5 healthcare policies to watch this month 

By Madeline Ashley, Erica Cerutti, Alan Condon, and Jakob Emerson – Congress is staring down a fast-approaching Sept. 30 government funding deadline. For hospitals and health systems, the outcome could shape years of strategy and operations. House Republicans are preparing to introduce a short-term continuing resolution to keep the government open through Nov. 20, but Democrats are warning they won’t support any deal that omits key healthcare provisions, according to Politico. Chief among them: an extension of enhanced Affordable Care Act premium tax credits, which are set to expire at the end of 2025. Read Full Article...

HVBA Article Summary

1. Uncertainty Surrounds the Future of ACA Tax Credits and Telehealth Flexibilities: The potential expiration of enhanced Affordable Care Act (ACA) premium tax credits by the end of 2025 could lead to major coverage losses, with ripple effects across emergency care, provider burnout, and hospital finances. At the same time, Congress is weighing bipartisan bills that would either extend or make permanent pandemic-era Medicare telehealth and hospital-at-home flexibilities, which have become vital care delivery models.

2. HHS Budget Proposal Reflects Shifting Priorities Amid Cuts: The proposed $108 billion HHS budget for FY 2026 includes major funding cuts for key agencies like the CDC and HRSA, but increases investment in rural health, chronic care telehealth, and prevention programs. While NIH funding is slightly reduced, some global health initiatives are preserved. These changes reflect an evolving focus on domestic healthcare infrastructure over international health programs.

3. Proposed 340B and Site-Neutral Payment Reforms Spark Controversy: HHS plans to pilot a 340B rebate model in 2026, replacing upfront drug discounts with post-sale rebates—a move that hospitals argue could increase costs for safety-net providers. Meanwhile, CMS is advancing site-neutral payment reforms that would equalize Medicare payments for services regardless of setting, aiming to curb incentives for hospital acquisitions of physician practices but raising concerns among hospital leaders.

U.S. FDA sends drug advertising warning letters to Lilly, Novo, Hims

By Mrinalika Roy and Kamal Choudhury – The U.S. Food and Drug Administration issued warning letters to Eli Lilly (LLY.N), Novo Nordisk (NOVOb.CO), and telehealth firm Hims & Hers Health (HIMS.N), last week as part of President Donald Trump's order to crack down on drug advertising. The FDA website shows dozens of letters issued on September 9, many to companies that make or sell weight-loss drugs, the day Trump signed an executive order on disclosure in direct-to-consumer prescription drug advertising. The order instructed the FDA to step up enforcement of laws against misleading ads. Read Full Article...

HVBA Article Summary

1. FDA Warnings to Drugmakers for Minimizing Safety Risks: The U.S. Food and Drug Administration (FDA) issued formal warning letters to Eli Lilly, Novo Nordisk, and Hims & Hers Health, highlighting concerns over how their respective medications—Zepbound, Mounjaro, Ozempic, Wegovy, and compounded semaglutide—were presented in public forums. The FDA cited specific media appearances, including a high-profile 2024 Oprah Winfrey special, where drug benefits were promoted while serious safety warnings, including boxed warnings, were either omitted or significantly downplayed. This raised red flags about potentially misleading marketing practices.

2. Regulatory Oversight and Enforcement Actions: In response to what it views as an industry-wide issue, the FDA reinforced its stance on the need for balanced, transparent communication of both benefits and risks in drug marketing. Commissioner Marty Makary announced the agency’s broader initiative to ensure compliance, revealing that around 100 cease-and-desist notices and thousands of letters would be sent to companies. These measures aim to uphold standards requiring that all drug promotions include comprehensive disclosures of side effects and safety information, particularly for drugs with serious health risks.

3. Company Responses and Market Impact: Lilly stated it did not control the content of the media interviews and therefore did not treat them as advertisements. Novo Nordisk did not provide an immediate comment. Hims responded by affirming alignment with the FDA’s focus on informed patient choices. Following the FDA's actions, shares of Hims dropped by over 7%, while Lilly's shares rose by 2.6%. The FDA gave the companies 15 working days to respond, warning of potential legal action if violations remain unresolved.

Benefits Think: How Rx headwinds are reshaping plan design

By Lisa Cummings – As health plan sponsors prepare for 2026 open enrollment, they face familiar concerns of rising claims trends and labor costs, while also confronting new ERISA litigation risks tied to pharmacy benefit manager (PBM) contracts. A consistent theme runs through these challenges: Increasing and opaque costs charged by vendors that must ultimately be borne by employers and employees. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. ERISA Fiduciary Litigation Is Expanding to Health Plans: Recent lawsuits—Lewandowski v. Johnson & Johnson, Knudsen v. MetLife Group, and Navarro v. Wells Fargo—highlight a new wave of ERISA litigation targeting health plan sponsors. Plan participants allege that fiduciaries failed to ensure reasonable prescription drug pricing, marking a shift from previous ERISA suits focused on retirement plan fees to healthcare cost transparency and oversight.

2. Plan Sponsors Must Address Rising Costs Proactively: In response to escalating healthcare costs, the article recommends a two-phase strategy: (1) near-term 2026 health plan design adjustments, and (2) long-term restructuring of provider and PBM (Pharmacy Benefit Manager) contracts. Strategies include adopting value-based care models, expanding telehealth, guiding employees to high-value providers, and applying predictive analytics to manage high-cost claimants. Advisers play a critical role in supporting these efforts by identifying opportunities to remove unnecessary administrative layers and opaque pricing, replacing them with transparent, outcome-driven arrangements.

3. PBM Contract Reform Is a Fiduciary Priority: Given that pharmacy costs are rising faster than other medical claims, PBM oversight has become a key fiduciary responsibility. The article emphasizes the importance of unbundling services, demanding full rebate and fee disclosures, and negotiating performance-based PBM contracts. These reforms aim to improve plan value, reduce costs, and ensure fiduciary compliance by aligning PBM incentives with measurable health outcomes.

Multicancer Detection Tests Not Ready for Prime Time, Review Suggests

By Mike Bassett – The jury is still out on the merits of multicancer detection (MCD) tests in asymptomatic adults, according to results from a systematic review. Across 20 studies reporting on the accuracy of 19 tests, test sensitivity ranged from 0.095 to 0.998, specificity ranged from 0.657 to 1.0, and area under the curve (AUC) ranged from 0.52 to 1.0, reported Leila C. Kahwati, MD, MPH, of RTI International in Research Triangle Park, North Carolina, and colleagues. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Insufficient Evidence for Clinical Utility of MCD Tests: Although multi-cancer detection (MCD) tests such as Galleri and OneTest are already available for clinical use with a physician’s order, the review found no completed controlled studies demonstrating their effectiveness in improving cancer detection rates, reducing mortality, or enhancing quality of life. The overall strength of evidence regarding their accuracy and potential harms was rated as insufficient, largely due to limitations in existing research and inconsistent or incomplete findings.

2. Methodological Concerns and High Risk of Bias in Studies: Among the 20 studies analyzed, which covered over 100,000 participants and 19 different MCD tests, many were found to have a high or unclear risk of bias. This was often due to issues such as non-random sampling, undefined test thresholds, and flawed reference standards. Notably, prediagnostic performance studies—measuring how well tests detect cancer in asymptomatic individuals—showed lower sensitivity and AUC compared to diagnostic studies, indicating weaker performance in real-world screening scenarios.

3. Urgent Need for Robust Research Before Widespread Use: Experts, including those commenting in an accompanying editorial, emphasized that current enthusiasm for MCD tests is not backed by strong clinical utility data. They stressed the need for rigorous future research to assess not only the benefits and harms across diverse populations but also the cost-effectiveness, appropriate screening intervals, and methods for effectively communicating risks and benefits to patients and providers. Until such evidence is available, caution is advised in the clinical adoption of these tests.

Employers brace for highest health cost increase in 15 years

By Alan Goforth – Health plan sponsors, already dealing with steadily rising costs, now face the highest increase in 15 years as they look ahead to 2026. The total health benefit cost per employee is expected to rise an average of 6.5% next year, even after accounting for planned cost-reduction measures. Employers estimated that plan cost would increase by nearly 9% on average if they took no action to lower cost, according to Mercer’s 2025 National Survey of Employer-Sponsored Health Plans. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Rising Health Benefit Costs Through 2026: Health benefit costs are projected to rise significantly through 2026, marking the fourth consecutive year of above-average growth following a prior decade of relatively stable 3% annual increases. This sustained surge in costs is prompting many employers to reevaluate their health care strategies, as both the price of services and the frequency of utilization continue to climb.

2. Drivers of Cost Growth – Innovation and Consolidation: Key factors fueling the cost increase include advancements in diagnostics and treatments — such as innovative cancer therapies and popular weight-loss medications — which, while often improving patient outcomes, tend to be more expensive than existing options. Additionally, the ongoing consolidation of health care providers into larger systems has increased their ability to negotiate higher reimbursement rates with insurers.

3. Employer Response: Cost-Cutting and Care Management: In response to the mounting pressure on health care budgets, nearly 6 in 10 employers plan to implement cost-cutting measures in 2026, such as raising deductibles or cost-sharing provisions, which may result in higher out-of-pocket expenses for employees. At the same time, many employers are also prioritizing strategies to manage high-cost claims, enhance chronic condition care, and improve behavioral health access, aiming to control spending without reducing affordability for plan members.

Why Patients Are Filing More Complaints Against Hospitals

By Jay Asser – Hospital leaders face a growing concern when it comes to the patient experience: Complaints are on the rise, and federal data show the problem is only intensifying. According to the latest State Performance Standards System report from CMS, complaints against hospitals have surged by 79% over the past five years and topped 14,500 in fiscal year 2024. That increase is straining the oversight system designed to ensure hospital quality and safety, while also revealing frustrations from patients about their care experiences. Read Full Article...

HVBA Article Summary

1. Oversight and Investigation Delays Are Tied to Stagnant Funding: State Survey Agencies, responsible for investigating patient complaints and conducting hospital recertification surveys, have been operating with the same federal funding levels since 2015. Meanwhile, their workloads and resource demands have steadily increased. This funding stagnation has contributed to delays in launching investigations and completing regular surveys, weakening oversight systems and leaving hospitals without consistent accountability checks.

2. Patient Dissatisfaction Is Growing Amid Perceived Oversight Failures: The inability to address patient complaints promptly has led to rising frustration and a sense that safety concerns are not being taken seriously. As investigations lag and regulatory presence feels diminished, more patients are resorting to filing formal complaints. This trend reflects a deeper erosion of trust in healthcare institutions and suggests that many patients feel their voices are being ignored in matters of care and safety.

3. Hospital Leaders Are Encouraged to View Complaints as Strategic Feedback: Although hospital CEOs cannot influence federal budgets, they do have control over how their organizations respond to patient concerns. The article encourages leaders to go beyond regulatory compliance by treating complaints as valuable insights into system weaknesses. Investing in rapid-response protocols, empowering frontline staff to resolve issues immediately, and improving patient communication can help rebuild trust, enhance quality scores, and reduce the volume of formal grievances.

Elevance health goes to court to protect its level-funded plan business

By Allison Bell – Elevance Health sees the market for level-funded health plans as a "burgeoning" and "highly competitive field." The expertise needed to offer a successful level-funded plan is "of great economic value," according to a complaint Elevance filed Friday in the U.S. District Court for the Eastern District of Virginia. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Elevance Sues Former Executive Over Non-Compete Violation: Elevance Health, the Indianapolis-based parent company of Anthem Blue Cross, has filed a lawsuit against its former executive Maria Gregory. The company alleges that Gregory breached a non-compete clause by accepting a senior underwriting role at Gravie, a company Elevance considers a direct competitor in the health benefits market.

2. Gregory's Role and Alleged Competitive Risk: Prior to her departure in July, Gregory managed a team of approximately 80 employees and was responsible for underwriting in several key segments, including small businesses, key accounts, and level-funded health plans. Elevance claims her new role at Gravie, which offers similar products and competes in overlapping markets, violates the terms she agreed to when receiving company stock grants.

3. Strategic Importance of Level-Funded Plans to Elevance: Elevance highlights in its legal filing that its Anthem Balanced Funding program—targeted at small and midsize employers—has experienced strong, consistent growth. The company views this business line as a central part of its future strategy and argues that any competitive threat, including Gregory's transition to Gravie, could impact that trajectory.