6 Steps to Manage Tariff Risks in a Trade War

As Trump seeks to raise U.S. tariffs (which currently tend to be among the lowest worldwide), manufacturers, distributors, retailers, and other companies that frequently import (“importers”) must determine the best strategy to deal with the resulting uncertainties. Determining such a strategy is further complicated by the fact that President Trump has made a number of different proposals depending on the country and product.

Trump Tariff Proposals

  • 25% tariffs on Mexico and Canda
  • 10% tariffs on China
  • 100% tariffs on BRICS countries (comprising Brazil, Russia, India, China, and more recently additional countries in the Middle East and Africa)
  • 10–20% tariffs on the rest of the world
  • “Reciprocal tariffs” that would impose varying tariff levels by country

But while the exact form of higher tariffs is unknown, the reality is that higher tariffs are coming. This means importers have three tariff-related problems:

  1. Identifying and Managing Immediate Risks and Cost Increases. Importers need to manage the immediate risk of higher tariffs, which can sharply change production cost structures.
  2. Nimbly Responding by Changing Supply Chain Structure. Importers need to ensure they can nimbly respond to rapid shifts in importing from planned suppliers, even if it means entirely changing long-standing supply chains.
  3. Maintaining Supply Chain Integrity to Avoid Detained Goods. Importers need to continue to comply with ongoing efforts of Customs & Border Protection (CBP) to emphasize supply chain integrity issues so that goods do not get detained at the border — specifically, supply chain integrity issues related to forced labor, human trafficking, and the importing of goods potentially violating the Uyghur Forced Labor Prevention Act (UFLPA).

To cope with these problems, importers need to identify their import-related risks, add flexibility within their supply chains, address tariff-related risks in both their buy- and sell-side contracts, and ensure their customs and supply chain integrity compliance is in good working order. Below are six practical steps that importers can take to identify and mitigate their import-related risks.

  • Step 1: Risk Identification – Understanding Your Company’s Importing Patterns and How They Impact Your Company’s Importing Risk ProfileImporters need to gather full information on their historic and planned import patterns so that they can understand the full scope of potential supply chain disruptions and higher tariffs on importing costs.
  • Step 2: Risk Planning – Understanding How to Add Flexibility to Your Supply Chain to Address Your Company’s Import-Related Risk. It is likely that the Trump Administration will announce tariff rates that target certain countries, including not just China, Canada, and Mexico but also Europe and countries that have free trade agreements with the United States. Accordingly, importers need to conduct risk planning and identify areas where they can build in supply chain flexibility to ensure they have the ability to quickly pivot import patterns if needed to respond to a rapidly changing tariff environment, particularly when importing from countries that maintain higher tariffs and non-tariff barriers, such as China, India, and Brazil (which will likely be targets of reciprocal tariffs).
  • Step 3: Contractual Risk Management – Identifying Ways to Increase Your Company’s Contractual Ability to Adapt to Unexpected Changes in the Importing EnvironmentImporters should gather and audit their contractual provisions, on both the buy and sell sides, to determine how the contracts address tariff-related risks. The goal is to ensure all contractual arrangements incorporate supply, sales, and pricing flexibility to deal with unanticipated tariff changes.
  • Step 4: Risk Minimization– Ensuring Your Company’s Customs Compliance Is in Order. In a high-tariff environment, tariff underpayments mount up much more quickly, as do potential penalties. As a result, manufactures must examine import-related compliance to ensure your company is exercising reasonable care in import operations and not underpaying customs tariffs.
  • Step 5: Opportunity Identification – Ensuring Your Company Is Maximizing Tariff Savings. In a high-tariff environment, it also is more important to identify potential tariff-saving opportunities. Therefore, importers must examine their historic and planned import patterns to identify available tariff-saving opportunities, including potential ways to minimize tariffs if USMCA disappears (or if it is substantially modified), or if additional tariffs are imposed on Canada or Mexico or other major sources of imports.
  • Step 6: Minimizing Supply Chain Integrity Risks– Understanding Your Supply Chain and Mitigating Supply Chain Integrity Risk, Right Down to the Last Sub-Supplier. Finally, CBP has been detaining a record number of goods for supply chain integrity issues, especially for UFLPA violations. An importer must carefully consider whether it has implemented measures to help ensure it is ethically sourcing goods from abroad, including the need to quickly vet secondary or alternative suppliers brought on board to expand supply chain flexibility.

EPA Administrator Zeldin Announces Five Pillar Initiative to Guide EPA; What Does It Mean for OCSPP?

U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin on February 4, 2025, announced the “Powering the Great American Comeback Initiative” (PGAC Initiative). It consists of five pillars and is intended to serve as a roadmap to guide EPA’s actions under Administrator Zeldin.

The five pillars are:

  • Clean Air, Land, and Water for Every American;
  • Restore American Energy Dominance;
  • Permitting Reform, Cooperative Federalism, and Cross-Agency Partnership;
  • Make the United States the Artificial Intelligence Capital of the World; and
  • Protecting and Bringing Back American Auto Jobs.

Administrator Zeldin explained Pillar 3 by stating, “Any business that wants to invest in America should be able to do so without having to face years-long, uncertain, and costly permitting processes that deter them from doing business in our country in the first place.” [Emphasis added.] We agree and would urge Administrator Zeldin to consider the years-long new chemical approval process under the Toxic Substances Control Act (TSCA).

There has been much discussion about the Trump Administration’s desire to reduce the size of the government by reducing the federal workforce and restore common sense to the decision-making process. What is getting lost in the discussion and actions taken to “right-size” the government is that chemical manufacturers and formulators rely on EPA action to bring new products to market. The public seldom hears about how agencies like EPA play a vital role in promoting innovation and supporting job creation. Instead, political rhetoric has been about reducing agency headcounts and budgets, but not enough about how to improve agency performance and efficiency.

This is not new. Dr. Richard Engler and I wrote in November 2024 about the newly unveiled Department of Government Efficiency (DOGE), “If DOGE can identify ways to improve the operation and efficiency of [EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP)] (e.g., by ensuring appropriate resources and updated technology), this could lead to economic gains, greater investment, innovation, and sustainability, and yes, more jobs in the United States.” I would expand what we wrote in November to include the PGAC Initiative.

American businesses need OCSPP, a critically important EPA office charged with conducting safety reviews of existing products and the gatekeeper for new chemical products, to be properly resourced (with funds, people, and technology), operate efficiently and effectively, and be held accountable for performance. If the PGAC Initiative and DOGE efforts lead to OCSPP’s proper resourcing, it would go a long way in reversing the trend of fewer new chemicals being submitted to EPA for approval in the United States and reducing the commercialization of innovative new chemistries overseas instead of here in the United States.

It Lives: Trump Administration Defends Corporate Transparency Act; May Modify its Application

On February 5, 2025, the Trump administration added a new chapter to the saga that has been implementation of the Corporate Transparency Act (CTA), filing a notice of appeal and motion for stay against an Eastern District of Texas injunction in Smith v. United States Department of the Treasury on enforcement of the CTA’s filing deadline.

In its filing, the Treasury Department stated that it would extend the filing deadline for 30 days if the stay is granted, and would use those 30 days to determine if lower-risk categories of entities should be excluded from the reach of the filing requirements. In light of the Supreme Court’s stay of the injunction in Texas Top Cop Shop, Inc., et al. v. Merrick Garland, et al., also from the Eastern District of Texas, it is likely that stay will be granted.

Passed in the first Trump administration but implemented during the Biden presidency, the CTA – an anti-money laundering law designed to combat terrorist financing, seize proceeds of drug trafficking, and root out illicit assets of sanctioned parties and foreign criminals in the United States – has faced legal challenges around the country.

The constitutionality of the CTA was challenged in several cases, with most courts upholding the law, but some issuing either preliminary injunctions or determining that the law is unconstitutional. In addition to the appeals of Texas Top Cop Shop and Smith, both before the Fifth Circuit, appeals are currently pending in the Fourth, Ninth, and Eleventh Circuits.

Although enforcement of the CTA deadline is currently paused, the granting of a stay in Smith, or a ruling by one of the circuits, could reinstate the deadline at any time, triggering the start of the 30-day clock to file. Entities may file now notwithstanding the injunction if they choose to do so, and entities may wish to complete the filing so that they do not need to monitor the situation and to avoid high traffic to the filing website in the event a deadline is reimposed.

Please note that if you file or have already filed and the law is ultimately found unconstitutional or otherwise overturned or rescinded, you will not be under any continuing obligation regarding that filing.

Entities can, of course, choose not to file or to keep filings updated. However, be aware that in addition to the potential need to file on short notice should the preliminary injunction be limited, stayed, or overturned, financial institutions may inquire as to whether the entity has filed a CTA and could require filing as part of the financial institution’s anti-money laundering program.

Corporate Transparency Act Recent Update

As previously reported, in early December, the District Court for the Northern District of Texas issued a nationwide injunction against the enforcement of the CTA [1]. The government quickly appealed. Just a few weeks later, on December 23, 2024, the Fifth Circuit Court of Appeals granted the government’s emergency motion to stay the nationwide injunction — effectively lifting the injunction and allowing the enforcement of the CTA to proceed. Given there was a January 1, 2025, deadline for millions of small business owners to file, FinCEN graciously decided to extend the filing deadline to January 13, 2025.

Then, just three days later, on December 26, 2024, in a short, one-page order, a different panel of judges from the same Fifth Circuit Court of Appeals reinstated the injunction, again placing the CTA and its enforcement provisions on hold. The government again quickly responded, petitioning the U.S. Supreme Court to lift the injunction. On January 23, 2025, the Supreme Court did precisely that — granting the government’s motion. The Supreme Court’s order, however, only applied to the injunction issued by the federal judge in Texas. Since a separate nationwide order issued by a different federal judge in Texas [2] was still in place, FinCEN posted a new update to its website one day later, stating:

“Reporting companies are not currently required to file beneficial ownership information with FinCEN despite the Supreme Court’s action in Texas Top Cop Shop. Reporting companies also are not subject to liability if they fail to file this information while the Smith order remains in force. However, reporting companies may continue to voluntarily submit beneficial ownership information reports. [3] “

Opinions vary regarding whether reporting companies should file voluntarily. At the very least, reporting companies should be prepared to file quickly if and when the “red light” turns green once again. In the meantime, we continue to watch for any additional rulings. To stay up to date, please check our website regularly or contact a member of our Corporate Transparency Team for advice.

[1] Texas Top Cop Shop, Inc. v. McHenry

[2] Smith v. U.S. Department of the Treasury

[3] https://www.fincen.gov/boi (last accessed February 3, 2025)

The Trade War Begins with Canada, China, and Mexico

On February 1, 2025, President Trump declared a national emergency based upon the threat posed by undocumented foreign workers and drugs entering the United States. The White House has published a fact sheet outlining steps to address the threat by implementing (i) a 25% additional tariff on imports from Canada and Mexico, (ii) a 10% additional tariff on imports from China, and (iii) a carveout for a lower 10% tariff for energy resources from Canada (see Fact Sheet: President Donald J. Trump Imposes Tariffs on Imports from Canada, Mexico and China – The White House).

President Trump declared the national emergency pursuant to the International Emergency Economic Powers Act (IEEPA) and the National Emergencies Act. This action marks the first time a President has used the IEEPA to impose tariffs. President Nixon had used a precursor law to impose 10% tariffs on all imports in 1971 in order to avoid a balance of payments crisis resulting from ending the U.S. dollar’s gold standard (see prior alert Can the President Impose Tariffs Without Congressional Approval?).

President Trump issued Executive Orders imposing these additional tariffs on Canada, China, and Mexico (see link to Canada EO, China EO (unpublished), and Mexico EO (unpublished)).[1] The Executive Orders generally provide that the IEEPA national security tariffs may be removed if Canada and Mexico demonstrate adequate steps have been undertaken to alleviate the illegal migration and illicit drug crisis through cooperative actions, and China demonstrates adequate steps have been taken to alleviate the opioid crisis through cooperative actions.

A quick overview of five key initial questions:

1. When do the IEEPA national security tariffs take effect?

These IEEPA national security tariffs will be collected at the ad valorem rate of duty beginning 12:01 am ET, Tuesday, February 4, 2025.

2. How do I know if my import is subject to the IEEPA national security tariffs?

The Executive Orders reference “all articles” suggesting that the IEEPA national security tariff will apply to all merchandise imported from Canada, China, and Mexico; excepting that, there will be a carveout for energy from Canada, with the definitions based upon section 8 of Executive Order 14156 of January 20, 2025 (Declaring a National Energy Emergency). The necessary modifications to the Harmonized Tariff Schedule of the United States will be updated by the Department of Homeland Security and published in the Federal Register.

3. How is the IEEPA national security tariff rate calculated and applied?

The IEEPA national security tariff will be collected at an ad valorem rate based upon the entered value of the merchandise, meaning that the IEEPA national security tariff will be calculated on the entered value of the merchandise and simply added to any other duty applicable on the subject merchandise.

4. Who is responsible for paying the IEEPA national security tariff?

The importer of record is responsible for paying all duties to U.S. Customs and Border Protection. There is no change to this requirement.

5. Is there a process to apply for exclusions from IEEPA national security tariffs?

There have been no stated exemptions or processes for exclusions from the IEEPA national security tariffs, but importers may continue to review mitigation strategies for application (see prior alert Preparing for Tariff Increases – Mitigation Strategies: Miller Canfield).

In addition, the Executive Orders further provide that:

  • There is no duty drawback available for the covered merchandise, i.e. the refund of duties, taxes, and fees paid on imported merchandise subsequently exported or destroyed;
  • Merchandise must be admitted as “privileged foreign status,” meaning the merchandise remains subject to the tariff based upon its imported state, regardless of whether the classification changes in a Free Trade Zone, i.e. no avoiding the tariff by importing the merchandise into a Free Trade Zone;
  • There is no de minimis treatment available under Section 321, i.e. duty free treatment for shipments below $800; and
  • The President may increase or expand in scope the tariffs imposed under the Executive Orders upon retaliation against the United States by Canada, China, or Mexico through the application of tariffs or similar.

Because the imposition of additional IEEPA national security tariffs remains in flux, importers should carefully monitor this situation. For up-to-date advice and assistance on mitigation options to tariff exposure applicable to your business, please contact your Miller Canfield attorney or one of the authors of this alert.

[1] Press reports indicate that the China EO and Mexico EO have been signed and are similar in form, but as of the time of this publication the China EO and Mexico EO have not yet been posted to www.whitehouse.gov.

New TCPA Consent Requirements Out the Window: What Businesses Need to Know

The landscape of prior express written consent under the Telephone Consumer Protection Act (TCPA) has undergone a significant shift over the past 13 months. In a December 2023 order, the Federal Communications Commission (FCC) introduced two key consent requirements to alter the TCPA, with these changes set to take effect on January 27, 2025. First, the proposed rule limited consent to a single identified seller, prohibiting the common practice of asking a consumer to provide a single form of consent to receive communications from multiple sellers. Second, the proposed rule required that calls be “logically and topically” associated with the original consent interaction. However, just a single business day before these new requirements were set to be enforced, the FCC postponed the effective date of the one-to-one consent, and a three-judge panel of circuit judges unanimously ruled that the FCC exceeded its statutory authority under the TCPA.

A Sudden Change in Course

On the afternoon of January 24, 2025, the FCC issued an order delaying the implementation of these new requirements to January 26, 2026, or until further notice following a ruling from the United States Court of Appeals for the Eleventh Circuit. The latter date referenced the fact that the Eleventh Circuit was in the process of reviewing a legal challenge to the new requirements at the time the postponement order was issued.

That decision from the Eleventh Circuit, though, arrived much sooner than expected. Just after the FCC’s order, the Eleventh Circuit issued its ruling in Insurance Marketing Coalition v. FCC, No. 24-10277, striking down both of the FCC’s proposed requirements. The court found that the new rules were inconsistent with the statutory definition of “prior express consent” under the TCPA. More specifically, the court held “the FCC exceeded its statutory authority under the TCPA because the 2023 Order’s ‘prior express consent’ restrictions impermissibly conflict with the ordinary statutory meaning of ‘prior express consent.’”

The critical takeaway from Insurance Marketing Coalition is that the TCPA’s “prior written consent” verbiage was irreconcilable with the FCC’s one-to-one consent and “logically and topically related” requirements. Under this ruling, businesses may continue to obtain consent for multiple sellers to call or text consumers through the use of a single consent form. The court clarified that “all consumers must do to give ‘prior express consent’ to receive a robocall is clearly and unmistakably state, before receiving a robocall, that they are willing to receive the robocall.” According to the ruling, the FCC’s rulemaking exceeded the statutory text and created duties that Congress did not establish.

The FCC could seek further review by the full Eleventh Circuit or appeal to the Supreme Court, but the agency’s decision to delay the effective date of the new requirements suggests it may abandon this regulatory effort. The ruling reinforces a broader judicial trend after the Supreme Court’s 2024 decision overturning Chevron deference – and curbing expansive regulatory interpretations.

What This Means for Businesses

With the Eleventh Circuit’s decision, the TCPA’s consent requirements revert to their previous state. Prior express written consent consists of an agreement in writing, signed by the recipient, that explicitly authorizes a seller to deliver, or cause to be delivered, advertisements or telemarketing messages via call or text message using an automatic telephone dialing system or artificial or prerecorded voice. The agreement must specify the authorized telephone number and cannot be a condition of purchasing goods or services.

This ruling is particularly impactful for businesses engaged in lead generation and comparison-shopping services. Companies may obtain consent that applies to multiple parties rather than being restricted to one-to-one consent. As a result, consent agreements may once again include language that covers the seller “and its affiliates” or “and its marketing partners” that hyperlinks to a list of relevant partners covered under the consent agreement.

A Costly Compliance Dilemma

Many businesses have spent the past year modifying their compliance processes, disclosures, and technology to prepare for the now-defunct one-to-one consent and logical-association requirements. These companies must now decide whether to revert to their previous consent framework or proceed with the newly developed compliance measures. The decision will depend on various factors, including the potential impact of the scrapped regulations on lead generation and conversion rates. In the comparison-shopping and lead generation sectors, businesses may be quick to abandon the stricter consent requirements. However, those companies that have already implemented changes to meet the one-to-one consent rule may be able to differentiate the leads they sell as the disclosure itself will include the ultimate seller purchasing the lead, which provides the caller with a documented record of consent in the event of future litigation.

What’s Next for TCPA Compliance?

An unresolved issue after the Eleventh Circuit’s ruling is whether additional restrictions on marketing calls — such as the requirement for prior express written consent rather than just prior express consent — could face similar legal challenges. Prior express consent can be established when a consumer voluntarily provides their phone number in a transaction-related interaction, whereas prior express written consent requires a separate signed agreement. If future litigation targets these distinctions, it is possible that the courts may further reshape the TCPA’s regulatory landscape.

The TCPA remains one of the most litigated consumer protection statutes, with statutory damages ranging from $500 to $1,500 per violation. This high-stakes enforcement environment has made compliance a major concern for businesses seeking to engage with consumers through telemarketing and automated calls. The Eleventh Circuit’s ruling provides a temporary reprieve for businesses, but ongoing legal battles could continue to influence the regulatory landscape.

For now, businesses must carefully consider their approach to consent management, balancing compliance risks with operational efficiency. Whether this ruling marks the end of the FCC’s push for stricter TCPA consent requirements remains to be seen.

President Trump Enacts Regulatory Freeze and Halts Public Communications for Federal Agencies

  • On January 20, 2025, President Donald Trump signed a memorandum titled, “Regulatory Freeze Pending Review,” imposing a regulatory freeze on all federal agencies.
  • The key points of the regulatory freeze are as follows:
    • Do not Propose or Issue Any New Rules: Agencies cannot propose or issue any new rules in any manner, including sending them to the Office of the Federal Register (OFR), until they are reviewed and approved by a department or agency head appointed by the President.
    • Automatically Withdrawing Unpublished Rules: Any rules that have been sent to the OFR but have not yet been published must be immediately withdrawn to be reviewed by a department head or agency head appointed by the President.
    • Delay Effective Date of Already Published Rules: For rules that have been published but have not yet taken effect, agencies are to consider postponing their effective date for 60 days to review any questions of fact, law, or policy. During this period, agencies may open a comment period for public input and consider further delaying the rules if necessary.
  • The freeze applies not only to rules but also to any substantive agency action, including Advanced Notices of Proposed Rulemaking (ANPR), Notice of Proposed Rulemaking, notices of inquiry, and any agency statement of general applicability that sets forth a policy on any regulatory or technical issue.
  • This freeze will impact all recently proposed rules by requiring them to undergo a review process, which may lead to the rules being withdrawn, modified, or delayed in implementation. The following recently proposed rules or finalized but not yet effective rules issued by FDA include:
  • Alongside the regulatory freeze, President Trump has directed federal agencies to temporarily stop all public communications. This includes press releases, social media updates, and other public statements. The pause is in effect through February 1.
  • Keller and Heckman will continue to closely monitor any changes made to pre-existing proposed or finalized rules and any new executive orders or rules promulgated by the new administration.

Business Immigration in 2025: Signals from Recent Executive Orders

Immediately after assuming office on Jan. 20, 2025, President Donald Trump began issuing numerous executive orders. While they may not immediately impact business immigration, many of them presage changes in the business immigration landscape. The following is an analysis of several of these executive orders from that perspective:

  • Protecting the United States from Foreign Terrorists and Other National Security and Public Safety Threats. This executive order largely reiterates Trump’s Proclamation 9645, Enhancing Vetting Capabilities and Processes for Detecting Attempted Entry Into the United States by Terrorists or Other Public-Safety Threats, an executive order from his previous term. It tasks various government agencies with reviewing all visa programs to prevent foreign nation-states or other hostile actors from hurting the United States. This order will most likely result in an increase in scrutiny of visa applications and an increase in processing times across the board for all business immigration. We can expect an increase in the number of visa applications subject to administrative processing. These effects may discourage business immigration as business realities clash with system slowdowns.
  • America First Trade PolicyThis executive order largely reiterates Trump’s Executive Order 13788, Buy American and Hire American (BAHA), from his previous term. The U.S. Trade Representative has been directed to review the implementation of trade agreements to ensure they favor domestic workers and manufacturers, consistent with the principles of that prior executive order. This may lead to a tightening of the labor market, as companies could be discouraged from hiring available foreign national candidates for positions. This could lead to an immigrant brain-drain as highly skilled immigrants trained at U.S. universities and institutions potentially immigrate to countries such as Canada. The USTR’s review may also affect treaty-based visas, such as the TN, E-1, E-2, and H-1B1 visas. Trump also issued America First Policy Directive to the Secretary of Statewhich may result in increased scrutiny of employment-based visa applications, as BAHA did under Trump’s previous term.
  • Guaranteeing the States Protection Against InvasionThis executive order characterizes migration at the southern border as an “invasion” and imposes vetting requirements on those immigrating to the United States. The likely impact is to create enhanced medical and security requirements for immigrants entering the U.S. While this executive order is drafted with the southern border in focus, Customs and Border Protection and the Department of Homeland Security will likely impose additional restrictions on business immigration as well, potentially creating travel disruptions due to inconsistent experiences at points of entry.
  • Designating Cartels and Other Organizations as Foreign Terrorist Organizations and Specially Designated Global Terrorists. The designation of criminal organizations in the United States and Central America may portend a crackdown on and enhanced vetting of immigrants, including business immigrants, from areas where these organizations operate. This could cause slowdowns in business immigration across the southern border with Mexico.
  • Protecting the American People Against Invasion. This executive order expands expedited removal and revokes humanitarian parole programs created by the prior administration. Individuals who have secured status under those programs will be unable to renew work permits. It may also result in the return of “public charge” policies, which previously resulted in a slowdown for business immigrants seeking lawful permanent residency status. Furthermore, increased scrutiny and interior enforcement may lead businesses to forego hiring immigrant workers.
  • Protecting the Meaning and Value of American Citizenship. This executive order seeks to re-interpret the Constitution’s guarantee of citizenship for those born within the United States territory and who are subject to the jurisdiction of the United States. Notably, this executive order attempts to remove the grant of citizenship to certain business immigrants’ children born in the United States. Lawsuits have been filed challenging the impact of this executive order. This action may lead to increased difficulties for companies in recruiting and retaining foreign workers.

Conclusion

While these orders do not have an immediate impact on business immigration, they will likely cause an increase in administrative costs for companies with foreign workers and create retention challenges for companies. This may lead to an immigrant brain-drain, as highly skilled professionals, some of whom have been trained and educated in the United States, potentially seek to leave the country.

DOJ Announces Modest Increase in FCA Recoveries, Fueled Largely by Whistleblower Lawsuits

The Department of Justice (“DOJ”) recently announced a modest increase in monetary recoveries for 2024 from investigations and lawsuits under the False Claims Act (“FCA”), which is the Government’s primary tool for combating fraud, waste, and abuse. In fiscal year 2024, the DOJ recovered over $2.9 billion from FCA settlements and judgments, marking a 5% increase over 2023’s total and the highest amount in three years. Recoveries were fueled largely by qui tam lawsuits previously filed by whistleblowers, which contributed to $2.4 billion of the $2.9 billion recovered. The number of qui tams filed last year was also the highest ever in a single year at 979 cases. While health care fraud continues to be the primary source of enforcement activity, the rise in lawsuits stemmed from non-health care related cases. This underscores the Government’s and private citizens’ intensified enforcement efforts through FCA investigations and litigation in both the health care sector and beyond.

FCA Recoveries by the Numbers

While the nearly $3 billion recovered last year resulted from a record-breaking number of 566 settlements and judgments, last year’s haul remains well below peak year recoveries, such as 2014’s $6.2 billion and 2021’s $5.7 billion. The following chart illustrates the FCA recoveries by fiscal year, showcasing monetary trends over the past decade.

Key Enforcement Areas

In announcing 2024’s recoveries, the Government highlighted several key enforcement areas, such as:

  • The opioid epidemic. The Government continues to pursue health care industry participants that allegedly contributed to the opioid crisis, focusing primarily on schemes to market opioids and schemes to prescribe or dispense medically unnecessary or illegitimate opioid prescriptions.
  • Medicare Advantage Program (Medicare Part C). As the Medicare Advantage Program is the largest component of Medicare in terms of reimbursement and beneficiaries impacted, the Government stressed this remains a critical area of importance for FCA enforcement.
  • COVID-19 related fraud. Given the historic levels of government funding provided as a result of the COVID-19 pandemic, the Government also continues to pursue cases involving improper payment under the Paycheck Protection Program as well as false claims for COVID-19 testing and treatment. Close to half of 2024’s settlements and judgments resolved allegations related to COVID-19.
  • Anti-Kickback Statute and Stark Law violations. Cases premised on alleged violations of the AKS and Stark Law remain a driving force in FCA litigation for health care providers. In the last several years, there seems to be renewed interest in Stark Law enforcement, in particular.
  • Medically unnecessary services. The provision of medically unnecessary health care services also remains a widely-used theory of FCA liability, despite this being a historically challenging enforcement area often involving disputes over subjective clinical decisions.

A Primer on Executive Orders and a Preview of the Road Ahead

On January 20, 2025, a new administration took control of the Executive Branch of the federal government, and it has signaled that it will make aggressive use of executive orders.

This would be a good time to review the scope of executive orders and how they may affect employers and health care organizations.

Executive orders are not mentioned in the Constitution, but they have been around since the time of George Washington. Executive orders are signed, written, and published orders from the President of the United States that manage and direct the Executive Branch and are binding on Executive Branch agencies. Executive orders can be used to implement or clarify existing federal law or policies and can direct and manage the way federal agencies interact with private entities. However, executive orders are not a substitute for either statutes or regulations.

The current procedure for implementing executive orders was set out in a 1962 executive order that requires that all such orders must be published in the Federal Register, the same publication where executive agencies publish proposed and final rules. Once published, any executive order can be revoked or modified simply by issuing a new executive order. In addition, Congress can ratify an existing executive order in cases where the authority may be ambiguous.

Although the President has extensive powers under Article II of the Constitution, that does not necessarily mean that executive orders can be issued and enforced on a whim. Over time, federal courts have reviewed executive orders and typically base their decisions on three questions: (1) has Congress delegated any authority to the President to act through an executive order?; (2) if so, what is the scope of any delegation?; and (3) did the President act within the scope of that delegation?

In a seminal case, Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579 (1952), the Supreme Court reviewed an executive order signed by President Truman directing the Secretary of Commerce to take possession of and operate most of the nation’s steel mills to prevent a strike from disrupting steel production during the Korean War. On appeal, the Court ruled that the executive order was not authorized under the Constitution or any statute, and that the President lacked any legislative power. It also rejected the argument that the President had an implied authority to issue the executive order under the military powers delegated to the President, as that did not extend to labor disputes.

More recently, during the COVID-19 pandemic, an executive order used the authority delegated in the Defense Production Act to address potential national defense and food supply disruptions. Nevertheless, deference to an executive order should not be presumed. Yet, even at the height of the pandemic, the Sixth Circuit ruled that the President lacked the authority to issue an executive order mandating that federal contractors be vaccinated against the COVID virus. In Kentucky v. Biden, 23 F.4th 585 (6th Cir. 2022), the Sixth Circuit ruled that the President’s reliance on the Federal Property and Administrative Services Act of 1949 (“FPASA”) was misplaced and did not authorize issuing an executive order binding on federal contractors; it determined that the act’s goal of improving economy and efficiency in federal procurement of property and services applied to the government itself and did not extend to issuing directives that may “improve the efficiency of contractors and subcontractors.”

The question of a delegation of authority to a President is not necessarily solved with an executive order directing an agency to issue regulations. For example, President Biden signed an executive order directing the Secretary of Labor to publish regulations setting a minimum wage of $15 per hour for federal contractors, based on his reading of FPASA. The regulations were challenged, and two Courts of Appeal reached opposite conclusions. In Bradford v. U.S. Dep’t of Labor, 101 F.4th 707 (10th Cir. 2024) the Tenth Circuit ruled that Congress had delegated broad authority under FPASA to the President in the language setting out the act’s purpose, and that he was justified in determining that a $15 minimum wage was consistent with the act’s goals. Nevertheless, in State of Nebraska v. Su, 121 F.4th 1 (9th Cir. 2024), the Ninth Circuit determined that the minimum wage mandate did exceed the authority granted to the President and the Department of Labor. That decision relied on a narrow reading of FPASA, and concluded that the intent of the statute was limited to ensuring that the federal government received value in contracts with private entities, and that setting a minimum wage for the employees of those contractors fell outside the reach of FPASA. Although there was a clear split among the circuits, the Supreme Court declined to resolve the matter. For now, disputes involving executive orders may have to be resolved on a case-by-case basis.

In the future, employers and health care organizations that supply goods or services to federal agencies or federally-funded programs should be concerned that if there are executive orders that affect their business, those orders should be examined carefully to evaluate not only the content of those orders, but whether they are authorized by law. EBG intends to monitor these developments along with any relevant rulemaking by federal agencies.