Government shutdown furloughs 75% of EBSA staff, halts research, audits

By Allison Bell – The partial shutdown of the U.S. federal government is suspending the work of 75% of the employees of the Employee Benefits Security Administration and forcing some to do their jobs without getting paid. Most of the government shut down today because Congress failed to come to an agreement on an "appropriations" bill, or funding bill, that could pay for the government's general operations. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Significant Furloughs at EBSA: The government shutdown has resulted in furloughing 504 out of 668 employees at the Employee Benefits Security Administration (EBSA), which constitutes 75% of its workforce. This suspension affects research, audits, and non-essential compliance assistance activities, significantly limiting the agency's operational capacity during the shutdown. Essential functions related to protecting life and property continue with a reduced staff.

2. Continued Operations for Certain Investigations and Implementations: Despite the shutdown, EBSA maintains funding and ongoing work for specific activities such as No Surprises Act surprise billing investigations and mental health and addiction treatment group health benefits parity investigations. Additionally, efforts to implement new laws, including the price transparency section of the No Surprises Act, continue uninterrupted due to separate appropriations. This ensures that some high-profile regulatory enforcement and rulemaking efforts proceed despite the broader furloughs.

3. Political Context and Funding Challenges: The shutdown stems from Congress's failure to pass an appropriations bill for general government operations, with the House passing a temporary anti-shutdown bill that failed in the Senate. Political disagreements, including disputes over Affordable Care Act premium subsidies, contributed to the impasse. Some EBSA employees continue working with pay due to separate legislative appropriations, while others work without pay as their roles are deemed necessary to protect life and property.

Trump administration backs off 100% pharma tariffs threatened to start [yesterday]

By Daniel Payne – President Trump told pharmaceutical companies last week that they should start building infrastructure in the U.S. — or face a 100% tariff, starting Wednesday. But a White House official told STAT on Wednesday that the tariffs have not gone into effect and that the administration would now “begin preparing” tariffs on companies that don’t build in the U.S. or make a drug pricing agreement with the administration. The official didn’t share a new timeline for those import taxes, which would apply to branded drugs. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Trump Administration Delays Pharma Tariffs to Strengthen Negotiating Leverage: The Trump administration has temporarily backed off its threat to impose 100% tariffs on pharmaceutical imports, despite previously promising swift action. This delay is not a retreat but a calculated effort to use the threat of tariffs as a negotiating tool. By holding off, the administration aims to extract voluntary commitments from drugmakers, such as lowering domestic drug prices and significantly increasing their investment in U.S.-based manufacturing.

2. Pfizer Strikes a Major $70 Billion Deal to Avoid Penalties: Pfizer has become the first major pharmaceutical company to formalize a deal with the administration. Under this agreement, the company has pledged $70 billion in new U.S. manufacturing investments and agreed to lower drug prices by indexing them to international standards and offering direct-to-consumer options. As a result of this commitment, Pfizer will be exempt from national-security-related tariffs for the next three years, setting a precedent for other companies to follow.

3. Tariffs Positioned as a Negotiation Weapon in Broader Industry Talks: Commerce Secretary Howard Lutnick confirmed that the administration will allow negotiations with additional drugmakers to continue before enacting any national-security tariffs. President Trump emphasized that similar deals are actively being discussed with other companies and warned that those who don’t engage constructively will face tariffs. The administration is using the looming threat of trade penalties as leverage to secure broader price concessions and domestic investments across the pharmaceutical sector.

ACA premiums to rise 114% without subsidy renewal

By Peter Sullivan – Premiums will more than double for millions of Affordable Care Act enrollees next year if Congress does not renew enhanced marketplace subsidies by year's end, according to a new analysis. Why it matters: The tax credits that help people afford premiums are at the center of the showdown over government funding, and the latest findings underscore the stakes if they are not renewed, as Democrats insist they must be. Driving the news: Average premiums would increase 114%, from $888 to $1,904 per year, the analysis from health policy research organization KFF finds. Read Full Article...

HVBA Article Summary

1. Significant Premium Increase Without Subsidy Renewal: If Congress does not renew the enhanced marketplace subsidies by the end of the year, premiums for millions of Affordable Care Act enrollees are expected to more than double, increasing by 114% on average. This would raise the average premium from $888 to $1,904 annually, imposing a substantial financial burden on the approximately 22 million subsidy recipients. The increase highlights the critical role these tax credits play in making health insurance affordable for many Americans.

2. Political Standoff Over Funding: The renewal of enhanced ACA tax credits is a central issue in the ongoing government funding negotiations. Congressional Democrats are demanding the renewal as a key condition, while GOP leaders have not ruled out a limited extension but prefer to delay negotiations. The timing is crucial as open enrollment for the next year begins on November 1, and failure to act could lead to many people dropping their coverage due to increased costs.

3. Potential Impact on Coverage and Market Stability: Without the subsidies, many enrollees may face sticker shock and decide to forgo health insurance, which could lead to coverage losses and higher premiums for others in the individual market. This scenario is already a concern in states like Washington, where officials warn that tens of thousands could lose coverage if subsidies expire. The uncertainty around subsidy renewal adds pressure on lawmakers to reach an agreement to maintain market stability and protect consumers.

Protecting self-funded health plans from cost surges: A guide for benefits advisors

By Bruce D. Roffé – High-cost medical claims are hitting harder and more often, putting increased pressure on benefits advisors to protect their clients' budgets and keep plans sustainable. According to recent projections, medical cost trend is holding at 8.5% for the group market, the highest in more than a decade, driven by rising inflation, runaway pharmacy costs and a 45% surge in behavioral health claims. For self-funded employers, the financial pressure is mounting, especially in high-dollar categories like cancer, cardiology and dialysis, where claims are both frequent and financially burdensome. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Proactive Claims Management is Critical to Cost Containment: Benefits advisors must go beyond reacting to expensive claims and instead build systems that detect and address them early. This includes using “trigger codes” for early identification, scrutinizing out-of-network charges, and enforcing oversight on specialty drug use. Effective tactics—such as skilled claims negotiation, prepayment reviews, and independent clinical assessments—can prevent runaway costs in high-impact areas like cancer treatment, cardiology procedures, and dialysis services.

2. Strategic Plan Design Enhances Both Savings and Care Quality: Carefully designed health plans can achieve cost savings while maintaining or even improving clinical outcomes. Leveraging tools such as reference-based pricing, site-of-care redirection, and pharmacy benefit controls helps reduce unnecessary spending. In behavioral health, integrated systems that guide employees to high-quality care and monitor utilization can produce strong returns—up to $159 in monthly savings per member—by minimizing fragmented treatment and supporting better outcomes through coordinated, evidence-based care.

3. Benefits Advisors Must Serve as Ongoing Strategic Partners: Today’s advisors must take an active, continuous role in protecting the financial integrity of self-funded health plans. This involves educating employers about the risks of high-cost claims, advocating for advanced oversight tools like line-item bill reviews and prepayment audits, and collaborating with specialized vendors to uncover hidden savings. By tracking outcomes and demonstrating clear financial impact, advisors not only defend plan budgets but also build long-term value as trusted, results-driven partners.

Health AI leaders split on utility of AI regulatory sandboxes as Ted Cruz says state AI moratorium still on the table

By Emma Beavins – Health AI leaders seem split on the usefulness of regulatory sandboxes in addressing the problems that AI developers and provider organizations are facing when it comes to the novel technology. The two most significant federal AI regulatory proposals in recent months, the SANDBOX Act introduced by Senator Ted Cruz, R-Texas, and Trump’s AI Action plan, aren’t targeting the most burdensome areas for developers, experts said. A moratorium on state AI laws died over the summer in Congress, and in recent months, Cruz and the White House have advocated for AI sandboxes at the federal level to exempt startups from "burdensome regulation." As advocates shrug at the sandbox proposal, Cruz says a state-level moratorium is still on the table. Read Full Article...

HVBA Article Summary

1. Divergent Views on AI Regulatory Sandboxes: Health AI leaders are divided on the effectiveness of regulatory sandboxes proposed at the federal level. While some, like the Coalition for Health AI CEO Brian Anderson, support the SANDBOX Act as a way to foster innovation and build public trust by allowing startups to test AI technologies under clear conditions, others remain skeptical. Critics argue that these sandboxes do not address the broader challenges posed by the patchwork of state AI laws and may not significantly impact innovation on a larger scale.

2. Details and Intent of the SANDBOX Act: Introduced by Senator Ted Cruz, the SANDBOX Act aims to temporarily waive certain federal AI regulations for up to two years, with possible renewals, to allow developers to experiment with AI tools. Applicants must demonstrate consumer benefits and disclose the experimental nature of their products. The legislation includes provisions for accountability, such as annual reporting to Congress on waivers and consumer engagement, and maintains criminal liability protections, reflecting a balance between innovation and risk mitigation.

3. Challenges Beyond Federal Regulation: Despite federal efforts, the absence of a comprehensive federal AI regulatory framework leaves startups grappling with a complex landscape of varying state laws. Many AI startups operate outside FDA regulation, limiting the utility of federal sandboxes for them and shifting compliance burdens to healthcare providers. Experts caution that waiving regulations may not inherently build trust and could place undue risk on implementers, emphasizing the need for careful consideration of safety and liability in deploying AI in healthcare.

Lack of employer health insurance in minority-owned SMBs fuels coverage gaps

By Michael Popke – A new study suggests that less than half of small businesses offer employer-sponsored health insurance — with minority-owned businesses offering insurance less often than White-owned businesses. Researchers at the University of Colorado Denver’s Department of Health and Behavioral Science used restricted data from the U.S. Census Bureau’s 2012 “Survey of Business Owners” and the bureau’s “Annual Survey of Entrepreneurs” from 2014 through 2016 to analyze trends during the rollout of the Affordable Care Act (ACA). Their study, published in the September issue of SSM-Population Health, revealed “substantial” disparities regarding the racial/ethnic composition of business owners and whether they offer health insurance. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Significant Disparities in Offering Employer-Sponsored Insurance: The study found that only 41% of White-owned small businesses offered employer-sponsored health insurance (ESI) in 2012, compared to just 26% of Black- and Asian-owned, and 23% of Hispanic-owned small businesses. These disparities persisted even after the implementation of ACA incentives, indicating systemic challenges for minority-owned businesses in providing health insurance to employees. This gap highlights a critical area for policy intervention to improve health coverage equity.

2. Impact on Health Insurance Access for Workers: The disparities in ESI offerings among minority-owned small businesses contribute to broader barriers in health insurance access for workers and their families in these communities. Since many employees work in co-ethnic environments, the lack of ESI in minority-owned businesses exacerbates health coverage gaps along racial and ethnic lines. Addressing these disparities is essential to improving overall healthcare access and reducing inequities in health outcomes.

3. Policy Recommendations and Future Research Needs: The researchers advocate for policies that specifically address the affordability and accessibility of ESI in small businesses, especially those owned by minorities. They emphasize the need for further research into social and economic mechanisms that could increase ESI offerings among small businesses. Policymakers are encouraged to develop targeted strategies to 'bend the curve' and strengthen healthcare systems in communities with high concentrations of minority-owned small businesses.

Sanofi to Offer All Sanofi Insulin for $35 a Month, Regardless of Income, Insurance Type

By Logan Lutton – Sanofi will offer a 30-day supply of any combination, type or quantity of their insulin for $35 to all patients with a valid prescription, regardless of income or insurance status, starting January 1, 2026, according to a recent company news release. This fixed monthly rate will be available through their Insulins Valyou Savings Program, which was originally established for patients without health insurance. Insulin brands covered include Admelog (insulin lispro), Apidra (insulin glulisine), Lantus(insulin glargine), Merilog (insulin aspart-szjj), Soliqua100/33 (insulin glargine and lixisenatide), and Toujeo (insulin glargine). Read Full Article...

HVBA Article Summary

1. Sanofi's Insulin Pricing Initiative: Starting January 1, 2026, Sanofi will provide a 30-day supply of any of its insulin products for a fixed price of $35, regardless of a patient's income or insurance status. This initiative expands their Insulins Valyou Savings Program, which was initially designed for uninsured patients. The program aims to improve affordability and access to insulin for millions of Americans living with diabetes.

2. Context of Insulin Pricing and Other Manufacturer Programs: This move aligns with a broader trend among insulin manufacturers to offer direct-to-consumer discount programs. For example, Lilly offers a similar $35 insulin program, and Novo Nordisk provides multiple discounts, including a $25 vial offer redeemable at Walmart. Additionally, President Trump's April executive order capped insulin prices at $35 a month for Medicare Part D enrollees, highlighting ongoing policy efforts to reduce insulin costs.

3. Diabetes and Insulin Cost Challenges in the U.S.: More than 37 million Americans have diabetes, with approximately 8.4 million relying on insulin to survive. Insulin prices in the U.S. can be up to 10 times higher than in other countries, causing about 1 in 5 patients to ration their insulin. The American Diabetes Association reports that diabetes-related medical costs rose 35% from 2012 to 2022, with an average annual healthcare expenditure of $19,736 per patient, underscoring the financial burden faced by many diabetes patients.