Sports Corporation, et al. Sets Stage for Trial on Issues of Implied Certification and Potential Damages