MAHA Report Cites Nonexistent, likely AI-Generated, Studies
The Make America Healthy Again (MAHA) Commission published its report detailing what it claims to be the main causes of chronic diseases. The report is receiving increased scrutiny after News of the United States (NOTUS), a nonprofit digital news site, published an article on Thursday, May 29 stating that many of the citations in the report either had large errors or even cited nonexistent studies. Some cited authors who were contacted by NOTUS were surprised to hear of their citation and denied ever working on the studies referred to in the MAHA Report.
Both The Washington Post and The New York Times published articles later that same day referring to even more errors and inaccuracies. The Washington Post article quoted artificial intelligence experts who suspect that many of the citations in the MAHA Report were likely produced by AI. Indeed, no authors are identified for the MAHA Report itself, which leaves considerable questions as to the scientific accuracy of its findings. The article points to the use of the text “oaicite” (OpenAI Cite) in some of the citation URLs within the report, which is “a marker indicating use of OpenAI, a U.S. artificial intelligence company.” This suggests that the conclusions reached in the report may have preceded the citations.
When asked about the NOTUS article and the potential reliance on AI, White House press secretary Karoline Leavitt referred to any inaccuracies as “minor citation and formatting errors.” The MAHA Report has since been updated to remove the incorrect citations at issue in the NOTUS article.
Separately, following public complaints from a number of grower groups regarding the MAHA Report, The America First Policy Institute (AFPI), a nonprofit think tank that was founded in 2021 by current Secretary of Agriculture Brooke Rollins, released its “Farmers First agenda for responsible nutrition policy” Driving Responsible Nutrition Policy on May 29.
The AFPI paper outlined the following principles:
Federal programs should allow states to incentivize healthier eating.
Federal government must ensure our domestic food supply is transparent, safe, and upholds nutritional integrity.
Federal nutrition programs must be reserved for the truly needy and must aim to restore the dignity of work.
Government and the private sector must collaborate to reduce food loss and waste.
Driving responsible nutrition policy also means supporting the domestic specialty crop sector, including fruit and vegetable farmers.
$222M Jury Verdict Against Walmart in Trade Secret Case Reflects Growing Trend
Monetary awards in trade secrets cases continue to grab headlines in 2025. A reported in this recent blog post, a Boston jury awarded a medical device company $452M for theft of trade secrets by a competitor, later reduced to $59.4 in exchange for a permanent injunction. Last month, an Arkansas jury found Walmart liable for trade secret misappropriation and awarded $222M to the plaintiff, Zest Labs, a provider of technology solutions for tracking food freshness. And then there is the $2.036 billion jury award in favor of Appian Software against Pegasystems that was vacated by the Virginia Court of Appeals in 2024 but was granted review by the Virginia Supreme Court just a few months ago. These awards are part of a growing trend of very large monetary awards in trade secrets cases.
Getting trade secrets cases to trial and winning on the merits is arguably easier than in patent cases. One of the main reasons for this belief is that patent infringement cases involve case-dispositive legal issues that courts decide pre-trial: the meaning and scope of the claims and whether claims are sufficiently definite. Many patent cases never get past this Markman stage. While courts in trade secrets cases often must decide whether the asserted trade secret is sufficiently identified to present to a jury, the plaintiff is frequently given several opportunities to fix its articulation of the secret before trial. By contrast, patent claims cannot be fixed during litigation. Moreover, given their fact intensive character, trade secrets cases often have an easier road to trial than patent cases, and strong narratives often emerge from these cases that involve related claims for breach of contractual secrecy obligations and civil conspiracy. A Stout 2024 report pegs trial win rates for plaintiffs bringing trade secret claims in federal court at 84% since 2017, with juries awarding some form of monetary damages in 78% of the cases.
Monetary and non-monetary remedies available for trade secret misappropriation, in both state and federal courts, are robust and relatively easy to access in comparison to patent cases. Patent jurisprudence on remedies often throttles damages recovery in ways that trade secrets law does not, and injunctive relief against post-trial infringement is significantly constrained because courts often regard harm as compensable by the availability of an ongoing royalty. Unlike in utility patent cases, disgorgement of ill-gotten gains is available in trade secret cases and often these alleged gains far exceed any provable economic loss. As with patent cases, proving damages in trade secrets cases depends heavily on expert testimony, but the controlling law in patent cases is far more developed and restrictive than in the trade secrets context when it comes to screening expert damages theories.
Similarly, although both patent and trade secrets law reserve an award of attorneys’ fees to the trial court’s discretion in exceptional cases, the practical threshold for such awards may be lower for successful plaintiffs in trade secrets cases. Last month, a federal court in California awarded attorneys’ fees to the plaintiff who proved misappropriation of only one of twenty-eight asserted trade secrets and only recovered 1.1% of the damages it originally sought. In granting the fees motion, the court held that winning “any significant issue … which achieves some benefit in bringing suit” is sufficient to justify a full recovery of attorneys’ fees.
Trade secret owners’ run of success in courtrooms across the country seems likely to continue. These cases are more likely to go to trial because of their fact-specific nature, and the enhanced remedies available to trade secret holders often justifies rolling the dice. This trend behooves those potentially facing trade secret misappropriation risk to carefully manage that risk through contracts with trade secret owners and to thoughtfully and proactively defend claims asserted against them while realistically evaluating the litigation risk they face.
GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health
Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity. At the heart of this shift is the explosive rise of GLP-1 receptor agonists, once a niche therapeutic class, now a multi-billion-dollar market shaping the future of chronic disease management. With this surge in clinical and commercial success, the GLP-1 technology space has become a hotbed for mergers and acquisitions (M&A), as major pharma players race to secure their foothold in what many consider the next blockbuster category.
This post explores the strategic drivers, recent deals, and future implications of M&A activity in the GLP-1 sector, unpacking why this field has become a focal point for investment, innovation, and consolidation.
GLP-1: From Diabetes Therapy to Weight Loss Powerhouse
Originally developed to help manage blood sugar in type 2 diabetes, GLP-1 receptor agonists have evolved beyond their initial indications. These drugs mimic the glucagon-like peptide-1 hormone, which enhances insulin secretion, suppresses glucagon, and slows gastric emptying. What made them revolutionary was their ability to induce weight loss, a feature that has become a cornerstone in the battle against obesity, a condition with vast medical, social, and economic implications.
The commercial success of drugs like Novo Nordisk’s semaglutide (Ozempic®, Wegovy®) and Eli Lilly’s tirzepatide (Mounjaro®, Zepbound®) has catalyzed not just clinical excitement but also intense investor and acquirer interest. These medications have demonstrated not only weight loss upwards of 15-20% but also cardiovascular and metabolic benefits, positioning them as game-changers in preventive medicine.
Why the GLP-1 Market Is Attracting M&A Interest
Massive Market Potential: Obesity affects over 890 million adults globally[1], with related comorbidities including diabetes, cardiovascular disease, and certain cancers. Analysts estimate the GLP-1 market could reach US$139 billion annually by 2030.[2]
Pipeline and Platform Expansion: As demand surges, big pharma companies are under pressure to expand their metabolic portfolios. M&A offers a fast-track route to diversify into GLP-1 and adjacent incretin-based therapies (e.g., GIP (Gastric Inhibitory Polypeptide), dual/triple agonists).
Technology Differentiation: Although current GLP-1s are effective, there is a premium on next-generation delivery systems (oral, transdermal, long-acting injectables) and multi-modal agonists. Acquiring innovative biotech firms with proprietary delivery platforms or novel peptide structures provides a competitive edge.
Limited In-House Innovation: Not all big pharma players developed GLP-1 assets internally. As a result, acquiring external innovation, whether through platform technologies or late-stage assets, is becoming a strategic imperative.
Recent M&A Moves in the GLP-1 Landscape
The following transactions illustrate the growing M&A momentum in the GLP-1 space:
Roche’s Acquisition of Carmot Therapeutics (2023):Roche paid US$2.7 billion upfront for Carmot, a clinical-stage biotech with a promising portfolio of incretin-based therapies, including dual GLP-1/GIP agonists. This move positioned Roche to compete in the metabolic disease arena, leveraging Carmot’s small molecule platforms to diversify beyond oncology.[3]
AstraZeneca’s Acquisition of CinCor Pharma (2023):Though primarily targeting hypertension, AstraZeneca’s US$1.8 billion buyout of CinCor included a nod toward combinational potential with metabolic therapies, signaling broader interest in cardiometabolic synergies.[4]
Pfizer’s Strategic Reassessment and Potential for Acquisitions (2024, 2025):After halting internal development of its oral GLP-1 candidate due to tolerability concerns, Pfizer has publicly stated its interest in acquiring external GLP-1 assets. Although no formal deal has closed, analysts speculate an acquisition could be imminent, especially in the wake of divestitures from its COVID-era portfolio.[5], [6]
Novo Nordisk’s Expansion via Catalent Deal (2024):Novo Nordisk’s US$16.5 billion acquisition of Catalent’s fill-finish facilities demonstrates another angle of strategic M&A, ensuring capacity for GLP-1 manufacturing and reducing supply chain risks amid skyrocketing demand.[7]
Beyond Big Pharma: Biotech’s Role as Innovation Engines
Small- to mid-cap biotech firms are proving essential in advancing the next frontier of GLP-1 therapies. These companies are often rich in innovation but resource-constrained, making them prime acquisition targets for larger players. A few noteworthy examples include:
Structure Therapeutics: Developing oral GLP-1R agonists, Structure has seen rapid investor interest post-Initial Public Offering (IPO) and is considered a prime candidate for acquisition due to its differentiated delivery approach.[8]
Terns Pharmaceuticals: The company recently announced positive Phase 1 clinical results for its oral GLP-1R agonist for treating obesity, triggering acquisition rumblings.[9]
Viking Therapeutics: The company is advancing early-stage GLP-1 or dual agonists with strong preclinical profiles and have recently experienced stock price surges on clinical data, fueling acquisition speculation.[10]
Strategic Implications and Risks
Although the M&A landscape in GLP-1 technology is vibrant, it is not without challenges, such as the following:
Supply Chain Constraints: Companies acquiring GLP-1 assets must also manage complex peptide synthesis, formulation, and delivery bottlenecks. This makes CMC (chemistry, manufacturing, controls) and scale-up capabilities a due diligence priority.
Regulatory Scrutiny: With GLP-1s being prescribed off-label for cosmetic weight loss, regulators may impose tighter restrictions, impacting long-term market forecasts.
Valuation Pressure: As competition intensifies, valuations are soaring. This poses a risk of overpaying for early-stage assets with limited clinical data. Strategic buyers must carefully weigh scientific promise against commercial risk.
Patent Life and Biosimilar Threats: The first-generation GLP-1s are already facing biosimilar competition timelines. Acquirers must assess exclusivity windows and invest in lifecycle management strategies.
The Future of M&A in the GLP-1 Arena
Looking ahead, several trends are likely to shape the next wave of M&A, including the following:
Combination Therapy Focus: Expect acquisitions targeting companies developing dual/triple agonists (GLP-1/GIP/Glucagon) to address broader metabolic endpoints.
Digital and Companion Tech Integration: Companies integrating wearables or AI-driven metabolic monitoring may become attractive M&A targets for firms aiming to offer holistic obesity/diabetes management solutions.
Emerging Markets Expansion: Firms with strong distribution in Asia, Latin America, or Africa may see M&A interest as acquirers look to expand the global footprint of GLP-1 therapies.
Conclusion
The GLP-1 revolution is not only transforming the treatment of diabetes and obesity, it is also reshaping the strategic priorities of the pharmaceutical industry. With blockbuster sales, novel delivery technologies, and growing clinical applications, GLP-1s have become a magnet for M&A. For investors, innovators, and pharma executives alike, the current M&A wave in the GLP-1 sector represents both opportunity and inflection, one that will define the metabolic health market for years to come.
As GLP-1 technology continues to evolve, one thing is certain: the race to acquire the next breakthrough is only just beginning.
[1] World Health Organization, Obesity and overweight, May 7, 2025; https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight#:~:text=In%202022%2C%201%20in%208,million%20were%20living%20with%20obesity.
[2] TD Securities, GLP-1 Market: The Pipeline Expands, Mar. 10, 2025; https://www.tdsecurities.com/ca/en/glp1-market-the-pipeline-expands#:~:text=Global%20sales%20of%20GLP%2D1,from%20sales%20posted%20in%202024.
[3] “Roche to acquire Carmot Therapeutics for $2.7bn,” Pharmaceutical Technology, Dec. 3, 2023; https://www.pharmaceutical-technology.com/news/roche-to-acquire-carmot-therapeutics/.
[4] “AstraZeneca to buy US-based CinCor Pharma for $1.8bn,” Pharmaceutical Technology, Jan 10, 2023; https://www.pharmaceutical-technology.com/news/astrazeneca-buy-cincor-pharma/#:~:text=AstraZeneca%20has%20signed%20a%20definitive%20agreement%20to%20buy,CinCor%20Pharma%20for%20%2426%20per%20share%20in%20cash.
[5] A. Zank, “Pfizer CFO talks strategic growth through acquisitions,” CFO Brew, Sept. 24, 2024; https://www.cfobrew.com/stories/2024/09/24/pfizer-cfo-talks-strategic-growth-through-acquisitions.
[6] M. Lee, “Pfizer Eyes $20 Billion Revenue From Acquisitions Amid Patent Cliff Challenges,” AInvest, Jan. 14, 2025; https://www.ainvest.com/news/pfizer-eyes-20-billion-revenue-from-acquisitions-amid-patent-cliff-challenges-25011010cf8550e9ae82e13f/.
[7] “Novo completes $16.5bn takeover of Catalent,” PharmaPhorum, Dec. 2024; https://pharmaphorum.com/news/novo-completes-165bn-takeover-catalent.
[8] “Structure Therapeutics Announces First Patients Dosed in Phase 2b ACCESS Clinical Study Evaluating Oral Small Molecule GLP-1 Receptor Agonist, GSBR-1290, for Obesity,” Global Newswire, Nov. 13, 2024; https://www.globenewswire.com/news-release/2024/11/13/2980634/0/en/Structure-Therapeutics-Announces-First-Patients-Dosed-in-Phase-2b-ACCESS-Clinical-Study-Evaluating-Oral-Small-Molecule-GLP-1-Receptor-Agonist-GSBR-1290-for-Obesity.html.
[9] “Terns Pharmaceuticals Announces Positive Phase 1 Clinical Trial Results with TERN-601 Once-Daily Oral GLP-1R Agonist for the Treatment of Obesity,” Global Newswire, Sept. 9, 2024; https://www.globenewswire.com/news-release/2024/09/09/2942701/0/en/Terns-Pharmaceuticals-Announces-Positive-Phase-1-Clinical-Trial-Results-with-TERN-601-Once-Daily-Oral-GLP-1R-Agonist-for-the-Treatment-of-Obesity.html.
[10] “Viking Therapeutic’s new GLP1 impresses at ObesityWeek 2024,” GLP1.Guide, Nov. 4, 2024; https://glp1.guide/content/viking-therapeutics-new-glp1-impresses-at-obesity-week-2024/.
The One Big Beautiful Bill Act (Tax Reform): Employee Benefits and Executive Compensation Breakdown
On May 22, 2025, the House of Representatives passed legislation titled “The One Big Beautiful Bill Act” (the “House Bill”) (available here), which includes several tax reform provisions. The House Bill is now being considered by the Senate.
If passed by the Senate and signed by the President, the House Bill would extend and/or modify a number of provisions from the 2017 Tax Cuts and Jobs Act (“TCJA”), and it would enact a number of new provisions. The following are key provisions from the House Bill related to employee benefits and executive compensation:
Employee Benefits Provisions
Deductions for Tips. Taxpayers earning $160,000 or less in 2025 (adjusted for inflation through 2028) would be allowed to deduct cash tips earned from an occupation that “traditionally and customarily received tips before January 1, 2025,” subject to certain limits. This deduction would be allowed only for tax years 2025 through 2028. To support the deduction, employers would have to report tip income on employees’ Forms W-2 using a special code in Box 12 (in addition to continuing to include this income in Boxes 1, 3, and 5).
Deductions for Overtime Compensation. Taxpayers earning overtime compensation would be allowed to deduct their overtime compensation for tax years 2025 through 2028. To support the deduction, employers would have to report overtime compensation on employees’ Forms W-2 using a special code in Box 12 (in addition to continuing to include this income in Boxes 1, 3, and 5).
Health Savings Accounts (“HSAs”). The House Bill includes several provisions that would expand eligibility to contribute to HSAs and make HSAs more flexible, effective for taxable years beginning after December 31, 2025:
Would allow individuals who are eligible for Medicare Part A to make or receive contributions to HSAs if they are also enrolled in a high-deductible health plan (“HDHP”).
An individual’s spouse being covered by a flexible spending account (“FSA”) would no longer disqualify the individual from eligibility to make or receive HSA contributions (subject to limitations).
Eligibility to receive the following items and services at an employer’s clinic (for both the employee and their spouse) would be disregarded for purposes of eligibility to contribute to an HSA: physical exams, immunizations, certain drugs (but not prescribed drugs), treatment for injuries incurred during the course of employment, and preventive care. This means employers would be allowed to offer these items and services with no deductible, but other items and services at an on-site clinic would continue to be subject HSA minimum deductible requirements.
Would treat certain sports and fitness expenses, such as membership fees and costs associated with physical exercise or activity, as qualified medical expenses that may be reimbursed through an HSA, up to $500 per year for single taxpayers and $1,000 per year for joint or head of household taxpayers (pro-rated on a monthly basis and subject to cost-of-living adjustments beginning in 2027).
An employee who enrolls in an HDHP and becomes eligible to contribute to an HSA would be allowed to transfer unused FSA and health reimbursement arrangement balances to their HSA (subject to a cap based on the FSA contribution limit).
An employee who enrolls in an HDHP that is HSA-eligible could use their HSA for expenses incurred any time after joining the HDHP, if they establish their HSA within 60 days after joining the HDHP.
An individual age 55 or older who is eligible to make their HSA catch-up contributions (up to $1,000) could make their catch-up contributions to their spouse’s HSA.
Would increase (in many cases double) the HSA contribution cap for individuals and families with taxable income less than a certain threshold ($75,000 for single taxpayers and $150,000 for joint filer taxpayers, with phase-outs ending at $100,000 and $200,000, respectively). The threshold would be indexed for inflation.
Health Reimbursement Arrangements (“HRAs”). The House Bill includes the following changes to HRA rules to make HRAs more flexible, effective for taxable years beginning after December 31, 2025:
Would codify the IRS’s final rules permitting employers to offer individual coverage HRAs (which would be renamed Custom Health Option and Individual Care Expense, or “CHOICE” arrangements). This would permit employees enrolled in a CHOICE arrangement through a cafeteria plan to purchase health insurance coverage on the individual healthcare exchange marketplaces with pre-tax dollars.
A credit would generally be available to employers with less than 50 full‑time employees and that have employees enrolled in a CHOICE arrangement. For the first year of the credit period, the credit would be $100 (adjusted for inflation beginning in 2027) per month per employee that is enrolled in a CHOICE arrangement, and, for the second year of the credit period, the credit would be one‑half of the amount determined for the first year.
Tuition and Student Loan Reimbursements. The House Bill would make permanent the ability to reimburse student loan payments under a Section 127 education assistance program (rather than letting that feature of Section 127 programs expire on December 31, 2025). In addition, the House Bill would provide inflation adjustments beginning in 2027 to the $5,250 limit on pre-tax reimbursements for qualifying education expenses (including student loans).
UBTI for Qualified Transportation Fringe Benefits. Tax-exempt organizations would have to recognize UBTI for amounts incurred for qualified transportation fringe benefits or any parking facility that is not directly connected to the organization’s unrelated trade or business. The change is economically comparable to a for-profit entity not being allowed to deduct these expenses (which is the rule under Section 274(a)(4)) and would apply for taxable years beginning after December 31, 2025.
Employer-Provided Child Care Credit. The maximum tax credit employers would be allowed for providing qualified child care would be increased from $150,000 to $500,000 ($600,000 for eligible small businesses), adjusted for inflation beginning in 2027. The change would apply for taxable years beginning after December 31, 2025.
Paid Family and Medical Leave Credit. The House Bill would make permanent the employer tax credit for a percentage of wages paid to qualifying employees while they are on paid family and medical leave (rather than letting it expire on December 31, 2025). In addition, the value of the credit would be expanded to include a percentage of premiums paid for certain insurance policies. The change would apply for taxable years beginning after December 31, 2025.
Reimbursements for Moving Expenses Would Continue to be Taxable. Before the enactment of the TCJA, qualified moving expense reimbursements were excluded from employees’ income and the paying employer could deduct the expenses. The TCJA eliminated that treatment (resulting in employees having to pay tax on moving expense reimbursements), except in the case of active duty members of the armed forces. The House Bill would make the TCJA’s changes permanent (rather than letting them expire at the end of 2025).
Bicycle Commuting Reimbursements Would Continue to be Taxable. Reimbursements of bicycle commuting expenses would continue to be taxable. Before the enactment of the TCJA, certain reimbursements were not taxable.
Executive Compensation Provisions
Deduction for Excessive Employee Compensation. The aggregation rule under Section 162(m), which currently applies for (a) identifying a corporation’s covered employees and (b) determining compensation that is subject to Section 162(m), would be expanded to pick up all members of a covered corporation’s controlled group and affiliated service group under Section 414(b), (c), (m) and (o) (a broader group than under the existing aggregation rule). The amount of deductible compensation would be allocated to each member of the controlled group or affiliated service group based on the pro-rata portion of the total compensation paid by that member. The change would apply for taxable years beginning after December 31, 2025.
Tax-Exempt Organization Excessive Employee Compensation Excise Tax. The excise tax that tax-exempt organizations must pay on compensation in excess of $1 million paid to employees would be expanded to apply with respect to all current and former employees of the tax-exempt organization, even if they were never among the top 5 highest paid. The change would apply for taxable years beginning after December 31, 2025.
Alternative Minimum Tax Exemption. The House Bill would extend indefinitely the increased alternative minimum tax (“AMT”) exemptions that were added by the TCJA and set to expire after December 31, 2025. This is relevant for employees who exercise incentive stock options, which are not recognized for income and FICA tax purposes but are recognized for AMT purposes.
As noted above, the House Bill is currently being considered by the Senate, which is expected to make changes. If the Senate passes a modified version of the House Bill, the legislation would then have to go back to the House for another vote because both chambers must pass the exact same legislation. We are continuing to monitor developments in the legislative process.
DOJ Adds Federal Immigration Violations to Corporate Whistleblower Awards Pilot Program
As of May 12, 2025, whistleblowers may receive a financial award in exchange for emailing the Criminal Division of the Department of Justice (DOJ) to provide information about potential corporate immigration violations. The Biden administration created the Corporate Whistleblower Awards Pilot Program in August 2024. The program provides a financial incentive for whistleblowers to report their current and/or former employers’ possible misconduct. If the whistleblower’s tip results in a successful forfeiture, then, if eligible, the whistleblower may be entitled to a percentage.
The original program focused on four different areas of corporate misconduct: (1) crimes involving financial institutions; (2) foreign corruption; (3) domestic corruption; and (4) health care fraud. Now, as part of its new white collar crime enforcement initiative called “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime,” the DOJ amended its Corporate Whistleblower Awards Pilot Program to include “violations by corporations of federal immigration law.”
The program includes a corporate enforcement and voluntary disclosure policy, which provides employers with a 120-day safe harbor to investigate, remediate, and self-disclose violations. Under this provision, companies that voluntarily self-report within 120 days of receiving an internal whistleblower report may be eligible to receive a declination of prosecution from DOJ. The inclusion of federal immigration law violations in the DOJ’s Corporate Whistleblower Awards Pilot Program emphasizes the administration’s focus on immigration compliance. Employers should take steps to enhance their internal reporting process, and also consider auditing their immigration compliance programs, from their I-9 and E-Verify practices to their visa and green card sponsorship programs. Employers should also confirm their relevant employees are trained and up to date with the updates and changes in this area.
One Big Beautiful Bill Act Has Many Impacts for Nonprofit Health Systems
The US House of Representatives passed its One Big Beautiful Bill Act on May 22, 2025 (the Act), but nonprofit health systems may not find much about the Act that’s attractive. If passed by the US Senate and signed into law, the Act would threaten already thin operating margins at nonprofit hospitals and health systems by expanding the executive compensation excise tax, taxing parking and similar employee benefits, potentially altering funds flow arrangements for academic medical centers, and increasing demand for financial assistance through sweeping Medicaid and Health Insurance Marketplace changes.
In Depth
Nonprofit Hospitals Face Challenging Financial Environment
Nonprofit hospitals have made slow but steady progress in recovering from the financial hangover that COVID-19 induced, exacerbated by increased contract labor expenses and lingering inflation. Fitch Ratings determined that even with this improvement, the median operating margin for nonprofit hospitals was only 1.2% in 2024. Any increase in operating expenses or decrease in reimbursement that results from the Act may push many nonprofit hospitals across the thin line that separates profitability from financial distress.
The Act May Increase Nonprofit Hospital Operating Expenses
The Act would increase nonprofit hospital operating expenses in two primary ways:
Expanding the executive compensation excise tax.
Taxing parking and similar employee benefits.
As part of the Tax Cuts and Jobs Act of 2017 (TCJA), Congress imposed a 21% excise tax on compensation paid by charitable organizations exceeding $1 million and on certain excess parachute payments. The excise tax applies to the organization’s top five highest compensated employees during both the current tax year and any prior tax year beginning after December 31, 2016. The excise tax does not apply to compensation provided in exchange for medical services.
The One Big Beautiful Bill Act would significantly expand the scope of the excise tax by applying it to all employees of a charitable organization who receive compensation exceeding $1 million or an excess parachute payment. The Act would not eliminate the medical services compensation exception, but the reach and financial consequences of the expanded excise tax could be significant for nonprofit hospitals and health systems that compete with privately held or publicly traded organizations for executive or administrative talent.
The Act also threatens to increase nonprofit hospitals’ operating expenses by resurrecting a tax on parking and other qualified transportation fringe benefits made available to employees. Congress first included this so-called “parking tax” as part of the TCJA. The tax requires charitable organizations to treat the amount of qualified parking and transportation fringe benefits as unrelated business income for federal tax purposes. The complexities of taxing a business expense as income led to widespread criticism of the parking tax, and Congress retroactively repealed the tax in 2019.
The Act May Disrupt Funds Flow Arrangements, Charitable Conditions
The Act contains other provisions that may have a direct or indirect impact on nonprofit health system operations or funds flow, such as:
Increasing the tax on net investment of colleges and universities from 1.4% up to 21% (based on endowment value per student). The magnitude of this tax may result in university sponsors of academic medical systems seeking to renegotiate funds flow arrangements to recapture a portion of revenue lost to the tax.
Increasing the excise tax on private foundations up to 10% (based on assets of $5 billion). This tax may decrease the amount of funding that private foundations are willing to contribute to nonprofit health systems.
Medicaid, Health Insurance Marketplace Changes May Increase Demand for Financial Assistance
The Act contains sweeping changes to Medicaid and Health Insurance Marketplaces.. The Congressional Budget Office has not conducted a full analysis of the passed bill but estimated an increase in the number of uninsured by each committee proposal, with 7.6 million uninsured as a result of the Medicaid provisions and, at a minimum, an additional 2.1 million individuals under the Marketplace reforms by 2034. As a result, nonprofit hospitals and health systems can expect to bear the financial burden of caring for those displaced by these cuts.
What’s Not in the Act and What May Come Next
Earlier versions of the Act contained provisions that likely would have resulted in decreased revenue or increased operating expenses for nonprofit hospitals and health systems. For example, the version of the Act that passed the House Ways and Means Committee would have automatically taxed name and logo revenue as unrelated business income.
The Act now moves to the Senate, where notable Republicans, including Senator Rand Paul (R-KY) and Senator Ron Johnson (R-WI) have already called for significant changes to the Act. The goal remains to finish and pass the reconciliation package by July 4, 2025.
Risk Bearing Entity Requirements: Massachusetts
This blog discusses the regulatory requirements that apply to risk-bearing entities in Massachusetts, including recent updates introduced by Chapter 343 of the Massachusetts Acts of 2024 (the Act). This blog is part of Foley & Lardner’s RBE series (see our Introduction posted November 18, 2024, and our post on New York and New Jersey’s Requirements posted February 24, 2025).
In Massachusetts, “Provider Organizations” are entities “in the business of health care delivery or management that represent one or more health care providers in contracting with carriers for the payments of heath care services.”[1] Certain Provider Organizations are required to register with the Massachusetts Health Policy Commission (the HPC) and submit data to the Massachusetts Center for Health Information and Analysis (CHIA) annually.[2]
Certain Provider Organizations with reimbursement models that incorporate financial risk must register with the Massachusetts Division of Insurance (the Division). Entities that take on financial risk in contracts with third-party payors where payment models are not solely based on fee-for-service reimbursements are classified as “Risk-Bearing Provider Organizations” (RBPO). Additionally, any Provider Organization that has a contracting affiliation with one or more providers or Provider Organizations is also classified as an RBPO.
Under the Division’s regulations, risk means the financial risk taken on by an RBPO under contracts where it manages some or all the care for a patient population for a fixed budgeted fee. Downside risk occurs when the cost of care exceeds the fixed payment amount, leaving the entity responsible for the overage. An RBPO that assumes the full or partial downside risk must seek a Risk Certificate annually from the Division.[3]
RBPO Registration
A Provider Organization that meets the definition of an RBPO, irrespective of its size or profit, must register with the Division annually unless it only takes on risk through the Medicare Program. To register, the RBPO must submit information including, but not limited to:
Filing Materials. All documents submitted to the HPC in connection with its Provider Organization registration, including information about its ownership, contracting arrangements, and total revenue by each third-party payor.
Downside Risk Contracts. A description of all downside risk contracts, including the level and nature of risk assumed.
Financial Information. Audited financial statements showing the RBPO’s sources of financial support and a financial plan.
Utilization Plan. A utilization plan that describes how the RBPO will monitor patient utilization under risk contracts.
Actuarial Certificate. An actuarial certificate that certifies that the downside risk contracts are not expected to threaten the RBPO’s financial solvency.[4]
An RBPO that can demonstrate its risk contracts do not contain significant downside risk may apply for a Risk Certificate Waiver, which requires significantly less information than a full Risk Certificate.
RBPOs that fail to comply with the Division’s registration requirements will be given an opportunity to cure their non-compliance. However, the Commissioner of the Division may suspend or cancel an RBPO’s Risk Certificate and has broad authority to “take such other action as appropriate under law to enforce the requirements.”[5]
Provider Organization Registration with the HPC and CHIA
The HPC currently requires Provider Organizations subject to registration to disclose the highest entity in its corporate structure that is engaged in health care delivery or management. The registrant must also disclose its corporate parent.
Approximately 50 organizations were required to register in 2024, the majority of which were hospital systems, physician groups, and behavioral health providers that received US$25 million or more in net patient service revenue from third-party payors.
The Act will expand the type of ownership information that Provider Organizations are required to submit to the HPC. Regulations are still in process, but the HPC will require additional information relating to significant equity investors, health care real estate investment trusts, and management services organizations that have an ownership interest in a Provider Organization.
Further, the Act increased penalties for Provider Organizations that fail to report parallel information to CHIA from US$1,000 per week for each week of non-compliance, capped at US$50,000, to US$25,000 per week for each week of non-compliance with no cap.
Conclusion
Awareness of the registration requirements required in Massachusetts is paramount for RBPOs seeking to maintain their financial and operational stability. Accordingly, such requirements — both those required of Provider Organizations and RBPOs — should be carefully reviewed prior to entering into any risk contracts to ensure regulatory compliance.
[1] 211 CMR 155.02; 958 CMR 6.02.
[2] 958 CMR 6.04.
[3] 211 CMR 155.04; 155.05.
[4] Mass. Gen. Laws Ann. ch. 176T, § 3.
[5] 211 CMR 155.08.
10 Key Factors That Influence the Value of Your Personal Injury Claim
Suffering an injury because of someone else’s negligence can be a life-altering experience. Beyond the physical pain and emotional stress, many people become overwhelmed with medical bills, time away from work, and uncertainty about the future. When pursuing a personal injury claim, it is important to understand the factors that can affect how much compensation you may receive. While every case is unique, certain key elements consistently play a significant role in determining the value of a claim.
1. Severity of Your Injuries
More serious injuries typically lead to higher settlements. A broken bone, spinal injury, or traumatic brain injury usually results in more compensation than a minor sprain or bruise.
2. Medical Expenses
This includes both past and future medical costs related to the injury. Doctor visits, hospital stays, surgeries, physical therapy, and even medical equipment all factor into your claim.
3. Lost Wages and Income
If your injury caused you to miss work or reduced your ability to earn a living, you can be compensated for the income lost and may continue to lose in the future.
4. Pain and Suffering
This refers to the physical pain and emotional distress caused by the injury. While more difficult to calculate, pain and suffering is a significant part of many claims.
5. Permanent Disability or Disfigurement
If the injury has caused long-term or permanent damage, such as scarring, loss of mobility, or loss of a limb, the claim’s value is likely to increase.
6. Liability and Fault
If the other party was clearly at fault, your claim is stronger. However, if the fault is disputed or you were partially responsible, it can reduce your compensation.
7. Available Insurance Coverage
Even if your claim is strong, the amount you can recover may be limited by the insurance policies involved, whether it is the at-fault party’s coverage or your own.
8. Documentation and Evidence
Having strong documentation, including photos, witness statements, police reports, and medical records, can make a big difference in supporting your claim and boosting its value.
9. Timeliness of Medical Treatment
Delays in seeking treatment or gaps in medical care may weaken your case, making it seem as if your injuries were not serious or were not caused by the accident.
10. Quality of Legal Representation
A qualified personal injury attorney can help build a strong case, negotiate with insurance companies, and fight for the compensation you deserve. Without legal guidance, you risk settling for far less than your claim is worth.
Conclusion
Understanding these factors can help set realistic expectations for your personal injury claim. While every case is unique, the best way to get an accurate assessment is to speak with an experienced attorney.
Healthcare Preview for the Week of: June 2, 2025
Reconciliation in the Senate
Congress is back from recess this week and the focus is on the Senate’s consideration of the House-passed reconciliation bill. Much of this work will be done behind the scenes, for example ensuring that provisions are consistent with the Byrd Rule. Senate Republicans must strike a delicate balance because they only have a three-vote margin, so they will need to come to near-full consensus to pass the bill, while also maintaining enough of the original provisions for it to get through the House again. And they are still trying to get a finished product to the President’s desk by July 4.
We are still waiting for an official, complete score from the Congressional Budget Office (CBO), but expect it to be released in the next few days. The CBO score will include the interactive effects of the various policies, including updated figures for the deficit and anticipated coverage losses, both of which are likely to be higher than earlier estimates.
Senators Collins (R-ME), Hawley (R-MO), Justice (R-WV), Moran (R-KS), and Murkowski (R-AK) have spoken out against the effects of various Medicaid provisions in the bill. In contrast, Senators Johnson (R-WI), Paul (R-KY), Lee (R-UT) and Rick Scott (R-FL) have spoken out against the bill not doing enough to cut future deficits. We’ll see if the updated CBO analysis brings out more concerns from additional senators.
Senate Democrats are united in opposition to the bill. Over the weekend, Senate Minority Leader Schumer (D-NY) sent an open letter to Senate Democrats outlining their opposition – with concerns about the Medicaid and ACA changes being front and center.
While that is the focus in the Senate, the House will be in session beginning on Tuesday and is scheduled to consider the H.R. 2483, the SUPPORT for Patients and Communities Reauthorization Act of 2025 in the full House. This bill has always been bipartisan, but it has faced Democratic opposition as it moved through the Energy and Commerce Committee this year because of the broader cuts impacting mental health and substance use disorder services being pursued by the Trump Administration.
The fiscal year (FY) 2026 appropriations process also begins this week. Last Friday, the Administration released the budget in brief and additional information to fill out their “skinny budget” submission, but many details are still missing. The Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies hold a hearing on Thursday. The major health health-related considerations will not happen until later in July when the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies is scheduled to meet.
The U.S. Department of Health and Human Services (HHS) budget highlights include:
$95 billion for HHS, a $31 billion, or 25% decrease from FY 2025 levels.
$14 billion in budget authority for the new Administration of a Healthy America (AHA), which HHS estimates to be a $6 billion cut compared to the current funding levels for all the programs that will be transferred to AHA. The Budget in Brief includes an overview of all the programs from the Health Resources and Services Administration, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Office of the Assistant Secretary for Health that will now be included in AHA, but many details are still missing.
$3.1 billion in budget authority for the Food and Drug Administration, a $409 million cut compared to FY 2025 levels.
$4.1 billion in budget authority for the Centers for Disease Control and Prevention, a $550 million cut compared to FY 2025 levels.
$27.5 billion in budget authority for the National Institutes of Health, a $17 billion cut compared to FY 2025 levels.
$3.5 billion in budget authority for the Centers for Medicare & Medicaid Services, a $673 million cut compared to FY 2025 levels.
Today’s Podcast
In this week’s Healthcare Preview, Debbie Curtis joins Maddie News to discuss forthcoming CBO scores and what the Senate margin means for ongoing reconciliation discussions.
HHS-OIG Issues Favorable Opinion on Community Health Center’s Primary Care Referral Services to Underserved Individuals Receiving Non-Medical Services such as Free Diapers, Books, Toys, and Door Locks
HHS-OIG released a favorable opinion regarding designated community health centers providing primary care referral services in combination with additional non-medical services (such as door locks for victims of crimes and free diapers to parents) that improve health outcomes for members of the community served by the CHC.
The proposed arrangement included safeguards, HHS-OIG said, that limited risk under the civil monetary penalty laws against beneficiary inducements and Anti-Kickback Statute and accordingly did not warrant sanctions.
The proposed arrangement may increase access to health care services, which is consistent with the statutory purpose and associated requirements of community health centers designated under Section 330 of the Public Health Service Act.
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 25-02, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws (CMP) against beneficiary inducements as applied to a designated community health center (CHC) under Section 330 of the Public Health Service Act (PHS Act), identifying community members in need of primary care services and referring these individuals to primary care providers.
Background
Designated CHCs under the PHS Act are required to provide outreach services that include certain non-medical, social, and educational services intended to improve health outcomes in the CHC’s community by enabling community members to access healthcare services, including but not limited to, supplemental health services that promote and facilitate optimal use of primary care health services by such individuals. Importantly, designated CHCs must also provide primary health care services to individuals within their community regardless of their ability to pay.
Here, the CHC requesting the advisory opinion (Health Center) provides certain Health Resources and Services Administration (HRSA)-approved additional services, such as lock replacements for victims of violent crime and diapers and other baby gear for children 5 years and under, to members of the community. According to Health Center, while many members of the community obtain these additional services from Health Center, frequently such individuals do not also attempt to access any primary healthcare services offered by Health Center, alone or in connection with their receipt of such additional services, due to financial concerns and/or insufficient awareness of the availability of, or knowledge about how to obtain access to, those primary healthcare services.
To address this issue, Health Center proposed providing any community member who has not completed a primary care visit in the past year with an alphabetized list of primary healthcare providers (which includes the Health Center). The list would be drafted and updated to include “any-willing” provider who elected to be included on the list, even if such providers were not employed by, or under an arrangement with, Health Center. If a community member selected a primary care provider employed by or contracted with Health Center from the provider list, Health Center would schedule an appointment for the individual or, if the individual chose a non-Health Center provider, then the Health Center would make an electronic referral to the provider chosen by the individual.
HHS-OIG’s Findings
In this instance, HHS-OIG found that the proposed arrangement implicates the AKS as the furnishing of additional (non-medical) services constitutes remuneration to the individual when coupled with the proposed offer to schedule a primary care provider appointment, which may induce individuals to obtain health care services from Health Center that are billable to federally funded healthcare programs. HHS-OIG further determined that the proposed arrangement implicates the CMP against beneficiary inducements because the provision of additional (non-medical) services in combination with the proposed primary care referral services could influence federal healthcare program beneficiaries to select Health Center to obtain primary care services.
In reaching its conclusion, HHS-OIG cited the following safeguards within the proposed arrangement as diminishing the risk of fraud and abuse:
Individuals in need of primary care services would be identified using an objective criterion (i.e., whether the individual has seen a primary care provider within the last year), which does not promote Health Center.
The list of primary care providers would be: (i) organized in alphabetical order; and (ii) drafted in a manner that does not promote Health Center (e.g., by not using bold font, underlining, or other emphasis to identify Health Center).
Health Center would include at least several providers on the list distributed to patients and also would implement an “any willing provider” standard, such that, if a community provider (e.g., CHC, hospital, primary care physician practice) would like to be included on the list of primary care providers that is given to individuals receiving additional services, then the request for inclusion on the list would be honored at all times.
Health Center certified that individuals could continue to receive its additional services without electing to also receive primary care services from Health Center. In the event an individual receiving such additional services selects a non-Health Center provider from the provider list, Health Center would provide complete contact information to the individual and the requested primary care provider sufficient to effectuate the referral.
An additional factor that HHS-OIG relied on in determining that the proposed arrangement poses low risk of fraud and abuse was the alignment between the stated purposes of the proposed arrangement and Health Center’s obligation as a CHC under the PHS Act to engage in activities to facilitate access to primary health care services for members of the community it serves, regardless of their ability of pay. According to HHS-OIG, the offer of HRSA-approved additional services together with confirmation and/or coordination of the individual’s access to primary care services would be consistent with Health Center’s statutory obligations under the PHS Act.
HHS-OIG ultimately concluded that the proposed arrangement poses little risk of fraud and abuse due to the safeguards and consistency with Health Center’s responsibility to increase health care access for patients in its community.
Key Takeaways
In this Advisory Opinion, HHS-OIG affirmed the role of CHCs under Section 330 of the PHS Act in providing programs that expand access to healthcare services for underserved patient populations. In doing so, HHS-OIG reiterated the importance of safeguards in developing and effectuating such programs to reduce fraud and abuse risk under the AKS and the CMP.
Chemical Policy Crossroads: MAHA Report’s Assessment Calls for Reform Amid Deregulatory Trends
In response to President Trump’s February 13, 2025, Executive Order (EO) 14212, “Establishing The President’s Make America Healthy Again Commission,” the White House issued part of what is being called “The MAHA Report” (with MAHA an acronym for Make America Healthy Again), entitled “Make Our Children Healthy Again: Assessment” (the Assessment) on May 22, 2025. Section One of the Assessment, “The Shift to Ultra-Processed Foods,” includes the Commission’s thoughts on the U.S. agricultural system, food additives, food industry regulation, and government food programs, while Section Two of the Assessment, “The Cumulative Load of Chemicals in our Environment,” includes its take on chemical exposures and pathways, corporate influence, and highlights some top concerns. The Assessment’s core messages add yet another element of business uncertainty that chemical stakeholders would be wise to note.
Section Two calls upon the public and private sectors, but especially the National Institutes of Health (NIH), to enhance understanding of the cumulative effects of multiple exposures on children’s health. Specifically, it highlights concerns related to:
Per- and Polyfluoroalkyl Substances (PFAS);
Microplastics;
Fluoride;
Electromagnetic Radiation (EMR);
Phthalates;
Bisphenols; and
Crop Protection Tools (including pesticides, herbicides, and insecticides).
The Assessment’s call-out of fluoride is particularly notable, citing studies that suggest a correlation between fluoride exposure and reduced intelligence quotient (IQ) scores in children. Some of the cited studies have been criticized for methodological flaws, misinterpretations, and incorrect understandings of key scientific fields. For instance, a systematic review and meta-analysis published by the American Medical Association in JAMA Pediatrics in January 2025 found an inverse association between high levels of fluoride exposure and children’s IQ scores, but the authors acknowledged limitations in the data and cautioned against drawing definitive conclusions or — perhaps most importantly — applying the findings to the U.S. population. The authors note that none of the included studies were conducted in the United States (45 of the 74 studies were conducted in China, where fluoride levels are generally higher than those in the United States), and the study does not account for the impact of other factors — including socioeconomic status — that might be expected to influence the findings.
Regarding pesticides, the Assessment specifically names chlorpyrifos, atrazine, and glyphosate as examples presenting notable risks from modern agricultural production methods. Section One of the Assessment spends much time on the problems said to be associated with the modern U.S. food production system: ultra-processed foods (UPF), nutrition, and typical industry practices. The result is disproportionate risks from the American diet compared to other Western countries, such as France or Germany. Like the fluoride example, there are footnotes citing studies to raise these concerns, although the established data about pesticide residues are found to be compliant with the requirements of the Food Quality Protection Act (FQPA). The safety standard in FQPA is that there is a reasonable certainty of no harm from pesticide residues, which is contrary to the Assessment’s tone that the food supply and its components are causing widespread harm to the consuming public.
The Assessment itself states that “a large-scale FDA study of pesticide residues (2009-2017) found the majority of samples ( >90%) were compliant with federal standards. More recent data from the USDA’s Pesticide Data Program found that 99% of food samples tested in 2023 were compliant with EPA’s safety limit.” If the Assessment’s unlikely point is that the U.S. government’s own safety thresholds are too low a bar, it is never explicitly stated. Indeed, it takes extra care in Section Two to point out that U.S. farmers (and U.S. consumers) rely on these crop protection tools, and that “actions that further regulate or restrict crop protection tools beyond risk-based and scientific processes set forth by Congress must involve thoughtful consideration of what is necessary for adequate protection.” The whiplash continues in the very next paragraph, as pesticide manufacturers are specifically called out for the “corporate influence” that comes from private corporations conducting environmental toxicology and epidemiology studies.
In addition to often feeling misaligned with itself, the Assessment also appears to be misaligned with other federal agencies, particularly the U.S. Environmental Protection Agency (EPA). While the Assessment advocates for stricter controls and greater regulatory oversight of certain chemicals, it argues against key regulations in the food industry and does not address the resource constraints faced by agencies like EPA, nor President Trump’s “Unleashing Prosperity Through Deregulation” Presidential Action. Notably, on March 12, 2025, EPA Administrator Lee Zeldin announced 31 deregulatory actions, touted as “the greatest and most consequential day of deregulation in U.S. history” and reflecting a broader governmental trend toward deregulation. Yet the Assessment calls for “the current regulatory framework [to be] continually evaluated to ensure that chemicals and other exposures do not interact together to pose a threat to the health of our children.” This juxtaposition highlights a disconnect between the Assessment’s recommendations and the current regulatory climate, inviting uncertainty in the business community.
Although both Administrator Zeldin and U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. have emphasized the importance of interagency coordination, it is unclear whether the Assessment reflects broad interagency deliberations and collaboration with key regulatory bodies. The Assessment has several instances where, after extensive condemnation of the modern food system, inserted is an ode to American farmers and farming: “Farmers are the backbone of America — and the most innovative and productive in the world. We continue to feed the world as the largest food exporter.” Such accolades apparently are the sole contribution of the U.S. Department of Agriculture (USDA) during the interagency review process. This siloed approach may undermine the efficacy of the Assessment’s recommendations and their potential implementation, creating further confusion for the regulated community.
Despite EPA’s prime position to play a critical role in moving forward with many of the Assessment’s goals, it is, along with USDA, notably absent from the list of agencies that the U.S. Department of Health and Human Services (HHS) press release cite as being “on the front lines” to “act swiftly to close research gaps and drive decisive action” associated with the Assessment. What agencies made the list of “agencies [that] will lead the charge”? NIH, the U.S. Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS).
Ultimately, the Assessment’s final recommendations, which it calls “Next Steps — Supporting Gold-Standard Scientific Research and Developing a Comprehensive Strategy,” is distilled into a ten-point list:
Addressing the Replication Crisis: NIH should launch a coordinated initiative to confront the replication crisis, investing in reproducibility efforts to improve trust and reliability in basic science and interventions for childhood chronic disease.
Post-Marketing Surveillance: NIH and FDA should build systems for real-world safety monitoring of pediatric drugs and create programs to independently replicate findings from industry-funded studies.
Real-World Data Platform: Expand the NIH-CMS autism data initiative into a broader, secure system linking claims, electronic health records (EHR), and environmental inputs to study childhood chronic diseases.
AI-Powered Surveillance: Create a task force to apply artificial intelligence (AI) and machine learning to federal health and nutrition datasets for early detection of harmful exposures and childhood chronic disease trends.
GRAS Oversight Reform: Fund independent studies evaluating the health impact of self-affirmed Generally Recognized As Safe (GRAS) food ingredients, prioritizing risks to children and informing transparent FDA rulemaking.
Nutrition Trials: NIH should fund long-term trials comparing whole-food, reduced-carb, and low-UPF diets in children to assess effects on obesity and insulin resistance.
Large-scale Lifestyle Interventions: Launch a coordinated national lifestyle-medicine initiative that embeds real-world randomized trials — covering integrated interventions in movement, diet, light exposure, and sleep timing — within existing cohorts and EHR networks.
Drug Safety Research: Support studies on long-term neurodevelopmental and metabolic outcomes of commonly prescribed pediatric drugs, emphasizing real-world settings and meaningful endpoints.
Alternative Testing Models: Invest in New Approach Methodologies (NAM), such as organ-on-a-chip, microphysiological systems, and computational biology, to complement animal testing with more predictive human-relevant models.
Precision Toxicology: Launch a national initiative to map gene-environment interactions affecting childhood disease risk, especially for pollutants, endocrine disruptors, and pharmaceuticals.
These recommendations, and the Assessment as a whole, coincide with President Trump’s May 23, 2025, EO 14303, “Restoring Gold Standard Science.” Once again demonstrating a lack of alignment between key players, the Assessment may not hold up to that “Gold Standard,” as even the White House acknowledges problems within the assessment (subsequently explained as “formatting issues”), and The New York Times and other news outlets report that the Assessment includes fake citations and faulty references. Many of the original 522 citations in the Assessment are reported to reference papers/studies that are mislabeled, contain incorrect publishing information, were not written by the cited author, include authors who did not work on the paper or omit researchers who had, or simply do not exist, with some correctly cited papers inaccurately summarized.
The errors have called into question the rigor of the Assessment and – given the type of errors made – led to claims that it may have been, at least in part, authored by AI. For an Assessment with a first “next step” of “improv[ing] trust and reliability in basic science,” it’s a stumble right out of the gate. The Assessment has no public authors. The White House has since uploaded a new copy of the Assessment with corrections. The MAHA Commission’s Make Our Children Healthy Again Strategy, in which it is expected to develop policy recommendations, is due in August 2025, with the White House requesting $500 million in funding from Congress to cover the cost of the MAHA initiative.
Why Wait? – Estate Planning for Young Families
Estate planning is often perceived as a concern only for the wealthy.
Especially in the beginning stages of building a family, legal documentation is not often top of mind. However, for young families, establishing a comprehensive estate plan is an important and proactive step toward safeguarding their loved ones’ future. In the event of a tragedy, having a plan in place is an enormous benefit to your family. Estate planning does not need to be complicated. Instead, implementing proper legal documents can save your family from dealing with major costs and complications down the road.
Why Estate Planning Matters for Young Families
Estate planning is not solely about wealth distribution; it’s about ensuring that your and your family’s needs are met in unforeseen circumstances. Without a proper plan, decisions about your health, assets, and children’s care could be left to the courts, potentially leading to outcomes that don’t align with your wishes. Key considerations include:
Healthcare Decisions: Designating someone to make medical decisions on your behalf if an unexpected accident or illness incapacitates you.
Financial Decisions: Designating someone to make financial decisions on your behalf if you are unable to do so, rather than forcing your loved ones into a costly and uncertain court proceeding.
Asset Distribution: Ensuring your assets are passed on according to your preferences, not default state laws.
Guardianship: Appointing trusted individuals to care for your minor children if you’re unable to do so.
Privacy: Keeping your financial affairs out of public probate records.
Potential Tax Savings: There are certain types of estate plans that may be implemented to mitigate estate taxes in the event of a tragedy.
Essential Estate Planning Documents
In order to plan for the worst, there are several documents that every individual should have. Those documents include the following:
Healthcare Power of Attorney: Designates an individual to make medical decisions on your behalf when you are unable to do so.
Durable Power of Attorney: Appoints someone to handle your financial and legal matters in the event that you become incapacitated.
Living Will: Specifies your wishes regarding end-of-life care.
HIPAA Authorization: Permits designated individuals to access your medical information, ensuring they can make informed decisions about your care.
Last Will and Testament: Outlines how your assets should be distributed and names guardians for your children. Without it, state laws determine these decisions, which may not reflect your intentions. In addition, navigating these laws incurs unnecessary time and costs for your family during a time that is already difficult enough.
Revocable Trust: Allows for the management and distribution of your assets without the need for probate, offering privacy, efficiency, and reducing costs. Probate avoidance is often not a consideration for younger individuals because it seems as though there is plenty of time to plan for death. However, our advice to everyone, no matter what age, is to plan for the worst. Revocable Trusts may be amended at any time, so there is no need to wait.
Asset Ownership and Beneficiary Designations
It is essential to review how your assets are titled and who you have named as beneficiaries on beneficiary-designated assets such as life insurance policies and retirement plans. These designations can override instructions that you provide in your Last Will and Testament or Revocable Trust, so ensuring consistency across all documents is vital. Seeking advice from experienced financial experts and estate planning professionals is the best way to ensure that your wishes are reflected in all of your assets.
Regularly Updating Your Estate Plan
Life changes—such as the birth of a child, marriage, divorce, or significant financial shifts—necessitate updates to your estate plan. All of the estate planning documents discussed above may be amended or revised at any time, and regular reviews will ensure that your plan remains aligned with your current circumstances and intentions.
Seeking Professional Guidance
Given the complexities of estate planning and the nuances of state laws, consulting with an experienced estate planning attorney is advisable. They can help tailor a plan that meets your family’s unique needs and ensures compliance with our ever-changing state and federal laws. By proactively addressing these considerations, young families can establish a comprehensive estate plan that provides peace of mind and protects their loved ones’ future.