Regulators resolve to check up on products for illustration integrity

By John Hilton - State insurance regulators are tired are trying to keep up with life insurers that quickly skirt attempts to tamp down illustrations. Read Full Article…

VBA Article Summary

1. Regulatory Shift in Focus: Instead of continuing with rulemaking, regulators, through the NAIC's Indexed Universal Life Illustration Subgroup, are now examining specific company examples of Indexed Universal Life (IUL) and annuities that utilize illustrations. This marks a significant shift from the past decade's approach of continually updating rules, as regulators are starting to notice discrepancies during product reviews and are emphasizing better communication between states to address these issues.

2. Avoiding Comprehensive Overhaul: Despite the consideration of a full rework of illustrations regulations, NAIC regulators are leaning away from reopening the overall illustrations model due to the lengthy process involved. Instead, they have implemented a series of actuarial guidelines (AG 49, AG 49-A, and AG 49-B) to address concerns around IUL illustrations without a complete overhaul of the existing regulations adopted in 1997.

3. Future Directions and Consumer Advocacy: While there are currently no plans or meetings scheduled to address illustration guidelines further, regulators express a desire to ensure that companies do not overpromise or understate the risks associated with their products. This goal aligns with concerns raised by consumer advocates, who call for updated regulations to eliminate unrealistic projections and non-guaranteed outcomes in illustrations, highlighting the ongoing debate and need for a consistent regulatory approach.

The obesity pipeline was 'late breaking.' Here's what the R&D landscape looks like now

By Annalee Armstrong and Gabrielle Masson - If you’re feeling like overnight obesity became the indication du jour, you’re not alone. Novo Nordisk was granted approval for semaglutide to be marketed as Wegovy for chronic weight management in June 2021, after being sold for diabetes as Ozempic. Then came Eli Lilly in the fall of 2023 with the approval of tirzepatide as Zepbound, which is also marketed for diabetes as Mounjaro. Read Full Article…

VBA Article Summary

1. Robust Pipeline of Obesity Medicines: The pharmaceutical industry is experiencing a significant surge in the development of obesity medications, with a current pipeline featuring 124 medicines, including 61 in phase 1, 47 in phase 2, eight in phase 3, and eight already on the market. This growth reflects a major commitment from the industry to address obesity with new and more effective treatments. Michael Kleinrock, IQVIA's Lead Research Director, highlights the emergence of medicines, particularly GLP-1 cluster drugs from companies like Novo and Lilly, which offer substantially higher degrees of weight loss compared to previous options, marking a shift in the sector's approach to innovation and effectiveness in obesity treatment.

2. Shift in Obesity Treatment Paradigm: Unlike past attempts to address obesity, which often led to short-lived or harmful solutions (e.g., the fen-phen craze of the 1990s), the current focus is on drugs that have demonstrated both efficacy and validated safety, like GLP-1 agonists. This new wave of treatments is also distinguished by a change in messaging, emphasizing health improvement over cosmetic weight loss. This shift, coupled with the surprising and unconventional clinical development path of GLP-1s—originally approved for diabetes before their weight loss benefits were discovered—signifies a hopeful turn for obesity medications, potentially overcoming historical challenges of market acceptance and commercial success.

3. Challenges and Future Prospects: Despite the optimism surrounding the efficacy and development of obesity medications, there are significant challenges ahead. The market's current heavyweights, Novo and Lilly, face not only each other but also potential future competition from several Big Pharmas entering the obesity space. Moreover, the societal burden of obesity and the current limitations on drug accessibility due to insurance coverage present additional hurdles. IQVIA's analysis indicates a desire for diversification in treatment modalities, including oral forms of medication, and raises important questions about market dynamics, payer willingness, and the overall trajectory of obesity management in the coming years, underscoring the complexity of translating clinical innovation into widespread patient benefit.

Drug Overdose Deaths in the United States, 2002–2022

By Centers for Disease Control and Prevention - Drug overdoses are one of the leading causes of injury death in adults and have risen over the past several decades in the United States (1–3). Overdoses involving synthetic opioids (fentanyl, for example) and stimulants (cocaine and methamphetamine, for example) have also risen in the past few years (1,4). Read Full Article…

VBA Article Summary

1. Overall Trends and Stability in Drug Overdose Deaths: The age-adjusted rate of drug overdose deaths in the United States nearly quadrupled from 8.2 per 100,000 in 2002 to 32.6 in 2022, indicating a significant rise over the two decades. However, the report highlights a stabilization in the overall rate of drug overdose deaths between 2021 and 2022, with a slight increase from 32.4 to 32.6 per 100,000, suggesting that the rate did not significantly change in the last recorded year.

2. Demographic Shifts in Overdose Death Rates: There was a notable shift in drug overdose death rates across different age groups and racial/ethnic categories between 2021 and 2022. Specifically, the rates decreased for individuals aged 15–34 and increased for those aged 35 and older. Additionally, rates increased for all race and Hispanic-origin groups, except for Native Hawaiian or Other Pacific Islander non-Hispanic and White non-Hispanic individuals, with the largest percentage increase observed among American Indian and Alaska Native people.

3. Changes in Substance-Specific Overdose Death Rates: The report detailed shifts in the substances involved in overdose deaths. There was a 4.1% increase in the rate of deaths involving synthetic opioids other than methadone (e.g., fentanyl) from 2021 to 2022. Conversely, rates for heroin, natural and semisynthetic opioids, and methadone declined during the same period. Furthermore, there were increases in the rates of drug overdose deaths involving cocaine and psychostimulants with abuse potential, underscoring the evolving landscape of substance use and its impacts on public health.

The ERISA Industry Committee Opposes Kentucky Senate Bill 188 Regulating Self-Insured Employer Plans and Pharmacy Benefit Managers

By ERIC - The ERISA Industry Committee (ERIC) submitted public comments…to the Kentucky Senate Standing Committee on Banking and Insurance expressing deep concerns with Kentucky Senate Bill 188, which attempts to control the network practices and plan options available to self-insured employer plans as well as the pharmacy benefit managers (PBMs) managing them. Read Full Article…

VBA Article Summary

1. Legislation Conflicts with Federal Law: ERIC's letter to the Senate Standing Committee on Banking and Insurance articulates that the proposed bill, by defining self-insured employer plans as "insurers" and imposing various requirements on them, conflicts with existing federal regulations. This could hinder the operation of employer-sponsored health plans across the United States, specifically those governed by the Employee Retirement Income Security Act (ERISA).

2. Potential Increase in Health Care Costs: The letter points out that the bill's provisions, such as network adequacy requirements, restrictions on mail-order pharmacy services, and a mandated minimum dispensing fee, could lead to increased health insurance and prescription drug costs in Kentucky. Such increases would not only affect employers but also potentially burden employees and other consumers statewide.

3. Risk of Legal and Operational Challenges: Dillon Clair, ERIC's Director of State Advocacy and Litigation, emphasizes the potential for the legislation to erode large employers' ability to manage uniform health benefits efficiently. The bill's restrictions could raise statewide health care costs and possibly lead to litigation due to ERISA preemption concerns, underscoring the need for amendments to avoid applying these rules to self-insured employer plans.

KFF: A look at healthcare spending trends in Medicare households

By Paige Minemyer - Medicare households are spending far more on healthcare than other households, according to a new KFF analysis. Read Full Article…

VBA Article Summary

1. Rising Healthcare Costs for Medicare Households: From 2013 to 2022, healthcare expenses for Medicare households grew by 53%, averaging $7,000 or 13.6% of total household spending by the end of the period. This compares to non-Medicare households, which saw a 71% increase in healthcare spending, but still spent a lower proportion of their total income on health-related expenses (6.5% or $4,900).

2. Disproportionate Burden on Medicare Households: The study highlighted that a significant portion of Medicare households face a heavier financial burden due to healthcare costs, with nearly 30% spending at least 20% of their total expenditures on health-related items, and 74% spending at least 10%. This contrasts with only 7% of non-Medicare households spending at least 20% of their budget on healthcare.

3. Challenges in Measuring True Healthcare Spending: The researchers pointed out a likely underestimation of healthcare spending in Medicare households, as the Consumer Expenditure Survey does not include individuals in long-term care facilities, who are often Medicare beneficiaries with high healthcare costs. This indicates a need for more comprehensive data to accurately assess and address the financial challenges faced by Medicare households in managing healthcare expenses.

Even among the insured, weight loss drugs are rarely prescribed, study suggests

By Sara G. Miller and Marina Kopf - Powerful weight loss medications aren’t reaching the people who need them most, according to researchers from Johns Hopkins University School of Medicine in Baltimore. The barriers to the drugs are many: Getting a prescription; finding a pharmacy with the drug in stock and being able to pay for it. Read Full Article…

VBA Article Summary

1. Obesity's Increasing Challenge and Emerging Treatments: Dr. Chiadi Ndumele highlighted obesity as a growing public health issue, presenting new findings at an American Heart Association meeting that emphasize the development of effective pharmacotherapies, such as GLP-1 receptor agonists (e.g., Ozempic, Wegovy, Zepbound), which have significantly impacted obesity treatment. Despite their potential, the adoption of these medications remains limited, influenced by factors like insurance coverage and physicians' hesitancy to prescribe them.

2. Disparities and Obstacles in Access to Treatment: The research, involving 18,000 patients from Johns Hopkins outpatient clinics, revealed that only 2.3% were prescribed weight loss drugs, despite having insurance coverage. This low rate was attributed to various barriers, including high copays, prior authorization challenges, and physicians' discomfort with discussing obesity. Moreover, the study uncovered racial and demographic disparities in prescription rates, with white adults, particularly those with certain health conditions or in their 40s, more likely to receive these medications than Asian or Black adults, despite higher obesity and hypertension rates among the latter.

3. The Need for Broader Solutions and Education: Experts like Dr. Christopher Chapman and Dr. Sahar Takkouche advocate for addressing the broader issues beyond insurance coverage to improve access to weight loss medications. They emphasize the importance of in-office conversations, addressing medication shortages, and the need for more physicians trained in obesity medicine. The goal is to overcome misinformation and make physicians more comfortable discussing and prescribing weight loss drugs, moving towards more equitable access to obesity treatments.

Red Sea Shipping Disruptions Don’t Have Pharma Companies Seeing Red Just Yet

By Frank Vinluan - When a patient fills a prescription at a pharmacy close to home, the transaction is the last part of a tightly controlled supply chain that starts on the other side of the world. In recent months, a crucial part of that chain has been strained. Read Full Article…

VBA Article Summary

1. Impact on Pharmaceutical Supply Chains: The ongoing missile attacks by the Iran-backed Houthi militia on container ships in the Red Sea disrupt one of the world's busiest shipping lanes, affecting the movement of goods including pharmaceutical products. The article highlights the particular vulnerability of generic drugs, mainly manufactured in India, to these disruptions. Companies like Dr. Reddy’s Laboratories are exploring alternative shipping methods, such as air freight, and strategies like increasing U.S. inventory to mitigate the impact. The unavailability of certain raw materials and component parts, including active pharmaceutical ingredients (APIs) sourced from overseas, poses significant challenges for drugmakers, impacting supply chains and planning capabilities.

2. Responses and Adaptations: In response to the disruptions, pharmaceutical companies are adjusting their logistics strategies. Air freight, while more expensive, is utilized for transporting high-margin brand name medicines and temperature-sensitive or costly APIs. The article mentions that relocating production facilities is not a straightforward solution due to the substantial investment required and the time it takes to receive FDA approval. Furthermore, manufacturing in regions with higher labor costs, like Europe or Central America, could avoid Middle East shipping disruptions but is not economically feasible for maintaining the same costs. The pharmaceutical industry has learned from the Covid-19 pandemic to maintain redundancy and diversification in sourcing key materials, moving from a "just in time" to a "just in case" supply chain management strategy.

3. Long-term Considerations and Pricing Impact: The article discusses the uncertainty over whether the Red Sea shipping disruptions will be a temporary challenge or a new normal for the pharmaceutical industry. It underscores the complexity of setting drug prices, which involves multiple factors beyond transportation costs. Although generic drugs have lower prices, their margins are decent, suggesting that while companies might initially absorb the extra costs, they could eventually pass them on to patients. The potential for increased drug prices depends on market dynamics, such as demand and the availability of alternatives. Additionally, the importance of strategic planning, including diversifying suppliers and manufacturers to prevent shortages, is emphasized as a lesson from the pandemic and ongoing global shipping challenges.

Change hack raises bigger questions for healthcare security

By Naomi Diaz - The Feb. 21 cyberattack on Change Healthcare is raising questions about how prepared healthcare is when it comes to cybersecurity, Politico reported March 18. Read Full Article…

VBA Article Summary

1. Critical Reassessment of Cybersecurity Vulnerabilities: The recent cyberattack on a significant healthcare firm, Change, has prompted a reevaluation of systemic vulnerabilities within the healthcare sector. Senior officials, including those from the U.S. Department of Health and Human Services (HHS), stress the necessity for a thorough examination and fortification of all potential points of weakness to prevent future incidents. This sentiment underscores the urgency for federal agencies and Congress to understand and address the complexity of cybersecurity threats facing the industry.

2. Questions About Governmental and Legislative Roles in Cybersecurity: The attack has sparked a series of crucial questions regarding the adequacy of governmental efforts in protecting critical healthcare infrastructure and the need for legislative action. Issues raised include the government's current capability to identify and protect key organizations like Change, the potential for mandatory cybersecurity standards for healthcare organizations, and the challenges posed by the size of companies like UnitedHealth in maintaining effective cybersecurity measures. These concerns highlight a perceived gap in the existing framework for cybersecurity defense and response within the healthcare sector.

3. Policy Considerations and Proposals for Enhancing Cybersecurity Measures: In response to the cybersecurity breach, there are calls for the implementation of mandatory minimum cybersecurity standards for healthcare entities, as proposed by President Joe Biden. Additionally, the debate extends to the viability of prohibiting ransom payments to attackers, as exemplified by the rumored $22 million ransom paid by UnitedHealth's Change to the ransomware gang ALPHV. These discussions are pivotal in shaping future policies that aim to fortify the healthcare sector against such vulnerabilities and ensure the protection of sensitive patient data against cyber threats.

5 prior authorization updates

By Andrew Cass - From HHS asking insurers to pause prior authorizations in the wake of the change Healthcare cyberattack to a report finding that Medicare Part D plans have ramped up restrictions on prescription drugs, here are five updates on prior authorization Becker's has reported since Feb. 15. Read Full Article…

VBA Article Summary

1. Response to Cyberattack - Following the Change Healthcare cyberattack, the Department of Health and Human Services (HHS) recommended that insurance companies temporarily suspend prior authorizations to mitigate disruptions. Conversely, America's Health Insurance Plans (AHIP) expressed concerns that such a suspension could lead to negative consequences, arguing that it might cause more harm than good.

2. Medicare Part D Restrictions - Research highlighted in the March edition of Health Affairs indicates that since 2011, there has been a notable increase in the restrictions imposed by Medicare Part D plans on prescription drugs. This trend underscores a tightening of control over drug access and cost management within the Part D program.

3. Legislative Moves in Illinois and AMA's Optimism - In Illinois, new legislation aims to eliminate prior authorization for mental health medications for Medicaid recipients, following Governor J.B. Pritzker's appeal to lawmakers for reform in mental healthcare management. This initiative is part of broader efforts to improve patient access to necessary treatments. Additionally, American Medical Association (AMA) President Jesse Ehrenfeld, MD, has voiced optimism regarding recent victories in prior authorization policy, suggesting a growing momentum towards significant reform in this area.

85% of hospital nurses said they'd quit by 2024. Did they?

By Alexis Kayser - A January 2023 nurse survey fueled fears of an exodus, as 85% of those in hospital roles said they planned to quit within the next 12 months. Read Full Article…

VBA Article Summary

1. Impact of Pandemic on Nurse Well-being and Retention Efforts: More than 14 months after a survey of over 18,000 registered nurses revealed significant declines in satisfaction and increases in emotional drain, the anticipated mass resignations among hospital nurses have not occurred. Despite these challenges, efforts to retain nurses have intensified, with health systems focusing on improving retention to mitigate the shortage. Christin Stanford, Vice President of Client Solutions at AMN Healthcare, emphasizes that the declines in nurse well-being remain a critical issue, and the pandemic's highlighting of staffing model gaps demands continued attention and action.

2. Innovative Retention Strategies and Their Efficacy: In response to the staffing crisis, healthcare organizations have adopted flexible work options, including gig shifts and schedules accommodating nurses' needs, alongside enhanced continuous development, education support, and significant financial incentives like sign-on and retention bonuses. These measures aim to address the preferences of a multigenerational workforce and prevent nurse turnover by making the profession more sustainable and appealing. However, questions remain about the long-term effectiveness of financial incentives in retaining staff beyond the incentive period.

3. Nurses Seeking Change and the Future of Staffing Practices: The current environment sees nurses more empowered, with many advocating for changes in staffing ratios and care quality through union activity. The emphasis is on creating a work environment that prioritizes nurses' well-being and allows them to focus on patient care, suggesting a shift towards more thoughtful staffing practices. The challenge for employers is to become the preferred choice for nurses by going beyond superficial gestures and addressing the core issues affecting their daily work and satisfaction levels.