OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and referrals between Medicare Advantage (“MA”) health plans, health care professionals, and third-party marketers (e.g., agents and brokers) and that can mislead MA enrollees into choosing specific health plans or providers that may not be in the MA enrollees’ best interests or meet their needs (“MA Marketing Alert”). As we have previously advised, special fraud alerts are few and far between—OIG has only issued six in the past 20 years. The importance of the MA Marketing Alert, like its predecessors, should not be taken for granted because it may be instructive as to subsequent enforcement action taken by OIG and/or the U.S. Department of Justice (“DOJ”).

In the MA space, historical enforcement actions taken by both OIG, under their administrative authorities, and DOJ, under the False Claims Act (“FCA”), have related to alleged MA risk adjustment payment inflation schemes. See, e.g., DaVitaSutter HealthBeaver MedicalMartin’s Point, and Cigna. While allegations of this nature continue to be a focus area (e.g., in OIG’s work plans), a light is also now being shone on inappropriate marketing schemes that could violate the Federal anti-kickback statute (“AKS”). And, based on historical empirical data connecting DOJ’s enforcement actions taken subsequent to OIG’s issuance of special fraud alerts, that light may broaden and brighten.

For example, in July 2022, OIG issued a special fraud alert about arrangements involving telemedicine companies. In a footnote, OIG provided three enforcement actions resolved under the FCA as examples of allegedly problematic arrangements. After providing the footnote examples, OIG described bullet-pointed “Suspect Characteristics” that tracked the allegedly inappropriate characteristics of the footnote examples. Since the alert’s issuance, DOJ has recovered millions under the FCA and also criminally charged and convicted many individuals and entities for allegedly submitting or causing the submission of more than $3.1 billion (in 2023 and 2024 pursuant to DOJ’s nationwide takedowns) in allegedly fraudulent Medicare claims resulting from telemedicine schemes.

While the MA Marketing Alert provides footnotes of only two enforcement actions resolved under the FCA as examples of allegedly problematic arrangements, the bullet point list of “Suspect Characteristics” is broader than and reaches beyond the footnote examples. This may signal OIG’s awareness of and current investigations into allegedly inappropriate arrangements relating to “Suspect Characteristics” that have yet to be settled or resolved.

It is possible that there may be forthcoming enforcement actions in these areas. And they may follow the same trend of enforcement actions taken by DOJ relating to telemedicine schemes after OIG’s July 2022 special fraud alert. We also note that the MA Marketing Alert aligns with the Centers for Medicare & Medicaid Services’ recently finalized regulatory updates relating to MA health plan marketing arrangements with agents, brokers, and Third-Party Marketing Organizations, which will be effective January 1, 2025, and prohibit such parties from creating direct or indirect incentives “that would reasonably be expected to inhibit an agent or broker’s ability to objectively assess and recommend which plan best fits the health care needs of a beneficiary.” Proskauer’s Health Care Group will continue to monitor these developments in and provide updates about these areas of scrutiny and enforcement.

Revisions to HSR Form Released

On October 7, 2024, the Federal Trade Commission (FTC), with the concurrence of the U.S. Department of Justice (DOJ), released its long-awaited final rule related to the revision of the Hart-Scott-Rodino (HSR) premerger notification form (the “Final Rule”).

The Final Rule will be effective 90 days after its publication in the Federal Register. The FTC and DOJ state that the revisions are intended to close the perceived gaps in current information provided in the HSR process, such as the disclosure of entities and individuals within the acquiring person; identification of potential labor market effects; identification of acquisitions that create a risk of foreclosure; identification of actions that may involve innovation effects, future market entry, or nascent competitive threats; and disclosure of roll-up or serial acquisition strategies.

The Final Rule dictates the use of two separate forms: one for the acquiring entity and one for the entity to be acquired. Each party will have to designate a “deal team lead” whose files must be searched for 4(c) and 4(d) documents, even if the deal team lead is not an officer or director. In addition, the acquiring entity must provide details not previously requested, including an organization chart, a list of officers and directors, a description of the ownership structure of the entity, and information on the transaction rationale.

While the information requested in the Final Rule is more limited than what was included in the original proposed rule, there are substantial changes that parties should expect to add significant time and cost to the filing process.

Unitary Executive Theory Surfaces in Court: District Court Rules Qui Tam Provisions of the False Claims Act Unconstitutional

On September 30, 2024, the United States District Court for the Middle District of Florida ruled that filing claims on behalf of the government under qui tam provisions of the False Claims Act (FCA) is unconstitutional in United States of America ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, et al. The ruling, made by Judge Kathryn Mizelle, a 33-year-old Trump-appointee, declares that False Claims Act whistleblowers undermine executive power by filing qui tam lawsuits.

The Zafirov decision follows a recent dissent by Supreme Court Justice Clarence Thomas in which he questioned the constitutionality of the FCA’s qui tam provisions. It also follows a political movement pushing the Unitary Executive Theory in the United States judicial courts.

This controversial decision mischaracterizes the qui tam provisions of the FCA and will likely be appealed to the Eleventh Circuit. Should the ruling stand, however, it and other similar challenges to the constitutionality of the FCA’s qui tam provisions will cripple what has been America’s number 1 anti-fraud law. Since the False Claims Act was modernized in 1986, qui tam whistleblower cases have allowed the government to recover more than $52 billion from fraudsters, over $5 billion of which came in cases where the government chose not to intervene.

Applying the ‘Unitary Executive’ Theory to Paint Whistleblowers as ‘Self-Selected Private Bounty Hunters’

Originally passed during the Civil War, the False Claims Act contains qui tam provisions enabling whistleblowers, also known as ‘relators’, to report government contracting fraud and work directly with government investigators. Once the whistleblower brings forward the suit, the government may intervene and continue to prosecute the litigation as the plaintiff. However, in the interest of accountability, the qui tam provision of the FCA permits the whistleblower to pursue a case even if the United States declines prosecution. Whistleblowers who file successful qui tam lawsuits are eligible to receive up to 30% of recovered damages.

The question of the constitutionality of the False Claims Act’s qui tam provisions was notably raised in a dissent by Justice Clarence Thomas in the 2023 Supreme Court case U.S., ex rel. Polansky v. Executive Health Resources. While Polansky discussed the issue of a relator pursuing a lawsuit after the government declines to intervene, Thomas raised a separate issue of constitutionality in his dissent. He stated that “there are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.” In a one-paragraph concurrence, Justice Brett Kavanaugh, joined by Justice Amy Coney Barrett, invited challenges to the constitutionality of the FCA’s qui tam provisions, writing that “In my view, the Court should consider the competing arguments on the Article II issue in an appropriate case.”

Judge Mizelle, a former clerk of Justice Thomas, drew heavily upon Justice Thomas’ dissent in her decision. Echoing Thomas’ dissent in Polansky, JudgeMizelle concluded that the qui tam provision “directly defies the Appointments Clause by permitting unaccountable, unsworn, private actors to exercise core executive power [litigating on behalf of the government] with substantial consequences to members of the public.” The District Court thus agreed with the defendants that the FCA’s qui tam provisions indeed violates the Appointments Clause of Article II of the Constitution.

The Zafirov ruling relies upon the ‘unitary executive theory,’ a constitutional law theory that states the President of the United States has sole authority over the executive branch and that power cannot be limited by Congress.

According to then-Assistant Attorney General William Barr’s 1989 Memo Constitutionality of the Qui TamProvision of the False Claims Actwhich repeatedly cited by both the judgment and the U.S. Chamber of Commerce amicus brief, the move to enable private citizens to file on behalf of the government represents a breach of the separation of powers allowing “Congress to circumvent the Executive’s check.” Barr rebrands whistleblowers as “private bounty hunters” and claims that the 1986 amendments which reincorporated the FCA’s qui tam provisions was a tactic by Congress to override presidential powers. Barr maintains that “only a unitary executive” that is, “only the President” can “take care that the laws be faithfully executed.”

In a dissent in the 1988 Supreme Court case Morrison v OlsenJustice Antonin Scalia interpreted the ‘Unitary Executive’ to have unchecked authority to appoint and remove executive officials, claiming that the firing of an independent counsel without cause falls within the limitless power of the President over the executive.

The Middle District of Florida ruling draws on Scalia’s rationale arguing that the right to pursue a qui tam case denies the President the executive authority of appointment of the relator. Under the FCA, however, whistleblowers are granted certain rights. For example, the executive must guarantee a whistleblower the “right to continue as a party” with or without the United States intervening and wait for the relator’s approval before settling the action.

The court agrees with the defendants’ argument that the FCA therefore “den[ies] the President necessary removal authority and sufficient supervisory control over [the relator].”

The court contends that the physician-turned-whistleblower Zafirov was “an improperly appointed officer” in violation of the Appointments Clause and the Take Care and Vest Clause of the Article. According to the ruling, by filing a qui tam against Medicare fraud, Zafirov was granted “core executive power” without any “proper appointment under the Constitution.”

A Mischaracterization of Qui Tam Whistleblowing

Judge Mizelle’s decision in United States ex rel. Zafirov v. Fla. Med. Assocs. first mischaracterizes the FCA’s qui tam as a breach of presidential power instead of as a provision that strengthens checks and balances. Second, the court ignores case law outlining government prerogatives over relators such that they are not menacing to the core Executive powers.

The revived qui tam provision of 1986 was a legislative move to improve government accountability over fraud—neither expanding Congressional oversight nor the size of government—by mobilizing private citizens rather than public agents. The Florida court wrongfully elevates the status of a relator to an ‘officer’ responsible to the government. A citizen pursuing a claim on behalf of the government is not and does not pretend to be an extension of the Executive Office and, therefore not subject to administrative appointment procedure. Rather the relator is a private person, and the government is a third party to the case. The Vt. Agency of Natural Res. v. United States ex rel. Stevens majority opinion also written by Justice Scalia discussing whether relators have judicial standing under Article III, qualifies that the relator is on “partial assignment of the Government’s damages claim.” A ‘partial assignee’—to which only some rights are transferred—may “assert the injury suffered by the assignor” (the U.S.) so long as the harm done is sufficient. Scalia reiterates the ‘representational standing’ of relators and makes no remarks on its challenge to the Unitary Executive. Judge Mizelle’s reliance on Morrison v Olsen to claim that like an independent counsel, a relator should also qualify as an officer ignores the Stevens Supreme Court ruling distinguishing relators as a type of assignee.

Mizelle also raises that relators seem to enjoy unbridled authority over the Executive by initiating a qui tam suit without government intervention. While Mizelle points to 31 U.S.C. § 3730 (c) to demonstrate the unchecked power of the relator, she neglects the numerous limitations specified in § 3730 (c)(2), including the broad power of the government to dismiss the qui tam action after intervening notwithstanding any objections from the relator. She frames the government intervention as “the government’s ability to pursue a parallel action and to exert limited control [which] does not lessen a relator’s unchecked civil enforcement authority to initiate.” In truth, the statute and years of judicial history maintain the government’s absolute discretion over whether to intervene in or completely stop the case by dismissing the action.

Contrary to Judge Mizelle’s belief, relators are not free from potential government intervention even when independently pursuing the case. On the contrary, relators are not able to independently pursue any binding action on the government unimpeded by the government. While Zafirov independently pursued the claim for five years, the government could have intervened and then dismissed the claim at any time. If the government intervenes, underlined in 31 U.S.C. § 3730 (c)(2), the government is empowered to settle the action with the defendant notwithstanding any objections from the relator and to restrict their participation in the course of the litigation. The fact that the government may choose not to intervene at one point does not divest them of their ability to intervene later and exercise significant authority over the relator.

Implications: Crippling the False Claims Act

Judge Mizelle’s decision seeks to end the historic success of the qui tam provision of the FCA by declaring the government’s most effective mechanism of detecting fraud as unconstitutional. While the decision does not invalidate the FCA nationally, this case could be the first step in a series of appeals that may elevate the issue to the Supreme Court.

The government’s largest obstacle to fighting white-collar crime such as fraud is detection. The diffuse and indirect nature of fraud requires those with insider knowledge to assist the government in pursuing corruption. In terms of the effectiveness of the qui tam provision, between 1987 and 2022, the Department of Justice Civil Fraud Division recovered $22.1 billion without the help of whistleblowers versus $50.3 billion with the help of whistleblower lawsuits. Since the 1986 amendments to the FCA, whistleblowers have been the direct source of approximately 70% of civil fraud recoveries by the federal government. From the Medicare billing fraud committed in Florida Medical Associates to Russian money laundering, the United States may lose its most effective tool to fight fraud fraud if the qui tam provisions of the FCA are ruled unconstitutional.

FTC Finalizes Major Rewrite of HSR Filing Requirements

Last week, the Federal Trade Commission (FTC) voted unanimously to issue a final rule that implements significant changes to the Hart-Scott-Rodino (HSR) premerger notification form and accompanying instructions. While the final rule includes numerous modifications from the draft proposal that was announced in June 2023 (see our previous client alert), this still represents the most substantial change to the HSR filing requirements in decades, and will require parties to HSR-reportable transactions to gather and provide considerably more information and documents than under the current rules. The final rule will take effect 90 days after publication in the Federal Register (unless there is a successful court challenge in the interim).

Under the HSR Act, parties to certain mergers and acquisitions are required to submit premerger notification forms that disclose information about their proposed deal and business operations. The FTC and the Antitrust Division of the US Department of Justice (DOJ) use this information to conduct a competitive impact assessment within the statutory HSR waiting period, which is typically 30 calendar days. According to the FTC’s press release accompanying the final rule, the new requirements are a necessary response “to changes in corporate structure and deal-making, as well as market realities in the ways businesses compete, that have created or exposed information gaps that prevent the agencies from conducting a thorough antitrust assessment of transactions subject to mandatory premerger review.”

Key Changes to HSR Filing Requirements

Some of the main changes will require the following:

  • A description of each party’s strategic rationales for the transaction, with cross-references to documents submitted with the HSR filings that support the stated rationales.
  • A new Overlap Narrative section that will require the buyer and target to identify and provide (i) a written description of current or planned products or services where they compete (or could compete) with each other, (ii) actual or projected revenues for each such product or service, (iii) a description of all categories of customers that purchase or use the product or service, and (iv) the top 10 customers for each customer category (e.g., retailer, distributor, broker, national account, local account, etc.).
  • A narrative describing supply relationships between the transaction parties or between the buyer and any other business that competes with the target, including the amount of revenue involved and the top 10 customers or suppliers.
  • In addition to requiring documents discussing the competitive aspects of the proposed transactions that were prepared by or for officers and directors (current Item 4(c)), filing persons must also submit (i) transaction-related documents prepared by or for a “supervisory deal team lead”, and (ii) ordinary course business plans and reports about overlapping products and services that were provided to the CEO or Board of Directors within a year prior to filing.
  • Acquiring persons must list all current and recent officers and directors (or in the case of unincorporated entities, individuals exercising similar functions) in cases where those individuals hold similar positions in entities that have overlapping operations with the target.
  • Identification of minority holders of additional entities related to the transaction parties, as well as more information about minority interest holders, including limited partners in partnerships where the limited partner has certain rights related to the board (or similar bodies) of the acquiring entity and its related parties, and in some cases, the target. (Currently, the HSR form only requires disclosure of the general partner.)
  • Additional information regarding certain prior acquisitions by both the buyer and the target. (Currently, only buyers must provide information regarding prior acquisitions.)
  • If an HSR filing is being made based on an executed letter of intent or term sheet rather than a definitive agreement, the filing must include a dated document containing sufficient details about the transaction.
  • Parties must submit the entirety of all agreements related to the transaction (not just the principal transaction agreement).
  • All foreign-language documents must be accompanied by English-language translations.
  • Filing parties must disclose economic subsidies received from certain foreign governments or entities of concern to the United States.
  • Information related to certain contracts with defense or intelligence agencies. 

    It is worth noting that a few particularly onerous or controversial proposals from the initial draft rule were not adopted, including the proposal to require collection and production of all drafts of responsive documents (rather than just final versions), as well as specific information about labor markets and each filing party’s workers.

    Related Changes to the Merger Review Process

    Significantly, the FTC announced that, following the final rule coming into full effect, it will lift its suspension on early termination of the waiting period for HSR filings involving transactions that clearly raise no competitive issues. According to the FTC, “[b]ecause the final rule will provide the agencies with additional information necessary to conduct antitrust assessments, the rule will help inform the processes and procedures used to grant early terminations.”

    The FTC also stated that it is introducing a new online portal for market participants, stakeholders, and the general public to directly submit comments on proposed transactions that may be under review by the FTC (it is unclear if the DOJ will follow suit). According to its press release, the FTC “welcomes information on specific transactions and how they may affect competition from consumers, workers, suppliers, rivals, business partners, advocacy organizations, professional and trade associations, local, state, and federal elected officials, academics, and others.”

    Practical Implications for Deals

    The final rule issued by the FTC marks a sea change in the preparation of filings for HSR-reportable transactions. The new requirements will significantly increase the time, effort and cost of preparing all HSR filings, with the impact likely to be magnified for deals where the buyer and target are competitors or operate within the same supply chain. Transaction parties will need to account for this new reality in their deal timelines and budgets. Transaction agreements will need to allow for more time to file HSR, and it may be advantageous for some parties to begin filing preparations much earlier in the deal process. In addition, the new transaction agreement requirements mean that key terms of deals will need to be more fully fleshed out before parties can file HSR and start the 30-day clock.

    Also, since filing parties will now have an affirmative obligation to disclose competitive overlaps as well as supplier-customer relationships, careful consideration will need to be given to how those are described, since statements made in the HSR filing could later be used against the parties in an in-depth investigation (if the reviewing agency issues a “Second Request”) or in litigation (if the agency challenges the deal). Moreover, for serial acquirors, descriptions of products and overlaps in one filing could have consequences for future HSR-reportable transactions.

    Additionally, the new obligation on filers to provide customer and/or supplier information in the HSR filing may cause parties to re-evaluate their approach towards third party outreach regarding proposed transactions, given the possibility of earlier and more frequent FTC/DOJ calls to those customers and suppliers.

The Murky Waters of Wash Trading Digital Assets – DOJ Charges 18 Individuals and Entities

The United States Attorney’s Office for the District of Massachusetts recently unsealed what it described as the “first-ever criminal charges against financial services firms for market manipulation and ‘wash trading’ in the cryptocurrency industry.” The SEC also filed parallel civil charges alleging violations of Securities for the same alleged schemes.

The government has charged eighteen individuals and companies, including four cryptocurrency market makers, with engaging in illegal market manipulation through “wash trading” digital assets. According to the DOJ and SEC filings, although these individuals purported to offer “market making services,” they were actually engaged in offering “market-manipulations-as-a-service” by engaging in artificial trading of digital assets to give the false appearance that there was an active (and heavily traded) market for those tokens.

How this case came to the DOJ’s attention is as novel as the legal theory behind the charging documents. According to DOJ spokespeople, the investigation started with a tip from the SEC about one of the companies at issue. Further investigations into that company—along with the help of cooperating witnesses—led authorities to set up a sham crypto firm, NextFundAI, and create a token associated with the firm. Posing as NextFundAI, the government communicated with the defendants—market makers who allegedly offered to trade and manipulate the price of NextFundAI’s token by wash trading, or trading the token back-and-forth between crypto wallets they controlled.

While there may be rules against wash trading in traditional securities markets (see, e.g., 26 U.S. Code § 1091), the rules are as clear in the digital asset space. Indeed, the regulatory vacuum facing the digital asset industry makes it difficult for those in the industry to avoid eventual regulatory action, and what many have referred to as “regulation by enforcement.” This is particularly true where the technological realities of digital assets do not fit squarely within the existing legal framework. There may be disagreement about the purpose or intent behind a cryptocurrency transaction where one individual is transferring cryptocurrency between wallets that person or entity controls. But there may not be a misrepresentation or fraudulent act inherent in this type of transaction. Indeed, the transaction itself (including the wallet address of the sender and recipient) is likely immediately and accurately recorded on the public blockchain. So, according to the government, the “fraud” is the intent behind the trades – to manipulate the market by artificially generating trade volume to signal interest and activity in the token.

The government’s allegations are also interesting because in addition to the wire fraud charges (18 U.S.C. § 1343), which generally do not require proof that the digital asset at issue is a security, the government has charged the defendants with conspiracy to commit market manipulation (18 U.S.C. § 371), which requires the government to prove that the token at issue is a security. This charge is significant because it will require the DOJ to prove at trial that the tokens at issue are securities.

Although several individuals involved have already pleaded guilty, there are several defendants who appear to be testing the government’s novel theory in court. We anticipate that this will be the first of many similar investigations and enforcement actions in the digital asset space.

DOJ Announces Changes to Guidance on Corporate Compliance Programs, Updates on Whistleblower Program

In an address this week to the Society of Corporate Compliance and Ethics, Principal Deputy Assistant Attorney General Nicole M. Argentieri of the Department of Justice’s (“DOJ”) Criminal Division, highlighted several updates relevant to corporate compliance programs, including the DOJ’s new whistleblower programs and incentives.

Sufficient Compliance: Updated Areas to Consider

The Evaluation of Corporate Compliance Programs (“ECCP”) is the compass by which the DOJ measures the efficacy of a corporation’s compliance program for potential credit or mitigation in the event an organization is potentially subject to prosecution.[1] Ms. Argentieri highlighted several key updates to the ECCP that the DOJ will now consider when evaluating whether a corporation’s compliance program is “effective” and thus deserving of credit and/or mitigation of criminal penalties.

These new factors include whether:

  • the resources and technology with which a company does business are applied to its compliance program, and whether its compliance program fully considers the risks of any technologies it utilizes (such as generative AI)[2];
  • the company had a culture of “speaking up” and protecting those who report on corporate misdeeds;
  • a company’s compliance department had access to adequate resources and data to perform its job effectively; and
  • a company learned from its past mistakes—and/or the mistakes of other companies.

Encouraging Self-Reporting: Presumptive Declination and Reduced Penalties

In her remarks, Ms. Argentieri stated that the previously announced Whistleblower Awards Program[3] had so far been successful in the eyes of the DOJ, but did not point to any specific case or outcome. Likely, it is too soon for the public to see the fruits of the program, given its nascent state and the time that usually elapses between the initiation of an investigation and its resolution. The DOJ appears to be stating, though, that it is receiving and following up on whistleblower reports already.

This new policy encouraging whistleblowing through financial incentives, however, was combined with an amendment to DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy, which provides that there is a presumptive declination to prosecute should a company make a disclosure of wrongdoing within 120 days of receiving an internal report of alleged misconduct and before DOJ contacts the company regarding that matter. In short, DOJ is seeking to incentivize a “race to DOJ” to report potential misconduct – perhaps before the company can even confirm whether the allegation is credible.[4]

Organizations that opt to not take the early self-disclosure route can still reduce any criminal penalties they may face by up to half by fully cooperating with the DOJ in its investigation. Considerations DOJ will factor in when evaluating whether an organization “fully cooperates” include, among other things, how timely the cooperation was and if the company took appropriate remedial action (such as improving compliance programs and disciplining employees). The DOJ continues to emphasize the importance of clawing back compensation and/or reducing compensation and bonuses of wrong-doers (if not also terminating them).[5]

Tipping the Scales

In sum, these programs are clearly intended to materially alter the disclosure calculus of whether a company should disclose misconduct by putting quantifiable incentives on the side of timely disclosure and cooperation, namely declination. Combined with the DOJ’s updates to the ECCP, these programs attempt to bring clarity and consistency to the world of corporate criminal penalties (and possibly how to avoid them altogether). Companies are well-advised to review their existing compliance programs in light of these new incentives and guidance from the DOJ to ensure that they address the new factors enumerated by the DOJ, but also account for increased incentives for corporate whistleblowers.


FOOTNOTES

[1] The U.S. Sentencing Guidelines also define what constitutes an “effective compliance and ethics program” for credit under the guidelines. U.S.S.G. §8B2.1.

[2] This is not the first time, and unlikely to be the last, where DOJ has emphasized the use of AI to enhance corporate compliance. See Lisa Monaco, Deputy Attorney General, Department of Justice, Remarks at the University of Oxford on the Promise and Peril of AI (Feb. 14, 2024).

[3] Under the Criminal Division’s whistleblower pilot program (and like those of other U.S. Attorney’s Offices who have thus far adopted similar programs), whistleblowers are financially rewarded—through criminal forfeiture orders—for bringing forward information on specific alleged violations, so long as that person first reports the misconduct to the company and DOJ has not already learned of it. The Criminal Division’s Pilot Program on Voluntary Self-Disclosure for Individuals also provide culpable individuals who report to receive non-prosecution agreements in exchange for reporting their own conduct and the conduct of the company.

[4] The “race to DOJ” incentivized by these programs may indeed alter the corporate disclosure calculus—by moving up the date for any disclosure in light of the threat that an employee or third-party, aware of any investigation, may choose to report the matter to DOJ. Likewise, it may also change the nature of the internal investigation in ways to limit knowledge of the investigation early-on, like limiting early interviews until documents and data can be reviewed and analyzed.

[5] Indeed, DOJ will permit companies to earn a dollar-for-dollar reduction of a criminal penalty for each dollar a company successfully claws back from a wrong-doer to further incentivize companies to seek to claw back compensation paid.

Former Acadia Employees Received Reward for Blowing the Whistle on Healthcare Fraud

The United States Department of Justice settled a False Claims Act qui tam whistleblower lawsuit against inpatient behavioral health facilities operator Acadia Healthcare Company, Inc. Under the terms of the settlement, the operator paid almost $20 million to the United States and the States of Florida, Georgia, Michigan, and Nevada. The relators, or whistleblowers, who filed suit in 2017, received a reward of 19% of the government’s recovery of misspent Medicare, TRICARE, and Medicaid funds. According to one of the Relators, Jamie Clark Thompson, a former Director of Nursing at Acadia’s Lakeview Behavioral Health facility, “I am passionate about advocating for improved and quality services for individuals living with mental illness. Unfortunately, our communities have seen the devastating impact when this vulnerable population receives inadequate care. I firmly believe that by continuously working to improve our mental health system, we can support recovery and well-being, benefiting our entire community. I hope that my actions have made a difference, and I know that properly allocating funds is crucial to supporting behavioral health services and those working tirelessly to improve them.”

Medicare, TRICARE, and Medicaid Fraud Allegations

According to the settlement agreement, the whistleblowers alleged Acadia and certain of its facilities submitted false claims to Medicare, TRICARE, and Medicaid. Specifically, the facilities allegedly admitted ineligible patients, provided services for longer than was medically necessary or did not provide treatment at all (but still billed the healthcare programs for it), did not provide sufficient care for those who needed acute care or individualized care plans, and hired the wrong people or failed to train their staff to “prevent assaults, elopements, suicides, and other harm resulting from staffing failures.”

Behavioral Health Facility Fraud

Behavioral healthcare facilities provide inpatient, outpatient, and residential care for adolescents, adults, and seniors for mental health conditions. As taxpayer-funded healthcare programs, Medicare, Medicaid, and TRICARE cover behavioral healthcare. Treating mentally ill Medicare, Medicaid, or TRICARE beneficiaries as cash cows, and either under-treating, over-treating, or not treating them at all both robs the individuals of the chance to recover, wastes taxpayer resources, and may even jeopardize their safety and well-being.

The Importance of Medicare, Medicaid, and TRICARE Whistleblowers

Whistleblowers who report behavioral health facility fraud are not only protecting vulnerable patients but also making sure federally funded healthcare dollars are being spent to properly treat adolescent, adult and older patients with significant behavioral health conditions. Three employees at different Acadia facilities came forward, faced retaliation for speaking up, and are now being rewarded for helping to fight fraud and abuse and for their courage.

by: Tycko & Zavareei Whistleblower Practice Group of Tycko & Zavareei LLP

Walgreens Settles for $106.8 Million Over FCA Violations

On September 13, the US Department of Justice (DOJ) announced that Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) agreed to pay $106.8 million to resolve allegations of violating the False Claims Act (FCA) and state statutes. The allegations pertain to billing government health care programs for prescriptions that were never dispensed. The government alleged that from 2009 until 2020, Walgreens submitted claims to federal health care programs for prescriptions that were processed but never picked up by beneficiaries. This resulted in Walgreens receiving 10s of millions of dollars for prescriptions that were never actually provided to health care beneficiaries.

Under the resolution, Walgreens agreed to enhance its electronic pharmacy management system to prevent future occurrences and self-reported certain conduct. In addition, Walgreens refunded $66,314,790 related to the settled claims, which allowed Walgreens to receive credit under the DOJ’s guidelines for taking disclosure, cooperation, and remediation into account in FCA cases.

Under the settlement agreement, the federal government received $91,881,530, and the individual states received $14,933,259 through separate settlement agreements. The settlement will resolve three cases pending in the District of New Mexico, Eastern District of Texas, and Middle District of Florida under the qui tam, or whistleblower, provision of the FCA. Whistleblowers Steven Turck and Andrew Bustos, former Walgreens employees, will receive $14,918,675 and $1,620,000, respectively, for their roles in filing the suits.

The DOJ’s press release can be found here.

CVS Health Subsidiary Settles FCA Allegations for $60 Million

On September 16, Chicago company Oak Street Health, a subsidiary of CVS Health, agreed to pay $60 million to resolve allegations that it violated the FCA by paying kickbacks to third-party insurance agents in exchange for recruiting seniors to Oak Street Health’s primary care clinics from September 2020 through December 2022.

According to the DOJ, in 2020, Oak Street Health developed a program called the Client Awareness Program. Under the program, which was developed to increase patient membership, seniors who were eligible for Medicare Advantage received marketing messages designed to generate interest in Oak Street Health. Upon receipt of these messages, third-party insurance agents organized three-way phone calls with Oak Street Health employees for the interested seniors. Oak Street Health paid agents around $200 per beneficiary referred or recommended as part of this service. Instead of basing referrals and recommendations on the best interest of the seniors, these payments allegedly encouraged agents to base referrals and recommendations on Oak Street Health’s financial interests.

The DOJ’s press release can be found here.

Dunes Surgical Hospital Settles for $12.76 Million Over FCA Violations

On September 16, South Dakota companies Siouxland Surgery Center LLP, d.b.a. Dunes Surgical Hospital, United Surgical Partners International Inc. (USPI), and USP Siouxland Inc. agreed to pay approximately $12.76 million to settle FCA allegations related to improper financial relationships between Dunes and two physician groups. Since July 1, 2014, USPI has maintained partial ownership of Dunes through USP Siouxland, a wholly owned subsidiary of USPI. Following an internal investigation, Dunes and USPI disclosed the arrangements at issue to the government.

From at least 2014 through 2019, Dunes allegedly made financial contributions to a nonprofit affiliate of a physician group whose physicians referred patients to Dunes. According to the complaint, those payments allegedly funded the salaries of referring employees. Other allegations include that Dunes provided a different physician group with below-market-value clinic space, staff, and supplies. The DOJ alleged that these arrangements violated both the Anti-Kickback Statute and the Stark Law, which are “designed to ensure that decisions about patient care are based on physicians’ independent medical judgment and not their personal financial interest.”

Following Dunes’ and USPI’s internal compliance review and independent investigation, the companies promptly took remedial actions and disclosed such arrangements to the DOJ. The companies also provided the government with detailed and thorough written disclosures and cooperated throughout its investigation, resulting in cooperation credit for the companies.

Under the settlement, Dunes and USPI will pay $12.76 million to the federal government for alleged violations of the FCA, and approximately $1.37 million to South Dakota, Iowa, and Nebraska for their share of the Medicaid portion of the settlement.

The DOJ’s press release can be found here.

California Man Convicted for Paying Illegal Kickbacks for Patient Referrals to Addiction Treatment Facilities

On September 11, a federal jury convicted Casey Mahoney, 48, of Los Angeles, for paying nearly $2.9 million in illegal kickbacks for patient referrals to his addiction treatment facilities in Orange County, California. The facilities involved are Healing Path Detox LLC and Get Real Recovery Inc.

According to court documents and evidence presented at trial, Mahoney paid illegal kickbacks to “body brokers” who referred patients to his facilities. These brokers appeared to pay thousands of dollars in cash to patients to induce them to procure treatment at Mahoney’s facilities. Mahoney allegedly concealed these illegal kickbacks through sham contracts with the body brokers. The contracts purportedly required fixed payments and prohibited payments based on the volume or value of patient referrals, when in reality, payments were negotiated based on patients’ insurance reimbursements and the number of days Mahoney could bill for treatment. Mahoney also allegedly laundered the proceeds of the conspiracy through payments to the mother of one of the body brokers, falsely characterizing them as consulting fees.

The Eliminating Kickbacks in Recovery Act formed the basis of the charges against Mahoney. He was convicted of one count of conspiracy to solicit, receive, pay, or offer illegal remunerations for patient referrals, seven counts of illegal remunerations for patient referrals, and three counts of money laundering. He is scheduled to be sentenced on January 17, 2025, and faces a maximum penalty of five years in prison for the conspiracy charge, 10 years in prison for each illegal remuneration count, and 20 years in prison for each money laundering count.

The DOJ’s press release can be found here.

© 2024 ArentFox Schiff LLP

by: D. Jacques SmithRandall A. BraterMichael F. DearingtonNadia PatelHillary M. Stemple, and Rebekkah R.N. Stoeckler of ArentFox Schiff LLP

For more news on FCA Violations visit the NLR Criminal Law Business Crimes section.

DOJ, FTC, DOL, and NLRB Join Forces and Announce Memorandum of Understanding on Labor Issues in Merger Investigations

On August 28, the US Department of Justice (DOJ) Antitrust Division, which enforces the US antitrust laws including the Sherman Act and Clayton Act, and the Federal Trade Commission (FTC), which enforces the Federal Trade Commission Act and other laws and regulations prohibiting unfair methods of competition (together, Antitrust Agencies), along with the US Department of Labor (DOL) and National Labor Relations Board (NLRB) (together, Labor Agencies), announced that they entered into a Memorandum of Understanding on Labor Issues in Merger Investigations (MOU).
The MOU took effect on August 28 and expires in five years, unless it is extended or terminated upon written agreement of each of the agencies.

Purpose of the MOU

The MOU outlines a collaborative initiative between the signatory agencies to assist the Antitrust Agencies with labor issues that may arise during the course of antitrust merger and acquisition (M&A) investigations, commenced under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). The HSR requires that parties to certain large M&As provide information to the Antitrust Agencies prior to the transaction’s consummation, which allows these agencies to analyze the anticipated transaction(s) and provide greater certainty to the parties regarding potential antitrust concerns.

From a labor perspective, these investigations may aim to evaluate whether the effect of a merger or acquisition could substantially lessen competition for labor. The stated goal of this MOU is to protect employees and promote fair competition in labor markets. Specifically, the MOU outlines methods by which the Labor Agencies may aid or advise the Antitrust Agencies on potential labor issues identified during the course of these evaluations. These methods include the following.

1. Labor Information Sharing

The MOU outlines various ways in which the Antitrust Agencies may work with the Labor Agencies to gather information used to evaluate potential impacts of M&As on labor markets. These include:

  1. Soliciting information from relevant worker stakeholders and organizations.
  2. Seeking the production of information and data with respect to labor markets.
  3. Searching publicly available sources of information made available by the Labor Agencies.
  4. Seeking production of non-public information and data related to labor markets from the Labor Agencies.

2. Providing Training and Technical Assistance

Labor Agencies agree to provide technical assistance and training to personnel from the Antitrust Agencies related to subject matter under their jurisdictions. For example, the NLRB will train personnel from Antitrust Agencies on labor-related issues such as the duty to bargain in good faith, successor bargaining obligations, and unfair labor practices. Additionally, the Antitrust Agencies may seek technical assistance on labor and employment law matters in merger reviews, including in the resolution of labor market merger investigations.

3. Collaborative Meetings

The Labor Agencies and Antitrust Agencies will seek to meeting biannually to discuss the implementation and coordination of activities outlined in the MOU.

This MOU expands upon collaborative efforts amongst the agencies and builds upon several MOUs executed in 2022 and 2023. MOUs between the DOJ and DOLDOJ and NLRBDOL and FTC, and FTC and NLRB all indicate that the purpose and scope of the agreements are to “strengthen the Agencies’ partnership through greater coordination in information sharing, coordinated investigations and enforcement activity, training, education, and outreach.”

Takeaways

This multi-agency agreement further emphasizes the current administration’s focus on protecting employees from alleged unfair methods of competition. This MOU is further evidence that antitrust regulators are looking at antitrust enforcement from a new perspective. Traditionally, Antitrust Agencies evaluated proposed M&As to identify potential risks of harm to consumers through the reduction of options or increased prices. Now, Antitrust Agencies appear to have turned their focus towards anticompetitive behaviors that may harm employees.

Employers interested or involved in an M&A deal should conduct thorough internal reviews to ensure compliance with both labor-related and fair competition laws. In the event of a review by the DOJ or FTC, employers should partner with experienced labor and employment lawyers to navigate through these investigations.

DOJ Implements New Whistleblower Reward Program

Companies who submit healthcare claims to private payors, provide financial services to customers, interact with domestic or foreign public officials, or otherwise operate in highly regulated industries should take note that the Department of Justice (DOJ) has taken another significant step in its ongoing effort to encourage new whistleblowers with information about potential corporate criminal malfeasance to report that information to the government. On August 1, 2024, the DOJ announced its long awaited Corporate Whistleblower Awards Program. The program seeks to fill “gaps” in existing whistleblower programs by providing awards of up to 30% of forfeited proceeds for reporting criminal conduct that is not otherwise covered by an existing system for awarding whistleblowers. The silver lining for companies is that the program incentivizes the whistleblowers to cooperate with the company’s internal compliance function. DOJ also provides for a presumptive declination of criminal charges for companies that self-report to DOJ within 120 days of the time the issue is first raised internally by the whistleblower, providing strong incentives for companies to investigate issues quickly.

The program represents the DOJ’s latest effort to increase the number of voluntary self-disclosures of corporate criminal activity. In January 2023, the DOJ announced its revised Corporate Enforcement and Voluntary Self Disclosure Policy, which sought to expand the incentives for companies to voluntarily self-disclose misconduct, cooperate with DOJ investigations, and take prompt and full remedial measures. The policy’s primary incentive was the prospect of a presumed declination for companies who followed its mandates.

As we discussed in a previous post, efforts to increase voluntary self-disclosures continued in April 2024 when the DOJ launched a Pilot Program on Voluntary Self Disclosures for Individuals. That initiative expanded the scope of potential whistleblowers by including those complicit in wrongdoing, granting them eligibility for immunity from prosecution in return for reporting the activity. In substance, that structure incentivized both individual wrongdoers and the corporations for whom they worked to be the first to report criminal activity. By pitting the would-be whistleblowers and the companies against each other, the DOJ effectively constructed a prisoners’ dilemma where the government stood to benefit regardless of which party acted first.

The program is a different verse from the same hymnal. It offers a different (but more traditional) incentive for whistleblowers – the opportunity for financial reward – while maintaining the goal of increasing the number of voluntary self-disclosures. The program seeks to achieve that objective by motivating those who are aware of misconduct, but perhaps are otherwise unable to qualify for a bounty under the current framework or otherwise uninterested in reporting the activity without a personal benefit.

The Basic Framework

Under the program, eligible individuals who voluntarily provide original information to the government in certain areas of focus and cooperate with the resulting investigation stand to receive 30% of any criminal or civil forfeitures over $1 million in accordance with a defined payment priority. The program lays out a basic structure for determining whether an individual is entitled to an award, but also affords the DOJ substantial discretion in deciding whether to make such awards, and in what amount. The key elements are:

  • Areas of focus – The program identifies four subject matter areas: 1) violations by financial institutions, their insiders and agents involving money laundering, fraud, and fraud against or non-compliance with regulators; 2) foreign corruption and bribery and violations of money laundering statutes; 3) domestic corruption violations including bribes and kickbacks paid to domestic public officials; and 4) healthcare offenses involving private or non-public healthcare benefit programs and fraud against patients, investors or other non-governmental entities in the healthcare industry, or other violations of federal law not covered by the federal False Claims Act (FCA).
  • Eligible individuals – The program excludes several categories of individuals, including those eligible to report under other whistleblower programs and those who “meaningfully participated” in the criminal activity reported (although those who played a “minimal role” can still participate).
  • “Original information” – Essentially, independent non-public knowledge or analysis in the individual’s possession is considered “original” information. Notably, information can be deemed “original” if it “materially adds to the information that the Department already possesses.” Information that the individual has already reported through the company’s internal whistleblower, legal or compliance procedures can still be deemed “original,” provided the individual also reports that information to the government within 120 days of reporting internally. Privileged information is not considered “original” unless the crime, fraud or other exception to state attorney conduct rules apply.
  • “Voluntary” submission – The information must be reported before the DOJ or any federal law enforcement or civil enforcement agency initiates any inquiry relating to the subject matter.
  • “Cooperation” – Individuals who report must also cooperate fully with the DOJ’s investigation, including by participating in interviews, testifying before a grand jury or at trial, producing documents and, if requested, working in a “proactive manner” with federal law enforcement. This could include clandestine activities to gather evidence, such as recording phone calls or wearing a wire.
  • Criteria for determining amount of award – The program lists several factors that could militate in favor of increasing or decreasing the whistleblower’s financial award. Increases may be justified by the significance of the information provided, by the nature and extent of assistance provided, and, notably, by participation in internal compliance programs. Decreases may be appropriate where the reporting individual was a minimal participant in the underlying activity, or where the individual unreasonably delayed reporting, interfered with the company’s internal compliance and reporting systems, or had management or oversight responsibilities over the offices or personnel involved in the conduct.
  • Payment priority – When the victim is an individual, he or she must first be compensated “to the fullest extent possible” before a whistleblower can recover. When the victim is a corporate entity or government agency, the whistleblower jumps the line and is compensated first.
  • Relationship to the Corporate Enforcement and Voluntary Self Disclosure Policy – While the program incentivizes whistleblower reports to the DOJ, a simultaneous amendment to the self-disclosure policy provides that “if a whistleblower makes both an internal report to a company and a whistleblower submission” to the DOJ, companies who self-report that conduct within 120 days of the internal report “will still qualify for a presumption of a declination[.]” This amendment underscores the DOJ’s focus on increasing self-disclosures, inasmuch as it effectively removes the need for them to be truly “voluntary.” A company that receives a complaint through its whistleblower program may still be eligible under the self-disclosure policy even if the individual has already reported the conduct to the DOJ, but it has a limited time to investigate and decide whether to self-report the conduct.

Key Takeaways

Reading the tea leaves, we see several potentially significant takeaways for companies evaluating the program’s likely impact.

  1. As a starting point, companies should evaluate whether and to what extent their operations create new reporting opportunities under the program, and thus necessitate action. That process should involve answering the following questions:
    • Does the company operate in one of the areas of focus? If so, the program creates new opportunities and incentives for whistleblowers, and the company must assess whether it is prepared to address an increase in reports and to recognize that a reporter may have already disclosed information to the DOJ.
    • Is the company publicly traded? If so, the company is already subject to the Sarbanes-Oxley Act (SOX), which should mean that systems are already in place to receive, investigate and determine whether to take action, including potentially making a voluntary self-disclosure. The program provides an opportunity to reassess the efficacy of those systems but should not necessarily require the creation of new ones. Note that even those companies with existing whistleblower programs should consider the need to expand those systems to cover new areas of focus. For example, a company with a SOX whistleblower policy should consider the need to expand its scope to cover domestic corruption violations, which may not otherwise be covered.
    • Does the company submit claims to government payors? If so, it is already subject to the FCA and should already have a system in place to analyze internal compliance concerns. If that system focuses on or prioritizes issues regarding government payors, the company should expand its focus to include claims and conduct regarding private payors, which may now be subject to whistleblower bounties under the program.
  2. For privately held companies operating in the areas of focus that are not subject to the FCA, the program necessitates a thorough and candid assessment of the risk the program creates. Depending on the extent of that danger, companies should consider the following measures:
    • Create, or enhance as necessary, internal reporting mechanisms to receive and evaluate whistleblower reports.
    • Publicize the company’s expectation that employees should promptly report concerns internally about potential violations of law or company policy, making clear that no retaliation will result from reports made in good faith.
    • Design a process for investigating whistleblower reports based on their nature and seriousness. Establish criteria for identifying those that can be investigated by HR, those that require the involvement of in-house counsel, and those that must be handled by outside counsel. If there is any possibility of criminal exposure, ensure an appropriate investigation is conducted and concluded in time to allow the company to determine whether to self-report in the 120-window for a presumptive declination.
  3. All companies should have in place a system for quickly and accurately evaluating whether to voluntarily self-disclose violations. This process is a multi-factor calculus that considers a range of factors, including primarily the merits of the underlying information and the amount of financial loss or gain that resulted. While decision-making in this context varies by situation, one essential element remains constant: the need for accurate information regarding the nature, scope and effect of the underlying conduct.

Only time will tell exactly how the program will impact the number and nature of whistleblower reports. But companies can take practical steps now to gauge whether and to what extent they are likely to be affected and begin installing the measures necessary to minimize the risk that might otherwise result.

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