Plaquemine Parish Awarded $740 Million in Landmark Case
Jurors found that energy giant Texaco, acquired by Chevron in 2001, had for decades violated Louisiana regulations governing coastal resources by failing to restore wetlands impacted by dredging canals, drilling wells, and billions of gallons of wastewater dumped into the marsh.
The jury awarded $575 million to compensate for land loss, $161 million to compensate for contamination, and $8 million for abandoned equipment.
The case will signal how juries will respond in the 40 other landmark lawsuits that were brought to hold oil and gas companies liable for Louisiana’s coastal land loss.
Jurors found that energy giant Texaco, acquired by Chevron in 2001, had for decades violated Louisiana regulations governing coastal resources by failing to restore wetlands impacted by dredging canals, drilling wells and billions of gallons of wastewater dumped into the marsh. The jury awarded $575 million to compensate for land loss, $161 million to compensate for contamination and $8 million for abandoned equipment.
www.wwltv.com/…
Top Five Labor Law Developments for March 2025
The National Labor Relations Board once again lacks a quorum to issue decisions. The U.S. Court of Appeals for the D.C. Circuit granted the Trump Administration’s emergency request to stay a lower court’s decision reinstating Board Member Gwynne Wilcox. Wilcox v. Trump, et al., No. 25-5057 (D.C. Cir. Mar. 28, 2025). In a 2-1 decision, the court majority ruled the Trump Administration is likely to demonstrate that President Donald Trump had authority to terminate Wilcox, finding the U.S. Supreme Court’s decision in Seila Law, 591 U.S. 197 (2020), controlling. The court explained that while Humphrey’s Executor, 295 U.S. 602 (1935), upheld the constitutionality of for-cause removal protections for federal agency leaders, Seila Law subsequently narrowed that decision as applying only to multimember agencies that “do not wield substantial executive power,” and thus is inapplicable to the Board. Wilcox filed a petition for en banc review of the panel’s decision.
President Trump nominated management-side attorney Crystal Carey as the next Board general counsel (GC). If confirmed by the Senate, Carey will serve as the head of the Board’s prosecutorial arm. A former Board attorney, Carey is expected to reverse many of the pro-labor initiatives set by her predecessor, Jennifer Abruzzo. While the GC’s office cannot effectuate changes in Board policy unilaterally, the GC can advance cases and arguments that give the Board opportunities to change the law and return to more employer-friendly standards. Interim GC William Cohen has already withdrawn several exceptions to administrative law judges’ decisions filed under Abruzzo’s tenure that sought precedent shifts. He also withdrew various GC memoranda that sought test cases to pursue such precedent shifts.
President Trump’s executive order (EO) targeting the Federal Mediation and Conciliation Service (FMCS) limits the use of federal mediators to resolve labor disputes and prevent work stoppages. The EO sought to reduce and eliminate certain federal agencies’ staffing levels to the maximum extent allowed by law. Historically, FMCS has played an essential role between employers and unions, providing mediation services to prevent and resolve labor disputes, including impending or ongoing work stoppages and contentious collective bargaining negotiations. Two weeks after the EO, FMCS placed nearly all staff on administrative leave to comply with the directive. FMCS’s dismantling could lead to an increase in strikes and labor disruptions and prolong collective bargaining negotiations.
President Trump issued an EO exempting certain federal agencies and subdivisions from collective bargaining. Pursuant to the EO, covered agencies (including the Department of Defense, Department of Justice, and the Department of State) are no longer required to engage in collective bargaining with unions. Further, subsequently issued guidance generally limits performance improvement plans to 30 days and requires the covered agencies and subdivisions to revert their discipline and performance policies to those established during the first Trump Administration. The guidance explains that the EO aims to strengthen performance accountability in the federal workforce and reduce procedural impediments to separating poor performers who may be protected by collective bargaining agreements.
The U.S. Chamber of Commerce and other business groups are urging the U.S. Court of Appeals for the Eleventh Circuit to find the Board’s order banning captive audience meetings violates the First Amendment. No. 24-13819 (11th Cir. Mar. 19, 2025). The case stems from a Board decision that prohibited employers from holding mandatory employee meetings to advocate against unionizing, overturning longstanding precedent, and marking a pivotal shift in how employers can communicate with their employees about unionization. In a joint brief, the group asserts the ban on captive audience meetings is content and viewpoint discriminatory and unlawfully regulates employers’ free speech rights. Eleven states have enacted laws containing restrictions on such meetings: Alaska, California, Connecticut, Hawaii, Illinois, Maine, Minnesota, New York, Oregon, Vermont, and Washington. Many believe such state laws are preempted by the National Labor Relations Act.
Preparing for the Implementation of Missouri Paid Sick Time: Key Deadlines and Compliance Requirements
The earned paid sick time provisions of Proposition A are set to take effect on May 1, 2025. Missouri Proposition A requires employers to provide employees working in Missouri at least 1 hour of sick leave for every 30 hours worked and allows carryover of up to 80 of such hours per year. The law applies to almost all Missouri employees, including full-time, part-time and temporary with limited exceptions. For more details on the requirements and background of this paid sick leave law, see our prior blog posts on Missouri Proposition A requirements here and litigation challenge here.
While ongoing litigation and legislative efforts seek to delay or modify certain aspects of the law, these initiatives are unlikely to affect the start date or the notice period required by the statute. Therefore, it is essential for employers to begin preparing for the implementation of the law to ensure compliance with the statutory requirements, including the mandatory notice and poster provisions.
Notice and Poster Requirements
Written Notice to Employees
Employers are required to provide written notice of the earned paid sick time policy to all employees by April 15, 2025. The notice must be provided on a single sheet of paper, using a font size no smaller than 14-point. This notice should be distributed along with the employer’s updated written policy.
The Missouri Department of Labor & Industrial Relations has provided a standardized notice for employers.
Poster Display Requirement
In addition to the written notice, Proposition A mandates that employers display a poster detailing the earned paid sick time policy in a “conspicuous and accessible place” at each workplace. This poster must be displayed starting April 15, 2025. The Missouri Department of Labor & Industrial Relations has also provided a poster for this purpose.
Litigation Update
On March 12, 2025, the Missouri Supreme Court heard oral arguments in a case brought by various business groups and associations challenging the constitutionality of Proposition A. The plaintiffs argue that the Proposition is unconstitutional due to its inclusion of both minimum wage and paid sick time issues on the same ballot.
While the Supreme Court has not yet issued a ruling, it typically takes between 100 and 200 days for the Court to render an opinion. Although the outcome of the case may ultimately affect certain provisions of the law, employers should continue preparing for the implementation of Proposition A as currently written, effective May 1, 2025.
Legislative Update
On March 13, 2025, House Bill 567 passed in the Missouri House of Representatives. This bill seeks to repeal the paid sick leave provisions of Proposition A, delay the scheduled minimum wage increase, and eliminate the annual adjustments to the minimum wage based on the price index. The bill cleared a public hearing in the Senate on March 26, and an executive session will be held on April 7.
If the bill passes the Senate and is signed into law by the Governor, it will not take effect until August 28, 2025. As a result, Proposition A will remain in effect beginning May 1, 2025, and employers should prepare for the law to be implemented as currently written.
Resources and Support
The Missouri Department of Labor & Industrial Relations has developed an overview and frequently asked questions (FAQ) section on its website to assist employers in understanding the requirements of Proposition A and the earned paid sick time benefits.
Missouri employers need to review and likely need to update their existing policies regarding sick time and/or paid time off to comply with Missouri paid sick leave requirements.
Unlocking the Secrets of the Endocannabinoid System: A New Frontier in Therapeutic Cannabis Research for Adolescents
Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS). Understanding the ECS is essential for comprehending the effects of cannabis and its compounds on the body, particularly in therapeutic applications.
Endocannabinoids are naturally occurring compounds in the body that bind to cannabinoid receptors located throughout the body. The ECS regulates physiological processes such as mood, appetite, sleep, immune response, pain sensation, memory, and growth and development. The ECS is present and active regardless of cannabis use. Compounds in cannabis, including THC (tetrahydrocannabinol) and CBD (cannabidiol), interact with the ECS by binding to the endocannabinoid receptors. THC can produce psychoactive effects when binding with these receptors, while CBD interacts indirectly and provides therapeutic benefits without causing a high. Current research is focused on the effects and benefits of cannabis-based medical products for adolescent diseases, including childhood cancer, treatment-resistant epilepsy, and Sturge-Weber Syndrome (SWS), a rare congenital disorder characterized by a facial birthmark, abnormal blood vessels in the brain, and eye abnormalities.
Current research is focused on the effects and benefits of cannabis-based medical products for adolescent diseases, including childhood cancer, treatment-resistant epilepsy, and Sturge-Weber Syndrome (SWS), a rare congenital disorder characterized by a facial birthmark, abnormal blood vessels in the brain, and eye abnormalities.
In 2018, the U.S. Food and Drug Administration approved Epidiolex oral solution (highly purified CBD) for the treatment of seizures associated with two severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Since then, scientists have studied whether Epidiolex is effective in treating pediatric patients with SWS. In 2024, researchers summarized early data on Epidiolex’s efficacy for preventing and treating epilepsy and neurocognitive impairments in patients with SWS. In their review, researchers found that CBD interacts with endocannabinoids and produces an anti-inflammatory, neuroprotective, and anti-epileptic effect. In addition to reduced seizure activity, patients demonstrated improvements in cognitive, behavioral, and motor functions as well as quality of life.
In another recent study, researchers conducted a review of published literature evaluating the use of cannabis in pediatric oncology patients. The review evaluated the safety, dosing, and effectiveness of cannabis products for managing symptoms in children with cancer. After examining ten observational studies involving 1,529 children and nine interventional studies with 398 participants, the researchers determined that cannabinoids may be beneficial in managing pain, nausea, and vomiting in pediatric patients, particularly when traditional pharmaceuticals are ineffective. The researchers explained that cannabinoids bind to cannabinoid 1 receptors of the ECS and prevent the release of emetogenic neurotransmitters, the chemical messengers that trigger nausea and vomiting. Notably, no serious cannabis-related adverse events were reported across all studies, but researchers underscored the need for further investigation into the composition of cannabis products, appropriate dosages, and potential drug interactions.
Research on cannabinoids and the ECS is evolving, with promising therapeutic applications for various health conditions. We will keep monitoring this research to uncover its potential benefits for adolescents and adults.
ONE WEEK AWAY: Critical FCC TCPA Dates Coincide on April 11, 2025– Are YOU Ready?
So Friday April 11, 2025 is shaping up to look a lot like January 24, 2025.
TCPAWorld followers readily recall the adventures of late January. With time ticking to a close before the effective date of TCPA one-to-one consent the FCC issued a last second stay of the ruling before the Eleventh Circuit struck it down 20 minutes later– at 4:55 pm the business day before it became effective!
Well if the FCC has something similar up its sleeve for the next big TCPA ruling set to go into effect they have not let on–and time is again running slim. But the TCPA revocation ruling isn’t the only thing hanging in the balance right now as April 11, 2025 looks to be a real red-letter date for TCPAWorld.
Most importantly, of course, next Friday is the effective date of the FCC’s DISASTROUS new revocation rules. Again for anyone who is not aware a revocation of ANY informational consent (e.g. a stop to an MFA or alert) will require revocation of ALL TCPA consent across all business units, channels and purposes for that phone number.
This is INSANE folks and I guarantee you a majority of companies are not ready.
I think a lot of folks are banking on a last minute FCC stay–and it certainly could happen– but I haven’t seen anything solid to that effect. And unlike last time Puja and I are NOT flying to D.C. for any last second meetings.
So the fate of the world is in someone else’s hands… (let’s hope they don’t screw it up.)
But April 11, 2025 is also the deadline for comment on the Delete, Delete, Delete effort. you can expect R.E.A.C.H. to weigh in and demand a destruction of the entire call blocking and labeling safeharbor framework and an end to the TCR and 10DLC registration process (Infobip is driving everyone nut.)
These companies are operating beyond the law to prevent access to SMS channel communication to companies at a massive scale– censoring COMPLETELY LEGAL speech and running roughshod over COURT ORDERS striking down the one-to-one rule. It is INSANE.
Will the Commission do anything about it? So far no action on the critical R.E.A.C.H. petition on the subject– let’s hope that changes.
But bottom line–April 11, 2025 will be a huge day. Stay tuned…
Trump DEI Executive Orders – Impacts on Small Businesses and Small Business Subcontracting
On January 20 and 21, 2025, President Trump signed two executive orders focused on Diversity, Equity, and Inclusion (DEI) programs: EO 14151, “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173, “Ending Illegal Discrimination and Restoring Merit‐Based Opportunity” (the “EOs”). You can read more about the content of these EOs here. While the EOs have broad ranging impacts on federal contractors in a number of areas, this blog focuses on the potential impacts specific to small businesses generally and to large businesses via small business subcontracting.
At the outset, the EOs require “Each agency, department, or commission head” to “direct the deputy agency or department head to . . . recommend actions . . . to align agency or department programs, activities, policies, regulations, guidance, employment practices, enforcement activities, contracts (including set-asides), grants, consent orders, and litigating positions with the policy of equal dignity and respect identified in section 1 of this order. . . .” EO 14151 (emphasis added).
The EOs take this approach because, unlike many policies and programs that are the creature of EOs, regulations, and contract terms; the various federal set-aside programs are creatures of statute – most notably the Small Business Act of 1953. Importantly, although the Small Business Act created the small business preference categories most likely to be in the crosshairs of the EOs (women-owned small businesses and socially/economically disadvantaged small businesses), the EOs do not (and cannot legally) do away with those statutory preferences.
To remove these preferences (or other subcategories), or to eliminate small business subcontracting preferences altogether, Congress would have to amend the Small Business Act. Although the President currently controls both houses of Congress, it still may be a tough political task to eliminate a program responsible for $178.6 billion dollars (FY23) annually awarded to small businesses. Accordingly, at the moment, the various federal set-aside programs remain in place.
The Small Business Administration’s (“SBA”) “Day One” Memo
Although the Trump administration cannot unilaterally eliminate the federal set-aside programs, it certainly can reprioritize. On February 24, 2024, in what is being labeled “a new day at SBA,” newly installed SBA Administrator Kelly Loeffler outlined her top priorities for “rebuilding the SBA into an America First engine for free enterprise.”
The first six priorities are directed at supporting the President’s “America First agenda.” These are largely internal changes, which include the following:
Transforming the SBA’s Office of International Trade into the Office of Manufacturing and Trade with the goal of “promoting economic independence, job creation, and fair trade practices to power the next blue‐collar boom.”
Enforcing the President’s anti‐DEI (EO 14151), only‐two‐sexes (EO 14168), and less restrictive environmental controls (EO 14154) Executive Orders.
Supporting the Department of Government Efficiency’s (“DOGE”) cost cutting efforts by, among other things, prioritizing the elimination of fraud and waste within the agency.
Mandating SBA’s employees return to the office full‐time.
Evaluating workforce reduction (e.g., assessing opportunities for workforce reductions).
Cracking down on fraud across all SBA programs, including establishing “a Fraud Working Group” and a “Fraud Czar” ‘to identify, stop, and claw back criminally obtained funds….”
The next four priorities outlined in Loeffler’s memo are directed at eliminating waste and reducing fraud. These are more likely to have a more immediate impact on federal contractors. They include:
Conducting an independent SBA‐wide financial audit in an effort to identify and counter delinquencies, defaults, and charge‐offs on SBA loan programs.
Evaluating SBA’s lending programs to maintain the “zero‐subsidy status” of some of its programs, reviving its collection programs, and restoring its underwriting standards, among other actions.
Banning illegal aliens from receiving SBA assistance.
Restricting “hostile foreign nationals,” particularly those with ties to the Chinese Communist party, from receiving SBA assistance.
The final five priorities are identified as “Empowering Small Businesses” and likely will have the largest and most immediate impact on small businesses. They include:
Establishing a “strike force” “to identify and eliminate burdensome regulations promulgated by all federal agencies….”
Improving SBA’s customer service, technology and cybersecurity, to improve digital interfaces, response times, and customer satisfaction.
Reducing the contractual goals for contracting with 8(a) companies – i.e., Small Disadvantaged Businesses – from the current 15% down to the statutory 5%. The rationale for this change is the concern that the higher goal had been “negatively impacting many veteran‐owned small businesses.”
Changing the locations of SBA regional offices to remove them from “sanctuary cities” and relocate them to “to less costly, more accessible locations in communities that comply with federal immigration law.”
Terminating SBA funded voter registration activities.
While most of the priorities above appear relatively straightforward, the shift away from 8(a) contracting (by reducing the contracting goals), is notable for a couple of reasons. First, the rationale suggests this administration is not interested in reducing preferences for veteran-owned small businesses, so those programs and goals very likely are safe. Second, this reprioritization suggests it is likely we may see a concurrent effort to reduce 8(a) small business subcontracting goals, which will have an impact on both small and large businesses, as discussed in more detail below.
Small Business Subcontracting Plans
Most large businesses contracting with the Federal Government are required to adopt subcontracting goals, make good faith efforts to achieve those goals, and to report to the Government the contractor’s success in meeting those goals. The goals cover subcontract spending on small businesses, minority owned small businesses, women owned small businesses, and more.
As noted above, the Federal Government’s small business subcontracting program is a preference program of the sort targeted by the EOs. Like the prime contract set-aside preference programs, however, most of the small business subcontracting requirements are established by statute. Thus, here again, it would take an act of Congress to eliminate certain preference categories, or the program altogether. Although we have little doubt Congress will take steps to align the law with the EOs, that has not happened yet. Accordingly, the subcontracting rules continue to apply. That is not to say the Government will expend any effort enforcing those rules. It would be unsurprising to see a directive to the SBA and other contracting agencies (most likely General Services Administration (“GSA”), Department of Defense (“DOD”), and National Aeronautics and Space Administration (“NASA”)) not to audit or enforce the Subcontracting Plan requirements. Still, large businesses should not ignore existing compliance obligations. Indeed, while the Government may not seek to enforce the rules, whistleblowers may. As such, noncompliance with the Subcontracting Plan requirements still presents a risk to large businesses.
Time will tell how the Trump administration’s priorities (including the 15 SBA priorities) will be implemented, and, thus, what impact they will have on small—and large—businesses. In the meantime, small business would be well advised to reassess compliance programs to ensure they are in sync with all current rules, regulations, and guidelines. Additionally, small businesses may want to take steps to prepare for an audit as we are likely to see an uptick in SBA audit activities. Likewise, large business would be well advised to do some advanced planning since (a) it is likely there will be a concurrent change in the SBA’s subcontracting programs and (b) the SBA’s new priorities likely will impact the pros and cons of partnership choices on federal opportunities.
We Aren’t in Kansas Anymore – Dr. Oz Confirmed as Head of CMS
Well, maybe they held off until after Medicarians, but the Senate has confirmed Dr. Mehmet Oz as the new head of the Center for Medicare and Medicaid Services (CMS).
Dr. Oz is probably most known for hosting a daytime TV-show. But, he is now in charge of the CMS and its substantial budget which equates to over 20 percent of federal outlays. Importantly, for TCPAWorld readers, CMS also is the primary regulator for the marketing of Medicare Advantage (MA) and Part D plans.
Dr. Oz has been vocal in his support for Medicare Advantage in the past and could work to make the MA process better for consumers. However, during his confirmation hearing, he did note that “We’re actually apparently paying more for Medicare Advantage than we’re paying for regular Medicare. So it’s upside down”.
With a proposed final rule still waiting to be finalized, it will be interesting to see how Dr. Oz’s leadership of the organization will affect agencies and marketers. One area of interest will be the finalization of the expansion of CMS’s oversight of “marketing” under the MA and Part D plans which will be bring even more advertising materials under the purview of CMS for review and approval. Prior to this proposed rule, whether a MA or Part D “communication” counted as “marketing” depended on two things: its content and its intent. “Content” meant it had to include details about plan benefits, costs, ratings, or MA-specific rewards.
Now, CMS is proposing a shift. They want to drop the content requirement entirely. If this rule is finalized, the only thing that will matter is the “intent” behind the communication. Does the communication intend to influence the consumer’s enrollment decision? CMS will figure this out by looking at objective factors like the audience and the message itself, not just the plan’s stated purpose. The expectation is that this will significantly increase the amount of materials that plans will need to submit for CMS review, leading to more comprehensive oversight of Medicare marketing.
Maybe under Dr. Oz’s leadership this rule will get another look. One thing is for certain, as Dr. Oz pointed out at his hearing, “There’s a new sheriff in town.”
The DOJ’s Final Rule on Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons
On December 27, 2024, the Department of Justice (the “DOJ”) issued its final rule (the “Rule”) carrying out Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” The Rule is designed to prevent access to certain categories of U.S. data by China (including Hong Kong and Macau), Cuba, Iran, North Korea, Russia, and Venezuela (collectively, “Countries of Concern”), as well as foreign entities or individuals with significant ties to these nations (“Covered Persons”) and will take effect on April 8, 2025.
Scope
The Rule applies to U.S. government-related data and the following categories of U.S. sensitive personal data, each as defined in the Rule (collectively, “Covered Data”):
Precise geolocation data
Biometric identifiers
Human ‘omic data
Personal health data
Personal financial data
Personal identifiers
The Rule sets out bulk thresholds applicable to each of these categories of U.S. sensitive personal data. There is no bulk threshold applicable to U.S. government-related data. Notably, the Rule applies to bulk U.S. sensitive personal data regardless of whether the data is anonymized, pseudonymized, de-identified or encrypted.
Under the Rule, transactions involving Covered Data with Countries of Concern or Covered Persons are categorized as: (1) Prohibited Transactions; (2) Restricted Transactions; or (3) Exempt Transactions, as detailed below:
Prohibited Transactions: The Rule prohibits the following:
Countries of Concern / Covered Persons: Any transaction of Covered Data involving data brokerage (e.g., sale, licensing, or other similar commercial transaction) with a Country of Concern or Covered Person;
Foreign Persons that are not Covered Persons: Any transaction of Covered Data involving data brokerage with a foreign person that is not a Covered Person unless certain requirements are met as set out in the Rule.
Restricted Transactions: The Rule prohibits the following, unless the U.S. entity conducting the data transaction complies with the Rule’s security and other requirements:
Any transaction of Covered Data with Countries of Concern or Covered Persons involving a/an (i) vendor agreement, (ii) employment agreement, or (iii) investment agreement (each as defined in the Rule).
Exempt Transactions – Certain data transactions are exempt from these prohibitions and restrictions, subject to specific conditions.
Compliance Deadlines
The Rule takes effect on April 8, 2025.
Additional diligence requirements for Restricted Transactions become enforceable beginning on October 6, 2025.
Implications & Next Steps
The Rule, designed to address risks to U.S. national security posed by access to sensitive data by foreign adversaries, is broad in its scope and regulates data transactions through a framework that deviates significantly from existing data privacy protection laws. The DOJ has stated it intends to issue additional guidance on the Rule’s requirements. We continue to monitor developments with respect to the Rule.
The Rule has significant implications for businesses handling sensitive data and engaging in cross-border data transactions. Organizations should assess their data-sharing and receiving practices, ensure compliance with the Rule’s requirements, and avoid Prohibited Transactions.
Correct application of the Rule requires careful analysis.
New York State Department of Health Releases FAQs Regarding PHL 45-A, the Material Transactions Law
Roughly two years in the making, the New York State Department of Health (NYS DOH) has issued long-awaited guidance on its material transactions law.
Notably, the guidance provides clarity on how to calculate the “de minimis” exception to the material transaction law requirement—including an indication that “related” transactions only need to have a single party in common, which is an important consideration for providers and investors pursuing a “roll-up” strategy.
N.Y. Pub. Health Law Article 45-A, “Disclosure of Material Transactions,” took effect on August 1, 2023, and requires “health care entities” involved in a “material transaction” to provide written notice to the NYSDOH at least 30 days prior the proposed closing of a transaction. As our colleagues wrote at the time, the legislation grew out of concerns with the “proliferation of large physician practices being managed by entities that are investor-backed” (e.g., private equity).
These concerns have only increased in the past two years; more than a dozen states including New York have enacted health care transaction notice requirements. Currently, several state legislatures are attempting to either amend existing requirements or create new ones. New York is one state that is potentially amending its existing notice requirement. As we noted in March, proposed legislative changes to the New York law would include an extension of the notice deadline to 60 days; a statement as to whether any party to the transaction owns any other health care entity that within the past three years has closed operations, is in the process of closing operations, or has experienced a substantial reduction in services; and a statement as to whether a sale-leaseback agreement, mortgage or lease, or other payments associated with real estate are a component of the proposed transaction.
We discuss the existing New York law, and the recent guidance, below. The guidance is brief; if you have additional questions in this area, please reach out to the authors.
Who is required to report material transactions?
The first topic addressed in the NYS DOH’s FAQs is “[w]hich entities are required to report Material Transactions under PHL Article 45-A?” As described in PHL 45-A and the FAQs, PHL45-A applies to both in-state and out-of-state “health care entities.” Both Section 4550(2) and Q1-Q2 of the FAQs clarify that “health care entities” subject to the reporting requirements include, but are not limited to:
Physician practices or groups;
Management services organizations or similar entities providing all or substantially all the administrative or management services that are under contract with at least one physician practice;
Provider-sponsored organizations;
Health insurance plans;
Health care facilities, organizations, or plans providing health care services in New York;
Dental practices;
Clinical laboratories;
Pharmacies (including wholesale pharmacies and secondary wholesalers);
Independent practice associations (IPAs); and
Accountable care organizations (ACOs).
Notably, the NYS DOH FAQs do not specify any other healthcare professions under the list of “health care entities,” including applied behavior analysts, chiropractors, clinical social workers, occupational therapists or physical therapists. There have been open questions whether such professions are captured under this law or whether a management services organization that provides administrative services to such professions are considered “health care entities” and subject to the law. The NYS DOH did not list such professions in the FAQ but included a disclaimer that the professions listed are not exhaustive but illustrative of the types of entities covered under the law.
What constitutes a material transaction?
Both Section 4550(4)(a) and Q3 of the FAQs state that a “material transaction” means any of the following—occurring during a single transaction or in a series of related transactions in a rolling twelve-month time period—that result in a “health care entity” increasing its total gross-in-state revenues by $25 million or more:
A merger with a health care entity;
An acquisition of one or more health care entities, including but not limited to the assignment, sale, or other conveyance of assets, voting securities, membership, or partnership interest or the transfer of control;
An affiliation agreement or contract formed between a health care entity and another person; or
The formation of a partnership, joint venture, accountable care organization, parent organization, or management services organization for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or health care providers as prescribed by the commissioner by regulation.
Exemptions
Both Section 4550(4)(b) and Q4-Q6 of the FAQs state that a material transaction does not include
Clinical affiliations of health care entities formed for the purpose of collaborating on clinical trials or graduate medical education programs;
Transactions already subject to review under certain provisions; and
De minimis transactions, meaning a transaction or a series of related transactions which result in a health care entity increasing its total gross in-state revenues by less than $25 million.
De Minimis Exemption:
Likely in response to questions from industry stakeholders, the FAQs clarify—with relevant examples—the de minimis transaction exemption and how the $25 million threshold is calculated on an annual basis.
Calculating de minimis transaction exception for a single transaction:
The guidance indicates that the state will consider the de minimis exception in one of two ways depending upon the transaction structure.
If the transaction in question is an acquisition where the acquiring entity will remain an ongoing concern, the guidance indicates that the parties must assess whether the entity or entities being acquired had $25 million or more in gross in-state revenue in the prior 12-month period from the anticipated closing date (“lookback period”).
If the transaction is a merger that results in a new corporate entity, the guidance indicates that the parties must assess whether the whether their total combined gross in-state revenues from the 12-month lookback period is greater than or equal to $25 million.
Calculating de minimis exception for a series of related transactions:
The guidance indicates that the state considers a series of related transactions to be those where the acquiring party remains the same regardless of the identity of the selling or acquired party. Therefore, the guidance instructs the parties to assess the revenue associated with each of the acquirer’s transactions that took place, or will take place, during the 12-month lookback period to determine if the total added combined gross in-state revenue calculated across all of the transactions is greater than or equal to $25 million or more.
CON Exemption:
If elements of a transaction are subject to separate review/approval processes—including but not limited to certificate of need (CON) laws—the parties to the proposed transaction must report the non-CON portions of the transaction, if a good faith estimation of the total in-state gross revenues of the transaction less the total in-state gross revenues of those elements subject to CON review/approval is calculated to be more than $25 million.
Impact assessments
Expanding on the directive in § 4552(1)(f) to determine the material transaction’s impact on cost, quality, access, health equity and competition in the impacted markets, Q7 of the FAQs state that the parties should provide a good faith assessment of the impact of the proposed material transaction, including but not limited to whether:
Services will be eliminated, reduced, added, or expanded;
Contracts with certain insurance carriers will be added or eliminated, including whether Medicaid participation will be impacted;
Locations will open or close, or expand or reduce service availability;
Healthcare staffing changes are expected;
Contracted commercial payor rate increases are anticipated;
Changes in the share of services provided to historically underserved populations are anticipated; and
The parties expect any increase in market consolidation.
More to Know
Additional requirements not covered in the FAQs, including the submission of names, addresses, copies of definitive agreements, location of services and revenue, closing date, and nature and purpose may be found in Section 4552.
The NYS DOH encourages stakeholders, counsel and the public to review its Material Transactions webpage, which includes a link to summaries of reported transactions. Question 8 of the FAQs notes that interested parties may comment on a proposed material transaction by emailing comments to MaterialTransactionDisclosure@health.ny.gov. (Additional questions not covered by the FAQs may be emailed to the same address).
Court Rejects Challenge to FDA Approval of Ammonia-Reducing Animal Drug
Yesterday the U.S. District Court for the Northern District of California granted summary judgment to FDA and drug manufacturer Elanco Animal Health, thereby rejecting a challenge to FDA’s approval of Experior, a drug intended to reduce ammonia production in feedlot cattle. See 20-cv-03703-RS (Law360 subscription required).
Plaintiffs (three advocacy groups) had challenged the approval and argued that FDA failed to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the National Environmental Policy Act (NEPA) in approving the drug.
Specifically, in regard to drug efficacy, the Court held that FDA had properly found that there was substantial evidence supporting approval of Experior for the “reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.” The conclusion was based on 5 well-controlled studies consisting of a total of 536 animals and the Court held that it was irrelevant that the mechanism of action was not well established and that FDA did not require proof of any particular environmental results.
In regard to the safety of the new animal drug, the Court held that FDA appropriately evaluated human food safety, user safety, and target animal safety and that Plaintiffs’ arguments would require the Court to inappropriately second-guess FDA’s judgment.
Finally, with regard to NEPA, the Court held that FDA’s Finding of No Significant [Environmental] Impact (FONSI) was a reasoned decision that was not inconsistent with the approval of an ammonia reducing drug.
Texas Senate Approves Two Bills Aimed at Artificial Food Additives
On March 12, the Texas Senate unanimously passed SB 25. While the bill, as currently drafted, does not ban the use of any food additives, it would require food manufacturers to label products that contain certain artificial colors or chemicals, such as titanium dioxide and red 40. Products containing any of the fifty listed substances would have to be labeled with the following text: “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.” If this bill becomes law as currently drafted, this requirement would take effect on September 1, 2025.
SB 25 would also establish a Nutrition Advisory Committee for the state, which would “examine the impact of nutrition on human health and examine the connection between ultra-processed foods, including foods containing artificial color and food additives, and the prevalence of chronic diseases and other chronic health issues.” Additionally, the Committee would “develop and maintain dietary and nutritional guidelines” for the State.
On March 12, the Texas Senate also passed SB 314, which would prohibit the use of the following food additives in free or reduced-price meals served in Texas public schools: (1) brominated vegetable oil (BVO); (2) potassium bromate; (3) propylparaben;(4)azodicarbonamide; (5) butylated hydroxyanisole (BHA); (6) red 3; (7) red 40; (8) yellow 5; (9) yellow 6; (10) blue 1; (11) blue 2; (12) green 3; (13) caramel; (14) titanium dioxide. If this bill becomes law as currently drafted, the ban would go into effect beginning with the 2026-2027 school year.
The Texas House Committee on Public Health is currently considering SB 25 and SB 314.
Mexico Bans the Cultivation of Genetically Modified Corn, Opening Door for Other Restrictions in the Future
According to a March 21, 2025 report issued by the U.S. Department of Agriculture (USDA)’s Foreign Agricultural Service, the scope of Mexico’s recent ban on the cultivation of genetically engineered (GE) corn is “ambiguous” and may leave the door open to restrictions on corn grain imported for food or feed use in the future. U.S. growers, distributors, and developers of GE plants should carefully monitor Mexico’s implementation of the cultivation ban and potential responses by the United States, particularly as U.S.-Mexico trade issues continue to receive heightened scrutiny under the Trump administration.
Legal Background
In the United States, GE plants and other organisms are jointly regulated by USDA, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) consistent with the Coordinated Framework for the Regulation of Biotechnology. This nearly 40-year-old federal policy describes each agency’s regulatory responsibilities under overlapping statutory frameworks. For example, when agricultural crops, such as corn, are genetically engineered to produce pesticidal substances, EPA regulates the substance (known as a plant-incorporated protectant, or “PIP”) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), USDA regulates the GE plant under the Plant Protection Act (PPA), and FDA ensures that GE products meet applicable food safety standards under the Federal Food, Drug, and Cosmetic Act (FFDCA).
By contrast, a de facto ban on GE corn planting has been in place in Mexico since 2013, and in effect, prohibitions have existed since 1998. In 2023, the Mexican government officially issued a decree mandating that competent authorities revoke and refrain from issuing permits for the release of GE corn seeds in Mexico, as well as authorizations for the use of such corn grain for human consumption. The decree also ordered the gradual elimination of GE corn used in animal feed and industrial uses intended for human consumption.
In August 2023, the United States formally challenged Mexico’s decree under the United States-Mexico-Canada Agreement (USMCA). In a December 20, 2024 decision, a duly established panel agreed with the United States that Mexico’s restrictions were inconsistent with USMCA principles because, among other reasons, the measures were not based on “relevant international standards, guidelines or recommendations.” In compliance with the panel’s decision, Mexico issued an agreement on February 5, 2025, that revoked the relevant portions of the 2023 decree.
New Constitutional Ban on the Cultivation of GE Corn in Mexico
On March 17, 2025, Mexican President Claudia Sheinbaum issued a new decree amending Articles 4 and 27 of the country’s Constitution, which addresses the conservation and protection of native maize varieties.
In relevant part, the amendment establishes that corn grown in Mexico “must be free from genetic modifications produced through techniques that surpass the natural barriers of reproduction or recombination, such as transgenic methods.” While it does not specifically address GE corn grain imports, the amendment provides that “any other use” of GE corn “must be evaluated in accordance with legal provisions to ensure it poses no threat to biosafety, public health, or Mexico’s biocultural heritage and population.” In addition, the amendment mandates federal promotion of traditional agricultural practices — particularly those using native seeds and agroecological methods — through investment, research, and institutional strengthening.
Continued potential for restrictions on imports under the new constitutional ban
While Mexico formally complied with the USMCA panel’s decision by nullifying the prohibitions against the uses of GE corn under the 2023 decree, the new 2025 amendment entrenches anti-GE corn principles in national law and creates a legal foundation that could support future restrictions on GE corn imports. This poses a potential risk of additional regulatory barriers, legal challenges, and renewed trade disputes, particularly if future measures are framed in terms of biosafety, biocultural protection, or food sovereignty, which are now protected goals under Mexico’s Constitution.
Despite not imposing a formal import ban, the 2025 Amendment enshrines a constitutional preference for the exclusion of GE corn from Mexican agriculture and strict oversight of any other uses. This may open the door to more rigorous approval standards on imported GE corn (such as labeling, traceability, or risk assessments) and provide a stronger legal basis for those who seek to challenge import authorizations on constitutional grounds going forward.