Health Law Advisor

On February 22, 2024, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2023, which ended on September 30, 2023. While the $2.68 billion in total recoveries continues an upward trend from the $2.24 billion reported in FY 2022, a primary takeaway is the focus on DOJ-driven investigations.

During remarks on February 22 at the Federal Bar Association’s Qui Tam Conference, DOJ Principal Deputy Assistant Attorney General Brian M. Boynton reported that in FY 2023, the United  States was a party to 543 FCA ...

In an indictment announced on October 26, 2023 in Miami, the U.S. Department of Justice, Criminal Division’s Fraud Section, working with the FBI and HHS-OIG, brought what may be only the second federal criminal charges directly related to the Medicare Advantage (Medicare Part C) risk adjustment payment methodology.  DOJ enforcement in the Medicare Advantage risk adjustment space overwhelmingly has proceeded civilly under the False Claims Act. Although the allegations suggest conduct far more troubling than prior civil cases under risk adjustment, these criminal charges ...

Six months from the date of closing. That’s how long acquiring companies have under the newly announced Department of Justice (DOJ) Mergers and Acquisitions (M&A) Safe Harbor Policy to disclose misconduct discovered in the context of a merger or acquisition – whether discovered pre or post-acquisition.  And the acquiring company has one year from the date of closing to remediate, as well as provide restitution to any victims and disgorge  any profits.

Over the last two years, the DOJ has made clear its priority to encourage companies to self-disclose misconduct aiming to ...

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.

• 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.

In a quiet yet shocking announcement on February 3, 2023, the Antitrust Division of the U.S. Department of Justice (DOJ) withdrew three major antitrust policy statements (collectively, the “Statements”) that have served for years as mainstays of health care antitrust enforcement guidance. Specifically, DOJ withdrew the following statements: Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (September 15, 1993); Statements of Antitrust Enforcement Policy in Health Care (August 1, 1996); and Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in Medicare Shared Savings Program (October 20, 2011).

On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for using advertising technologies on its websites and mobile app that resulted in the unauthorized disclosure of consumers’ personal and health information to advertisers and other third parties. On the same day, the U.S. Department of Justice, acting on behalf of the FTC, filed a Complaint and Proposed Stipulated Order detailing the FTC’s allegations and the terms of the proposed settlement. 

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.

In this episode of the Diagnosing Health Care Podcast:  How does the U.S. Department of Justice (DOJ) intend to leverage its enforcement authority under the False Claims Act to advance DOJ’s recently announced Civil Cyber-Fraud Initiative?

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 July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is ...

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 ...

On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division's 2017 guidance publication “Evaluation of Corporate Compliance Programs.”  In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.”  He noted that DOJ also sought “to provide additional transparency in how [it] will analyze a company's ...

The U.S. Department of Justice reached a January 31, 2019 settlement of an American with Disabilities Act ("ADA") Title III complaint against health care provider Selma Medical Associates relating to provision of medical services to an individual with opioid use disorder ("OUD").  The settlement is notable for health care providers and employers as it makes clear that DOJ considers OUD as a disability under the ADA thereby triggering the full panoply of ADA rights for those with OUD.

The DOJ complaint was premised on the alleged refusal of Selma Medical to schedule a new patient family ...

During a November 29, 2018 speech, Deputy Attorney General Rod Rosenstein announced changes to Department of Justice (“DOJ”) policy concerning individual accountability in corporate cases.  The announcement followed the DOJ’s year-long review of its individual accountability policies and the September 2015 memorandum issued by then-Deputy Attorney General Sally Yates, commonly known as the “Yates Memo.”

While making clear that pursuing individuals responsible for corporate wrongdoing remains a top priority in every investigation conducted by DOJ, Mr ...

While the opioid crisis has inspired a wave of new legislation by Congress, the U.S. Department of Justice (“DOJ”) has continued to increase its own response to the prevalent rate of opioid-related drug crimes with a number of new initiatives.  On October 17^th, Deputy Attorney General Rod Rosenstein recently delivered remarks at the America’s Health Insurance Plans 2018 National Conference on Medicaid and highlighted the Department’s continued determination to tackle the opioid crisis. Rosenstein’s remarks reiterated Attorney General Jeff Sessions’ recent ...

Our colleague Joshua A. Stein at Epstein Becker Green has a post on the Retail Labor and Employment Law blog that will be of interest to our readers in the health care industry: “DOJ Finally Chimes In On State of the Website Accessibility Legal Landscape – But Did Anything Really Change?”

Following is an excerpt:

As those of you who have followed my thoughts on the state of the website accessibility legal landscape over the years are well aware, businesses in all industries continue to face an onslaught of demand letters and state and federal court lawsuits (often on multiple ...

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 Monday, August 12, 2018, the U.S. Department of Justice (“DOJ”) announced a new addition to its regional Medicare Fraud Strike Forces: a Newark/Philadelphia Regional Medicare Strike Force that will target both healthcare fraud and opioid overprescription.[1] The newly-formed Newark/Philadelphia Strike Force joins nine existing regional Medicare Strike Forces, all of which are focused in geographical areas of high healthcare fraud risk: Miami, Florida; Los Angeles, California; Detroit, Michigan; Southern Texas; Southern Louisiana; Brooklyn, New York; Tampa ...

Tuesday’s decision by Judge Richard Leon of the U.S. District Court for the District of Columbia categorically approving the merger of AT&T and Time Warner, without imposing any conditions or limitations and rejecting granting a stay for appeal purposes, will, unless blocked if there is an appeal, open the way for a series of pending vertical merger deals.

A “vertical merger” is a merger of two companies that do not compete and that are at different levels of the product or service-provision process. Such mergers do not reduce the number of competitors in a given market and, by ...

In the midst of one of the worst flu seasons to date, many hospitals and other health care organizations enforced mandatory flu vaccine policies for their employees to boost vaccination rates. However, recent litigation and governmental actions should serve as a reminder that health care entities should carefully consider safeguards whenever implementing mandatory vaccine policies and to not categorically deny all requests for religious exemptions based on anti-vaccination beliefs.

In January, the Department of Health and Human Services (HHS) announced the formation of a ...

Recent settlement agreements between the United States Department of Justice (the “DOJ”) and two urologist business partners suggests that the government may be focusing increased enforcement efforts on the Stark Law’s “group practice” requirements and the Stark exception for “in-office ancillary services.”  The urologists agreed to pay over $1 million to resolve the allegations.

In early January 2018, the DOJ entered into settlement agreements with Dr. Aytac Apaydin and Stephen Worsham to resolve allegations that the physicians submitted improper claims to ...

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 ...

Our colleague Joshua A. Stein, a Member of the Firm at Epstein Becker Green, has a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry: “Latest Website Accessibility Decision Further Marginalizes the Viability of Due Process and Primary Jurisdiction Defenses.”

Following is an excerpt:

In the latest of an increasing number of recent website accessibility decisions, in Gorecki v. Hobby Lobby Stores, Inc. (Case No.: 2:17-cv-01131-JFW-SK), the U.S. District Court for the Central District of California ...

Many health care providers rely on a worked relative value unit ("wRVU") based compensation model when structuring financial relationships with physicians. While wRVUs are considered an objective and fair method to compensate physicians, payments made on a wRVU basis do not always offer a blanket protection from liability under the Federal Stark Law.  As recent settlements demonstrate, wRVU based compensation arrangements that are poorly structured or improperly implemented can result in significant liability.

The wRVU physician compensation model is particularly favored ...

Our colleague Joshua A. Stein, a Member of the Firm at Epstein Becker Green, has a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry: “Nation’s First Website Accessibility ADA Trial Verdict Is In and It’s Not Good for Places of Public Accommodation.”

Following is an excerpt:

After years of ongoing and frequent developments on the website accessibility front, we now finally have – what is generally believed to be – the very first post-trial ADA verdict regarding website accessibility. In deciding Juan ...

The Federal Trade Commission ("FTC") and the Antitrust Division of the Department of Justice ("Antitrust Division") released their respective year-end reviews highlighted by aggressive enforcement in the health care industry. The FTC, in particular, indicated that 47% of its enforcement actions during calendar year 2016 took place in the health care industry (including pharmaceuticals and medical devices). Of note were successful challenges to hospital mergers in Pennsylvania (Penn State Hershey Medical Center and Pinnacle Health System), and Illinois (Advocate Health ...

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 ...

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 ...

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 ...

Our colleagues Joshua Stein, co-chair of Epstein Becker Green’s ADA and Public Accommodations Group, and Stephen Strobach, Accessibility Specialist, have a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry:  “DOJ Refreshes Its Efforts to Promulgate Title II Website Accessibility Regulations and Other Accessible Technology Updates – What Does It All Suggest for Businesses?”

Following is an excerpt:

On April 28, 2016, the U.S. Department of Justice, Civil Rights Division, withdrew its Notice of ...

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 ...

On October 26, 2015, the Federal Trade Commission ("FTC") and the Antitrust Division of the U.S. Department of Justice ("DOJ") (collectively the "Agencies") issued a joint statement to the Virginia Certificate of Public Need ("COPN") Work Group encouraging the Work Group and the Virginia General Assembly to repeal or restrict the state's certificate of need process.  The Virginia COPN Work Group was tasked by the Virginia General Assembly to review the current COPN process and recommend any changes that should be made to it.

Thirty-six states currently maintain some form of ...

by Patricia M. Wagner and Ross K. Friedberg

On April 19, 2011, the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) was published in the Federal Register. As noted in the Proposed Statement, the antitrust enforcement agencies (the Department of Justice Antitrust Division and the Federal Trade Commission issued the Proposed Statement in response to a perceived preference by potential accountable care organization (“ACO”) participants to ...