Weight loss drug shortage: Zepbound and Wegovy in short supply, says FDA

By Alan Gofarth - Manufacturers of popular GLP-1 weight-loss drugs are struggling to keep up with unprecedented demand. Wegovy from Novo Nordisk and Zepbound from Eli Lilly & Co. are in tight supply and may be hard to obtain for the next several months. Read Full Article…

VBA Article Summary

1. Zepbound Limited Availability: The FDA's updated drug shortage database highlights limited availability of most doses of Zepbound due to a surge in demand for the drug. Patients typically begin treatment with the lowest dose, but currently, only this dose is readily accessible, posing challenges for those needing higher doses.

2. Challenges with Wegovy Supply: The availability of Wegovy, another weight-loss medication, is also constrained, with only the highest dose accessible, and remaining doses in short supply for an undetermined duration. Novo Nordisk, the manufacturer, has been managing supply shortages and paused some marketing efforts to mitigate further demand, emphasizing their commitment to patient treatment continuity.

3. Industry-Wide Shortages: The scarcity of weight-loss drugs reflects broader challenges within the pharmaceutical industry. A report from the American Society of Health-System Pharmacists and Utah Drug Information Service indicates that drug shortages have hit an all-time high in 2024, with 323 active medication shortages in the first three months alone, surpassing previous records set since 2001. This trend underscores systemic issues affecting medication access and distribution beyond specific drug categories.

Senate Finance Committee introduces legislation aimed at fixing drug shortages

By Joseph Choi - The Senate Finance Committee on Friday introduced bipartisan legislation aimed at preventing and reducing generic drug shortages by leveraging Medicare and Medicaid programs. Read Full Article…

VBA Article Summary

1. Introduction of New Standards: The proposed provisions for Medicare participants entail adopting stringent criteria for supply chain resilience, reliability, and transparency in generic drug purchasing. This includes mandating minimum three-year contracts with manufacturers, purchase volume commitments, and contingency contracts with alternate manufacturers. Transparency regarding manufacturer quality control issues is also emphasized.

2. Incentivized Compliance: Providers meeting the core standards are eligible for quarterly lump-sum incentive payments. These incentives are designed to encourage adherence to the prescribed standards, thereby bolstering the stability and reliability of the generic drug supply chain.

3. Addressing Root Causes: Amidst record-high domestic drug shortages, attributed in part to monopolistic practices of middlemen, the bipartisan proposal aims to leverage the power of Medicare and Medicaid to mitigate shortages. Committee chair Ron Wyden emphasizes the need to hold middlemen accountable and prevent their detrimental contracting practices from exacerbating the drug shortage crisis, while Ranking Member Mike Crapo underscores the urgency of addressing these challenges to ensure consistent, affordable access to life-saving medications nationwide.

Trade group files first lawsuit against the DOL fiduciary rule

By John Hilton - The Federation of Americans for Consumer Choice filed a lawsuit in a Texas federal court Thursday to stop the Department of Labor fiduciary proposal from taking effect. Read Full Article…

VBA Article Summary

1. Legal Challenge against Fiduciary Expansion: The Financial Annuity Consumer Coalition (FACC) and independent insurance agents file a lawsuit challenging the Retirement Security Rule (RSR), published in the Federal Register on April 25. The lawsuit, lodged in the Eastern District of Texas, contends that the Department of Labor (DOL) has overstepped its authority by extending fiduciary standards to most annuity transactions, echoing a successful argument from a 2018 Fifth Circuit decision.

2. Legal Strategy and Arguments: FACC, represented by Figari & Davenport, seeks a preliminary injunction to halt the RSR's implementation pending the lawsuit's resolution. The lawsuit argues that the RSR and amended Prohibited Transaction Exemption 84-24 contravene the intent of Congress as outlined in ERISA and accuses the DOL of acting arbitrarily and capriciously in promulgating these rules.

3. Government Response and Compliance Challenges: Acting Labor Secretary Julie Su defends the RSR during a House Committee hearing, asserting its alignment with existing case law. However, if the injunction is not swiftly granted, financial institutions, including broker-dealers, investment advisers, banks, and insurance companies, face significant compliance challenges in preparing for the RSR's September 23 implementation deadline, requiring substantial training, process development, and documentation.

Every Dropbox Sign user stung in cyberattack

By Matt Kapko - The company said it became aware of unauthorized access to Dropbox Sign on April 24 and immediately responded with the assistance of third-party forensic experts to investigate, contain and remediate the intrusion. Read Full Article…

VBA Article Summary

1. Nature of the Attack: The cyberattack on Dropbox Sign targeted an automated system configuration tool, granting unauthorized access to the platform's production environment. This breach compromised a significant amount of user data and authentication details, including API keys, OAuth tokens, multifactor authentication information, hashed passwords, emails, usernames, and phone numbers.

2. Extent of Compromise: The breach impacted not only active Dropbox Sign users but also individuals who had interacted with the platform, even if they never created an account. Consequently, email addresses and names of non-account holders were exposed. However, Dropbox clarified that the contents of users' accounts, such as agreements, templates, or payment information, were not accessed by the threat actor.

3. Response and Mitigation Efforts: Dropbox's security team promptly responded by resetting users' passwords and initiating the rotation of all API keys and OAuth tokens. This action was crucial given the potential severity of the breach, particularly concerning compromised API keys and OAuth tokens, which could grant unauthorized access to sensitive services. Despite the breach, Dropbox expressed confidence in containing the incident to Dropbox Sign infrastructure, mitigating potential material impacts on its broader business operations.

States ranked by Ozempic demand

By Paige Twenter - Demand for Type 2 diabetes drug Ozempic is high across the U.S., but interest varies by state, according to research conducted by Bison Pharmacy. Read Full Article…

VBA Article Summary

1. Highest Interest: New York leads with the highest volume of Google searches for "Ozempic" and "Ozempic price," with 159.39 queries per 100,000 residents. This indicates a significant level of interest or concern about the medication within the state.

2. Urban Interest: The District of Columbia follows closely behind New York, indicating a substantial interest in the nation's capital with 137.50 queries per 100,000 residents. This suggests a concentrated urban interest in understanding the medication and its pricing.

3. Regional Variances: There's notable disparity across states, with Massachusetts, New Jersey, and Washington rounding up the top five. This suggests that interest in Ozempic and its price can vary significantly by region, potentially influenced by factors such as demographics, healthcare infrastructure, or marketing efforts by pharmaceutical companies.

Care about caregivers? Make sure there are ERGs for your working parents

By Deanna Cuadra - Between work and family, many caregivers get little breathing room for themselves — and it takes a toll. As employers try to make their benefits and policies more inclusive, they may need to question whether they have a pulse on what their caregivers need. Read Full Article…

VBA Article Summary

1. Recognition of Caregiver Struggles: Guardian Life's research highlights the significant mental health toll caregiving responsibilities can take, with a majority of caregivers reporting poor mental health and increased stress levels. Despite heightened awareness during the pandemic, many employees still struggle with finding relief from these challenges.

2. Implementation of Caregiver Employee Resource Groups (ERGs): Bright Horizons suggests that employers establish caregiver ERGs as a starting point to offer support. These groups provide a platform for caregivers to share experiences, voice their needs to company leaders, and disseminate information about available resources. ERGs foster solidarity among employees facing similar challenges and promote utilization of benefits and support services.

3. Fostering Inclusive Workplace Cultures: Guardian Life's CARE ERG demonstrates the pivotal role ERGs play in creating healthy workplace cultures. By providing a space for caregivers to discuss their responsibilities openly, ERGs help normalize caregiving experiences and combat feelings of isolation. Leadership buy-in is crucial for the success of ERGs, signaling a commitment to listening to employees' needs and incorporating them into company policies and decisions. Ultimately, ERGs facilitate the creation of a more inclusive work environment where caregivers feel valued, heard, and supported.

Cigna writes off $1.8B of its investment in Walgreens' VillageMD

By Paige Minemyer - In late 2022, Cigna's Evernorth unit made a $2.5 billion investment in VillageMD, and gained a minority stake in the primary care business that was primarily owned by Walgreens. Read Full Article…

VBA Article Summary

1. Write-down and Investment Loss: In the first quarter of 2024, The Cigna Group conducted a significant write-down of its investment in VillageMD, totaling about $1.8 billion, representing more than half of its stake in the provider. This decision was attributed to VillageMD's underwhelming growth, partly due to the closure of Walgreens clinics. CEO David Cordani cited broader market challenges as a contributing factor to this write-down.

2. Strategic Focus and Performance: Despite the write-down, Cigna remains committed to its strategic partnership with VillageMD. Cordani emphasized a continued focus on established markets where VillageMD is performing well, albeit with some adjustments in growth plans. The new carrying value of the investment stands at just above $900 million, reflecting the revised assessment of its worth.

3. Financial Performance and Outlook: Despite the investment loss, Cigna posted strong financial results, surpassing Wall Street expectations. Revenue for the quarter reached $57.3 billion, exceeding previous figures. Moreover, Cigna raised its outlook for 2024, projecting revenue of at least $235 billion and earnings per share of at least $28.40. Membership declined slightly, but Cigna saw growth in pharmacy benefit members, attributed in part to onboarding new clients like Centene. The Evernorth Health Services division and Cigna Healthcare segment both reported revenue growth, reflecting the company's diversified capabilities and offerings.

How the virtual care market is shaking out in 2024 as Walmart, Optum exit the telehealth business

By Heather Landi - News this week that Walmart is shuttering all 51 health centers along with its virtual care services came on the heels of recent media reports that Optum also was exiting the telehealth business. Read Full Article…

VBA Article Summary

1. Shift in Telehealth Models: Recent closures of major telehealth services like Optum Virtual Care and Walmart Health Virtual Care mark a shift away from transactional telehealth models. The emphasis is now on providing more holistic, longitudinal care experiences for patients rather than purely urgent or primary care interactions.

2. Market Evolution and Consumer Expectations: The closure of these services reflects a broader evolution in the virtual care market, moving away from commoditized models towards integrated, hybrid care approaches. Consumers now expect more than just virtual appointments, seeking features like messaging, online booking, and seamless integration with existing healthcare providers.

3. Opportunities for Innovation and Partnership: Despite closures, the telehealth industry remains robust, with opportunities for innovation and partnership. Companies like Wheel are leveraging technology to power the next generation of virtual care, emphasizing scalability and meeting diverse patient needs. As retailers like Walmart refocus on core businesses, partnerships with telehealth companies and digital health startups are poised to expand, driving further evolution in the market.

Labcorp, Quest Diagnostics add to roster of blood-based biomarker testing for Alzheimer’s

By Shenaz Bagha - Labcorp and Quest Diagnostics have both announced the availability of blood-based biomarker testing for Alzheimer’s disease, one which detects glial fibrillary acidic protein and another for phosphorylated tau. Read Full Article…

VBA Article Summary

1. GFAP Test Advancements: Labcorp's release highlights the innovative use of highly sensitive immunoassay technology in the GFAP test, enabling the measurement of glial fibrillary acidic protein (GFAP) levels from a simple blood draw. This advancement facilitates efficient assessment of neurodegenerative diseases such as multiple sclerosis, glioblastoma, and traumatic brain injury, offering a rapid means for physicians to gauge disease presence and progression.

2. Expansion of Blood-Based Biomarkers: The collaboration between Labcorp and Quest Diagnostics signifies a significant expansion in blood-based biomarker tests for the early detection of Alzheimer’s disease (AD) and other neurodegenerative conditions. Labcorp's chief medical and scientific officer, Brian Caveney, underscores the importance of this milestone in extending Labcorp's leadership in the field, reflecting their commitment to providing cutting-edge technology for the evaluation and treatment of neurodegeneration.

3. Diverse Approaches to Alzheimer’s Assessment: Quest Diagnostics' announcement of the launch of a blood-based test for phosphorylated tau 217 (p-tau 217), alongside the development of similar assays by Roche, Eli Lilly & Co., and Quanterix, indicates a diverse approach to Alzheimer’s disease assessment. Michael Racke, MD, emphasizes the rapid evolution of testing modalities and biomarkers for AD, suggesting a future landscape that includes a variety of testing approaches to help clinicians identify patients in the early stages of disease progression.

AdminaHealth's New Employee Benefits Payroll Reconciliation Feature Disrupts the Status Quo

By AdminaHealth - AdminaHealth®, the leading provider of Software-as-a-Service (SaaS) solutions for employee benefits billing and payment, today announced the expansion of the AdminaHealth Billing Suite® payroll comparison capabilities with its new patented "Pay As Deducted" reconciliation. Read Full Article…

VBA Article Summary

1. Enhanced Reconciliation Accuracy: The new payroll reconciliation feature meticulously identifies disparities between employee payroll deductions and employer enrollment data, heightening the precision of benefits budgeting and premium payments. By pinpointing inconsistencies before forwarding data to carriers, it significantly diminishes the likelihood of service delivery disruptions and billing errors.

2. Automated Deduction Management: 'Pay As Deducted' revolutionizes reconciliation by employing purpose-built patented technology to recognize discrepancies and facilitating employer funding of carrier invoices through deductions throughout the plan year. This innovative approach minimizes administrative burdens by automating manual tasks and ensuring that billing data becomes increasingly accurate with each cycle.

3. Transparency and Efficiency: Employers benefit from real-time insights into payroll deductions and billing details, fostering increased transparency in benefit administration. With streamlined processes, companies can optimize their resources, enhance service delivery, and ultimately improve employee job satisfaction. 'Pay As Deducted' represents a significant advancement in reconciliation, reflecting AdminaHealth's commitment to providing greater functionality and value to its customers.

Labcorp, Quest Diagnostics add to roster of blood-based biomarker testing for Alzheimer’s

By Healio - The FDA has approved an abbreviated new drug application for naloxone hydrochloride nasal spray, paving the way for the opioid overdose treatment to be available without a prescription. Read Full Article…

VBA Article Summary

1. FDA Approval for Over-the-Counter Access: Amneal Pharmaceuticals Inc. receives FDA approval for its USP 4 mg formulation of generic naloxone nasal spray, allowing it to be purchased without a prescription, offering easier access to life-saving medication for opioid overdose reversal.

2. Impact on Opioid Crisis: With synthetic opioids like fentanyl causing a significant number of deaths under age 50, surpassing other major causes such as heart disease and cancer, the approval of over-the-counter naloxone spray presents a crucial intervention tool. CDC statistics indicate that in nearly half of overdose deaths, there was potential for intervention, highlighting the importance of widespread access to emergency treatments like naloxone.

3. Affordability and Accessibility: Amneal's co-CEOs emphasize the company's commitment to addressing the public health emergency of opioid overdose by providing naloxone nasal spray at an affordable price and without the need for a prescription. By enhancing access to this emergency treatment, they aim to empower individuals and communities to intervene effectively, potentially saving countless lives and preventing further devastation caused by opioid overdoses.