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  • Trump Administration May Expand Access to IVF Services

    Trump Administration May Expand Access to IVF Services

    CLIENT ALERT / US POLICY

    Trump Administration May Expand Access to IVF Services

    February 20, 2025

    Read time: 2 min

    Key takeaways
    Overview

    On February 18, 2025, US President Donald Trump signed an executive order directing his administration to develop policy recommendations within 90 days to increase access to in vitro fertilization (IVF) services and to reduce the cost of IVF treatments for patients.

    While the executive order has no immediate impact, it represents the Trump administration’s first step in addressing campaign promises to expand coverage for IVF services and limit the out-of-pocket and health insurance costs of IVF treatments. Given bipartisan support for these efforts in US Congress, there is potential for some action at the federal level even though several states already mandate coverage of certain IVF services by health insurance plans. Particular interest will be on how the Trump administration plans to make IVF services more affordable and ensure access to IVF treatment, with the executive order highlighting the Trump administration’s goal of easing “unnecessary statutory or regulatory burdens.”

    Interested parties should continue to monitor developments in this space by the Trump administration and in Congress, with the McDermott health & life sciences team ready to help with navigating federal statutory or regulatory changes impacting the fertility industry.

    In depth
    Authors

    ,IV M. Brian Hall

    Partner

    Washington, DC

    Sarah Kitchell

    Partner

    Boston

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  • FAQs on the Gender-Affirming Care Executive Order

    FAQs on the Gender-Affirming Care Executive Order

    FAQS / US POLICY

    FAQs on the Gender-Affirming Care Executive Order

    March 11, 2025

    Read time: 2 min

    Key takeaways
    Overview

    On January 28, 2025, the Trump administration issued an executive order that threatens federal research and education funding received by, and the Medicare and Medicaid participation of, medical institutions that provide gender-affirming care to individuals under the age of 19. Aspects of the executive order that jeopardize federal research and education funds have been enjoined nationally via several preliminary injunctions. However, regulatory and subregulatory actions on other aspects of the executive order are beginning to emerge. The executive order continues to present a myriad of legal and operational issues that medical institutions need to consider as they determine what actions, if any, to take in response to the executive order and the federal government’s efforts to implement it.

    This set of frequently asked questions (FAQs) provides an overview of these issues. It also discusses practical steps medical institutions should consider when evaluating their gender-affirming care programs in light of the executive order and federal efforts to restrict gender-affirming care for individuals under age 19 through the regulatory and subregulatory processes.

    In depth

    For information on the recent United States v. Skrmetti decision, download our related FAQs document which outline key takeaways for providers, hospitals, health systems, health plans, and employer plan sponsors who are navigating the implications of the ruling.

    Authors

    Travis Jackson

    Partner

    Los Angeles

    Kristen O'Brien

    McDermott+

    Washington, DC

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  • Trump, Court Actions Curtail Union Involvement in Federal Contracts

    Trump, Court Actions Curtail Union Involvement in Federal Contracts

    CLIENT ALERT / US POLICY

    Trump, Court Actions Curtail Union Involvement in Federal Contracts

    February 7, 2025

    Read time: 5 min

    Key takeaways
    Overview

    Federal contractors spent the past three years navigating executive mandates limiting their ability to select their own workforces after being awarded a large federal service contract. These mandates also required them to use unionized workforces on certain federal construction projects, even when these requirements increased costs or delayed project completion. In the span of two days, the Trump administration and the US Court of Federal Claims took successive action to remove some of these requirements, providing federal contractors greater flexibility in managing their workforces and costs when bidding on and fulfilling federal contracts:

    • On January 20, 2025, President Donald Trump revoked a Biden administration rule requiring federal contractors to offer continued employment to their predecessor’s employees, even when the predecessor’s unionized employees may not be ideally suited to fulfill the contract at issue. The Biden executive order (EO) made successor contractors “perfectly clear successors” under the National Labor Relations Act (NLRA) when the predecessor contractor had a unionized workforce. The “perfectly clear successor” designation required the successor contractor to bargain initial terms with the union or recognize an existing collective bargaining agreement.
    • On January 21, 2025, the US Court of Federal Claims invalidated a Biden administration mandate that all federal contractors awarded construction projects costing $35 million or more use unionized workers, in large part because the government’s own studies established that the mandate was anticompetitive and increased costs.

    The net result of these actions is that contractors can once again bid for and execute federal contracts to the best of their ability and in a cost-effective manner without having to assume certain obligations to union employees. Federal contractors should review current and upcoming bidding opportunities to determine if they can offer increased savings over incumbents through more competitive pricing.

    In depth

    Elimination of Employees’ “Right of First Refusal”

    Before January 2025, any federal contractor that won a service contract valued at more than $250,000 was required to offer existing employees a “right of first refusal” before hiring a new workforce. For example, a contractor that won a facility maintenance contract previously held by a different contractor must offer the prior contractor’s employees’ jobs before hiring its own candidates. This often led to legal obligations and operational issues, including the following:

    • Under the NLRA, a successor employer acquiring a unionized operation may set its own initial terms of employment for union employees prior to bargaining, unless the successor employer is a “perfectly clear successor.” A successor is a “perfectly clear successor” if it intends to hire all, or virtually all, the predecessor’s employees. A “perfectly clear successor” cannot set its own initial employment terms before bargaining with the union and must comply with all its predecessor’s obligations, including any existing collective bargaining agreements and/or bargaining obligations. As a result, the Biden EO’s “right of first refusal” often acted as a requirement that contractors interested in bidding on certain service agreements be willing to assume union bargaining obligations as the cost of entry, even when doing so impacted their ability to perform the contract on budget.
    • The predecessor may have been saddled with staffing or employment contracts objectively shown to increase costs and delay fulfillment of the contract’s requirements.

    No more. Now, federal contractors must focus on cost-effectiveness and efficiency when determining how to staff new contracts, even when that means hiring new employees.

    Elimination of Mandatory Project Labor Agreements

    Project labor agreements (PLAs) are collective bargaining agreements between a contractor and a union covering workers on a specific construction project. Until January 2025, an EO issued by former President Joe Biden required any federal contractor capable of bidding on a large construction project valued over $35 million to execute a PLA with a union just to be eligible for the contract.

    The impact of this order was stark: When a contractor without a PLA submitted a competitive bid that was under budget, it was rejected out of hand, even if every other bidder came in over budget based on costs associated with their PLAs. Consequently, these contractors were forced to recognize and bargain with a union if they were awarded a qualified contract.

    No more. The US Court of Federal Claims ruled the mandate is unlawful as applied because the “agencies’ own market research conclude[ed] project labor agreements would be anticompetitive,” but the agencies required PLAs anyway. Moving forward, federal agencies must utilize selection criteria designed to award contracts to the most qualified and cost-effective contractor through open competition, regardless of whether that contractor uses union workers.

    Next Steps

    Both developments discussed above reflect the anticipated pro-business policy shifts underway at all federal agencies under the current administration. The US Court of Claims decision applies to the specific contracts at issue in that case and to future agency decisions. It does not apply retroactively. Any contractors currently operating with a PLA must continue to abide by its terms until it expires. Future contracts, however, will not be subject to the PLA requirement.

    Federal contractors bidding on construction contracts or service agreements should quickly reassess current and upcoming contract opportunities and the workforce obligations that come with applying for and maintaining relevant federal contracts. Service contractors will have greater flexibility in managing their workforces and interacting with incumbent unions on predecessor contracts. In addition, potential service contractors without unions can remain union-free while applying for federal contracts.

    Authors

    Tony W. Torain II

    Partner

    Washington, DC, New York – One Vanderbilt Avenue

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  • Responding to Stop Work Orders Implementing Recent Executive Orders

    Responding to Stop Work Orders Implementing Recent Executive Orders

    CLIENT ALERT / US POLICY

    Responding to Stop Work Orders Implementing Recent Executive Orders

    February 4, 2025

    Read time: 9 min

    Key takeaways
    Overview

    Since the inauguration of US President Donald Trump on January 20, 2025, many companies that hold or support Federal contracts, grants, and other awards have received so-called “stop work orders” or other directives to cease certain activities in connection with their Federal work. Federal agencies have issued many of these orders and directives to prime contractors and recipients. In turn, those prime contractors and recipients have passed them onto subcontractors and subrecipients, among others.

    In depth

    On January 31 and February 3, 2025, Federal district courts in Rhode Island and the District of Columbia simplified the playbook for responding to many of these stop work orders. On January 31, the US District Court for Rhode Island issued a Temporary Restraining Order (the Rhode Island TRO) in a lawsuit filed by 23 state attorneys general challenging a January 27, 2025, memorandum issued by the Office of Management and Budget (OMB) pausing all disbursements and obligations under Federal grants, cooperative agreements, and other Federal financial assistance subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 C.F.R. Part 200 (the Uniform Guidance).

    The Rhode Island TRO directs that President Trump, OMB, and various Federal agencies named as defendants in the lawsuit “shall not pause, freeze, impede, block, cancel, or terminate [the Government’s] compliance with awards and obligations to provide federal financial assistance to the States,” and “shall not impede the States’ access to such awards and obligations, except on the basis of the applicable authorizing statutes, regulations, and terms.” The Court ordered the defendants’ lawyers to provide written notice of the TRO to all “agencies and their employees, contractors, and grantees” and to file a copy of the notice with the Court. In a filing on February 3, the defendants’ lawyers confirmed that written notice had been sent to the referenced parties on January 31, 2025, and filed a copy of that notice with the Court (the Government’s notice).

    The Rhode Island District Court found that the state attorneys general were likely to succeed on their claims that the pause in disbursements exceeds the executive branch’s authority under the US Constitution and applicable statutes. The Court ruled:

    The Executive’s action unilaterally suspends the payment of federal funds to the States and others simply by choosing to do so, no matter the authorizing or appropriating statute, the regulatory regime, or the terms of the grant itself. The Executive cites no legal authority allowing it to do so; indeed, no federal law would authorize the Executive’s unilateral action here.

    Although OMB had rescinded its January 27 memorandum on January 29, the Rhode Island District Court found that “the alleged rescission of the OMB Directive was in name only and may have been issued simply to defeat the jurisdiction of the courts. The substantive effect of the directive carries on.”

    On February 3, the US District Court for the District of Columbia issued a similar injunction (the DC TRO) in a lawsuit filed by several coalitions of nonprofit organizations. Although the Trump administration had already interpreted the Rhode Island TRO as applying to “all awards or obligations – not just those involving the Plaintiff States,” the DC TRO enjoins the implementation of the January 27 memorandum “to the maximum extent provided for by Federal Rule of Civil Procedure 65(d)(2) and 5 U.S.C. §§ 705 and 706,” the latter of which has been interpreted to authorize injunctions without party limitation. And whereas the Rhode Island TRO prohibited the Government from “imped[ing] the States’ access to awards and obligations,” the DC TRO directs the Government “to release any disbursements on open awards that were paused” because of OMB’s January 27 memorandum.

    Based on the Rhode Island and DC TROs, companies that received a stop work order invoking any of the executive orders issued by the Trump administration since January 20 should immediately seek clarification from the agency that issued the order on (1) whether and to what extend the order remains in effect, and (2) the legal basis for giving any effect to the order in the wake of the Rhode Island and DC TROs. Companies that plan to resume operations that were previously stopped or suspended should advise agencies of their plans, and companies that have identified cost impacts and disruptions from the stop work orders should advise agencies of those impacts and disruptions to the best of their ability. Companies should direct the attention of the agency that issued the order to the Rhode Island and DC TROs, as well as the Government’s notice to agencies regarding the Rhode Island TRO, which states, “Federal agencies cannot pause, freeze, impede, block, cancel, or terminate any awards or obligations on the basis of the OMB Memo, or on the basis of the President’s recently issued Executive Orders.” Although the Government’s notice was required to be disseminated to all Government “employees, contractors, and grantees by Monday, February 3, 2025, at 9 a.m.,” many companies that received stop work orders have yet to receive this notice. Companies should also follow up on all outstanding payment requests and demand payment for any amounts due. As noted above, the DC TRO expressly directs the Government “to release any disbursements on open awards that were paused” because of OMB’s January 27 memorandum.

    The Rhode Island and DC TROs arguably are limited to awards of Federal financial assistance under the Uniform Guidance, as those awards were the subject of the since-rescinded January 27 OMB memorandum that triggered the lawsuits. As such, the Rhode Island and DC TROs arguably do not directly enjoin pauses in disbursements resulting from stop work orders issued under procurement contracts subject to the Federal Acquisition Regulation (FAR) at 48 C.F.R. Parts 1-52. Although much of the reasoning behind the Rhode Island and DC TROs should also condemn similar stop work orders issued under the clause at FAR 52.242-15, Stop Work Order, companies should be aware of substantial differences between the FAR and the Uniform Guidance in this area.

    Unlike the FAR, the Uniform Guidance generally does not provide for a broad right to terminate grants, cooperative agreements, and other awards for the Government’s convenience. Rather, 2 C.F.R. 200.340(a)(4) contemplates that a Federal award may be terminated “pursuant to the terms and conditions of the Federal Award, including, to the extent authorized by law, if an award no longer effectuates the program goals or agency priorities.” The Uniform Guidance does not contemplate stop work orders or suspensions of performance at all, although some agency supplements to the Uniform Guidance do, with reference to similar language to Section 200.340. Regardless, the “program goals” and “agency priorities” referenced in Section 200.340(a)(4) are the goals and priorities established for the program at the time the grant was awarded. The regulatory history of this provision does not indicate that it was intended to provide the Government with a vehicle to unilaterally terminate – or suspend – grants because the Government no longer wishes to achieve those goals and priorities. Moreover, Section 200.340, by its terms, does not give the Government any rights, and instead directs the parties to a grant to the “terms and conditions of the Federal Award.” Individual awards may not address terminations for anything other than nonperformance or may include termination provisions that more closely resemble FAR termination for convenience clauses.

    Although the FAR provides Government agencies with a broad right to terminate contracts for the Government’s convenience, and although the FAR specifically allows the Government to stop work under a contract, the reasoning in the Rhode Island and DC TROs calls into question stop work orders issued under procurement contracts as well. Contractors that received stop work orders invoking the Trump administration’s executive orders should seek to clarify the status of those orders following the TROs. Contractors seeking to recommence performance under a stopped contract can also submit a claim under the Contract Disputes Act seeking a declaration that the stop work order is unlawful. Such a claim may be a prerequisite to further judicial review for FAR-based contracts, particularly if the contracting agency does not provide the requested clarification.

    Next Steps

    Although the Rhode Island and DC TROs should trigger the rescission of many stop work orders issued since the inauguration, more stop work orders are likely to come. The Government’s notice to agencies regarding the Rhode Island TRO emphasizes that, “Agencies may exercise their own authority to pause awards or obligations, provided agencies do so purely based on their own discretion – not as a result of the OMB Memo or the President’s Executive Orders – and provided the pause complies with all notice and procedural requirements in the award, agreement, or other instrument relating to such a pause.”

    For companies holding grants, cooperative agreements, and other awards under the Uniform Guidance, we have prepared a checklist to help companies digest and respond to stop work orders invoking the Trump administration’s executive orders, as well as stop work orders that attempt to navigate the Rhode Island and DC TROs. Companies receiving stop work orders under the FAR will spend substantially less time determining the source and scope of the government’s rights under the contract than companies receiving stop work orders ceasing performance of awards under the Uniform Guidance and can more easily determine whether to dispute a stop work order and proceed accordingly.

    McDermott’s Government Contracts Group can assist contractors and recipients in navigating this evolving landscape. For more information, reach out to the authors of this article or your regular McDermott lawyer(s).

    Authors

    Daniel P. Graham

    Partner

    Washington, DC

    Tara L. Ward

    Partner

    Washington, DC

    Llewelyn M. Engel

    Partner

    Washington, DC

    Peter M. Routh

    Associate

    Washington, DC

    Elizabeth Hummel

    Associate

    Chicago

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  • Trump Administration Places DOL’s ESOP Proposals in Regulatory Moratorium

    Trump Administration Places DOL’s ESOP Proposals in Regulatory Moratorium

    CLIENT ALERT / US POLICY

    Trump Administration Places DOL’s ESOP Proposals in Regulatory Moratorium

    February 4, 2025

    Read time: 7 min

    Key takeaways
    Overview

    On January 16, 2025, the US Department of Labor’s (DOL) Employee Benefits Security Administration (EBSA) released two pieces of guidance that, if finalized, would dramatically change the landscape for fiduciaries responsible for determining the value of stock in privately held corporations when engaging in a transaction with an employee stock ownership plan (ESOP). The first piece of guidance involves the long-awaited and highly anticipated “adequate consideration” regulations under the Employee Retirement Income Security Act of 1974 (ERISA), which apply when setting the price at which an ESOP can buy and sell stock. The second piece involves a proposed prohibited transaction exemption (PTE) that would create a safe harbor for selling shareholders and plan fiduciaries when engaging in an initial transaction with a newly established ESOP.

    On January 20, 2025, a slew of executive orders issued by the new administration froze all pending proposals from the prior administration, including the proposed regulations and the proposed PTE. Previously scheduled to be published in the Federal Register on January 22, 2025, the proposed guidance was withdrawn, and its unpublished versions were removed from the Federal Register website until new administration can review and approve – or modify in whole or in part – the proposed adequate consideration regulations and the proposed PTE.

    Given the removal of the proposed guidance from the Federal Register, the recently issued proposed regulations and PTE have no force or effect. We caution against using such information to guide current thinking on ESOP transactions.

    In depth

    Adequate Consideration Under ERISA

    Background

    The proposed adequate consideration regulations released on January 16 aimed to provide more clarity on valuing non-publicly traded employer stock acquired or sold by ESOPs in accordance with ERISA’s requirements. The acquisition or sale of qualifying employer securities is not exempt from the prohibited transaction rules under ERISA unless, among other requirements, the transaction is for adequate consideration. Current guidance (namely, the 1988 DOL proposed regulations) defines adequate consideration as a price not less favorable to the plan than the “fair market value” of the stock determined in good faith by the trustee or named fiduciary pursuant to the terms of the plan and in accordance with regulations promulgated by the DOL. Fair market value for purposes of the definition of adequate consideration is the price at which an asset would change hands between a willing buyer and a willing seller. The absence of clearer and more objective guidance regarding the definition of “adequate consideration” – other than the “I know it when I see it test” – has exposed ESOPs and their fiduciaries to expensive lawsuits over the years that challenge the valuation process or methodology used, the substantive value concluded, and/or both in ESOP transactions.

    Proposed Regulation

    The January 16 proposed regulations set forth a two-part test for adequate consideration: fair market value and a good faith determination of that value:

    1. If the employer stock is not readily tradable, fair market value generally means the price at which the employer stock would change hands in an arm’s-length transaction between a willing buyer and a willing seller when the former is not under any compulsion to buy and the latter is not under any compulsion to sell, the parties are both willing and able to trade, and have reasonable knowledge of the facts relevant to the stock’s value.
    2. Whether the fair market value has been determined in good faith entails independent plan trustees or named fiduciaries determining value in accordance with a prudent process designed to ensure a sound conclusion as to the stock’s fair market value in accordance with ERISA’s fiduciary standards of prudence and loyalty. Components of such a process include requirements that the fiduciary prudently:
      1. Select a qualified independent appraiser to prepare a written valuation report.
      2. Oversee production of a written valuation report based on complete, current, and accurate information.
      3. Review the valuation report to ensure that it may reasonably be relied upon.

    It is further noted that the preamble to the adequate consideration regulations emphasizes the need for a “prudent” and good faith process to determine if adequate consideration has been appropriately determined. Unfortunately, while purporting to focus on fiduciary process, the proposed adequate consideration regulations go further to prescribe certain absolute requirements that should, in our view, be left to the appropriate fiduciary review and process, as opposed to dictated by regulation. A deep dive into such issues is beyond the scope of this alert, but it is noted that even if reissued and finalized in their proposed form, the adequate consideration regulations are not likely to make establishing new ESOPs easier, less costly, or subject to less litigation.

    The proposed adequate consideration regulations include a revocation of the 1988 proposed rule, which was never finalized or withdrawn by the DOL. However, until reissuance of the withdrawn January 16 proposed regulations, they may not be used as the standard for review by the DOL, and fiduciaries and courts must continue – reluctantly – to rely on the 1988 proposed regulations for guidance.

    Proposed PTE Safe Harbor

    The proposed PTE establishes a safe harbor for fiduciaries buying, and shareholders (of the ESOP sponsor) selling, non-publicly traded employer stock in an initial transaction with a newly established ESOP. The safe harbor in the proposed PTE is subject to protective conditions designed to ensure that any transaction relying on the safe harbor complies with ERISA.

    Specifically, any trustee that represents the interests of the ESOP in a transaction must be independent of the employer and solely responsible for determining the appropriate transaction purchase price for the employer stock. The independent trustee may rely upon a valuation of an appraiser so long as the appraiser is independent of the employer and the independent trustee determines that the appraiser’s advice is sound, prudent, and loyal to the ESOP participants. Lastly, the independent trustee and appraiser would be able to provide to the selling shareholders certifications to verify compliance with the exemption upon which the selling shareholders would be permitted to rely.

    As drafted, the tick-list approach of the proposed PTE would almost certainly have unintended negative consequences if ultimately finalized. As drafted, such guidance clearly erodes any focus on a thoughtful, principles-based valuation process and provides a false sense of security dependent on detailed and burdensome checklist items rather than an understanding of the underlying requirements and goals of an ESOP purchase. Further transactions following such PTE “rules” may or may not actually serve to protect participants who are the intended beneficiaries of an ESOP implementation transaction. The PTE also calls into question those plan sponsors, fiduciaries, and sellers who acted in good faith under the terms of the proposed adequate consideration regulations (if issued), which would further vitiate the certainty that was sought upon the ESOP community’s clamoring for appropriate guidance in the form of regulations.

    Ultimately, the new administration must now work its way through the proposed, and now suspended, regulations and PTE issued by the prior administration to determine what, if anything, will be kept on reissuance (if any). Practitioners, in the meantime, are left with the prior, antiquated guidance and significant uncertainty. This process has underscored the need for appropriate and thoughtful regulation that will allow employers to create ESOPs to benefit employees through an almost-solely employer-provided program.

    McDermott’s employee benefits team will continue to analyze in detail both proposals, ready comments on both proposals for consideration by the new administration, and provide a detailed analysis and commentary upon their release for public inspection in the Federal Register.

    Authors

    Allison Wilkerson

    Partner

    Dallas

    Erin Turley

    Partner

    Dallas

    Myriem Bennani

    Associate

    Chicago

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  • End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

    End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

    CLIENT ALERT / US POLICY

    End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

    February 3, 2025

    Read time: 6 min

    Key takeaways
    Overview

    On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies.

    Under the new guidance, titled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (503A interim policy) and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (503B interim policy), FDA will change certain procedures related to the collection and publication of information on bulk drug substances. Specifically, FDA will no longer categorize and publish bulk substances submitted for inclusion on the 503A and 503B bulk lists to its website. FDA states that these procedures no longer serve the agency’s objective to avoid disruption in patient care.

    In depth

    Background

    Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) allow compounded drug products to be exempt from some otherwise fundamental statutory requirements – such as use labeling, or new drug application or abbreviated new drug application review – if certain conditions are met. Section 503A applies to compounding pharmacies, and Section 503B applies to registered outsourcing facilities that may prepare orders that are not patient specific. Both sections require that compounded products utilize bulk drug substances that:

    • Comply with the standards of the US Pharmacopeia or National Formulary monograph, if applicable
    • Are components of FDA-approved drugs
    • Appear on the respective bulk drug list

    See our previous On the Subject for a discussion of the requirements of Sections 503A and 503B in greater detail.

    To assist FDA in developing the 503A and 503B bulk lists, it has historically requested nominations for bulk drug substances along with supporting detailed information regarding clinical needs. Since 2013, FDA has received thousands of nominations from industry stakeholders for certain bulk substances to be included in either or both lists. Because regulatory review would necessarily take significant time and resources, stakeholders raised concerns regarding disruptions to patient care in the interim period between nomination and publication of the final lists, during which time compounding would be prohibited.

    The 2017 Interim Policies

    In 2017, to address stakeholder concerns about potential interruption to compounding services while balancing FDA’s bulk drug information requirements, the FDA issued parallel 503A and 503B interim policies. These policies allowed nominated bulk substances to be used in compounding if FDA was sufficiently reassured that the substances met safety criteria.

    The policies explained that FDA would review the current nominations on a rolling basis, categorize the nominations into one of three categories discussed below, and publish the categorization to the FDA website.

    • Category 1 – Substances Nominated for Bulks List Currently Under Evaluation
    • Category 2 – Substances Nominated for the Bulks List That Raise Significant Safety Risk
    • Category 3 – Substances Nominated for the Bulks List Without Adequate Support

    Under the 2017 interim policies, Category 1 substances were substances eligible for inclusion on the bulk lists and nominated with sufficient supporting information. Category 2 and 3 substances were potentially eligible for the lists but contained safety risks or were nominated with insufficient supporting information. FDA advised that it did not intend to take action against state-licensed pharmacies, federal facilities, or licensed physicians for compounding drug products using unapproved bulk substances in Category 1 provided all of the following conditions were met:

    • The original and all subsequent manufacturers of the bulk substance were registered under Section 510 of the FDCA
    • The bulk substance had a valid certificate of analysis
    • The compounded drug product using the bulk substance was created in compliance with all other conditions of Sections 503A and 503B.

    The 2025 Interim Policies

    The new 2025 interim policies eliminate the use of Categories 2 and 3. Bulk substance nominations submitted on or after January 7, 2025, will no longer be categorized and published to the FDA website, although FDA will continue to review nominations it receives. According to FDA, the 2017 interim policies’ categorization of nominations “no longer serves the interim [policies’] stated objective of avoiding unnecessary disruption to patient treatment.” Instead, FDA notes that nominators have had ample opportunity to provide sufficient supporting information for the placement of bulk drug substances in Category 1 since the introduction of the policies in 2017.

    FDA confirmed that bulk substances currently listed in Category 1 will continue to be afforded the enforcement discretion provided under the previous policies. Bulk substances listed in Categories 2 or 3 will not be afforded such discretion even where stakeholders update the nominations to provide sufficient information. FDA clarified that it will focus resources on finalizing the 503A and 503B bulk drug lists through rulemaking in batches.

    Analysis

    The 2025 interim policies indicate FDA’s continued focus on regulating the compounding of drugs under Sections 503A and 503B. The updated policies further indicate FDA’s intention to finalize the bulk drug lists through rulemaking, a process that has spanned almost a decade. The new interim policies should not change the current practice of compounding: Category 1 drug substances will remain generally available for compounding, but FDA reserves its authority to exercise enforcement discretion. However, stakeholders should be aware that new nominations to the bulk lists will not be afforded enforcement discretion and should not be compounded until published in the finalized bulk drug lists following their complete evaluation by FDA.

    The McDermott Difference

    McDermott will continue to monitor updates on these interim policies and any notices related to the bulk drug lists. For more information, please contact one of the authors or any other member of McDermott’s Food, Drug & Medical Device Regulatory Practice Group.

    Authors

    James R. Ravitz

    Partner

    Washington, DC

    Jeff Weinstein

    Counsel

    Washington, DC

    Marissa Hill Daley

    Associate

    Washington, DC

    Jae Hyun Lee

    Associate

    New York – One Vanderbilt Avenue

    Tyler Barton

    Associate

    New York – One Vanderbilt Avenue

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  • How Employers and Healthcare Providers Can Navigate Immigration Enforcement

    How Employers and Healthcare Providers Can Navigate Immigration Enforcement

    CLIENT ALERT / US POLICY

    How Employers and Healthcare Providers Can Navigate Immigration Enforcement

    January 30, 2025

    Read time: 10 min

    Key takeaways
    Overview

    Despite the anticipation of increased enforcement of US immigration laws, the rules and practical advice related to an employer’s legal duties under the Immigration Reform and Control Act (IRCA) and what to do if US Immigration and Customs Enforcement (ICE) officers present themselves at your place of business have not changed.

    This client alert provides a brief overview, proactive suggestions, and practical tips for employers, as well as for healthcare providers, whose patients may be the target of an ICE visit.

    In depth

    Employer’s Legal Duties Under the IRCA, and DHS-ICE Authority to Enforce Immigration Laws

    Under the IRCA, it is unlawful in the United States to hire, recruit, or continue to employ a person who is not in the country legally and not authorized to work (“an unauthorized alien,” as defined by law). An employer has a defense if it, in good faith, reviewed and accepted Form I-9 documentation that reasonably appeared to be genuine on its face.

    The US Department of Homeland Security (DHS) has the authority to conduct worksite inspections and audits. ICE, the DHS component responsible for enforcing the IRCA, has the authority to appear at a worksite with a notice of inspection or subpoena, demanding the production of various documents within three days, including:

    • Historical lists of workers
    • Payroll and tax records
    • Company ownership information
    • Staffing vendor information
    • I-9 forms
    • Copies of identity and authorization documents presented by employees

    During an audit, ICE may issue a “Notice of Suspect Documents” for workers believed to be unauthorized based on database checks, even if the Form I-9 was completed correctly. Employers must either contest the finding or terminate the workers, often with little time for resolution. ICE is rarely wrong about suspect documents, and confronting the worker often results in the worker not returning to work.

    DHS may investigate employers, plant undercover agents within the workforce, and conduct raids with armed agents, presenting search and seizure warrants. They may seize documents, computers, and phones, and arrest unauthorized workers. The department may also prosecute employer owners and managers on charges such as harboring and trafficking unauthorized workers, mail and wire fraud, document fraud, and tax evasion. Criminal charges can result in significant fines and imprisonment.

    ICE has the authority to arrest and detain most non-citizens, including those with arrest histories and certain long-term permanent residents. It can conduct workplace raids and other enforcement activities to effectuate these arrests. ICE must present a judicial warrant to enter nonpublic areas of a workplace. A judicial warrant is signed by a federal judge, not an immigration officer. The warrant must provide specific details, such as the name of the individual to be arrested, the location, and the reason for the arrest. Without a warrant, ICE is only allowed to be in public areas of the workplace.

    According to a recent DHS memorandum, the department is availing itself of law enforcement components of the US Department of Justice (DOJ) – including the US Drug Enforcement Administration (DEA), the ATF, the US Marshals Service, and the Federal Bureau of Prisons (BOP) – to carry out “functions” of an immigration officer to enforce immigration law. Historically, only the US Marshals were tapped to assist when a migrant became a fugitive. Although it remains to be seen how these DOJ law enforcement resources will be directed, it is possible that DHS’s immigration enforcement capacity will be more far-reaching than under previous administrations.

    Potential Sanctions and Penalties

    Employers are subject to sanctions for incorrectly completed I-9 forms, missing forms, or knowingly hiring unauthorized workers, which can range from $300 to $30,000 per worker, as well as debarment from federal contracts. Employers are allowed 10 days to correct technical errors, but certain substantive errors cannot be corrected to avoid penalties. ICE can also fine employers for failing to comply with technical requirements for electronic storage of completed forms.

    Interfering with an ICE arrest warrant can also lead to criminal charges for obstructing justice. This can include fines and imprisonment, depending on the severity of the interference.

    General Tips for All Employers

    • Maintain and enforce a comprehensive, compliant immigration policy.
    • Identify coordinators and designated points of contact in the event of any visit by ICE agents, including an ICE raid.
    • Conduct annual self-audits of I-9 forms to identify and address any issues before enforcement actions occur. Note: An employer is required to accept a List A document, or a List B and C document, from employees. Accepting and keeping copies of too many documents is also an IRCA violation.
      • Hint: If an employee presents a document from all three lists, return them and ask them to either provide a List A document, or provide a List B and a List C document. Let the employee choose, then review the requisite and correct number of documents for the Form I-9 Verification.
    • Ensure proper Form I-9 verification and storage, including in digital format. Designate and train individuals in I-9 verification and retention.
    • Enroll in E-Verify to verify social security numbers and names and ensure compliance with the IRCA. E-Verify is a platinum standard protection for employers. But it is not a safe harbor. Employers can still be fined for I-9 violations.
    • Use the Social Security Administration (SSA) website, if your organization is not enrolled in E-Verify, to confirm social security numbers match the employee’s name and identification.
    • Comply with no-match letters from the SSA by presenting the letter to the employee and asking them to present correct and valid documentation. Check that new documentation matches the name using the SSA website.
    • Identify and stop systematic improprieties in hiring practices.
    • Pay employees and submit tax withholding payments correctly, using real and correct social security numbers.
    • Educate staff on how to interact with ICE, DHS, or other law enforcement agents, including calling counsel and managing the situation calmly and professionally.

    Special Considerations for Hospitals and Other Healthcare Facilities

    In 2011 and 2021, ICE established a policy that generally prohibited engaging in enforcement actions at “sensitive locations,” such as healthcare facilities, schools, and religious institutions, unless exigent circumstances existed (namely, public safety threats, imminent risk of death, violence, physical harm, or destruction of evidence material to an ongoing investigation). On January 20, 2025, the Trump administration rescinded that policy, and ICE may again conduct enforcement actions in these locations. Enforcement actions may include interviews, arrests, searches, inspections, surveillance, and requests for protected health information (PHI). The Privacy Rule adopted under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits (but does not require) disclosure of PHI in accordance with a valid court order or court-ordered warrant or a subpoena or summons issued by a judicial officer.

    Healthcare professionals may have state law or ethical obligations to consider the best interests of patients. Accordingly, healthcare workers should consider any state law or ethical responsibilities to protect patients’ health with their obligations to comply with federal law. For example, in a case where ICE presents a valid judicial warrant for the arrest of a patient, if that patient is in a life-threatening or severe state, the healthcare provider could explain this to ICE officers and request that ICE officials work with the healthcare provider to determine a safe course of action for the patient.

    Tips for Healthcare Facilities

    • Ensure staff members are familiar with the organization’s policies on patient confidentiality and the rights of both patients and healthcare providers.
    • Comply with the law and be mindful of emerging state laws on this issue. California is advising healthcare providers not to document patients’ immigration status on bills and medical records and advising patients and providers that they do not have to assist federal agents in arrests. Florida and Texas, by contrast, require healthcare facilities that accept Medicaid to ask the immigration status of patients (although a patient may decline to answer) and tally the cost to taxpayers of providing care to immigrants living in the United States without authorization.
    • Develop and train on protocols that outline the steps to be taken in the event of an ICE raid.
    • Designate specific roles to appropriate staff members, such as who will act as the point of contact with ICE agents and who will interact with patient(s) in question.
    • Healthcare facilities may post signage about patient rights, including that exam-room conversations are confidential and that privacy laws protect information in the medical record (including identifying information), and patients’ right to remain silent in the event of an ICE raid.
    • Healthcare facilities that are HIPAA-covered entities must provide patients an opportunity to decline to be listed in a facility directory or otherwise restrict or prohibit use of PHI for facility directory purpose.

    What To Do If an ICE Agent Visits, or if Raids Occur at a Healthcare Facility

    • All staff members should remain calm and composed.
    • Only the designated points of contact should interact with ICE agents. These individuals should be well-versed in the organization’s policies and the legal rights of patients and staff.
    • Designated points of contact should have ICE agents identify themselves by name and badge number. While healthcare workers and organizations have no affirmative legal obligation to report undocumented immigrants to officials, healthcare workers must lawfully abide with providing information and access to facilities where a valid warrant is presented.
    • Designated points of contact should politely request to see and review any warrants presented by ICE agents and ensure the warrants are valid and specific to the premises before permitting access to any private areas. For the warrant to be valid, it must be signed by a federal judge (a judge’s signature will indicate such).
      • Hint: If the warrant is a DHS Form I-200 or I-205 signed by an immigration officer, this is not a judicial warrant. In this case, the healthcare provider can advise the ICE agent that the warrant is not a valid judicial warrant and that the ICE agents may not enter any private areas – they must remain only in public areas.
    • Points of contact should provide information or documents required by a valid warrant but need not provide information or records falling outside of the warrant to maintain patient confidentiality.
    • After the ICE visit or raid, document the event by immediately identifying the names and badge numbers of ICE agents who were present, the time and duration of their presence, and any actions taken by the agents. Secure all patient records that may have been accessed during the event.
    • Patient liaisons may reach out to all patients affected by the raid to inform them of what occurred and reassure them of their safety and the confidentiality of their records. Patient liaisons may also provide impacted patients and their families with information to immigration advocacy organizations and legal aid groups who can provide legal support, particularly if a patient is taken into immigration custody.

    Conclusion

    Employers and healthcare providers must remain vigilant and proactive in managing immigration compliance to avoid significant penalties and disruptions. By following these tips and working closely with experienced counsel, organizations can be in legal compliance, navigate the complexities of immigration control, and protect their businesses and managers.

    Authors

    Joan-Elisse Carpentier

    Partner

    New York – One Vanderbilt Avenue, San Francisco

    Yesenia M. Gallegos

    Partner

    Los Angeles

    Joseph Mulherin

    Partner

    Chicago

    Maria C. Rodriguez

    Partner

    Los Angeles

    Mary Schnoor

    Partner

    Washington, DC

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  • Unpacking the Biden Administration’s Last-Minute Antitrust Worker Protections

    Unpacking the Biden Administration’s Last-Minute Antitrust Worker Protections

    CLIENT ALERT / US POLICY

    Unpacking the Biden Administration’s Last-Minute Antitrust Worker Protections

    January 22, 2025

    Read time: 6 min

    Key takeaways
    Overview

    In the final week of the Biden administration, the antitrust enforcement agencies – the Federal Trade Commission (FTC) and the US Department of Justice (DOJ) – released two policies potentially impacting labor markets. The first, released by the FTC on January 14, 2025, is a Policy Statement on the Exemption of Protected Labor Activity for Independent Contractors. The second, released concurrently by the FTC and DOJ on January 16, 2025, is the Antitrust Guidelines on Business Practices that Impact Workers. The policies address antitrust law as applied to workers in different ways.

    One policy contemplates new antitrust liability protections for independent contractors (especially “gig workers”) similar to the existing antitrust exemption for collective action by employees. The other provides a broad list of types of conduct by employers related to workers that “could” violate the antitrust laws. We expect the new Trump administration will revisit these last-minute policy releases. In the meantime, these policy statements and guidelines reflect agency positions and do not themselves change applicable law. The National Labor Relations Act continues to statutorily exclude independent contractors from unionization rights and processes.

    In depth

    Policy Statement on Labor Exemption for Independent Contractors

    In a 3-2 vote along partisan lines, the FTC released a policy statement that clarifies the antitrust liability for independent contractors involved in labor organizing. This policy statement extends the exemption from antitrust liability for labor organizing and bargaining to independent contractors and gig workers. The FTC clarifies their position is that the formal classification of a worker as an “employee” or as an “independent contractor” does not affect their potential protection from antitrust liability if they are engaged in protected labor activities such as organizing and collective bargaining activity.

    In the FTC’s open commission meeting on January 14, 2025, Commissioner Bedoya emphasized that labor organizing protections are rooted in the First Amendment and should not be dependent on whether somebody is paid on a 1099 or a W-2. Commissioner Slaughter referenced recent merger enforcement wins that proposed unionized labor as a plausible market for antitrust purposes as evidence that courts agree with such an interpretation. Commissioner Slaughter also expressed concern that the US Department of Labor, during President Trump’s first term, conducted rulemaking that ran counter to treating independent contractors similarly to employees. This may foreshadow how the FTC under the new Trump administration may view this policy statement.

    Commissioners Ferguson and Holyoak, the former having been selected as the next chair of the FTC, issued a short dissent in which they did not address the substance of the policy statement. However, they raised strong reservations about the FTC making such a statement so close to the Biden-Trump changeover, lending uncertainty to the statement’s future. Although the FTC, under the new Trump administration, likely cannot succeed in taking formal action to repeal the statement, which was issued by a majority of the commissioners, until a third Republican commissioner is confirmed, this categorical dissent likely means that such a repeal may be in the future. Mark Meador has been nominated by President Trump as the third Republican commissioner, but he will need to proceed through the Senate confirmation process before taking office and creating a Republican majority.

    Guidelines on Business Practices That Impact Workers

    In another final act, the Biden FTC and DOJ replaced the 2016 Antitrust Guidance for Human Resource Professionals with new Guidelines on Business Practices that Impact Workers. The new guidelines lay out a list of agreements that “may” violate the law, including:

    • Agreements between employers not to recruit, solicit, or hire workers, or to fix wages or terms of employment.
    • Agreements between franchisors and franchisees not to poach, hire, or solicit workers.
    • Exchanging competitively sensitive employment information among companies that compete for workers.
    • Employment restrictions that restrict workers’ freedom to leave their jobs.
    • Various potentially restrictive, exclusionary, or predatory employment conditions that harm competition, including overbroad nondisclosure agreements that effectively prevent a person from working in the same industry.

    The guidelines generally do not provide clarity around the circumstances under which various conduct will be viewed as violating the law. Instead, they provide a list of things that “may” violate the law and “general principles” for analyzing such cases. As such, although they purport to be “guidelines,” they are not particularly useful in providing clarity around the government’s approach to analyzing the conduct at issue but are more a shot across the bow, listing the conduct that could be problematic. Their practical usefulness seems limited, and companies will need to look to case law to try to assess their exposure rather than taking guidance from them.

    These guidelines were also released on a 3-2 vote along partisan lines. Commissioner Ferguson, again joined by Commissioner Holyoak, issued another scathing dissent. Although agreeing that the FTC has the responsibility to review and update its guidance, the dissent takes no position on the substance of the guidelines. Instead, the dissent, like that in the policy statement above, vehemently disagrees with the decision to take such an action in the waning days of the Biden administration, noting that it is inappropriate to release new guidance when “[t]he Biden-Harris FTC has no future.”

    Therefore, the only certainty is that the 2016 Guidance for Human Resource Professionals is no longer in effect.

    Recently, the Commission brought several cases aimed at protecting labor, including challenges to mergers of competing employers and cases involving other agreements among employers related to their labor practices, such as nonsolicit agreements. The Republican commissioners have supported some of those actions, so we expect that the Trump FTC will continue to pay attention to labor competition issues, but they will not be as progressive as the previous Democratic majority. Former FTC Chair Lina Khan announced she will leave the FTC in the coming weeks. Following that, the Commission will be split 2-2 on partisan lines until the fifth commissioner is confirmed, and it is unlikely the FTC will bring any novel enforcement actions under the new Guidelines on Business Practices that Impact Workers, but more mainstream labor theories will continue to be in play.

    A majority is also needed to repeal the new guidelines, so repeal is unlikely in the near term. However, once the third Republican commissioner is seated, it appears highly likely that the FTC will review and potentially repeal or significantly alter these new guidelines, particularly given the Republican commissioners’ dissent.

    Authors

    Jon B. Dubrow

    Partner

    Washington, DC

    Michelle Lowery

    Partner

    Los Angeles, Chicago

    Royce E. Brosseau

    Associate

    Washington, DC

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  • Data Privacy and Cybersecurity Developments We Are Watching in 2025

    Data Privacy and Cybersecurity Developments We Are Watching in 2025

    CLIENT ALERT / US POLICY

    Data Privacy and Cybersecurity Developments We Are Watching in 2025

    January 6, 2025

    Read time: 8 min

    Key takeaways
    Overview

    The act of predicting what will become the dominating storyline of data privacy and cybersecurity in 2025 is a hazardous enterprise, as one is almost surely to get something wrong. Without fail, every year, regulators and the plaintiffs’ bar push data privacy and cybersecurity in a direction that seemed unlikely the prior calendar year. Yet, we are undeterred. After canvassing our global group of data privacy and cybersecurity professionals, below are the topics that we are watching most closely as we kick off 2025. While these may not be the headlines that dominate when we look back after 12 months, we anticipate that companies will have spent significant time in 2025 working through the developments below.

    In depth

    Website Tracking: Make Sure You’re Doing It Right

    As we explained in our recent Cookie Deep Dive webinar, there has been an explosion of enforcement and litigation targeting the use of cookies, chat bots, session replay, and other technologies (collectively, cookies). Regulators in the United States have undertaken extensive investigations and imposed massive fines. Plaintiffs allege cookies constitute “wiretapping” under archaic laws such as the California Invasion of Privacy Act (CIPA), which permit statutory damages of $5,000 to $10,000 per violation. The trend of more plaintiffs’ firms asserting additional claims and increasing settlement demands is likely to escalate given the trend in recent CIPA jurisprudence. Fortunately, there was some good news for defendants in 2024. The Massachusetts Supreme Court, in a case argued by McDermott Partner Dave Gacioch, held that Massachusetts’ wiretapping law did not apply to cookies.

    To mitigate these heightened risks, clients are focusing more on cookie management while still enabling marketing, analytics, and data monetization. Now is the time to audit practices, document procedures, and make a plan, because we see no end in sight to these risks heading into 2025.

    Artificial Intelligence (AI): Because of Course

    There may not have been a bigger story in 2024 than the proliferation of publicly available AI tools. And the race to regulate AI likely is still in its early stages. Generative AI (GenAI) provides incredible capabilities but presents a bevy of privacy and potential security risks. GenAI tools also pose novel issues related to intellectual property rights and data ownership. To fully grasp and balance the potential risks and benefits of GenAI, companies first must understand the types of data being used to train the model, the provenance of such data, and ensure that the company has the appropriate rights and consents to use that data. Keeping up with the AI curve can feel daunting, but we have developed a series of standard operating procedures, templates, and training materials that can make things less scary. McDermott’s Artificial Intelligence Law Center is a resource for those looking to dig into this cutting-edge issue.

    PCI DSS 4.0: It’s Almost Here!

    The Payment Card Industry Data Security standard (PCI DSS) 4.0 for credit-card processing is fully effective March 31, 2025. If a company accepts credit cards as a merchant, it has PCI DSS and card-brand obligations under its contracts with its bank and any third-party processors. The new 4.0 security obligations are some of the most robust and onerous of any framework, and they will have numerous implications for any company taking, processing, or storing credit or debit cards. Preparing for these changes will require significant time and effort. The transition to new PCI DSS 4.0 controls involves numerous new workflows, including the need for new policies, processes, and technology solutions. We recently examined how PCI DSS 4.0 will impact digital health and healthcare companies, especially as e-commerce models expand.

    There are a number of challenges and obstacles to full PCI DSS 4.0 compliance, including the fact that many companies mistakenly believe that fully outsourcing credit card functions to a third-party payment platform exempts them from PCI DSS obligations. That is not true. If you are not sure about the state of your company’s PCI DSS compliance, now is the time to dig in.

    Federal Privacy Regulation and Enforcement: What Comes Next?

    What will the second Trump administration bring? Between chatter of shuttering entire agencies and shifting enforcement priorities, the one thing that is clear is that 2025 will see a change in the way that the federal government approaches its role in the consumer privacy arena.

    One development we are watching is what is going to happen with the Consumer Financial Protection Bureau (CFPB). The CFPB recently issued a proposed rule seeking to bring certain data brokers within the scope of the Fair Credit Reporting Act (FCRA). The proposed rule would revise the definitions of “consumer reporting agency” and “consumer report” in Regulation V and modify restrictions on when consumer reporting agencies may furnish, and users may obtain, consumer reports. Comments on the proposed rule are due March 3, 2025, but what will be interesting to see is whether the rule making process will continue under the new administration.

    State Laws: You Knew We Couldn’t Omit This One

    Seven. That was the number of new state consumer privacy laws passed in 2024. That was on the heels of eight new laws passed in 2023. The smart money for 2025 is that there will be another half-dozen states that enact consumer privacy laws as we move closer and closer to a complete patchwork of state consumer privacy laws in the absence of a federal consumer privacy law (the likelihood of which, under Republican control, is low). It can be hard to keep up with all the changes and requirements of the different laws, which is why McDermott has an online resource to help you keep track. Our consumer privacy law map is regularly updated and is a free resource.

    Another thing that bears watching, of course, is the progress of the new California Consumer Privacy Act (CCPA) regulations, which are in the public comment period. These proposed regulations are onerous and overbroad, and they seem destined for a legal challenge if they are finalized.

    EU Data Act: Something Like We’ve Never Seen Before

    Among the EU Digital Package regulations, the EU Data Act is quite likely to be the most challenging to implement. We anticipate that many clients will begin or continue their implementation work streams well into 2025. The three primary obligations of the EU Data Act include:

    1. The obligation to provide an access mechanism by design and by default and, if technically feasible, to provide users with direct access to their data (Data Act, Art. 3(1)).
    2. The obligation to provide users with indirect access to their data (Data Act, Art. 4(1)).
    3. The obligation to provide third parties with data upon request from users (Data Act, Art. 5(1)).

    When these obligations become applicable will vary based on a variety of factors, including jurisdiction and product type. However, they will phase in between September 2025 and September 2026. Given this time frame, we anticipate that many companies will focus significant effort on their EU Data Act compliance activities in 2025 if they have not already started doing so.

    EU Cybersecurity Frameworks: Time to Revisit Past Practices

    In 2025, businesses operating in the EU will need to focus their cybersecurity efforts to comply with either the Network and Information Security 2 (NIS2) Directive (the cornerstone of the EU legal framework for cybersecurity), the Digital Operational Resilience Act (DORA, a cybersecurity regulation for financial institutions), or the Cyber Resilience Act (a regulation applying to manufacturers of products with digital elements placed on the EU market). This framework imposes, among others, cybersecurity controls and obligations to report incidents, and it is backed up by potentially heavy fines and, in some cases, personal liability of members of boards of directors.

    While the NIS2 Directive became applicable in October 2024, only a handful of EU countries (e.g., Belgium, Italy) have implemented the Directive through their legal order. In 2025, we expect other EU countries to do the same. The NIS2 Directive covers businesses from a broad spectrum of industries deemed highly critical – such as energy, health, and digital infrastructure – and critical. DORA becomes effective on January 17, 2025, and applies to financial institutions. For both DORA and NIS2, covered entities must implement measures ensuring supply chain security, including supply chain contractual terms with their direct suppliers/service providers.

    Take a Deep Breath: It Will (Mostly) Be OK

    Reviewing the above, it is easy to see how in-house privacy counsel could become overwhelmed. But for (almost) every problem, there is a solution. It begins with understanding whether any of the above laws apply to your business. Most companies have already some cybersecurity measures in place, so the project will inevitably entail conducting a gap analysis. At this point, companies will have to design methods to address and mitigate any existing gaps. McDermott has a variety of toolkits, templates, presentations, and other materials that can help companies address the privacy and cybersecurity challenges that they may face heading into 2025.

    If you have any questions or would like to discuss anything contained in this article, contact your regular McDermott lawyer or one of the article’s authors.

    Authors

    David P. Saunders

    Partner

    Chicago

    Mark E. Schreiber

    Counsel

    Boston

    David Sorenson

    Associate

    Los Angeles

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  • How Cross-Border M&A May Be Impacted by Trump Administration Tax Reform

    How Cross-Border M&A May Be Impacted by Trump Administration Tax Reform

    ARTICLE / CLIENT ALERT / US POLICY

    How Cross-Border M&A May Be Impacted by Trump Administration Tax Reform

    December 27, 2024

    Read time: 6 min

    Key takeaways
    Overview

    President-elect Donald Trump is set to return to the White House with Republicans narrowly securing both the US Senate and the US House of Representatives. Having control of both chambers positions the party well to pursue significant tax reforms, likely through the budget reconciliation process, similar to the Tax Cuts and Jobs Act of 2017 (TCJA). Although Trump did not present a formal tax proposal during his campaign, he highlighted key areas of tax policy, including extending TCJA provisions, introducing new tariffs, lowering corporate tax rates, and proposing an intellectual property (IP) purchasing initiative. These anticipated reforms are extensive and will impact individuals and businesses, with significant implications for cross-border mergers and acquisitions (M&A).

    In depth

    Extension of the TCJA

    Trump intends to seek an agreement to extend the TCJA’s expiring tax provisions within his first 100 days back in office, saying in a recent interview that it is one of his top priorities. Despite Trump’s remarks, disagreement among Republicans in US Congress has raised questions on how quickly those provisions could be extended. Senate Republican leaders want two separate reconciliation bills next year to address border policy first and tax provisions later. However, House Ways and Means Committee Chair Jason Smith intends to advocate for one bill in 2025, warning that delaying tax measures could hinder lawmaker support.

    Extending the TCJA provisions beyond 2025 may have a significant influence on cross-border M&A by maintaining the current tax incentives and regulatory environment that shape these transactions. For example, the bonus depreciation provision, which allows businesses to immediately deduct a large percentage of the cost of eligible property, would continue to incentivize capital investments by reducing upfront costs. In many M&A transactions, buyers engage in basis step-up planning to increase the tax basis of the acquired assets to their fair market value at the time of purchase, which can lead to higher depreciation deductions, further reducing taxable income and enhancing the financial attractiveness of such deals. This can be particularly relevant for non-US buyers who acquire US businesses with material hard assets that may qualify for 100% bonus depreciation. Trump has also proposed a research and development (R&D) expensing provision, which would allow for the immediate deduction of R&D costs and continue to encourage innovation by reducing the tax burden on companies investing in new technologies.

    Additionally, Trump has proposed easing the interest expense limitations, which would allow businesses to deduct a higher percentage of their interest expenses and impact companies with significant debt financing. Trump appears inclined to retain the foreign-derived intangible income (FDII) provision, providing a lower tax rate on income from exports of goods and services, and the global intangible low-taxed income (GILTI) provision, imposing a minimum tax on foreign business income. The FDII and GILTI effective tax rates are set to increase in 2026; it remains unclear whether Trump will modify such provisions.

    Together, these extensions may enhance the attractiveness of US companies as acquisition targets and support outbound investments by providing a stable and favorable tax environment for cross-border M&A transactions.

    Tariffs

    Under the incoming Trump administration, proposed tariffs are being discussed. The proposed tariffs generally include tariffs of 10% to 20% on all imports, 60% to 100% on imports from China, and 100% to 200% on certain imports from Mexico. It remains unclear whether the tariffs could be used as a device to offset revenue losses from tax cuts, which may depend on whether Congress is involved in the process. These tariffs could substantially impact cross-border M&A by increasing the cost of imported goods, thereby reducing the attractiveness of foreign acquisitions and potentially leading to retaliatory tariffs from affected countries. This environment of heightened trade barriers and economic uncertainty may deter cross-border investments and complicate the strategic planning of multinational corporations. Additionally, these tariffs may have a meaningful impact on M&A in terms of liability, risk allocation, and due diligence, especially for entities that heavily rely on exclusive imports.

    Corporate Tax Rates

    The new Trump administration is proposing to lower corporate tax rates even further, aiming for a 20% rate and a 15% rate for American-produced goods. While this reduction is expected to attract more foreign investment to the United States, it may also decrease the value of net operating losses (NOLs), prompting companies to utilize them more quickly before the rate cuts diminish their value. For cross-border M&A, these lower corporate tax rates could make US companies more attractive acquisition targets because of their enhanced profitability and reduced tax burdens. However, the potential decrease in NOL value might lead to a rush in utilizing these losses, impacting the timing and strategy of M&A transactions. Additionally, legal entity rationalization will become crucial as companies seek to streamline their structures to maximize tax benefits and operational efficiencies in this new tax environment.

    IP Purchasing

    Trump’s proposed IP purchasing initiative, which emphasizes stricter enforcement and increased penalties for IP violations, aims to protect domestic innovation and combat international IP theft. This could make US companies more attractive targets for cross-border M&A, but the heightened trade tensions and enforcement measures may also create an uncertain investment environment. Additionally, considerations around how IP will be owned and operated post-acquisition will be critical, as acquiring companies will need to navigate the complexities of IP management and enforcement in this stricter regulatory landscape. US-international groups may need to consider various tax ramifications from both an M&A and restructuring perspective if these IP changes come to fruition.

    Pillar Two: The 15% Global Minimum Tax

    Under the new Trump administration, the future of Pillar Two, which aims to implement a global minimum tax for companies with average gross revenues exceeding €750 million, remains uncertain. Commentators suspect that the new Trump administration will not adopt Pillar Two and will instead use retaliatory measures, such as tariffs, to combat the negative impact on US companies. Notwithstanding, US groups with non-US subsidiaries situated in adopting Pillar Two jurisdictions remain subject to these rules. The expected disalignment may continue to complicate cross-border M&A transactions.

    How Tax Reform is Passed

    The enactment of tax reform under the incoming Trump administration is likely to follow a two-step budget reconciliation process. This legislative process helps lawmakers make necessary tax and spending changes to meet the congressional budget resolution. Both houses of Congress must approve a concurrent budget resolution with reconciliation instructions. Importantly, reconciliation bills cannot increase deficits beyond the budget window. To achieve this, budget cuts, the closing of loopholes, and proposed tariff increases may be implemented, which is crucial to monitor in an M&A context.

    Authors

    Michael J. Bruno

    Partner

    Miami

    Alejandro Ruiz

    Partner

    San Francisco

    Larissa Mussi

    Associate

    Dallas

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