Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list

By Brendan Pierson - Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's (NOVOb.CO) weight-loss and diabetes treatments Wegovy and Ozempic from its shortage list, a move that will sharply curtail the ability of compounders to sell cheaper versions of the medicines. Read Full Article…

HVBA Article Summary

1. Legal Challenge Against FDA's Shortage Decision: The Outsourcing Facilities Association and FarmaKeio Custom Compounding are challenging the FDA's decision to remove semaglutide from the drug shortage list, arguing that the agency's ruling was "arbitrary and capricious." They claim that the FDA relied on manufacturers' assurances of supply without fully considering ongoing patient access issues.

2. Implications for Compounding Pharmacies and Consumers: U.S. regulations permit compounding pharmacies to produce large quantities of brand-name drugs only if they are officially listed as being in short supply. The lawsuits have significant implications for the availability of cheaper compounded alternatives to popular weight-loss and diabetes drugs like Wegovy and Mounjaro, which many consumers have turned to due to high costs and limited availability of the brand-name versions.

3. Ongoing Legal Disputes and FDA's Response: The current lawsuit follows a similar ongoing case regarding tirzepatide, another active ingredient used in weight-loss and diabetes medications. Despite agreeing to reconsider its decision, the FDA maintained its stance that there is no longer a shortage of tirzepatide. In both cases, the FDA has provided a 60- to 90-day grace period for compounders before enforcement actions are taken.

Recent Prescribing Regulations – DEA & HHS Delay Implementation of Final Rules

By CCHP - The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have announced a delay in the effective date for the recently issued final rules regarding the telemedicine prescribing of buprenorphine and telemedicine for Veterans Affairs Patients (which are further detailed below). Originally scheduled to become effective February 18, the rules will now take effect on March 21, 2025. Read Full Article… 

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1. Regulatory Freeze and Extension of Telemedicine Flexibilities: The DEA and HHS are adhering to the White House's regulatory freeze memorandum by postponing the effective dates of new rules and extending telemedicine flexibilities for prescribing controlled substances through December 31, 2025. This extension ensures continued waivers of in-person visit requirements for the remainder of 2025.

2. Key Provisions of the Buprenorphine and Veterans Affairs Rules: The new Buprenorphine Rule allows telemedicine prescriptions for opioid use disorder treatment under specific conditions, including PDMP review and pharmacist identity verification. The Veterans Affairs Rule permits VA practitioners to prescribe controlled substances via telemedicine without a prior in-person evaluation if another VA practitioner has previously evaluated the patient in person.

3. Introduction of the Proposed Telemedicine Special Registration Rule: The DEA's proposed rule aims to establish a formal framework for telemedicine prescribing of controlled substances by introducing three special registration types. These include permissions for general telemedicine prescribing, advanced prescribing by specialized practitioners, and telemedicine platform registrations, with specific requirements for identity verification, PDMP checks, and electronic prescribing.

The states that would be the hardest hit by Medicaid cuts

By Jakob Emerson - Almost 11 million people would become uninsured if Medicaid expansion states can’t fulfill spending obligations left by potential federal Medicaid cuts, according to a Feb. 24 analysis from the Urban Institute and the Robert Wood Johnson Foundation. Read Full Article…

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1. Potential Financial Impact on States: If the enhanced FMAP is eliminated, Medicaid expansion states will face a collective loss of $44.3 billion in federal funding in 2025, resulting in an average state spending increase of 25.6%. States like North Dakota (46.9%), Indiana (39.7%), and Montana (36.2%) would see the highest required increases, significantly impacting their budgets and potentially leading to cuts in other public services.

2. Political and Policy Drivers: The Department of Government Efficiency, launched by Elon Musk under President Donald Trump, is intensifying scrutiny of federal healthcare spending. This initiative, alongside the House Republicans' budget blueprint calling for $880 billion in savings from Medicare and Medicaid by 2034, signals a strong push towards reducing federal healthcare costs, potentially through measures like work requirements, stricter eligibility, or funding caps.

3. Impact on Uninsured Rates: If states roll back Medicaid expansion due to reduced federal support, the uninsured population could dramatically increase, particularly in states like New York (195.1%), the District of Columbia (141.9%), and Kentucky (104.3%). This rise in uninsured rates could lead to higher uncompensated care costs for hospitals and increased financial strain on low-income populations.

The Death Of Traditional Employee Benefits—And What Comes Next

By Nirit Cohen - You're losing 17% of your employees' work time. Instead of focusing on their jobs, they’re stuck dealing with personal distractions. And your benefits? They’re doing nothing to help. That’s the hidden cost businesses are paying today. For decades, the formula for employee benefits was simple: offer healthcare, retirement plans, and a few perks—like gym memberships or wellness stipends—and employees would stay loyal, engaged, and productive. This worked in a world where people climbed corporate ladders and stayed employed, sometimes even with the same employer for decades. Read Full Article…  ^{_{(Subscription required)}}

HVBA Article Summary

1. Evolving Workforce Dynamics Require Flexible Benefits: The modern workforce is increasingly fluid and independent, with employees juggling multiple roles, including freelance gigs and entrepreneurial ventures. Traditional benefits designed for long-term stability no longer align with this dynamic career landscape. Companies must rethink how they offer support, moving towards more flexible, personalized benefits that cater to diverse career paths and life situations.

2. Rising Costs and Ineffective Solutions Burden Employers: Employers face escalating costs for benefits that fail to deliver measurable outcomes, leading to financial pressure and growing dissatisfaction among employees. The traditional model is particularly ineffective for independent contractors and gig workers, who often lack access to essential benefits. As a result, organizations must reevaluate their strategies to ensure cost efficiency while providing meaningful support.

3. The Future of Benefits: Personalized, Purpose-Driven Support: The next generation of employee benefits must prioritize well-being, mental health, and everyday life management. Innovative solutions like “well-being wallets” and AI-driven platforms can provide personalized, adaptive support, reducing cognitive load and enhancing productivity. By shifting focus from retention to creating a positive employee experience, companies can better engage their workforce and foster long-term loyalty.

Unrealistic dental bills could hit employers in the mouth, plan designer warns

By Allison Bell - Employers and their benefits professionals should pay close attention to states' efforts to set minimum dental loss ratios, according to Sam Melamed. Melamed, the chief executive officer of NCD Agency, a Dallas-based dental plan manager and distributor, talked about state minimum dental loss ratio efforts this week in an interview. Read Full Article…  ^{_{(Subscription required)}}

HVBA Article Summary

1. State Regulations on Dental Loss Ratios: Employers and advisors must pay closer attention to state actions on dental loss ratios—the percentage of dental premiums spent on care. Unlike major medical coverage, dental premiums are significantly lower (about $30 per month per person), making it challenging for dental insurers to meet high loss ratio standards without affecting market stability.

2. Challenges of Applying Major Medical Standards to Dental Plans: Applying major medical loss ratio standards to dental plans can lead to market disruptions, as seen in Massachusetts, where an 83% minimum loss ratio resulted in insurers exiting the market or raising premiums significantly. This demonstrates that standards suitable for major medical insurance may not be appropriate for dental coverage due to the lower premium base.

3. Potential Impact on Employers and Employees: Stricter dental loss ratio regulations could lead to fewer insurance providers and higher costs, impacting employer-sponsored dental benefits. This may reduce access to dental care for employees, many of whom rely on insurance to seek necessary dental treatments, ultimately affecting public oral health outcomes.

Eli Lilly expands Zepbound single-dose vial options at lower price

By Nicole DeFeudis - Eli Lilly will start selling additional single-dose vials of its weight loss drug Zepbound at a lower price for certain patients. The company launched single-dose vial formulations for the two lowest Zepbound doses in August at roughly half the price of other incretin obesity medicines on the market. Before that, the drug was typically available in autoinjector pens at a list price of more than $1,000 per month. Read Full Article…  ^{_{(Subscription required)}}

HVBA Article Summary

1. Expanded Access and Price Adjustments: Lilly announced the availability of two new higher-dose options (7.5 mg and 10 mg) for its single-dose vials priced at $499 per month. Additionally, the prices for its 2.5 mg and 5 mg vials were reduced by about $50 per month. These discounted prices are accessible exclusively through Lilly’s digital platform, LillyDirect, for patients paying out-of-pocket.

2. Debate on Affordability and Coverage: While Lilly's move was praised by the Obesity Action Coalition for increasing access, criticism arose from Sen. Bernie Sanders, who argued that the prices remain unaffordable for many Americans. Lilly's leadership emphasized the need for better insurance coverage for obesity treatments, highlighting a disconnect between medical recognition of obesity as a chronic disease and current insurance policies.

3. Legal Battles Over Compounding and Market Competition: To protect its market share, Lilly has initiated lawsuits against compounding pharmacies producing cheaper alternatives to its medications. Although compounding is legal under certain conditions, including drug shortages, the FDA stated that shortages of Lilly’s medications have been resolved. Legal disputes are ongoing between the Outsourcing Facilities Association and the FDA over the status of these shortages.

Zurich to beef up middle-market business with underwriter hires

By Clair Wilkinson - Zurich North America said Tuesday it plans to add over 100 underwriting roles as it expands its U.S. middle-market business to additional geographies. Zurich’s U.S. middle-market business is looking to hire or place underwriters in all regions, including the South, West, Midwest and the East, the Schaumburg, Illinois-based insurer said in a statement. Read Full Article…

HVBA Article Summary

1. Rapid Growth and Strategic Expansion: Zurich North America's middle-market business has experienced double-digit growth since becoming a separate unit in 2020, highlighting the strategic importance of this segment. The company is focusing on expanding its reach beyond major cities to connect with middle-market businesses and brokers across diverse regions.

2. Leadership and Workforce Development: Lisa Diers has been appointed as the head of onboarding and development for the middle-market division, signaling Zurich’s commitment to strengthening leadership and enhancing operational efficiency. Additionally, Zurich Resilience Solutions is expanding its team by adding risk engineer positions to better support middle-market clients.

3. Ambitious Financial Targets: Zurich aims to grow its middle-market business from $7.5 billion to over $10 billion within three years, with a target to increase operating profit from $3.6 billion to $4.2 billion. This aggressive growth strategy underscores the company’s focus on middle-market and specialty coverages as key drivers of its future profitability.

Obesity increases costs more for younger workers, team finds

By Allison Bell - For workers at big U.S. employers, obesity may have a stronger correlation with claim costs for younger workers than for older workers. Craig Kurtzweil, an executive at UnitedHealth's UnitedHealthcare unit, and Patty Starr, president of the Health Action Council, have presented data raising that possibility in a new analysis of the impact of obesity on employers and workers in the United States. Read Full Article…  ^{_{(Subscription required)}}

HVBA Article Summary

1. Significant Cost Impact: The analysis reveals that adult participants in employer health plans living with obesity incur significantly higher average claim costs per member per month compared to those without obesity. Notably, the financial burden of obesity-related healthcare expenses effectively ages a member by 27 years, underscoring the substantial economic impact on employers and the healthcare system.

2. Increased Risk of Chronic Conditions: The report highlights a strikingly higher prevalence of chronic and autoimmune conditions among participants with obesity, including a 56% higher likelihood of multiple sclerosis and at least a 100% higher likelihood of lupus. These findings suggest complex and far-reaching health implications of obesity beyond the commonly associated conditions like diabetes and heart disease.

3. Policy Implications and Economic Burden: The findings come at a critical time as U.S. policymakers, including Health and Human Services Secretary Robert F. Kennedy Jr., are exploring solutions to address obesity. With obesity and related illnesses projected to cost the U.S. up to $1.7 trillion annually through healthcare costs, lost productivity, disability, and premature death, the report underscores the urgent need for comprehensive policy and health interventions.