FDA Commissioner Marty Makary talks the ‘AI revolution’ at the agency

By Cassie McGrath – Last week, the Washington Post reported the Centers for Medicare and Medicaid is “going all in on AI.” But it’s not the only federal health agency doing so. FDA Commissioner Marty Makary, an embattled pick who was confirmed on March 25 last year, sat down for an interview with Healthcare Brew to talk about how AI is already in use at the agency (though there have been anonymous complaints about some of the tools) and how pivotal he believes it is for the pharmaceutical industry. He also shared about his plans for the technology, ‘including long-term goals for making drug approval more efficient using AI. Read Full Article...

HVBA Article Summary

1. AI Integration at the FDA: The FDA has encouraged its developer community to propose AI solutions for various agency workflows, resulting in 181 submissions aimed at improving processes such as document review, compliance, and manufacturing oversight. While not all of these tools have been implemented yet, some AI systems are already assisting scientific reviewers with tasks like formatting checks and safety signal detection. This approach is intended to streamline tedious administrative work and allow human experts to focus on higher-level decision-making.

2. Balancing Innovation and Risk: Commissioner Makary emphasized the need to modernize the FDA’s regulatory framework to better accommodate AI technologies. He acknowledged that the current system, developed before the rise of AI, can stifle innovation and must evolve to tolerate certain risks inherent to new technologies. Makary argued that society has already accepted some level of risk with AI in other domains, and similar flexibility is necessary in healthcare to foster growth and learning.

3. Efficiency and Cost Savings: Makary highlighted that AI tools have already saved FDA staff thousands of hours by automating repetitive tasks, such as verifying the completeness of drug applications. He cited the potential for AI to dramatically reduce processing times, using the example of a 60-day filing period that could be shortened to minutes with automation. Additionally, advancements like computational modeling and organ-on-a-chip technology are expected to lower research and development costs by reducing reliance on animal testing, benefiting especially smaller drug development companies.

Stryker attack raises concerns about role of device management tool

By David Jones – A suspected wiper attack against medtech giant Stryker has led much of the security community to examine the role of Microsoft Intune. Stryker, a Portage, Mich.-based specialist in surgical equipment, was hacked last week in an attack that affected thousands of mobile devices and other systems. The company, in a regulatory filing, confirmed the attack impacted its Microsoft environment and warned in a customer update that its electronic ordering systems remain unavailable. An Iran-linked hacker tracked under the name Handala claimed credit for the attack, according to Check Point Research. Read Full Article...

HVBA Article Summary

1. Abuse of Device Management Tools in Cyberattacks: The Stryker incident highlights how legitimate device management platforms like Microsoft Intune can be weaponized by attackers to execute destructive actions, such as remotely wiping data from thousands of devices. This attack required the perpetrators to obtain high-level administrative privileges, demonstrating the risks associated with compromised credentials in enterprise environments. The event underscores the importance of securing access to management tools and monitoring for unusual administrative activity.

2. No Inherent Flaw in Microsoft Intune Identified: Experts, including a senior analyst at Forrester, noted that the attack did not exploit a vulnerability within Microsoft Intune itself. Instead, the attackers used standard features of the platform in a malicious way, a tactic known as "living-off-the-land." This approach allows attackers to bypass traditional security controls by leveraging trusted software, emphasizing the need for layered defenses and strict access controls.

3. Broader Trend of Attacks via Management Platforms: The Stryker breach is part of a larger pattern where attackers use mobile device management (MDM) and unified endpoint management (UEM) platforms to carry out significant cyberattacks. Previous incidents, such as those targeting the European Commission and a multinational firm, demonstrate that this method is not new. Security experts recommend implementing multi-factor authentication and multi-account approval processes for critical actions to reduce the risk of similar attacks in the future.

Average states' small-group premiums climbed 11% in 2025

By Allison Bell – Premiums for standard, fully insured small-group health insurance climbed 11% in the average state between 2024 and 2025, according to a comparison of a new preliminary premium table from the Center for Consumer Information & Insurance Oversight with the comparable table published in 2025. The average small-group premium in all states was $603 per month. The state-level averages ranged from $391, in Mississippi, up to $957, in Alaska. Average premiums fell 15% or more in three states, and 24% in Mississippi. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Significant Variation Across States: While the national average increase in small-group health insurance premiums was 11%, there was considerable variation at the state level. Some states experienced substantial decreases, such as Mississippi with a 24% drop, while others saw sharp increases, including Georgia with a 72% rise. This disparity highlights the uneven impact of market forces and regulatory environments on insurance costs across the country.

2. Implications for Small Employers: The rising premiums in many states may make it more difficult for small employers to offer affordable, fully insured health coverage to their employees. In states where premiums have surged, small businesses could face increased financial strain or may be forced to reduce benefits or drop coverage altogether. This trend could have broader implications for employee access to health care and the stability of the small-group insurance market.

3. Role of Federal Risk Adjustment Program: The premium tables referenced in the article are compiled by the Center for Consumer Information & Insurance Oversight (CCIIO) to support the administration of an Affordable Care Act risk-adjustment program. This program is designed to balance costs by transferring funds from plans with healthier enrollees to those with higher-risk populations. The preliminary nature of the data means figures could change, but the tables provide important insight into market trends and the effectiveness of federal risk mitigation efforts.

How to Solve One of the Most Expensive Problems in Employer Healthcare

By Elizabeth Rice, Shealynn Buck, Carrie Bowling, Steven J. Lester, Oyebode Taiwo – In 2019, Monte Leifheit, a warehouse operator at 3M, noticed his left eye was bloodshot and swollen. What began as a minor irritation turned into a yearlong medical odyssey marked by the lack of a diagnosis, ineffective treatments, and compounding side effects—all while costs escalated. “I had some really low moments,” Leifheit recalls. “At one point I remember thinking, ‘If I die in my sleep, it would be better than the pain I’m dealing with.’” Leifheit’s story illustrates a systemic failure in American healthcare, one rooted in unnecessary utilization, repeated visits, redundant tests, and delayed interventions that account for a disproportionate share of healthcare spending. Read Full Article...

HVBA Article Summary

1. High Healthcare Spending Concentrated Among Complex Patients: A small proportion of individuals enrolled in employer-sponsored health plans account for a large share of total healthcare spending, often due to undiagnosed or complex conditions. These patients frequently experience fragmented care, repeated specialist visits, and redundant testing without receiving a clear diagnosis or effective treatment. As a result, traditional cost-management strategies such as narrow provider networks or utilization controls may not address the underlying problem of diagnostic uncertainty.

2. Diagnostic-Focused Centers of Excellence for Complex Care: A newer model of centers of excellence emphasizes rapid, coordinated diagnostic evaluations for patients with unresolved or complex conditions. Programs such as the Mayo Clinic Complex Care Program bring together multidisciplinary specialists to compress months of testing and consultations into a short evaluation period. Employers may support access by identifying high-risk members and covering travel or reducing out-of-pocket costs to facilitate specialized care.

3. Evidence Suggests Potential Cost Savings and Improved Care Plans: Data cited in the article indicate that multidisciplinary diagnostic programs often lead to changes in diagnoses and treatment plans for many patients. Claims analyses found substantial reductions in healthcare spending after evaluations, largely due to improved diagnostic accuracy and the avoidance of unnecessary procedures or hospitalizations. Employers may view these programs as a strategy to improve patient outcomes while managing healthcare costs for a small but high-cost segment of plan members

The Rise of Oral GLP-1s

By Renzo Luzzatti – No pharmacy therapeutic class has transformed plan sponsor's pharmacy benefits as much as GLP-1s in recent years. What started two decades ago as a novel approach to controlling blood sugars for people with type 2 diabetes has now turned into one of the leading treatment strategies for promoting weight loss and reducing cardiovascular risk. While these drugs have produced meaningful health benefits, they've also resulted in unprecedented demand and created cost-containment challenges that plan sponsors must address directly. Read Full Article.... ^{_{(Subscription required)}}

HVBA Article Summary

1. GLP-1 Medications Have Expanded from Diabetes Treatment to Obesity and Cardiovascular Care: Early GLP-1 therapies helped people with type 2 diabetes control blood sugar but required daily injections and did not lead to weight loss. Newer injectable drugs such as semaglutide and tirzepatide demonstrated that patients could lose more than 15% of body weight and also reduce cardiovascular risk, expanding their role beyond diabetes management. As a result, these medications have become widely used and now represent more than 20% of total pharmacy spending for many large employer health plans.

2. Oral GLP-1 Drugs Offer a Needle-Free Option but Show Mixed Market Impact: The first oral GLP-1, Rybelsus, received FDA approval in 2019 and is taken once daily, compared with the once-weekly dosing of injectable Ozempic, but it produced weaker blood-sugar and weight-loss results and was priced similarly to injectables. In December 2025, the FDA approved oral Wegovy for weight loss, and clinical trials showed 16.6% average weight loss in the OASIS 4 trial, close to the 17.4% reduction seen with injectable Wegovy in the STEP 4 trial. The SOUL trial also found a 14% reduction in serious cardiovascular events, and the drug carries a list price of about $1,350 for a 30-day supply, though direct-to-consumer pricing ranges from $149–$299 monthly, compared with $349–$499 for injectable versions.

3. Employers Are Expanding Coverage but Increasing Utilization Controls Due to High Costs: Coverage of GLP-1 medications is rising, with 36% of employers covering them for both diabetes and weight loss in 2025, up from 34% in 2024, while one in four employers not currently covering them are considering doing so. However, many plans apply strict eligibility rules such as BMI thresholds or required participation in lifestyle programs, and some insurers have reduced coverage after large spending increases, including BCBS of Michigan removing coverage for several GLP-1 weight-loss drugs following a 29% jump in pharmacy costs. As more therapies enter the pipeline, employers are expected to continue balancing patient access, clinical outcomes, and long-term financial sustainability.

Screen time surges for desk workers, straining eyes and productivity

By Jimmy Nesbitt – The third annual Workplace Vision Health Report found that desk workers now average 99.2 hours of screen time per week, up from 97 hours last year. Most (71%) say screen-related eye strain is affecting their performance, with nearly a full day of productivity lost each week. "With so many employers offering remote or hybrid working arrangements and the increase in exposure to digital devices across all facets of our lives, screen time continues to increase for many individuals — even if they don't work behind a desk," says Dr. Valerie Sheety-Pilon, VSP Vision Care senior vice president of clinical and medical affairs. Read Full Article...

HVBA Article Summary

1. Rising Screen Time and Eye Health Concerns: A survey conducted by VSP and Workplace Intelligence found that many employees report increased screen time is negatively affecting their eye health. Excessive screen exposure is associated with eye strain, headaches, and discomfort in the neck, shoulders, and back. Over time, continued strain on eye muscles may lead to more persistent symptoms such as blurred vision and ongoing dry eye, potentially affecting overall quality of life.

2. Practical Strategies to Reduce Digital Eye Strain: Eye care professionals recommend several routine adjustments to help reduce screen-related eye discomfort. These include updating prescriptions, positioning screens at a comfortable distance, adjusting brightness or contrast to reduce glare, and considering lens options such as blue-light filtering or anti-reflective coatings. Additional habits such as using artificial tears, taking regular breaks from screens, and scheduling annual eye exams can help maintain eye health.

3. Vision Benefits and Employer Support: Employers can help address digital eye strain by offering accessible vision benefits that cover eye exams, glasses, and contact lenses. Survey results indicate that while most HR leaders and employees view vision care as important, many workers still do not receive annual eye exams. Improving communication about available benefits and ensuring plans are affordable and easy to navigate may help increase participation in preventive eye care.

CHROs, CFOs, and corporate board members all have their eye on healthcare spending

By Courtney Vinopal – Employers grew more concerned about the high cost of pharmaceutical drugs last year, even as the White House rolled out a series of policies intended to lower prices of some popular medications. Nearly three-quarters of employers said they were moderately, very, or extremely concerned about pharmacy costs being “unsustainable” in 2025, according to a recent report from NFP, a benefits consultancy that’s part of Aon. That’s up from 67% who expressed moderate to extreme concern about pharmacy costs in 2024. Read Full Article...

HVBA Article Summary

1. Rising Employer Pharmacy Costs Driven by GLP-1 Medications: Employer healthcare costs are projected to increase by more than 9%, with GLP-1 medications for diabetes and weight loss identified as a major contributor to rising prescription drug spending. Although the Trump administration introduced policies aimed at lowering drug prices and pharmaceutical companies such as Eli Lilly and Novo Nordisk have agreed to reduce some medication prices, these drugs remain a significant cost driver for employer-sponsored health plans. As a result, organizations are placing greater focus on managing pharmacy spending and evaluating strategies to control these expenses.

2. GLP-1 Coverage Emerging as a Talent Strategy: Despite their high cost, GLP-1 medications are increasingly viewed by some employers as a potential benefit for attracting and retaining employees. Survey data indicates that 29% of workers would consider switching jobs to gain access to GLP-1 coverage. However, employer decisions about whether to offer this benefit vary widely, reflecting the challenge of balancing workforce demand with financial sustainability.

3. Employers Adopt Targeted Solutions to Manage GLP-1 Spending: To address rising costs, many employers are implementing specialized management approaches such as pharmacy benefit manager programs or third-party vendors that help determine eligibility and monitor utilization of GLP-1 medications. Some companies are also choosing point solutions that manage GLP-1 coverage separately from other prescription drug benefits. Addressing these spending pressures is increasingly involving collaboration among HR leaders, finance teams, and corporate boards to guide benefit strategy decisions.