Health Law Advisor

On Monday, February 26, 2024, BioMarin Pharmaceutical, Inc. (“BioMarin”) disclosed in its annual filing that the company recently received a subpoena from the U.S. Department of Justice (DOJ) requesting certain documents regarding BioMarin’s sponsored testing programs relating to two of its products, VIMIZIM and NAGLAZYME.[1] BioMarin also stated that the company “produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or [BioMarin’s] other operations or programs, will not be ...

On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is relevant to scienter, rather than what an “objectively reasonable” person may have known or believed.

The case in question, U.S. ex rel. Schutte v. SuperValu Inc., consolidated from two lower court decisions, involved allegations that the defendants, two retail pharmacy chains, overcharged the government for prescription drugs in violation of ...

• Lowest Total Recoveries Since 2008
• Record-Shattering Number of New Cases Filed
• Health Care and Life Sciences Cases Continue to Dominate

On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022.[1] While total recoveries exceeded $2.2 billion, this is a drop of more than 50 percent from the $5.7 billion recovered in FY 2021, marking the lowest annual reported recovery in 14 years. The total recoveries in fraud cases brought with respect to the health care and life sciences industries fell to the lowest level since 2009.

From our Thought Leaders in Health Law video series:  The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021.

That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care and life sciences industries.

On February 1, 2022, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2021.^[1]

With collections amounting to $5.6 billion, FY 2021 marks DOJ’s largest annual total FCA recovery since FY 2014, and more than twice the $2.3 billion received in FY 2020. FY 2021 was also a record-shattering year for DOJ as it relates to health care fraud enforcement; over $5 billion (90% of the total) was obtained from cases pursued against individuals and entities in the health care and life sciences industries.

On August 30, 2021, the DOJ announced a $90 million dollar settlement with Sutter Health and affiliates[1] (“Sutter Health”) to settle False Claims Act (“FCA”) allegations brought by qui tam relator, Kathy Ormsby, related to the Center for Medicare & Medicaid Services’ (“CMS”) MA Program.[2] Sutter Health elected to settle with DOJ and the relator without an admission of liability. As part of the Settlement Agreement, the Office of Inspector General (“OIG”) required Sutter Health to enter into a Corporate Integrity Agreement.

On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.[1]

Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.”[2]  The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation.  “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others.

In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma SA (“Aventis”) attorneys’ fees in a False Claims Act (“FCA”) case brought by a competitor, Amphastar Pharmaceuticals Inc. (“Amphastar”). The FCA contains a fee-shifting component, permitting prevailing parties to recover attorneys’ fees from the opposing party—but the playing field is not equal. This fee-shifting provision entitles a prevailing plaintiff to an award of reasonable attorneys’ fees and costs, regardless of whether the government elects to intervene in the case. 31 U.S.C. § 3730(d)(1)-(2). A defendant, on the other hand, can only be awarded attorneys’ fees in cases in which the government has declined to intervene and where the defendant can show that the opposing party’s action was “clearly frivolous, clearly vexatious, or brought primarily for purposes of harassment.” 31 U.S.C. § 3730(d)(4).

On March 26, 2021, the U.S. Department of Justice (“DOJ”) reported on the agency’s heightened criminal and civil enforcement activities in connection with COVID-19-related fraud.[1]  As of that date, DOJ had publicly charged 474 defendants with criminal offenses in connection with COVID-19-related schemes across 56 federal districts to recover more than $569 million in U.S. government funds.

The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a federal law, enacted on March 29, 2020, designed to provide emergency financial assistance to the millions of Americans who are suffering the economic effects caused by the COVID-19 pandemic.  The CARES Act provides relief through a number of different programs, including the Paycheck Protection Program (“PPP”), Economic Injury Disaster Loans (“EIDL”), the Provider Relief Fund, and Unemployment Insurance (“UI”).[2]  With the promulgation of these programs, DOJ has ramped up efforts in identifying and investigating fraud to protect the integrity of the $2.2 trillion in taxpayer funds appropriated under the CARES Act.

Criminal Enforcement Activities

The majority of fraud cases brought by DOJ have originated in the Criminal Division’s Fraud Section, accounting for at least 120 defendants charged with PPP fraud.[3]  The PPP allows qualifying small businesses and other organizations to receive loans with a maturity of two years and an interest rate of 1 percent.  PPP loan proceeds must be used by businesses for payroll costs, interest on mortgages, rent, and utilities.  Most of these defendants are facing charges for allegedly misappropriating loan payments for prohibited purposes, such as luxury purchases, while another significant portion are charged in connection with allegedly inflating payroll expenses in order to obtain larger PPP loans.[4]

DOJ also announced that it has seized over $580 million in fraudulent application proceeds in connection with the EIDL program, which is designed to provide loans to small businesses and agricultural and nonprofit entities.  DOJ’s primary concerns with respect to this program have related to fraudulent applications for EIDL advances and loans on behalf of shell or nonexistent businesses.

In response to a rise in UI fraud schemes, DOJ has established the National Unemployment Insurance Fraud Task Force to investigate domestic and international organized crime groups targeting unemployment funds through the use of identity theft.  Since the start of the pandemic, over 140 defendants have been publicly charged with federal offenses related to UI fraud.[5]

On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest level since 2008 and almost $1 billion less than was recovered in 2019. The total recoveries in 2020 reflect the first of many anticipated resolutions of fraud enforcement actions in the COVID-19 world, and over 80% of all recoveries—amounting to almost $1.9 billion—came from the health care and life sciences industries.

HIGHEST NUMBER OF NEW FILINGS EVER REPORTED

Significantly, 2020 saw the largest number of new FCA matters initiated in a single year. The government initiated new FCA matters at its highest rate since 1994, with 250 new cases brought in 2020. Strikingly, the number of government-initiated cases against health care entities more than doubled from 2019 to 2020 and was at the highest level ever reported. Likewise, qui tam relators filed 672 new matters in FY 2020, an increase over FY 2019 and the fifth highest number of cases in reported history. Qui tam relators filed, on average, almost 13 new cases a week. Of the 672 qui tam cases filed, 68% were related to health care.

QUI TAM FILINGS CONTINUE TO BE THE DRIVER

Total recoveries from qui tam-initiated actions generated almost $1.7 billion. While the largest recoveries continue to come from cases where the government intervenes, cases pursued by relators post-declination generated more than $193 million in FY 2020, the fifth largest annual recovery in non-intervened cases since 1986. These cases continue to be rewarding for relators; over $309 million in relators’ share awards were paid in FY 2020, of which more than $261 million were paid in cases pursued against health care entities.

The Department of Justice (DOJ) announced on January 12, 2021, the first civil settlement to resolve allegations of fraud against the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.[1] SlideBelts Inc. and its president and CEO, Brigham Taylor, have agreed to pay the United States a combined $100,000 in damages and penalties for alleged violations of the False Claims Act (FCA) and the Financial Institutions Reform, Recovery, and Enforcement Act (FIRREA).[2]

The CARES Act was enacted in March 2020 to provide emergency financial assistance to individuals and businesses affected by the COVID-19 pandemic.[3] The CARES Act established the PPP, which provided $349 billion in forgivable loans to small businesses in order to assist in job retention and business expenses.[4] Since March 2020, Congress has authorized an additional $585 billion in PPP spending to be distributed under the Small Business Administration (SBA).

SlideBelts operates as an online retail company, and filed a petition for relief under Chapter 11 of the Bankruptcy Code in August 2019. Between April and June of 2020, while its petition was pending in the U.S. Bankruptcy Court for the Eastern District of California, SlideBelts and Taylor allegedly made false statements to federally insured financial institutions that the company was not involved in bankruptcy proceedings in order to influence the institutions to grant, and for SBA to guarantee, a PPP loan. SlideBelts received a loan for $350,000 based off of these purported false claims, which SlideBelts repaid in full to the PPP.

The government was able to recover damages and civil penalties from SlideBelts under the FCA for submitting alleged fraudulent claims for payment to the government and under the FIRREA for violations of federal criminal statutes that affect federally insured banks. This settlement is the end result of the first, but not the last, of many civil investigations and, ultimately, litigations relative to the CARES Act in the coming months and years under the FCA. In fact, during a June address to the Chamber of Commerce, Principal Deputy Attorney General Ethan Davis stated, “Going forward, the Civil Division will make it a priority to use the False Claims Act to combat fraud in the Paycheck Protection Program.”[5]

As the SBA prepares to issue a second round of PPP loans, the DOJ is likely to continue to use the FCA and the FIRREA to pursue entities receiving funds on the theory that those entities intend to exploit for their benefit these federal programs.[6]

Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related to COVID-19 and indicating that DOJ plans to “vigorously pursue fraud and other illegal activity.”[1] As discussed below, Davis’s remarks not only highlighted principles that will guide enforcement efforts of the Civil Fraud Section under the False Claims Act (FCA) and of the Consumer Protection Branch (CPB) under the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA) in response to the COVID-19 public health emergency (PHE), they also provide an indication of how DOJ might approach enforcement over the next few years.

DOJ'S KEY CONSIDERATIONS & ENFORCEMENT STRATEGY FOR COVID-19

Davis highlighted two key principles that would drive DOJ’s COVID-related enforcement efforts: the energetic use of “every enforcement tool available to prevent wrongdoers from exploiting the COVID-19 crisis” and a respect of the private sector’s critical role in ending the pandemic and restarting the economy.[2] Under that framework, DOJ plans to pursue fraud and other illegal activity under the FCA, which Davis characterizes as “one of the most effective weapons in [DOJ’s] arsenal.”[3]

However, as DOJ pursues FCA cases, it will also seek to affirmatively dismiss qui tam claims that  DOJ finds meritless or that interfere with agency policy and programs.[4] DOJ also plans to collect certain information from qui tam relators regarding third-party litigation funders during relator interviews.[5] DOJ’s emphasis on qui tam cases—cases brought under the FCA by relators or whistleblowers—for COVID-related enforcement highlights the impact such matters have on DOJ’s enforcement agenda.[6]

1. DOJ will consider dismissing cases that involve regulatory overreach and are not otherwise in the interest of the United States.

Although Davis emphasized that the majority of qui tam cases would be allowed to proceed, in order to “weed out” cases that lack merit or that DOJ believes should not proceed, DOJ will consider dismissing cases that “involve regulatory overreach or are otherwise not in the interest of the United States.”[7] This is consistent with the principles reflected in the 2018 Granston Memo that instructed DOJ attorneys to consider “whether the government’s interests are served” when considering whether cases should proceed and listed considerations for seeking alternative grounds for dismissal of FCA cases.[8] Davis gave examples throughout his speech of actions DOJ might consider dismissing:

• Cases based on immaterial or inadvertent mistakes, such as technical mistakes with paperwork
• Cases based on honest misunderstandings of rules, terms, and conditions
• Cases based on alleged deviations from non-binding guidance documents
• Cases against entities that reasonably attempted to comply with guidance and “in good faith took advantage of the regulatory flexibilities granted by federal agencies in the time of crisis.”[9]

DOJ litigators have been advised to inform relators of the possibility of dismissal.[10] Additionally, qui tam suits based on behaviors temporarily permitted during the COVID-19 pandemic, particularly in circumstances in which agencies exercised discretion to waive or not enforce certain requirements, might
“fail as a matter of law for lack of materiality and knowledge.”[11]

2. DOJ will now include a series of questions during relator interviews to identify third-party litigation funders.

During each relator interview, DOJ has instructed line attorneys to ask a series of questions to identify whether the relator or their counsel has a third-party litigation funding agreement,[12] which is an agreement in which a third party—such as a commercial lender or a hedge fund—finances the cost of litigation in return for a portion of recoveries.[13] Under the new policy detailed in Davis’s speech, if a third-party funder is disclosed, DOJ will ask for the following:

• the identity of the third-party litigation funder,
• information regarding whether information of the allegations has been shared with the third party,
• whether the relator or their counsel has a written agreement with the third party, and
• whether the agreement between the relator or their counsel and the third party includes terms that entitles the third-party funder to exercise direct or indirect control over the relator’s litigation or settlement decisions.

Relators must inform DOJ of changes as the case proceeds through the course of litigation.[14] While Davis characterizes these changes as a “purely information-gathering exercise for the purpose of studying the issues,” the questions are in furtherance of DOJ’s ongoing efforts to uncover the potential negative impacts third-party litigation financing may have in qui tam actions. [15] The questions Davis referenced in his remarks reflect DOJ’s concerns with third-party litigation funding as expressed by Deputy Associate Attorney General Stephen Cox in a January 2020 speech.[16] Davis emphasized that DOJ particularly sought to evaluate the extent to which third-party litigation funders were behind qui tam cases DOJ investigates, litigates, and monitors; the extent of information sharing with third-party funders; and the amount of control third-party funders exercised over the litigation and settlement decisions.[17] While the Litigation Funding Transparency Act of 2019 has remained inactive since its introduction in February 2019 by Senator Grassley[18] and the 2018 proposal by the U.S. Court’s Advisory Committee on Civil Rights’ Multidistrict Litigation Subcommittee to require disclosure of third-party litigation funding remains under consideration,[19] DOJ’s plans to include this line of questioning potentially signals DOJ’s intention to take more concrete and significant steps to address third-party litigation funding in the future.

Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act (“FCA”) for fiscal year (“FY”) 2019. An increase over the $2.9 billion recovered in FY 2018, FY 2019 reflected the ninth highest amount of recoveries in the past 30 years. The accompanying statistics released by DOJ reflect several themes related to FCA enforcement concerning the health care and life sciences industry.

The Health Care and Life Sciences Industry Accounted for Approximately 87 Percent of FY 2019 Recoveries

Consistent with previous years, fraud actions involving the health care and life sciences industries continue to drive DOJ’s FCA recoveries. Health care-related fraud recoveries alone have now exceeded $2 billion for 10 consecutive years. In FY 2019, health care-related matters generated approximately $2.6 billion in recoveries, or 85 percent of recoveries from all sectors combined, which does not include recoveries from state-based Medicaid actions with which DOJ may have assisted. The $71 million increase in recoveries from health care-related matters between FY 2018 and FY 2019 marks the third consecutive year of increasing health care-related recoveries. Notably, recoveries from health care-related cases brought directly by DOJ increased from $568 million to $695 million between FY 2018 and FY 2019, the second highest amount recovered in 30 years.

On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations.  CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse.  The RFI specifically states CMS’ aim “to ensure proper claims payment, reduce provider burden, and overall, conduct program integrity activities in a more efficient manner.”  The RFI follows last month’s White House ...

On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene ...

On May 7, 2019, the Department of Justice (“DOJ”) released new guidance for trial attorneys in the DOJ’s civil division regarding how entities under False Claims Act investigation can receive credit for cooperation.  The release of this new guidance follows public comments delivered in March by Michael Granston, director of DOJ’s civil fraud section, noting that DOJ was considering issuing additional guidance on cooperation credit related to False Claims Act matters.

The policy explains that cooperation credit in False Claims Act cases may be earned by “voluntarily ...

The Department of Justice (DOJ) announced this week that it has entered into a settlement agreement with Davita Medical Holdings (Davita) for $270 million dollars to resolve certain False Claims Act liability related to Medicare Advantage risk adjustment payments.

As the settlement agreement describes, Davita acquired HealthCare Partners (HCP), a large California based independent physician association in 2012. HCP, subsequently Davita Medical Group (or Davita), operated as a medical service organization (MSO) who contracted with Medicare Advantage Organizations ...

On June 25, 2018, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) published Advisory Opinion 18-05, allowing a nonprofit medical center to provide or arrange for certain support services for individuals who care for adults with chronic medical conditions (the “Opinion”).  The Opinion is significant because it helps to define the limits of recently enacted exceptions to the Civil Monetary Penalties Law (“CMP Law”).  In addition, the Opinion follows other recent guidance and regulations promulgated by OIG and the Centers for ...

For health care providers and other government contractors, perhaps no law causes more angst than the False Claims Act, 31 U.S.C. §§ 3729 et seq. (“FCA”).  A Civil War-era statute initially designed to prevent fraud against the government, the FCA is often leveraged by whistleblowers (also known as “relators”) and their counsel who bring actions on behalf of the government in the hope of securing a statutorily mandated share of any recovery.  These qui tam actions often can be paralyzing for health care entities, which, while committed to compliance, suddenly find ...

On December 21, the Department of Justice ("DOJ") reported its fraud recoveries for Fiscal Year 2017. While overall numbers were significant - $3.7 billion in settlements and judgments from civil cases involving allegations of fraud and false claims against the government - this was an approximate $1 billion drop from FY 2016. However, the statistics released by DOJ reflect themes significant to the healthcare industry.

Greatest Recoveries Come From The Healthcare Industry

As in years past, matters involving allegations of healthcare fraud were the driver, accounting for more ...

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG"), has made pursuing fraud in the personal care services ("PCS") sector a top priority, including making it a focus of their FY2017 workplan.

Last week, OIG released a report, Medicaid Fraud Control Units Fiscal Year 2016 Annual Report,  which set forth the number and type of investigations and prosecutions conducted nationwide by the Medicaid Fraud Control Units ("MFCUs") during FY 2016.  Overall, the MFCUs reported 1,564 convictions, over one-third of which involved PCS attendants; fraud cases ...

On April 18, 2017, the U.S. District Court for the Middle District of Florida adopted a magistrate judge's recommendation to grant summary judgment in favor of defendant BayCare Health System ("BayCare") in a False Claims Act whistleblower suit that focused on physician lease agreements in a hospital-owned medical office building, thereby dismissing the whistleblower's suit.

The whistleblower, a local real-estate appraiser, alleged that BayCare improperly induced Medicare referrals in violation of the federal Anti-Kickback Statute and the Stark Law because the lease agreements with its physician tenants included free use of the hospital parking garage and free valet parking for the physician tenants and their patients, as well as certain benefits related to the tax-exempt classification of the building. The brief ruling affirms the magistrate judge's determination that the whistleblower failed to present sufficient evidence to establish either the existence of an improper financial relationship under the Stark Law or the requisite remuneration intended to induce referrals under the Anti-Kickback Statute.

The alleged violation under both the Anti-Kickback Statute and the Stark Law centered on the whistleblower's argument that the lease agreements conferred a financial benefit on physician tenants – primarily, because they were not required to reimburse BayCare for garage or valet parking that was available to the tenants, their staff and their patients.  However, the whistleblower presented no evidence to show that the parking was provided for free or based on the physician tenants' referrals.  To the contrary, BayCare presented evidence stating that the garage parking benefits (and their related costs) were factored into the leases and corresponding rental payments for each tenant.  Further, BayCare presented evidence to support that the valet services were not provided to, or used by, the physician tenants or their staff, but were offered only to patients and visitors to "protect their health and safety."

In light of the evidence presented by BayCare, and the failure of the whistleblower to present any evidence that contradicted or otherwise undermined BayCare's position, the magistrate judge found that: (i) no direct or indirect compensation arrangement existed between BayCare and the physician tenants that would implicate the Stark Law, and (ii) BayCare did not intend for the parking benefits to induce the physician tenants' referrals in violation of the Anti-Kickback Statute.

A recent settlement demonstrates the importance of compliant structuring of lending arrangements in the health care industry. The failure to consider health care fraud and abuse risks in connection with lending arrangements can lead to extremely costly consequences.

On April 27, 2017, the Department of Justice ("DOJ") announced that it reached an $18 Million settlement with a hospital operated by Indiana University Health and a federally qualified health center ("FQHC") operated by HealthNet. United States et al. ex rel. Robinson v. Indiana University Health, Inc. et al., Case No. 1:13-cv-2009-TWP-MJD (S.D. Ind.).  As alleged by Judith Robinson, the qui tam relator ("Relator"), from May 1, 2013 through Aug. 30, 2016, Indiana University Health provided HealthNet with an interest free line of credit, which consistently exceeded $10 million.  It was further alleged that HealthNet was not expected to repay a substantial portion of the loan and that the transaction was intended to induce HealthNet to refer its OB/GYN patients to Indiana University.

While neither Indiana University Health nor HealthNet have made any admissions of wrongdoing, each will pay approximately $5.1 million to the United States and $3.9 million to the State of Indiana. According to the DOJ and the Relator, the alleged conduct violated the Federal Anti-Kickback Statute and the Federal False Claims Act.

For more details on the underlying arrangement and practical takeaways . . .

Both the Department of Justice and the Department of Health and Human Services Inspector General have long urged (and in many cases, mandated through settlements that include Corporate Integrity Agreements and through court judgments) that health care organizations have "top-down" compliance programs with vigorous board of directors implementation and oversight. Governmental reach only increased with the publication by DoJ of the so-called Yates Memorandum, which focused government enforcers on potential individual liability for corporate management and directors in ...

Frequently, parties in both civil and criminal cases where fraud or corporate misconduct is being alleged attempt to defend themselves by arguing that they lacked unlawful intent because they relied upon the advice of counsel. Such an assertion instantly raises two fundamental questions:  1) what advice did the party's attorney actually give?;  and 2) what facts and circumstances did the party disclose, or fail to disclose, in order to obtain that opinion?  It is well understood that raising an advice of counsel defense consequently waives attorney/client privilege.  Moreover ...

As discussed previously in this blog, efforts to curb fraud, waste and abuse are generally "bi-partisan." Given the significant monetary recoveries the Government enjoys through enforcement of the federal False Claims Act ("FCA"), we have predicted that efforts in this arena will continue under a Trump administration. However, this is dependent, in part, on the priorities of the new administration and the resources it devotes in this arena. To this end, the testimony of Attorney General nominee Sessions during his confirmation hearing on January 10th may have given us some ...

The federal government continues to secure significant recoveries through settlements and court awards related to its enforcement of the False Claims Act (FCA), particularly resulting from actions brought by qui tam relators. In fiscal year (FY) 2016, the federal government reported that it recovered $2.5 billion from the health care industry. Of that $2.5 billion, $1.2 billion was recovered from the drug and medical device industry.  Another $360 million was recovered from hospitals and outpatient clinics.

Government Intervention Drives Recoveries

The FY 2016 FCA statistics ...

As many pundits speculate regarding the future of the Yates Memo[1] in a Trump administration, on Wednesday, November 30, 2016, Department of Justice ("DOJ") Deputy Attorney General, Sally Q. Yates, provided her first comments since the election.  The namesake of the well-known, "Yates Memo," Yates spoke at the 33^rd Annual International Conference on Foreign Corrupt Practices Act in Washington, D.C. and provided her perspective on the future of DOJ's current focus on individual misconduct.

Yates, who has served at the DOJ for over twenty-seven years, stated that while the DOJ has ...

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration ("FDA") or the Centers for Medicare & Medicaid Services ("CMS") should be aware that the U.S. Department of Health and Human Services ("HHS") is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.

The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have ...

Entities that provide goods and services to the federal government, including health care providers and life sciences companies, should take note of the new civil monetary penalty amounts applicable to False Claims Act ("FCA") violations. After much anticipation, the U.S. Department of Justice ("DOJ") issued an interim final rule on June 30, 2016 confirming speculation that the penalty amounts will increase twofold.

The new minimum per-claim penalty amount will increase from $5,500 to $10,781, and the maximum per-claim penalty amount will increase from $11,000 to $21,563. The ...

The U.S. Supreme Court has rendered a unanimous decision in the hotly-awaited False Claims Act case of Universal Health Services v. United States ex rel. Escobar.  This case squarely presented the issue of whether liability may be based on the so-called "implied false certification" theory.  Universal Health Service's ("UHS) problem originated when it was discovered that its contractor's employees who were providing mental health services and medication were not actually licensed to do so. The relator and government alleged that UHS had filed false claims for payment because ...

In fiscal year 2015, the U.S. Department of Justice ("DOJ") recovered more than $3.5 billion from False Claims Act ("FCA") cases. A staggering $1.9 billion of that amount was recovered from health care providers who were alleged to have provided unnecessary care, paid kickbacks or overcharged federal health care programs.  While this amount may seem high, the drastic increases in FCA penalties expected this summer have the potential to skyrocket FCA recoveries in coming years. DOJ has not yet released the increased penalty amounts that would apply to FCA cases involving companies in ...

Our colleagues George B. Breen, Jonah D. Retzinger, and Daniel C. Fundakowski of Epstein Becker Green have published a client alert that will be of interest to our readers: "OIG Issues New Guidance on Its Evaluation Process and Non-Binding Criteria for Section 1128(b)(7) Exclusions."

Following is an excerpt:

On April 18, 2016, the Office of Inspector General ("OIG") of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act ("Act"), pursuant to which OIG may exclude ...

On November 24, 2015, in United States ex rel. Purcell v. MWI Corp., No. 14-5210, slip op. (D.C. Cir. Nov. 24, 2015), the District of Columbia Circuit Court of Appeals ruled that federal False Claims Act ("FCA") liability cannot attach to a defendant's objectively reasonable interpretation of an ambiguous regulatory provision. While outside of the health care arena, this decision has implications for all industries exposed to liability under the FCA.

In Purcell, the government alleged that false claims had been submitted as a result of certifications made by defendant MWI ...

On July 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit made clear that in False Claims Act cases brought under an implied certification theory, certifying compliance with the federal statute or regulation at issue must be a condition of payment.

In United States ex rel. Davis v. District of Columbia, No. 14-7060, 2015 WL 4153919 (D.C. Cir. Jul. 10, 2015), a qui tam relator alleged that the District of Columbia had failed to maintain certain records supporting certain cost reports it submitted to the District of Columbia Medical Assistance Administration ...

In a unanimous decision announced May 26, the U.S. Supreme Court, in Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, 2015 BL 163948, U.S., No. 12-1497, 5/26/15, ruled that the Wartime Suspension of Limitations Act ("WSLA") applied only to criminal charges and not underlying civil claims in times of war. Thus, the WSLA – which suspends the statute of limitations when the offense is committed against the Government - cannot be used to extend the statute of limitations in cases such as those brought under the False Claims Act ("FCA"). This ruling reversed a decision of ...

The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf).  The OIG's permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant's response to the ...

By Daniel C. Fundakowski

                   I.            Background

On June 6, 2014, in Foglia v. Renal Ventures Management, LLC the Third Circuit revived a dismissed False Claims Act ("FCA") lawsuit, holding that the New Jersey District Court applied Federal Rule of Civil Procedure 9(b) too rigorously when granting Renal's 12(b)(6) motion to dismiss.  Under Rule 9(b), an FCA whistleblower must allege "with particularity the circumstances constituting fraud or mistake."

Foglia was hired in 2007 as a registered nurse for Renal Ventures Management, a dialysis provider, and was terminated in 2008.  Foglia ...