Drugmakers form new group to lobby on impact of Medicare drug price negotiations

By John Wilkerson - A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records. The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a “coalition analyzing the impact of Medicare Drug Price Negotiation on patients.” Read Full Article… ^{_{(Subscription required)}}

HVBA Article Summary

1. Pharmaceutical Industry Resistance to Price Negotiations: Drugmakers have expressed strong opposition to Medicare’s new authority to negotiate certain prescription drug prices, arguing that it amounts to government price-setting and could stifle investment in research and development, ultimately slowing innovation in the pharmaceutical sector. Despite this opposition, they support other provisions in the law, especially measures that cap out-of-pocket costs for seniors, which they view as a positive step for patient affordability and access.

2. DLA Piper’s Role and Research Focus: The IRA Watchdog operates within the law firm DLA Piper and is staffed by former aides to ex-Sen. Richard Burr, a long-time supporter of the biotechnology industry in his home state of North Carolina. Leveraging this background, DLA Piper has conducted and published a series of studies examining how Medicare’s price negotiations may affect the healthcare landscape, including potential reductions in the number of available Medicare Part D and Medicare Advantage plans, changes to premiums and formularies, rising copays for certain conditions such as diabetes, and decreased access to some rare disease treatments.

3. Key Medicare Reforms Under the IRA: The Inflation Reduction Act implements a series of significant reforms to Medicare, aiming to improve affordability and redistribute cost-sharing responsibilities. These include enabling Medicare to negotiate the prices of select high-cost drugs, capping monthly insulin expenses at $35 for beneficiaries, and redesigning the Medicare Part D program to include an annual out-of-pocket spending cap. Once that cap is reached, the share of costs shifts away from the federal government and more heavily onto insurers and pharmaceutical companies, altering the financial dynamics of the program.

ERISA preemption and state PBM laws: NAIC team might get in the middle

By Allison Bell - Insurance regulators might try to write something about the clash between the Employee Retirement Income Security Act and state efforts to rein in pharmacy benefit managers. The ERISA Working Group, an arm of the National Association of Insurance Commissioners, is talking about setting up a "drafting group focused on ERISA preemption of state PBM laws." Read Full Article… ^{_{(Subscription required)}}

HVBA Article Summary

1. ERISA Preemption and PBM Regulation Uncertainty: The NAIC working group is evaluating how ERISA’s preemption of state regulation impacts state efforts to oversee pharmacy benefit managers (PBMs). While the 2020 Rutledge v. Pharmaceutical Care Management Association decision suggested states could impose some rules on PBMs without directly targeting ERISA-governed plans, a recent Supreme Court decision declining to review an Oklahoma case has left regulators and PBMs uncertain about which state laws can withstand federal legal challenges.

2. Diverging Perspectives on PBMs: Critics—including pharmacy groups, drug manufacturers, and some employers—argue that large PBMs inflate employer pharmacy benefit costs and retain significant portions of prescription drug spending. In contrast, PBMs contend they help curb drug cost inflation and reduce profit margins for other stakeholders, framing their actions as beneficial to the healthcare system overall.

3. NAIC’s Role in State Policymaking: The NAIC serves as a central resource for state insurance regulators, providing model laws, regulations, and guidance that often form the basis of state legislative and regulatory initiatives. In the PBM context, NAIC’s collaboration may shape future state approaches to regulation within the constraints of federal law.

New CMS data suggest future ACA market turmoil as feds crack down on fraud

By Noah Tong - The Centers for Medicare & Medicaid Services (CMS) this week released new data fueling a narrative of rampant broker fraud on the Affordable Care Act (ACA) exchanges. Plans received data finding 23% of enrollees did not have a claim in 2019. That number jumped sharply to 35% last year. Read Full Article…

HVBA Article Summary

1. Rising Share of Nonutilizing Enrollees: Since the pandemic, the proportion of Affordable Care Act (ACA) enrollees who have no recorded insurance claims has grown significantly, especially among those in federal exchange Medicaid non-expansion states (rising from 24% to 41%) and expansion states (from 22% to 32%). State-based exchanges experienced only a modest increase (22% to 24%). This trend suggests shifts in enrollment composition, with more members either not using services or potentially being enrolled for reasons unrelated to active healthcare needs.

2. Market Pressures from Policy and Subsidy Changes: Upcoming program integrity rules, stepped-up enforcement against waste and fraud, and the possible expiration of enhanced premium tax credits at year’s end are expected to push out both fraudulent and legitimate low-utilization members. This will likely shrink the insured pool, weaken the risk mix, and increase financial pressure on insurers. As a result, some carriers are already requesting substantial premium hikes—such as more than 50% in Arkansas—while the median national increase projected for next year is 18%.

3. Industry and Political Reactions: Responses from industry and policymakers vary: insurers like Centene, anticipating greater financial strain, are requesting larger rate hikes than competitors, while some state regulators and governors are pushing back, calling the increases excessive or unlawful. These disputes underscore the challenge of balancing affordability for consumers, sustaining insurer profitability, and implementing stricter oversight to preserve the program’s integrity.

Benefits Think: When trusted advisers must lead the disruption

By Louis C. Bernardi - A few months ago, I was speaking with a group of like-minded advisers — professionals who dedicate themselves to helping employers and employees break free from a broken healthcare system. We were sharing insights and frustrations, and a common theme emerged: Why is it so hard to get the attention of HR leaders, CFOs and CEOs — the very people who have the most to gain from better health plans? Read Full Article… ^{_{(Subscription required)}} 

HVBA Article Summary

1. Conditioned Inaction and Lack of Awareness: Employers are not apathetic about healthcare change but have been conditioned over decades by managed care to expect annual premium increases and believe no better alternatives exist. This passivity stems from a lack of awareness about root causes such as profit-driven care steering, hidden PBM roles, and withheld data. Many remain unaware that evidence-backed strategies can lower costs by 20% or more while improving care and transparency, leaving them disengaged and unable to envision practical solutions.

2. Industry Gatekeeping and Misaligned Incentives: Access to high-performance, transparent health plans is limited by structural and financial barriers. Brokers, payroll vendors, and HR organizations may have financial ties to insurers, while “disruptor” events sometimes block true solution advisers from participating. When commissions take precedence over client outcomes, advisers risk perpetuating the same misaligned incentives that drive costs upward, even in markets with restrictive rules such as New York’s ban on small-group self-funding.

3. Shifting Adviser Approach and 5-Step Engagement Model: Advisers must replace jargon-heavy, complex presentations with simple, relatable strategies that spark curiosity and build trust. The article outlines a 5-step approach: (1) Lead with curiosity, not complexity, (2) Speak in business outcomes, not benefit jargon, (3) Build tools that educate, not overwhelm, (4) Meet plan sponsors where they are, not where we wish they were, and (5) Focus on exposure, not conversion. This clarity-driven approach aims to help employers understand what’s possible and engage them in meaningful, lasting change.

Participants Lack Awareness of Mental Health Coverage Despite Improved Offerings

By Emily Boyle - Plan sponsors have improved their coverage of mental health care in response to heightened demand—but participants may be unaware that the parity between care coverage types has increased. Eighty-three percent of people surveyed in the Employee Benefit Research Institute’s 2024 Consumer Engagement in Health Care Survey said mental health care services should be covered in the same way as other health care services. However, 39% of respondents were unsure whether their own health plan did. Read Full Article…

HVBA Article Summary

1. Parity Laws and Policy Disputes: Federal protections such as the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, the Affordable Care Act of 2010, and amendments in the Consolidated Appropriations Act of 2021 require that mental health and substance use disorder benefits not be more restrictive than medical/surgical benefits. Yet only 46% of survey respondents said their health plan treats mental and physical health coverage the same way. A pending lawsuit from the ERISA Industry Committee led the Trump administration to pause enforcement of certain parity rules, a move praised by some employers for reducing “burdensome” requirements and criticized by major mental health organizations as undermining legal protections.

2. Access and Cost Barriers: Shortages of providers (exacerbated by pandemic-related burnout) and high costs under high-deductible health plans (minimum annual family deductible of $3,300 in 2025, with some up to $6,000) remain significant deterrents. Many mental health providers do not accept insurance due to incomplete reimbursements, limiting coverage usability. Employees without preventive-care-like cost exemptions for mental health must often pay entirely out of pocket until meeting high deductibles.

3. Shifting Demand and Employer Response: The share of people under age 65 with employer health coverage diagnosed with a mental health disorder rose from 14.2% in 2013 to 18.5% in 2020, mostly before the pandemic. Demand is especially strong among younger generations: 67% of Gen Z and 59% of Millennials said mental health benefits increase their likelihood of staying with their employer, compared to 43% of Gen X and 31% of Baby Boomers. Employers are more focused on mental health than a decade ago, partly due to COVID-19 and recognition of the productivity link, but communication gaps mean employees may be unaware of benefits already available—sometimes free of charge.

Clinical Trials May Not Differentiate, but Data Show Women More Likely to Report Issues With GLP-1s

By Christine Bahls - If it weren’t for post hoc analyses and findings from curious academic labs, the substantial list of biological differences that separates the sexes would still be relegated to the shadows. That list — including research from the fields of neurology, cardiology, immunology, oncology, endocrinology — shows that the longtime presumption of men and women reacting as one to diagnoses, disease progression, and treatment should be considered, scientifically speaking, passé. Read Full Article…

HVBA Article Summary

1. Underrepresentation of Women in Clinical Trials: Many clinical trials, including those for GLP-1 receptor agonists, enroll fewer women than their real-world disease prevalence would suggest and often fail to stratify results by sex. This underrepresentation can obscure sex-specific adverse events, which is significant because women metabolize drugs differently, often resulting in higher drug concentrations and a greater likelihood of side effects.

2. ‘Sex-Related Differences in GLP-1 RA Outcomes: Analyses show women report a disproportionately higher share of adverse events, particularly neurologic and gastrointestinal issues, when taking GLP-1 receptor agonists, and tend to have higher circulating levels of these drugs. Despite these findings, published and ongoing studies often lack sex-stratified data, even for conditions such as Alzheimer’s disease that disproportionately affect women.

3. Importance of Personalized Prescribing and Trial Planning: Experts recommend tailoring GLP-1 RA treatment to each patient—especially women—through careful dosing, gradual titration, and dietary adjustments to improve tolerance and adherence. They stress that integrating sex-based evidence into early trial design could reduce side effects, enhance drug efficacy, and provide more precise guidance for clinical practice.

HSA withdrawals increase as Americans use accounts to cope with rising costs

By Michael Popke - A new report from Lively, a health and lifestyle benefits platform, indicates how U.S. account holders are using Health Savings Accounts (HSAs) to cope with record-high health care prices. According to the company’s seventh annual “HSA Spend Report,” withdrawals increased 13% in 2024 — from $1,162 to $1,320, closely mirroring the national average of $1,370. Read Full Article… ^{_{(Subscription required)}} 

HVBA Article Summary

1. Increased Utilization of HSAs for Immediate Healthcare Costs: Hospital spending rose 5%, while the percentage of assets retained in HSAs dropped to 20%, indicating that more account holders are actively withdrawing funds to cover healthcare expenses. This trend suggests that HSAs are increasingly serving as real-time financial tools for managing rising medical costs rather than solely as long-term savings vehicles.

2. Underutilization of HSAs Due to Education Gaps: Despite their potential to provide significant financial advantages—particularly tax-free investing—HSAs remain underused because many Americans lack the necessary knowledge to leverage them strategically. This shortfall is attributed not to disinterest, but to a systemic education gap that spans employers, brokers, HR leaders, and platform providers.

3. Need for Year-Round, Engaging HSA Education: The report emphasizes that effective HSA adoption and satisfaction depend on continuous, engaging education that accommodates different learning styles. Recommended strategies include offering video and podcast formats, integrating HSAs with other benefits, and making investing options accessible. Employers who prioritize such efforts throughout the year—rather than only at open enrollment—see stronger employee engagement and better cost management outcomes.