California Legislation to Regulate PBMs Puts Self-Insured Plans at Risk, ERIC Warns

By Remy Samuels - The ERISA Industry Committee has urged members of the California State Assembly to pay close attention to a California State Senate bill that aims to control the cost of prescription drugs by enacting new regulations on pharmacy benefit managers. Read Full Article…

HVBA Article Summary

1. Legislative Requirements and Goals: SB 966, introduced by State Senators Scott Wiener and Aisha Wahab, mandates that pharmacy benefit managers (PBMs) in California must obtain a license from the California Department of Insurance by January 1, 2027. Additionally, the bill requires PBMs to adopt a passthrough pricing model, ensuring payments made by health care service plans to PBMs are equivalent to the amount PBMs pay to pharmacies. This legislative change aims to stabilize or reduce prescription drug costs for providers and patients.

2. Concerns Over Federal Preemption and Legal Challenges: The ERISA Industry Committee (ERIC) has expressed concerns that SB 966 could infringe upon federal authority by impacting the design and administration of health plans covered under the Employee Retirement Income Security Act (ERISA). ERIC argues that the bill's broad definitions could extend state regulatory authority to self-insured ERISA plans, potentially leading to legal challenges due to ERISA's preemption over state laws affecting its plans.

3. Recommendations for Legislative Amendments: ERIC advocates for amendments to SB 966 to specifically exempt self-insured ERISA plans from being categorized as engaging in the insurance business. This change would help mitigate potential conflicts with federal law and ensure that large employers can continue to offer consistent, cost-effective health benefits without state interference. The bill is currently under review in the California State Assembly’s Committee on Appropriations, with further discussions scheduled.

Republicans challenge CMS premium stabilization program legality

By Noah Tong - Leading Republicans are looking toward the Government Accountability Office (GAO) to ensure CMS' new premium stabilization demonstration program is legal and in the best interest of seniors. Read Full Article…

HVBA Article Summary

1. Concerns Over CMS Program Legality and Effectiveness: Senior Republican lawmakers, including House Energy and Commerce Committee Chair Cathy McMorris Rodgers and others, have expressed concerns about the legality and effectiveness of a new voluntary demonstration program by the Centers for Medicare & Medicaid Services (CMS). The program, part of the Medicare Part D under the Inflation Reduction Act (IRA), aims to stabilize premiums but lacks "clear statutory basis or credible research goals" according to the lawmakers. They argue that the program is a rushed response to flawed legislative processes and lacks proper budgetary analysis and transparency, potentially transferring undue financial responsibility to taxpayers.

2. Market Impact and Health Plan Responses: The implementation of the IRA is criticized for leading to market instability, evidenced by fewer plan options and rising premiums. For instance, Blue Cross and Blue Shield of Kansas City is exiting Medicare Advantage, citing economic competitiveness issues and regulatory challenges. This departure highlights the broader market repercussions attributed to the IRA's implementation strategies and the regulatory environment it fosters.

3. CMS Program Details and Objectives: Despite criticisms, CMS has detailed its objectives for the Part D Premium Stabilization Demonstration, which includes reducing the base beneficiary premium by $15, imposing a $35 yearly increase limit on total Part D premiums, and adjusting risk corridors for greater government risk sharing. The program also sets out to test new financial mechanisms to see if they can enhance the Part D framework, with the aim of improving premium stability for beneficiaries and ensuring the financial sustainability of the program over the next three years.

An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

By Katie Adams - The White House could soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Read Full Article…

HVBA Article Summary

1. Legal Reversal and Continued Appeal: In September of the previous year, Judge John D. Bates from the U.S. District Court for the District of Columbia overturned a 2021 rule permitting copay accumulators, which do not count pharmaceutical company assistance towards patients' out-of-pocket maximums. His decision responded to patient advocacy groups' challenge to this rule from the Trump administration. Despite this, the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) appealed the decision, prompting a bipartisan group of 19 U.S. senators to request HHS reconsider its appeal to better protect patients from high medication costs.

2. Impact on Patients: Copay assistance, as noted by Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute, is essential for patients with serious conditions like cancer, arthritis, and multiple sclerosis, to manage their high copays. However, with the implementation of copay accumulators, patients face unexpected high bills once their assistance is exhausted—often leading to a painful choice between accruing debt or foregoing necessary medications.

3. Economic and Ethical Concerns: Schmid criticized the use of copay accumulators and similar schemes by about half of all employer plans, arguing that these programs withheld nearly $5 billion in assistance from patients last year alone. He questioned the insurers' rationale behind these practices, highlighting the ethical dilemma of balancing drug cost management against patient harm. The decision on the appealed rule by the White House remains pending, adding to the uncertainty faced by millions depending on these crucial medications.

Tim Walz on health care: 7 things to know about Harris' VP pick

By Allison Bell - Kamala Harris, the Democratic nominee for president, today picked Minnesota Gov. Tim Walz to be her vice president — and may have signaled that she'll be tilting toward the center on health policy issues and other benefits issues. Read Full Article…

HVBA Article Summary

1. Educational and Military Background: Tim Walz, born in Nebraska, pursued a bachelor's degree in education at Chadron State College and a master’s degree in educational leadership from Minnesota State University, Mankato. He served in both the Nebraska and Minnesota Army National Guards, achieving the rank of master sergeant and operating as a command sergeant major. His military career included specializing in heavy artillery and active duty in Europe post-9/11.

2. Political Career and Legislative Impact: Walz transitioned from a high school teacher and football coach to a political career, serving as a U.S. Representative from 2007 to 2019. Notably, he focused on veterans' benefits, sponsoring significant legislation like the Clay Hunt Suicide Prevention for American Veterans Act. Despite his active legislative role, he did not cosponsor the main "Medicare for All" bills during his time in Congress.

3. Governorship and Health Policy Initiatives: As the Governor of Minnesota, Walz has managed significant health-related programs, including MNsure, the state's public health insurance exchange, and MinnesotaCare, a Medicaid buy-in program. He has supported the creation of a public option for health insurance and signed legislation aimed at controlling insulin costs, illustrating his ongoing commitment to health policy innovations tailored to the needs of Minnesota residents.

Who gets Ozempic? People with private insurance and generous health plans, study shows

By Sara Chernikoff - The demand for popular prescription drugs that treat diabetes, obesity and heart disease has skyrocketed over the past few years. New research from the University of Southern California showed a 442% increase in prescriptions for semaglutide between January 2021 and December 2023. Semaglutide is the active ingredient in diabetes drugs Ozempic, Rybelsus and Wegovy, a heart disease prevention and weight-loss drug. Read Full Article…

HVBA Article Summary

1. Coverage Challenges for High-Cost Drugs: Patients, particularly those with Medicaid and Medicare, face significant obstacles in accessing costly medications like Ozempic, Rybelsus, and Wegovy, which are often not covered for weight loss. Private insurance holders are more likely to have their prescriptions filled, representing 90% of Wegovy prescriptions in December 2023, while Medicare and Medicaid patients encounter stringent coverage restrictions and high out-of-pocket costs.

2. Insurance Disparities in Access: The USC study highlighted in the JAMA Health Forum reveals a stark disparity in drug access between privately insured individuals and those on government-funded programs like Medicare and Medicaid. Less than 1% of Wegovy prescriptions were filled by cash-paying customers, and only 1.2% by Medicare Part D patients, underscoring a significant gap in healthcare equity.

3. Escalating Federal Expenditure on Weight-Loss Drugs: Despite restrictions on coverage, federal spending on drugs such as Ozempic, Rybelsus, and Mounjaro has seen a dramatic increase, from $57 million in 2018 to $5.7 billion in 2022. This trend is expected to continue, with projections suggesting a potential annual cost of nearly $3 billion for Medicare if 10% of eligible adults use Wegovy for preventive purposes. This growing financial burden highlights the tension between drug costs, manufacturing expenses, and the healthcare system's capacity to sustain these expenditures.

The top priorities for healthcare CEOs

By Modern Healthcare Staff - What's the top priority in the second half? What's the biggest challenge? Those are likely two of the questions under discussion in C-suites as second-quarter results are disclosed and companies use their first-half performance to guide them through the rest of the year. Read Full Article…

HVBA Article Summary

1. Focus on State Expansion and Insurance Challenges: Brooke Boyarsky Pratt, CEO of Knownwell, highlights their focus on thoughtful state-by-state growth and capital efficiency. A significant challenge she notes is the constantly shifting landscape of insurance coverage for obesity-related services, which poses a risk to their insurance-based business model.

2. Enhancing Behavioral Health and Leadership Training: Martin Fattig, CEO of Nemaha County Hospital, discusses implementing behavioral health services via telehealth and leadership training for middle managers. He emphasizes the difficulty in maintaining a positive operating margin due to shifts from traditional Medicare to Medicare Advantage, affecting their cost-based reimbursement.

3. Advocating for Collective Bargaining and Regulatory Oversight: Nancy Hagans, president of National Nurses United, is committed to expanding collective bargaining rights and pushing for the VA Employee Fairness Act. She also mentions the ongoing battle for Medicare for All and concerns over new technologies in healthcare, stressing the importance of rigorous testing and regulatory oversight to ensure patient and worker safety.

Novo Nordisk gears up for FDA filing with late-phase insulin plus semaglutide data

By Ayisha Sharma - Novo Nordisk, with data on-hand from a late-stage trial of IcoSema, is preparing for an FDA filing in type 2 diabetes slated for the second half of the year. Read Full Article…

HVBA Article Summary

1. Clinical Trial Results: IcoSema, combining Novo’s insulin icodec and GLP-1 agonist semaglutide, demonstrated notable efficacy in the late-phase COMBINE-1 trial, reporting an average reduction in HbA1c levels by 1.6% at 52 weeks, compared to a 0.9% decrease with insulin icodec alone among 1,300 participants with inadequately controlled type 2 diabetes. The trial also highlighted a significant weight loss benefit, with IcoSema recipients losing an average of 3.7 kg, in contrast to a 1.9 kg weight gain in those receiving only insulin icodec.

2. Regulatory Challenges and Opportunities: Despite the promising results of IcoSema, Novo faced regulatory hurdles as the FDA rejected insulin icodec for type 2 diabetes due to manufacturing process concerns, delaying any potential U.S. approval until post-year-end. Meanwhile, insulin icodec is already approved in other major markets under the brand name Awiqli, illustrating a mixed regulatory landscape.

3. Financial Performance and Market Competition: The second quarter revealed a challenging financial picture for Novo, with total sales of 68 billion DKK falling below analyst expectations. This was compounded by lower-than-expected sales of semaglutide products Wegovy and Ozempic, totaling 21 billion DKK and 57 billion DKK, respectively. In contrast, competitor Eli Lilly has gained significant market share with its GLP-1 products, emphasizing the intense competition in this sector.

New Study Links Sweetener to Heart Risk: What to Know

By Julie Stewart - Is going sugar-free really good advice for patients with cardiometabolic risk factors? That's the question raised by new Cleveland Clinic research, which suggests that consuming erythritol, a sweetener widely found in sugar-free and keto food products, could spur a prothrombotic response. Read Full Article…

HVBA Article Summary

1. Prothrombotic Effects of Erythritol: In a study by Stanley Hazen and his team, healthy participants who consumed 30 grams of erythritol exhibited increased platelet aggregation and markers of platelet activation, including the enhanced release of serotonin and CXCL4. This contrasted with participants who ingested glucose and showed no such effects, suggesting a unique prothrombotic action specific to erythritol.

2. Potential Mechanisms and Implications for Heart Disease: Hazen proposed that erythritol might interact with a specific receptor on platelets, similar to how taste receptors detect sugars, thereby lowering the threshold for platelet activation. This interaction raises concerns about the long-term risk of heart attacks and strokes, especially given erythritol's common use as a sugar substitute in various food products.

3. Research Context and Future Directions: This study builds on earlier research linking erythritol to cardiovascular risks and emphasizes the need for further investigation into the effects of erythritol and other sugar alcohols on thrombosis, particularly in individuals with genetic predispositions to clotting disorders. Future studies are also called for to explore the impacts of lower doses of erythritol over extended periods and in higher-risk groups like those with prediabetes and diabetes.

Chronic, new anxiety may increase risk for dementia, but anxiety resolution negates risk

By Moira Mahoney - New and chronic anxiety were associated with an increased risk for all-cause dementia, especially among individuals aged 70 years and younger, according to a study published in Journal of the American Geriatrics Society. Read Full Article…

HVBA Article Summary

1. Impact of Anxiety Resolution on Dementia Risk: The study reveals that patients with resolved anxiety by the time of follow-up exhibited a dementia risk comparable to those who had never experienced anxiety. This significant finding underscores the potential benefits of effective anxiety management and could shift clinical approaches towards prioritizing timely intervention.

2. Influence of Chronic and New Onset Anxiety: The research highlighted a markedly increased risk of all-cause dementia in individuals with chronic and newly developed anxiety, emphasizing the need for early detection and continuous management of anxiety symptoms to potentially mitigate associated dementia risks.

3. Future Research Directions: The study's lead, Kay Khaing, suggests that future research should explore how different types of anxiety treatments, both pharmacological and non-pharmacological, and the duration of these treatments, may influence the risk of developing dementia. This direction could provide deeper insights into tailored treatment strategies that effectively reduce dementia risk among anxiety sufferers.

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