The Antitrust Investigator Will See You Now: What Healthcare And Pharma Should Expect In A World Of Enhanced Antitrust Scrutiny

Highlights

  • Healthcare entities should expect heightened government scrutiny of mergers, acquisitions, and business behaviors that could be construed as restricting competition in healthcare and pharma
  • The FTC, DOJ, and HHS have advanced a “whole-of-government approach,” including data sharing, cooperative enforcement, and enhanced antitrust training
  • Businesses should take note of practices that are likely to trigger investigatory and enforcement actions

According to media reports, the Department of Justice (DOJ) has opened an antitrust investigation into UnitedHealth Group, which is the owner of the United States’ largest health insurer, UnitedHealthcare. The focus of the inquiry appears to be the relationship between the UnitedHealthcare insurance plan and one of its health services divisions, Optum, and the potential impact on rivals and consumers.

While tech giants have grabbed most of the headlines when it comes to enhanced antitrust scrutiny, this new matter is the DOJ’s second antitrust investigation into UnitedHealth Group in recent years, giving teeth to the administration’s claim that it has an aggressive antitrust policy in the healthcare sector.

In another example of increased antitrust scrutiny, the Federal Trade Commission (FTC) recently announced a new initiative in partnership with the DOJ and Department of Health and Human Services (HHS) to address what they consider to be the effects of anticompetitive behavior in the healthcare and pharmaceutical spaces. According to the government, these new efforts are aimed at lowering consumer costs and will include “partnering on new initiatives which include a joint Request for Information to seek input on how private-equity and other corporations’ control of health care is impacting Americans.”

Although interagency cooperation is the focus of the recent push to ramp up antitrust investigations and enforcement, each agency will still spearheaded their own regulatory activity.

Federal Trade Commission

FTC Chair Lina Khan has made it clear that her agency will devote more resources to enforcement in the healthcare industry, and emphasized that “safeguarding fair competition and rooting out unlawful business practices in health care markets is a top priority for the FTC.” In furtherance of these priorities, the commission has recently taken the following actions:

  • Orange Book Policy: The FTC challenged more than 100 patents held by pharmaceutical companies that they claim are inaccurately or improperly listed in the FDA’s Orange Book. The commission also released a policy statement explaining its renewed focus on Orange Book infractions.
  • Proposed Non-compete Rule: The FTC presented a new rule that would place a ban on non-compete clauses in employee contracts.

U.S. Department of Justice

Jonathan Kanter, Assistant Attorney General of the DOJ’s Antitrust Division, highlighted the division’s emphasis on the healthcare space when he said, “we are committed to weeding out anticompetitive practices and market consolidation that hinder Americans’ access to quality care at affordable rates, or deprive health care workers of fair wages and opportunity.” The following are just a few examples of how the DOJ has implemented this renewed focus:

  • Criminal Penalties: Recently, the DOJ’s Antitrust Division successfully secured a deferred prosecution agreement against Teva Pharmaceuticals, obtaining the largest monetary penalty ever (over $200 million) against a purely domestic producer that was allegedly operating an antitrust cartel.
  • Blocked Mergers: The Antitrust Division filed a suit to stop Aon plc’s $30 billion proposal to acquire Willis Towers Watson, two of the three largest brokers of health insurance and retirement benefits consulting. The companies later ceased their pursuit of the merger.

U.S. Department of Health and Human Services

HHS Secretary Xavier Becerra made his agency’s priorities clear when he recently stated that “the Biden-Harris Administration remains laser-focused on increasing access to high-quality, affordable health care for all Americans, like by making hearing aids available for sale over the counter and lowering prescription drug costs through the Inflation Reduction Act.” The department’s initiatives have included:

  • Ownership Transparency: For the first time, HHS, via the Centers for Medicare & Medicaid Services, made ownership data available on federal qualified health centers and rural health clinics on data.cms.gov. HHS hopes the release of this data will help catalyze enforcement actions by identifying common ownership.
  • Medicare Advantage Marketing: HHS also announced new efforts to crack down on what it considers “predatory marketing” that seeks to steer patients towards Medicare Advantage plans that “may not best meet their needs.”

Takeaways

In light of the government’s renewed focus on increased competition, expanded enforcement actions, access to quality care, more affordable services and products, and transparency of ownership in the healthcare and pharmaceutical industries, legal and compliance departments should consider being proactive about conducting thorough reviews of current practices. This is particularly true for mergers and acquisitions, competitive strategies, and pricing decisions, which are the business activities most likely to conflict with these recently energized regulatory bodies. Even healthcare providers with stellar compliance programs should expect to receive more frequent and targeted requests for information from enforcement authorities about their business partners, payors, and marketing practices.

FTC Announces 2024 Increase in HSR Notification Thresholds and Filing Fees

The Federal Trade Commission (FTC) has announced the annual revisions to the Hart-Scott-Rodino Antitrust Improvements Act (HSR Act) thresholds and HSR filing fees, which will become effective on March 6, 2024. The revised thresholds will apply to any merger or acquisition closing on or after the effective date.

The FTC is required to adjust the HSR thresholds annually based upon the change in gross national product. This year, the change in the “size of transaction” threshold has increased from $111.4 million to $119.5 million.

Under the HSR Act, when a deal satisfies the “size of person” and “size of transaction” thresholds, and no exemption from reporting is available, the deal must be reported to the FTC and the US Department of Justice, and the parties must wait for a designated period of time before closing the transaction.

Size of Person. The revised size of person thresholds will generally be met if one party involved in the deal has assets or annual sales totaling $239 million or more and one other party involved in the deal has assets or annual sales of at least $23.9 million. Satisfaction of the size of person thresholds is not required, however, if the transaction is valued at more than $478 million.

Size of Transaction. The revised size of transaction threshold will be met if the buyer will hold an aggregate amount of stock, non-corporate interests and/or assets of the seller valued at more than $119.5 million as a result of the deal.

The notification thresholds applicable to purchases of voting securities will increase as follows:

February 1, 2001 Thresholds (Original) Current Thresholds as of February 27, 2023 New Thresholds Effective March 6, 2024
$50 million $111.4 million $119.5 million
$100 million $222.7 million $239 million
$500 million $1.1137 billion $1.195 billion
25% if worth more than
$1 billion
25% if worth more than $2.2274 billion 25% if worth more than $2.39 billion
50% if worth more than
$50 million
50% if worth more than $111.4 million 50% if worth more than $119.5 million

The thresholds applicable to many exemptions, including those governing foreign acquisitions, also will increase. However, the $500 million threshold applicable to acquisitions of producing oil and gas reserves and associated assets will not change.

The civil penalty for failing to comply with the notification and waiting period requirements of the HSR Act has also increased to up to $51,744 per day for each day a party is in violation.

HSR Filing Fees. Additionally, the HSR filing fee thresholds and filing fee amounts have increased as follows:

Original Filing Fee Original Applicable Size of Transaction 2024 Adjusted Filing Fee 2024 Adjusted Applicable Size of Transaction
$30,000 Less than $161.5 million $30,000 Less than $173.3 million
$100,000 Not less than $161.5 million but less than $500 million $105,000 Not less than $173.3 million but less than $536.5 million
$250,000 Not less than $500 million but less than $1 billion $260,000 Not less than $536.5 million but less than $1.073 billion
$400,000 Not less than $1 billion but less than $2 billion $415,000 Not less than $1.073 billion but less than $2.146 billion
$800,000 Not less than $2 billion but less than $5 billion $830,000 Not less than $2.146 billion but less than $5.365 billion
$2,250,000 $5 billion or more $2,335,000 $5.365 billion or more

The new fees also will become effective on March 6, 2024.

Becoming Antitrust Aware in 2024: Top Five Recommendations for the New Year

A new year means resolutions which are often centered around self-improvement measures like weight loss, exercise plans, and other health improvement measures. Companies can also benefit from resolutions. Increasing antitrust awareness is not usually on the resolution list but here we offer some ideas for companies as they embark on a new year.

Treat antitrust as a priority in 2024.

As antitrust lawyers, our viewpoint may be biased, and we certainly appreciate that most companies already have a lengthy list of priorities for their in-house and outside legal teams. Given that all companies, regardless of their size, are subject to the antitrust laws, and given the high stakes involved (including criminal penalties and treble damages awards), antitrust certainly deserves to be on the priority list. One relatively easy way to get the ball rolling is to put fresh eyes on your company’s antitrust policy. When was the last time it was updated? What type of trainings does your company use to teach the concepts contained in the policy? The training doesn’t need to be – and shouldn’t be – boring or esoteric. Instead, trainings should be engaging and tailored to the specific antitrust risks that workgroups may face. For example, the sales team will need different antitrust training than those working on supply chain or environmental, social, and governance (ESG) initiatives. Ask your antitrust lawyer to create easy-to-follow, lively online trainings that can be viewed on demand. And if your company doesn’t have an antitrust policy, we suggest that creating one be moved to the top (or near top) of the legal department’s to-do list in 2024.

Understand the current antitrust enforcement priorities.

2024 will be a significant year for antitrust. It’s an election year, which means 2024 may be the Biden Administration’s last year to execute on plans that have been in the works since President Biden issued Executive Order 14036, “Promoting Competition in the American Economy,” in July 2021. Some of the Administration’s more dramatic plans include significant revisions to the Hart-Scott-Rodino (HSR) premerger notification process. While we don’t expect all the FTC and DOJ’s sweeping proposals to make it into the HSR final rule, we do expect some changes to be made, and they will likely mean significant additional burdens for filing parties. We also expect to see the FTC’s new rule on non-compete agreements. The FTC’s proposal would ban most non-compete agreements, and some states have already enacted their own prohibitions on non-compete agreements.

If your company engages in M&A, be aware of the new Merger Guidelines.

The newest Merger Guidelines, addressing both horizontal and vertical mergers, were unveiled in December 2023 . One of the most significant changes announced in the 2023 Merger Guidelines are the decreased levels of concentration that will trigger a rebuttable presumption of illegality. Under the new Guidelines, a market share of greater than 30% and a concentration increase of 100 points will be enough to trigger that rebuttable presumption. That is not to say the presumption is the death knell for a transaction, but it does mean that the government enforcement will be aggressive. Also be aware that the 2023 Guidelines introduce new topics, such as labor markets. Early analysis and planning will be critical, requiring involvement of skilled antitrust counsel.

Understand that application of the antitrust laws is constantly evolving.

The language of the core U.S. antitrust laws – the Sherman Act, the Clayton Act, and the FTC Act, hasn’t changed, but the application of these laws is always evolving. For example, the antitrust enforcers and private plaintiffs are increasingly focused on labor issues, such as “no poach” agreements and wage fixing. Antitrust enforcers are also focused on private equity, as evidenced by the FTC’s recent lawsuit against Welsh, Carson, Anderson, and Stowe and some of the changes contained in the proposed revisions to the HSR Rules. Technology is also a significant factor that provokes interesting questions that don’t have answers, at least not currently. For example, do pricing algorithms lead to price fixing? How will antitrust enforcers deal with artificial intelligence?

Pay attention to state antitrust enforcers.

The federal regulators at the Department of Justice and Federal Trade Commission may get most of the attention, but we must never forget that states have their own antitrust laws and their own antitrust enforcers, who have the power to investigate and bring legal action. Often, the state regulators work collaboratively with their federal counterparts, but the state regulators are free to go their own way, such as those targeting various ESG initiatives. Also bear in mind that states are increasingly blazing new trails, such as bans on non-competes. Thirteen states have also enacted “mini” HSR premerger notification statutes for health care deals. It’s always prudent to check the laws of the state or states where business is conducted to determine if there are any state-specific antitrust considerations.

FTC and DOJ Propose Significant Changes to US Merger Review Process

On 27 June 2023, the Federal Trade Commission (FTC) and the Department of Justice–Antitrust Division (DOJ) (collectively, the Agencies) announced sweeping proposed changes to the US-premerger notification filing process. The proposed changes mark the first significant overhaul of the federal premerger notification form since its original release in 1978 and would require parties to report

On 27 June 2023, the Federal Trade Commission (FTC) and the Department of Justice–Antitrust Division (DOJ) (collectively, the Agencies) announced sweeping proposed changes to the US-premerger notification filing process. The proposed changes mark the first significant overhaul of the federal premerger notification form since its original release in 1978 and would require parties to reportable transactions to collect and submit significantly more information and documentation as part of the premerger review process. If finalized, the proposed rule changes would likely delay deal timelines by months, requiring significantly more time and effort by the parties and their counsel in advance of submitting the required notification form.

In this alert, we:

  • Provide an overview of the current merger review process in the United States;
  • Describe the proposed new rules announced by the Agencies;
  • Explain the Agencies’ rationale for the new proposed rules;
  • Predict how the proposed new rules could impact parties’ premerger filing obligations, including deal timelines; and
  • Explain what companies should expect over the next several months.

BACKGROUND ON THE HSR MERGER REVIEW PROCESS

The Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act or “HSR”) requires certain persons making acquisitions of assets, voting securities, and non-corporate interests (i.e., interests in partnerships and limited liability companies) to:

(a)    File premerger notifications with the FTC and DOJ; and

(b)    Wait until the expiration or termination of a waiting period (usually 30 days) before consummating the acquisition.

Most mergers and acquisitions valued in excess of USD$111.4 million fall under the HSR Act subject to size-of-party thresholds in certain cases. Additionally, there are several exemptions that may apply to an otherwise reportable transaction.

The FTC or the DOJ reviews the parties’ HSR filings during the waiting period to determine whether the transaction may substantially lessen competition in violation of the antitrust laws. If, at the end of the waiting period any concerns have not been placated, the reviewing agency may issue a Request for Additional Documents and Information (commonly referred to as a Second Request), a very broad subpoena-like document seeking documents, data, and interrogatory responses from the filers. This tolls the waiting period until both parties substantially comply with the Second Request. The reviewing agency then has an additional 30-day period to decide whether to challenge the transaction in court.

WHAT ARE THE PROPOSED CHANGES?

On 27 June 2023, the FTC and DOJ announced a number of significant changes to the HSR notification form and filing process, the first such overhaul in almost 45 years. The Agencies released the proposed changes and rationale for the same in a 133-page Notice of Proposed Rulemaking (Notice) that will be published in the Federal Register later this week. While antitrust practitioners are still digesting the full extent of all of the proposed changes, it is clear that they would require parties to submit significantly more information and documentation to the Agencies as part of their HSR notification form. The most notable additional information and documentation includes:

  • Submission of additional deal documents, including draft agreements or term sheets (as opposed to just the preliminary agreement), where a definitive transaction agreement has not yet been executed; draft versions of all deal documents (as opposed to just the final versions); documents created by or for the deal team lead(s) (as opposed to just officers and directors); and verbatim translations of all foreign language documents.
  • Details about acquisitions during the previous 10 years.
  • Identification of and information about all officers, directors, and board observers of all entities within the acquiring person, including the identification of other entities these individuals currently serve, or within the two years prior to filing had served, as an officer, director, or board observer.
  • Identification of and information about all creditors and entities that hold non-voting securities, options, or warrants totaling 10% or more.
  • Disclosure of subsidies (e.g., grants and loans), by certain foreign governments, including North Korea, China, Russia, and Iran.
  • Narrative description of the strategic rationale for the transaction (including projected revenue streams), a diagram of the deal structure, and a timeline and narrative of the conditions for closing.
  • Identification and narrative describing horizontal overlaps, both current and planned.
  • Identification and narrative describing supply agreements/relationships.
  • Identification and narrative describing labor markets, as well as submission of certain data on the firms’ workforce, including workforce categories, geographic information on employees, and details on labor and workplace safety violations.
  • Identification of certain defense or intelligence contracts.
  • Identification of foreign jurisdictions reviewing the deal.

WHY ARE THESE CHANGES BEING PROPOSED?

In its press release announcing the proposed new rules, the FTC stated that “[t]he proposed changes to the HSR Form and instructions would enable the Agencies to more effectively and efficiently screen transactions for potential competition issues within the initial waiting period, which is typically 30 days.”The FTC further explained:

Over the past several decades, transactions (subject to HSR filing requirements) have become increasingly complex, with the rise of new investment vehicles and changes in corporate acquisition strategies, along with increasing concerns that antitrust review has not sufficiently addressed concerns about transactions between firms that compete in non-horizontal ways, the impact of corporate consolidation on American workers, and growth in the technology and digital platform economies. When the Agencies experienced a surge in HSR filings that more than doubled filings from 2020 to 2021, it became impossible to ignore the changes to the transaction landscape and how much more complicated it has become for agency staff to conduct an initial review of a transaction’s competitive impact. The volume of filings at that time also highlighted the significant limitations of the current HSR Form in understanding a transaction’s competitive impact.2

Finally, the FTC also cited certain Congressional concerns and the Merger Fee Filing Modernization Act of 2022, stating that the “proposed changes also address Congressional concerns that subsidies from foreign entities of concern can distort the competitive process or otherwise change the business strategies of a subsidized firm in ways that undermine competition following an acquisition. Under the Merger Filing Fee Modernization Act of 2022, the agencies are required to collect information on subsidies received from certain foreign governments or entities that are strategic or economic threats to the United States.”

HOW WILL THESE CHANGES POTENTIALLY IMPACT PARTIES’ HSR FILINGS?

The proposed changes, as currently drafted, would require significantly more time and effort by the parties and their counsel to prepare the parties’ respective HSR notification forms. For example, the proposed new rules require the identification, collection, and submission of more deal documents and strategic documents; significantly more information about the parties, their officers, directors and board observers, minority investments, and financial interests; and narrative analyses and descriptions of horizontal and non-horizontal relationships, markets, and competition. Gathering, analyzing, and synthesizing this information into narrative form will require significantly more time and resources from both the parties and their counsel to comply.

Under the current filing rules, it typically takes the merging parties about seven to ten days to collect the information needed for and to complete the HSR notification form. Under the proposed new rules, the time to gather such information and complete an HSR notification form could be expanded by multiple months.

WHAT IS NEXT?

The Notice will be published in the Federal Register later this week. The public will then have 60 days from the date of publication to submit comments. Following the comment period, the Agencies will review and consider the comments and then publish a final version of the new rules. The new rules will not go into effect until after the Agencies publish the final version of the new rules. This process will likely take several months to complete, and the new rules–or some variation of them–will not come into effect until that time.

While the final form of the proposed rules are not likely to take effect for several months, the Agencies’ sweeping proposed changes to the notification form and filing process are in line with the type of information that the Agencies have been increasingly requesting from parties during the merger review process. Accordingly, parties required to submit HSR filings over the next several months should be prepared to receive similar requests from the Agencies, either on a voluntary basis (e.g., during the initial 30-day waiting period) or through issuance of a Second Request, and they should build into their deal timeline (either pre- or post-signing) sufficient time to comply with these requests.

 

“FTC and DOJ Propose Changes to HSR Form for More Effective, Efficient Merger Review,” FTC Press Release, June 27, 2023, available at FTC and DOJ Propose Changes to HSR Form for More Effective, Efficient Merger Review | Federal Trade Commission.  

“Q and A on the Notice of Proposed Rulemaking for the HSR Filing Process,” FTC Proposed Text of Federal Register Publication, available at 16 CFR Parts 801 and 803: Premerger Notification; Reporting and Waiting Period Requirements | Federal Trade Commission (ftc.gov).

Copyright 2023 K & L Gates

EU Foreign Subsidies Regulation Enters Into Force In 2023

On December 23, 2022, Regulation (EU) 2022/2560 of December 14, 2022 on foreign subsidies distorting the internal market (FSR) was published in the Official Journal of the European Union. The FSR introduces a new regulatory hurdle for M&A transactions in the European Union (EU), in addition to merger control and foreign direct investment screening. The FSR’s impact cannot be overstated as it introduces two mandatory pre-closing filing regimes and it gives the Commission wide-reaching ex officio investigative and intervention powers. Soon, the Commission will also launch a public consultation on a draft implementing regulation that should further detail and clarify a number of concepts and requirements of the FSR.

The bulk of the FSR will apply as of July 12, 2023. Importantly, the notification requirements for M&A transactions and public procurement procedures will apply as of October 12, 2023.

We highlight the key principles of the FSR below and provide guidance to start preparing for the application of the FSR. We refer to our On The Subject article ‘EU Foreign Subsidies Regulation to Impact EU and Cross-Border M&A Antitrust Review Starting in 2023’ of August 2, 2022 for a more detailed discussion of the then draft FSR. We also refer to our December 8, 2022 webinar on the FSR. Given the importance of the FSR, we will continue to report any future developments.

IN DEPTH

FSR in a Nutshell

The FSR tackles ‘foreign subsidies’ granted by non-EU governments to companies active in the EU and which ‘distort the internal market’.

  • First, a ‘foreign subsidy’ will be considered to exist where a direct or indirect financial contribution from a non-EU country or an entity whose actions can be attributed to a non-EU country (public entities or private entities) confers a benefit on an undertaking engaging in an economic activity in the EU internal market, and where that benefit is not generally available under normal market conditions but is, instead, limited, in law or in fact, to assisting one or more undertakings or industries. A ‘financial contribution’ covers a broad spectrum and encompasses, amongst others, positive benefits such as the transfer of funds or liabilities, the foregoing of revenue otherwise due (e.g., tax breaks, the grant of exclusive rights below market conditions, or the provision or purchase of goods or services).

  • Second, a ‘distortion in the internal market’ will be considered to exist in case of a foreign subsidy which is liable to improve the competitive position of an undertaking and which actually or potentially negatively affects competition in the EU internal market. The Regulation provides some guidance on when a foreign subsidy typically would not be a cause for concern:
    – A subsidy that does not exceed EUR 200,000 per third country over any consecutive period of three years is considered de minimis and therefore not distortive;
    – A foreign subsidy that does not exceed EUR 4 million per undertaking over any consecutive period of three years is unlikely to cause distortions; and
    – A foreign subsidy aimed at making good/recovering from the damage caused by natural disasters or exceptional occurrences may be considered not to be distortive.

The FSR looks at ‘undertakings’, as is the case for merger control. Therefore, the Commission will not look merely at the legal entity concerned, but at the entire corporate group to which the entity belongs in order to calculate the total amount of foreign financial contributions granted to the undertaking. Even companies headquartered in the EU that have entities outside of the EU that have received foreign financial contributions are covered by the FSR.

The FSR introduces three tools for the European Commission (Commission): (i) a notification requirement for certain M&A transactions, (ii) a notification requirement for certain public procurement procedures (PPP) and (iii) investigations on a case by case basis.

Notification Requirement for Certain M&A Transactions

M&A transactions (or “concentrations”) involving a buyer and/or a target that has received a foreign financial contribution shall be notifiable if they meet the following cumulative conditions:

  • At least one of the merging undertakings, the acquired undertaking (target, not buyer) or the joint venture is established in the EU and has an EU turnover of at least EUR 500 million, AND

  • The combined aggregate financial contributions provided to the undertakings concerned in the three financial years (combined) prior to notification amounts to more than EUR 50 million.

M&A transactions that meet these criteria will need to be notified and approved by the Commission prior to implementation. During its review, the Commission will determine whether the foreign financial contributions received constitute foreign subsidies in the sense of the FSR and whether these foreign subsidies actually or potentially distort or negatively affect competition in the EU internal market. The Commission likely will consider certain indicators including the amount and nature of the foreign subsidy, the purpose and conditions attached to the foreign subsidy as well as its use in the EU internal market. For example, in a case of an acquisition, if a foreign subsidy covers a substantial part of the purchase price of the target, the Commission may consider it likely to be distortive.

Notification Requirement for Certain Public Procurement Procedures

A notifiable foreign financial contribution in the context of PPP shall be deemed to arise where the following cumulative conditions are met:

  • The estimated value of the public procurement or framework agreement net of VAT amounts to at least EUR 250 million, AND

  • The economic operator was granted aggregate foreign financial contributions in the three financial years prior to notification of at least EUR 4 million from a non-EU country.

Where the procurement is divided into lots, the value of the lot or the aggregate value of all lots for which the undertaking bids for must, in addition to the two criteria set out above, also amount to at least EUR 125 million.

Through this procedure, the Commission will ensure that companies that have received non-EU country subsidies do not submit unduly advantageous bids in public procurement procedures.

During the Commission’s review, all procedural steps may continue except for the award of the contract.

Even if the thresholds are not met, the Regulation requires undertakings to provide to the contracting authority in a declaration attached to the tender a list of all foreign financial contributions received in the last three financial years and to confirm that these are not notifiable, which the contracting authority will subsequently send to the Commission.

Investigations on a Case-by-case Basis

The Commission may on its own initiative investigate potentially distortive foreign subsidies (e.g. following a complaint). These investigations are not limited to M&A transactions or PPP. However, on the basis of this power, the Commission may investigate M&A transactions and awarded contracts under PPP which do not fall within the scope of the notification requirements set out above.

If the Commission carries out an ex-officio review, its analysis will be structured in two phases: a preliminary examination and an in-depth investigation. Although these phases have no time limits, the Commission will endeavor to take a decision within 18 months of the start of the in-depth investigation.

HOW TO PREPARE FOR THE APPLICATION OF THE FSR

Application of the FSR – Timetable

As mentioned above, the FSR will apply as of July 12, 2023. The FSR shall apply to foreign subsidies granted in the five years prior to July 12, 2023 where such foreign subsidies create effects at present, i.e., they distort the internal market after July 12, 2023. By way of derogation, the FSR shall apply to foreign financial contributions granted in the 3 years prior to July 12, 2023 where such foreign financial contributions were granted to an undertaking notifying a concentration or notifying a PPP pursuant to the FSR.

The FSR shall not apply to concentrations for which the agreement was signed before July 12, 2023. The FSR shall also not apply to public procurement contracts that have been awarded or procedures initiated before July 12, 2023.

In general, the FSR shall apply from July 12, 2023 while the notification obligations for M&A transactions and PPP shall only apply from October 12, 2023. However, it is advisable to start preparing immediately for the application of the FSR, given the substantial scope of the regulation.

Actions to Take Now

Businesses which conduct activities in the EU, should put in place a system to monitor and quantify foreign financial contributions received since at least July 2020 – to cover the three-year review – and, preferably, July 2018. In particular, attention should be paid to positive benefits and reliefs from certain costs normally due by the company. External counsel can assist in determining whether these foreign financial contributions constitute a ‘foreign subsidy’.

As soon as a company decides to engage in an M&A or PPP in the EU, the company should map all relevant foreign financial contributions for the relevant time period to check whether the relevant notification thresholds are met. Subsequently companies must carefully consider whether any such financial contribution constitutes a foreign subsidy and, if so, whether such foreign subsidy may have a distortive effect. It is also advisable to determine whether there any positive effects relating to the subsidy that could be invoked. Companies should ensure that the preparation above is ably assisted by external counsel.

In particular with regard to M&A transactions, companies should carry out an FSR analysis in addition to merger control and foreign direct investment reviews. Even at the stage of due diligence, it would already be advisable to check whether the target has received any foreign financial contributions. If the transaction might eventually trigger a notification to the Commission, the M&A agreement should provide for Commission approval in the closing conditions. When acting as a bidder for a target that meets the EU turnover threshold, your bid will be much better viewed when accompanied with clear assurances that no FSR filing is required or, alternatively, that a filing may be required but that the foreign subsidies received are not distortive of competition.

© 2023 McDermott Will & Emery
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Buying, Selling, and Investing in Telehealth Companies: Navigating Structural and Compliance Issues

A multi-part series highlighting the unique health regulatory aspects of Telemedicine mergers and acquisitions, and financing transactions

Investors in the telehealth space and buyers and sellers of telehealth companies need to account for a set of health regulatory considerations that are unique to deals in this sector. As all parties to potential telehealth transactions analyze their long term role in the telehealth marketplace, two of the central issues to any transaction are compliance and structure – both in terms of structuring the telehealth transaction itself and due diligence issues that arise related to a target’s structure.

The COVID-19 pandemic, combined with strained health care staffing and provider availability, have accelerated the growth of the telehealth, and start-ups and traditional health systems alike are competing for access to patient populations in the telehealth space. However, as we adjust to life with COVID-19 as the norm, the expiration of the federal Public Health Emergency (PHE) looms, and the national economy contracts, we expect that the remainder of 2022 and into 2023 will see consolidation as the telehealth market begins to saturate and the long-term viability of certain platforms are tested. Telehealth companies, health systems, pharma companies and investors are all in potential positions to take advantage of this consolidation in a ripening M&A sector (while startups in the telehealth space continue to seek venture and institutional capital).

This is the first post in a series highlighting the unique health regulatory aspects of telehealth transactions. Future installments of this series are expected to cover licensure and regulatory approvals, compliance / clinical delivery models, and future market developments.

Telehealth Transaction Structure Considerations

The structure of any given telehealth transaction will largely depend on the business of the telehealth organization at play, but also will depend on the acquirer / investor. Regardless of whether a party is buying, selling or investing in a telehealth company, structuring the transaction appropriately will be important for all parties involved. While a standard stock purchase, asset purchase or merger may make sense for many of these transactions, we have also seen a proliferation of, affiliation arrangements, joint ventures (JV), alliances and partnerships.  These varieties of affiliation transactions can be a good choice for health systems that are not necessarily looking to manage or develop an existing platform, but instead are looking to leverage their patient populations and resources to partner with an existing technology platform. An affiliation or JV is more popular for telehealth companies operating purely as a technology platform (with no core business involving clinical services being provided). For parties in the traditional healthcare provider sector that provide clinical services, an affiliation or JV, which is easier to unwind or terminate than a traditional M&A transaction, can allow the parties to “test the waters” in a new, combined business venture. The affiliation or JV can take a variety of forms, including technology licensing agreements; the creation of a new entity to house the telehealth mission, which then has contractual arrangements with the both the JV parties; and exclusivity arrangements relating to use of the technology and access to patient populations.

While an affiliation or JV offers flexibility, can minimize the need for a large upfront investment, and can be an attractive alternative to a more permanent purchase or sale, there can be increased regulatory risk. Entrepreneurs, investors, and providers considering any such arrangement should bear in mind that in the wake of the COVID-19 pandemic and proliferation of telehealth, the Office of Inspector General of the Department of Health and Human Services (HHS-OIG) has expressed a heightened interest in investigating so called “telefraud” and recently issued a special fraud alert regarding suspect arrangements, discussed in this prior post. Further, the OIG’s guidance on contractual joint ventures that would run afoul of the federal Anti-Kickback Statute (AKS) should be front of mind and parties should strive to structure any affiliation or JV in a manner that meets or approximates an AKS safe harbor.

Target Telehealth Company Structure Compliance

Where telehealth companies are providing clinical services, and are not purely technology platforms, structuring and transaction diligence should focus on whether the target is operating in compliance with corporate practice of medicine (CPOM) laws. The CPOM doctrine is intended to maintain the independence of physician decision-making and reduce a “profits over people” mentality, and prevent physician employment by a lay-owned corporation unless an exception applies. Most states that have adopted CPOM impose similar restrictions on other types of clinical professionals, such as nurses, physical therapists, social workers, and psychologists. Telehealth companies often attempt to utilize a so-called “friendly PC” structure to comply with CPOM, whereby an investor-owned management services organization (“MSO”) affiliates with a physician-owned professional corporation (or other type of professional entity) (a “PC”) through a series of contractual agreements that foster a close working relationship between the MSO, PC, and PC owner and whereby the MSO provides management services, and sometimes start-up financing. The overall arrangement is intended to allow the MSO to handle the management side of the PC’s operations without impeding the professional judgment of the PC or the medical practice of its physicians and the PC owner.

CPOM Compliance Considerations and Diligence for Telehealth Companies

A sophisticated buyer will want to confirm that the target’s friendly PC structure is not only formally established, but is also operationalized properly and in a manner that minimizes fraud and abuse risk. If CPOM compliance gaps are identified in diligence this may, at worst, tank the deal and, at best, cause unexpected delays in the transaction timeline, as restructuring may be required or advisable. The buyer may also request additional deal concessions, such as a purchase price reduction and special indemnification coverage (with potentially a higher liability limit and an escrow as security). Accordingly, a telehealth company anticipating a sale or fund raise would be well served to engage in a self-audit to identify any CPOM compliance issues and undertake necessary corrective actions prior to the commencement of a transaction process.

Below are nine key questions with respect to CPOM compliance and related fraud and abuse issues that a buyer/investor in a telehealth transaction should examine carefully (and that the target should be prepared to answer):

  1. Does target have a PC that is properly incorporated or foreign qualified in all states where clinical services are provided (based on the location of the patient)?
  2. Does the PC owner (and any directors and officers of the PC, to the extent different from the PC owner) have a medical license in all states where the PC conducts business (to the extent in-state licensure is required)? To the extent the PC has multiple physician owners and directors/officers, are all such individuals licensed as required under applicable state law?
  3. Does the PC(s) have its own federal employer identification number, bank account (including double lockbox arrangement if enrolled in federal healthcare programs), and Medicare/Medicaid enrollments?
  4. Does the PC owner exercise meaningful oversight and control over the governance and clinical activities of the PC? Does the PC owner have background and expertise relevant to the business (e.g., a cardiologist would not have appropriate experience to be the PC owner of a PC that provides telemental health services)?
  5. Are the physicians and other professionals providing clinical services for the business employed or contracted through a PC (rather than the MSO)? Employment or independent contractor agreements should be reviewed, as well as W-2s, and payroll accounts.
  6. Is the PC properly contracted with customers (to the extent services are provided on a B2B basis) and payors?
  7. Do the contractual agreements between the MSO and PC respect the independent clinical judgment of the PC owner and PC physicians and otherwise comply with state CPOM laws.
  8. Do the financial arrangements between the MSO, PC, and PC owner comply with AKS, the federal Stark Law, and corollary state laws and fee-splitting prohibitions, to the extent applicable?
  9. Is the PC owner or any other physician performing clinical services for the PC an equity holder in the MSO? If so, are these equity interests tied to volume/value of referrals to the PC or MSO (i.e., if the MSO provides ancillary services such as lab or prescription drugs) or could equity interests be construed as an improper incentive to generate healthcare business (e.g., warrants that can only be exercised upon attainment of certain volume)?

Telehealth companies considering a sale or financing transaction, and potential buyers and investors, would be well served to spend time on the front end of a potential transaction assessing the above issues to determine potential risk areas that could impact deal terms or necessitate any friendly PC structuring.

© 2022 Foley & Lardner LLP

Antitrust Enforcers’ “Second Listening” Forum On Merger Reform Highlights Issues In The Healthcare Industry

In March of this year the Antitrust Division of the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) jointly announced a series of “listening forums” that would help gather real world input from participants in key industry segments on possible reforms to the antitrust regulations pertaining to mergers and acquisitions.Co-led by DOJ Deputy Assistant Attorney General (“DAAG”) Doha Mekke and FTC Chairperson Lina Khan, the second of the four announced forums, focusing on healthcare, was held on April 14, 2022. 2  In addition to DAAG Mekki and Chairperson Khan, the program included eight panelists that provided perspectives from nurses, doctors, patients, pharmacists and small businesses. 3

DAAG Mekki started off the discussion by reaffirming the antitrust enforcement agencies’ collective commitment that “healthcare markets remain competitive” because it “is essential to our livelihood or the livelihood of the nation.” Mekki referenced ongoing work by the agencies in the healthcare field, including recent DOJ enforcement actions. 4

The healthcare panelists highlighted several ongoing issues in the industry, such as the adverse impact of care due to post-merger hospital staff downsizing that was tied to merger-specific efficiencies, reduced options to tertiary care, higher healthcare costs for patients, and unfair competition in the pharmaceutical and small business markets, and other impacts in the research and labor markets.

Chairperson Khan indicated that the comments resonated with the concerns that the FTC had in the hospital, pharmacy benefits management, and pharmacy industries. Ms. Khan also suggested a renewed interest in examining the potential anticompetitive effects of vertical integration in addition to horizontal mergers and acquisitions, which is consistent with the FTC’s position when it indicated that it wanted to revisit this issue while withdrawing the Vertical Merger Guidelines in 2021. Khan also reaffirmed the importance of examining anticompetitive effects in the labor market. All of these issues, according to Khan, are important in assessing how the antitrust laws can be used to improve the quality of healthcare for patients.

The forum ended with some of the more than two hundred public comments, most of which echoed similar concerns raised by the panelists in addition to concerns such as disparities in hospital-physician group contracting situations and racial disparities in access to healthcare as a result of healthcare system mergers.

Once again, all signs point toward an unprecedented time in antitrust enforcement in the healthcare industry. Accordingly, it is important that healthcare companies revisit, revise, and implement best practices with regard to their respective antitrust compliance programs. A proactive, as opposed to a reactive, approach would provide companies the best risk management strategy. It is also important to engage antitrust counsel early in potential transactions to assess how the antitrust agencies may view the deal.

The DOJ and FTC Listening Forums continue with Media and Entertainment, which was held on April 27, 2022, and the final one on Technology, which will be held on May 12, 2022. Click here to download the alert. 

FOOTNOTES

1    “Forums to focus on markets commonly impacted by mergers: food and agriculture, health care, media and entertainment, and technology,” March 17, 2022, available at: https://www.ftc.gov/news-events/news/press-releases/2022/03/ftc-justice-department-launch-listening-forums-firsthand-effects-mergers-acquisitions

2   See “Antitrust Enforcers’ First ‘Listening Forum’ On Merger Reform Highlights Ongoing Concerns in the Food and Agriculture Industry” May 9, 2022, available at: https://www.polsinelli.com/intelligence/antitrust-forum-highlights-concerns-in-food-and-ag

Full transcript of forum available at: https://www.ftc.gov/system/files/ftc_gov/pdf/FTC-DOJ-Listening-Forum-%20Health-Care-Transcript.pdf. It should be noted that Assistant Attorney General Jonathan Kanter did make an appearance at the end of the session, reiterating the importance of this forum.

4    See “DOJ Faces Two Strikeouts in First Health Care Wage-Fixing and ‘No Poach’ Prosecutions,” April 20, 2022, available at: https://www.polsinelli.com/intelligence/doj-faces-two-strikeouts-in-first-health-care

© Polsinelli PC, Polsinelli LLP in California
Article By Arindam Kar with Polsinelli PC.
For more articles about antitrust law, visit the NLR Antitrust law section.

Cybersecurity Due Diligence Is Crucial in All M&A—Including Energy M&A Transactions

Can a single data breach kill or sideline a deal? Perhaps so. Last month Verizon signaled that Yahoo!’s disclosure of a 2014 cyberattack might be a “material” change to its July $4.83 billion takeover bid—which could lead Verizon to renegotiate or even drop the deal entirely. Concern over cybersecurity issues is not unique to technology or telecommunications combinations. In a 2016 NYSE Governance Services survey of public company directors and officers, only 26% of respondents would consider acquiring a company that recently suffered a high-profile data breach—while 85% of respondents claimed that it was “very” or “somewhat” likely that a major security vulnerability would affect a merger or acquisition under their watch (e.g., 52% said it would significantly lower valuation).

Bottom Line: Cybersecurity should play a more meaningful role in the due diligence portion of any potential M&A deal. Certainly this is so when a material portion of the value in the acquisition comes from intangible assets that might be most vulnerable to hackers. Financial information comes to mind. Personal information of employees does as well. But companies also need to be concerned about their trade secrets, know-how and other confidential business information whose value inheres in its secrecy. Therefore, a merely perfunctory approach to cybersecurity can become very costly. The union of companies today is a union of information, malware and all.

Energy M&A Is Not Immune

To weather the plunge in prices, many oil companies have sought out new innovations to reduce the cost of extraction and exploration. Investments in digital technologies will likely only increase—a 2015 Microsoft and Accenture survey of oil and gas industry professionals found that “Big Data” and the “Industrial Internet of Things” (IIoT) are targets for greater spend in the next three to five years. Cybersecurity threats were perceived in the survey as one of the top two barriers to realizing value from these technologies.

These developments in energy industry—bigger data and bigger vulnerabilities—are here to stay. The proposed merger of General Electric and Baker Hughes also speaks to the growing importance of analytics to oil production. Commentators note that the acquisition would allow GE more fully to implement its Predix platform, an application of IIoT to connect everything from wellhead sensors to spreadsheets. However, as last month’s massive cyberattack on DNS provider Dyn, Inc. demonstrated, the IIoT holds unique challenges as well as great promise for operational efficiency. (In this attack, reportedly 400,000 internet-linked gadgets were hacked and used to reroute web traffic to overload servers.)

Bottom Line: Robust cybersecurity diligence should be de rigueur for energy M&A.

What Can Companies Do to Protect Deal Value?

For starters, energy companies should treat cybersecurity as a separate and more involved category for due diligence.

Liability for or damages from legacy data breaches or malware can become expensive—damages to systems, theft of information and liability from the release of personal or reputation-damaging information, to name a few. Therefore, anticipating problems post-merger, cataloguing past vulnerabilities and most importantly, discovering actual breaches before closing is crucial to avoid deals blowing hot and cold.

Companies should retain IT specialists who can do an objective assessment of the cybersecurity posture of a proposed merger or acquisition. This can help prospective acquirers better determine the adequacy of a target’s cybersecurity programs, such as its policies over incident response, how access to data is distributed, the extent of a company’s online presence and vulnerabilities, and how remediation of any potential cyberthreats or actual breaches may best proceed.

A cybersecurity questionnaire should also be developed, covering such topics as:

  • How and where has company data been stored?

  • Who has had access?

  • Have there been any actual or attempted intrusions into (or leaks) of company data?

An acquirer could further insist on specific representations and warranties from a target company regarding their cybersecurity compliance, as well as bargain towards indemnity for prior data breaches.

On the target side, energy companies should prepare (in turn) for more scrutiny over their data security and privacy practices. Among other benefits to “knowing thyself,” getting ahead of this process should offer targeted companies a better negotiating position. It would also allow them to take a more proactive role in defining the policies of the combined company post-merger. At the very least, these efforts could help avoid the kind of hiccups and uncertainties that lead to undervaluation. In any event, poor cybersecurity practices can give an impression that a target lacks risk management in other areas—not an ideal pose to strike in any bargain.

Parting Thoughts

It is a trope in cybersecurity writing to invoke figures like Sun Tzu and shoehorn in quotes about war stratagem. Well, these habits are in some ways unavoidable: For all intents and purposes, fighting anonymous hackers resembles battle prep—a method of self-awareness and readiness that defies box-checking.

Energy companies could take these words to heart from the inestimable Miyamoto Musashi, a samurai who won 60 duels: “If you consciously try to thwart opponents, you are already late.” (A sentiment echoed more recently by Mike Tyson’s truistic “Everyone has a plan until they get punched in the mouth.”)

And This Key Takeaway: Any cybersecurity program must go hand-in-hand with a corporate culture that respects data as among its most valued assets. Efforts in detection, reporting and remediation are challenges that fall throughout the ranks and, if reflexive to the unknown, stand the best chance of being fully realized.

Bottom Line: Mind Your Data!

Unclaimed Property in M&A Transactions: The Potential for an Unwelcome Surprise

GT Law

As the economy continues to recover, an increase in M&A activity is expected. A target company’s historical compliance with unclaimed property laws is an important, but often overlooked, area for due diligence in M&A transactions. A target company’s failure to comply with unclaimed property laws can potentially create multi-million dollar exposure for the buyer. The transaction itself may have the effect of drawing the attention of state unclaimed property regulators and third party contingency fee auditors. There are various ways, as discussed below, for the buyer to control or limit its potential exposure.

A Brief Introduction to Unclaimed Property

While the exact parameters of what constitutes “unclaimed property” vary from state to state, unclaimed property generally consists of a wide range of both tangible and intangible property held by a business. Once the business has held the property for a statutorily mandated holding period without communication with the owner, it becomes unclaimed property subject to escheat. Some examples of unclaimed property include: un-cashed rebate checks and other customer credits; unused gift certificates and gift cards; un-cashed vendor checks; un-cashed dividend checks; insurance proceeds; and the underlying stock or other evidence of an ownership interest in a business.

Businesses are responsible for reporting unclaimed property to the states on an annual basis in accordance with priority rules established by the U.S. Supreme Court. The first-priority rule is that unclaimed property escheats to the state of the apparent owner’s last known address, as shown on the company’s books and records. The second-priority rule provides that the unclaimed property escheats to the state of the company’s incorporation if: (1) the apparent owner’s address is unknown, (2) the last known address is in a foreign country, or (3) the last known address is in a state that does not provide for escheat of the property in question. As the unclaimed property laws vary from state to state, the outcome of this jurisdictional priority analysis can have a meaningful impact on the property required to be escheated. Some states even require negative reports to be filed, stating that no unclaimed property is due and owing to the state.

The Importance of the Transaction’s Structure

A transaction’s structure can significantly impact the unclaimed property exposure that a buyer may inherit from the target. In an asset purchase, the buyer acquires only those liabilities specifically identified in the purchase document. While it is still possible for the buyer to acquire certain unclaimed property liabilities in an asset purchase (such as those associated with bank accounts, accounts receivable, or gift cards), the buyer’s potential exposure for the target’s failure to comply with unclaimed property laws will typically be less than in a stock purchase where the buyer generally acquires all of the target’s disclosed and undisclosed liabilities, including its unclaimed property liabilities.

In addition, unclaimed property can arise in the context of a merger involving a share exchange, where the former stockholders (who now cannot be located) fail to receive the shares issuable to them in the merger. At least one SEC reporting company recently entered into a settlement with the State of Delaware as a result of more than four million shares which were reserved for issuance in the merger, but which were not claimed by former stockholders. The settlement resulted in the SEC reporting company making a $20,000,000 cash payment to the State of Delaware.

The Impact of a Target’s Failure to Comply with Unclaimed Property Laws

There are a number of factors that can make a target’s failure to comply with the unclaimed property laws very costly for a buyer. In many states, there is no statute of limitations on unclaimed property. As a result, even voluntary compliance arrangements with the states can result in a look-back period of five to ten years or even longer. Audit look-back periods can be significantly longer. Oftentimes, the buyer will not have complete records from the target. In such situations, state regulators in a post acquisition audit have been known to use various formula to estimate the liability. The target may have made acquisitions itself prior to being acquired, further compounding the potential for non-compliance. Once interest (and potentially even penalties) is added to the equation, a potential multi-million dollar exposure can be created — definitely an unwelcome surprise for the buyer.

Methods for Avoiding an Unwelcome Surprise

Prospective buyers can take proactive steps to manage and minimize potential exposure. Below are a few such steps:

Structure of Transaction. If possible, buyers should consider structuring a transaction as an asset purchase to minimize the unclaimed property liabilities inherited from the target. The purchase document should be carefully drafted and negotiated to leave any unclaimed property liabilities out of those liabilities acquired by the buyer.

Due Diligence. Oftentimes, unclaimed property compliance is overlooked in the due diligence process. As a starting point, buyers should request copies of the target’s unclaimed property policies and procedures, a description of the target’s unclaimed property due diligence process, copies of historical unclaimed property reports filed by the target, correspondence with state unclaimed property regulators, and any unclaimed property audit notifications. Given the current interest, especially in Delaware, in equity property (e.g., stock, dividends, etc.), buyers should make sure the target’s response includes materials that permit the buyer to determine the target’s compliance for this property type, especially because this information may be in possession of the target’s transfer agent or other third party. Depending on the materials provided, additional due diligence may be warranted.

Representations and Warranties. Unclaimed property is not a tax and thus is typically not covered by the tax representations and warranties. The purchase document should include specific representations and warranties of the target, backed by an indemnity and an escrow if possible, regarding the target’s historical unclaimed property compliance. The target’s indemnity obligations should be excluded from any basket and cap exceptions applicable to indemnities. Most representations and warranties only survive for a specified period following the closing of the transaction. However, as discussed above, oftentimes there is no statute of limitations with respect to unclaimed property compliance. If possible, the target’s representations and warranties regarding unclaimed property compliance should survive closing indefinitely. Additionally, even if the target is current in its compliance, provision should be made for property still in its dormancy period, i.e., property that may be abandoned but not yet subject to escheat.

Voluntary Compliance Initiatives. If it is determined that the target is not in compliance with the unclaimed property laws, the buyer should consider whether voluntary compliance is a viable option. Many states offer voluntary compliance programs with limited look-back periods.

©2012 Greenberg Traurig, LLP