Would presidential hopeful Harris replace FTC Chair Khan? The implications for PBM reform

By Noah Tong - Wealthy Democratic donors, seemingly reinvigorated by the new-look presidential race, are publicly expressing contempt for Federal Trade Commission (FTC) Chair Lina Khan, one of the nation’s key antitrust watchdogs. Read Full Article…

HVBA Article Summary

1. Strategic Influence and Potential Outcomes: The article outlines a strategic move by certain powerful business figures to influence Vice President Kamala Harris to potentially replace Lina Khan as chair of the FTC, emphasizing a shift from President Biden's current business regulations. This change is expected to impact the FTC's approach towards antitrust regulations, particularly in healthcare, where Khan has been notably aggressive in investigating Pharmacy Benefit Managers (PBMs), suspected of contributing to high drug prices and unethical business practices.

2. Public and Expert Reactions: The narrative captures a divisive public and expert debate regarding Khan’s effectiveness and the FTC's current direction under her leadership. Supporters argue that Khan's actions against PBMs are groundbreaking, while critics, including influential business leaders and some former FTC staff, label the efforts as ineffective or mismanaged. This contention highlights differing perspectives on the balance between aggressive regulation and business-friendly policies.

3. Implications for Future Regulatory Actions: The article discusses the broader implications of potentially ousting Khan, which might include a softer stance on PBMs and other antitrust matters depending on who succeeds her. The upcoming end of Khan's term and the subsequent presidential election could lead to significant changes in how the FTC addresses antitrust issues, influencing both the healthcare industry and broader corporate practices.

The Standard to Acquire Allstate Employer Voluntary Benefits Business; Companies Announce Distribution Partnership

By Business Wire - StanCorp Financial Group, Inc. (The Standard) and The Allstate Corporation (NYSE: ALL) announced earlier today a definitive agreement under which The Standard will acquire Allstate’s Employer Voluntary Benefits business for approximately $2 billion and enter into a product distribution partnership. The transaction is expected to close in the first half of 2025, subject to regulatory approvals and other customary closing conditions. Read Full Article…

HVBA Article Summary

1. Strategic Acquisition and Partnership: The Standard will acquire Allstate’s Employer Voluntary Benefits business, enhancing its position in the U.S. workplace benefits market. This transaction includes the transfer of employees and operations to The Standard, and establishes a five-year exclusive distribution partnership with Allstate, where The Standard will be the exclusive carrier for Allstate's group life, disability, and voluntary products.

2. Mutual Benefits and Growth Opportunities: Both companies emphasize the synergistic potential of this deal. Dan McMillan, President and CEO of The Standard, highlighted the compatibility of Allstate’s supplemental and voluntary products with The Standard’s group benefits business. This acquisition is poised to provide broader protection options and higher value for over 3.5 million of Allstate’s customers, according to Tom Wilson, Chair, President and CEO of The Allstate Corporation.

3. Advisory and Legal Support: The acquisition process is supported by major financial and legal advisors, demonstrating the significance and complexity of the transaction. Citi is serving as the exclusive financial advisor with Debevoise & Plimpton as legal counsel for The Standard. Meanwhile, Allstate has engaged J.P. Morgan and Ardea Partners for financial advisement and Willkie Farr & Gallagher LLP for legal services.

States ranked by total residents with employer-sponsored health coverage

By Jacob Emerson - Eight states have at least five million residents that receive health coverage from their employer, according to AHIP's 2024 "Coverage at Work" report published in July. Read Full Article…

HVBA Article Summary

1. Leading the Pack: California tops the list with the highest number of residents covered by employer-sponsored health insurance, totaling 17.95 million. This significant figure underscores California's massive workforce and the extensive reach of employer health coverage in the state.

2. Key States with Major Coverage: Following California, Texas and New York also show substantial numbers, with 13.85 million and 9.05 million residents covered, respectively. These figures highlight the importance of employer-sponsored health insurance in supporting large populations in major economic hubs.

3. Coverage Trends in Smaller States: On the other end of the spectrum, states like Vermont and Wyoming have the fewest residents with employer-sponsored coverage, at 300,000 and 284,000, respectively. This stark contrast illustrates the varying levels of employment-based health insurance access across different states, influenced by population size and economic factors.

Weight-loss drugs hit health care real estate

By Tina Reed - Weight-loss drugs are so ubiquitous that some health systems are scaling back bariatric surgery centers and recalculating other investments as they grapple with the drugs' potential for changing the prevalence of chronic diseases. Read Full Article…

HVBA Article Summary

1. Shift in Health Care Infrastructure: The emergence of GLP-1 medications like Ozempic and Wegovy has led to a significant decline in bariatric surgeries, prompting health systems to reevaluate and potentially downscale traditional surgical facilities. This trend reflects a broader pivot in healthcare from heavy reliance on invasive procedures to focusing more on lifestyle and metabolic health management, influencing future designs and functions of healthcare facilities.

2. Economic and Strategic Realignments: Health systems are adjusting their long-term planning and capital expenditures in response to the effectiveness of GLP-1 drugs in managing conditions such as obesity and diabetes. The closure of a bariatric surgery center in Oklahoma and the cancellation of a planned expansion in Philadelphia underscore the financial and strategic shifts underway as health providers anticipate reduced demand for certain surgical interventions.

3. Long-Term Healthcare Implications: While the immediate effects of GLP-1s are evident in shifting health service demands, the long-term impact remains uncertain. Healthcare leaders are cautious, drawing parallels to past experiences with medications like statins that shifted but did not eliminate the need for certain healthcare services. This cautious approach reflects an understanding of the potential for significant change in healthcare delivery and the need for adaptive strategies in planning and investment.

Novartis loses bid to thwart launch of MSN's Entresto generic—for now

By Fraiser Kansteiner - After seeking to block the launch of MSN Pharmaceuticals’ recently approved Entresto generic, Novartis has hit a snag in its multiyear crusade to thwart copycats of its top-selling heart failure drug. Read Full Article…

HVBA Article Summary

1. Legal Decision on Infringement Claims: Delaware District Judge Richard Andrews rejected Novartis' claims that MSN infringed on its '918 patent by planning to launch a generic version of the heart failure drug Entresto. The judge also denied Novartis' request for an injunction to prevent MSN's product launch, scheduled following FDA approval received on July 24. The court held that Novartis failed to meet its burden of proof concerning the alleged infringement and likelihood of success in its claim.

2. Impact and Implications of the Ruling: The court's decision not to grant an injunction is based on skepticism about the irreparable harm Novartis claimed it would suffer from the generic launch. Judge Andrews specifically refuted the idea that MSN's actions alone could cause significant market disruption for Entresto, noting that such outcomes would be the result of broader market dynamics and Novartis' own strategic decisions regarding its cardiovascular drug salesforce.

3. Ongoing Legal and Market Strategies: Novartis is considering all available options following the ruling, including a potential appeal, as it seeks to maintain its financial outlook for the year. Additionally, Novartis is challenging the FDA's approval of MSN's generic in a separate lawsuit, alleging improper labeling that omits critical safety information. This legal battle is part of Novartis' broader strategy to defend Entresto's market exclusivity against multiple generic competitors, even as the drug continues to generate significant revenue ahead of upcoming Medicare price negotiations.

Medicare Advantage insurers ranked by prior authorization denial rates

By Rylee Wilson - Medicare Advantage insurers denied 7.4% of prior authorization requests in 2022, according to data published by KFF. In a report published Aug. 5, KFF examined data submitted to CMS by Medicare Advantage insurers in 2022. Read Full Article…

HVBA Article Summary

1. Increasing Denial Rates: CVS Health exhibited the highest denial rates for prior authorization requests among major Medicare Advantage insurers in 2021 and 2022. The company denied 13% of requests in 2022, a slight increase from 12% the previous year, underscoring a trend towards stricter approval criteria.

2. High Volume of Requests by Humana: In 2022, Humana had the highest number of prior authorization requests per member at 2.9. This statistic highlights Humana's relatively intensive use of the prior authorization process compared to other insurers.

3. Comparison of Insurers: A broader comparison of major insurers in 2022 shows varied levels of prior authorization requests and denial rates. While Humana led with the highest number of requests per member, CVS Health had the highest denial rate at 13%. In contrast, Elevance Health (Anthem) had one of the lowest denial rates at 4.2%, despite a high volume of requests, indicating differing policy enforcement levels across insurers.

Prior authorization bottlenecks patient care, critics say

By Alan Goforth - The use of prior authorization by health insurers appears to be on the rise. Although insurers argue that this practice is a critical tool to control costs and reduce inappropriate service utilization, providers and patients raise concerns that it can inhibit patient care and increase administrative burdens. Read Full Article…

HVBA Article Summary

1. Expanding Scope of Prior Authorization: The Georgetown University Center on Health Insurance Reforms highlights an increase in the number and scope of medical services requiring prior authorization, particularly for durable medical equipment, high-cost drugs, and mental health or substance use disorder services. This expansion has prompted various stakeholders to call for reforms to manage the growing complexities and challenges associated with prior authorization processes.

2. Proposed Reforms and State Legislation: In response to widespread dissatisfaction among providers and patients, state lawmakers introduced over 90 bills aimed at reforming prior authorization practices in early 2024. Proposed reforms include enhancing transparency about which services require prior authorization, setting strict timelines for insurers to respond to requests, standardizing forms for submitting requests, and mandating peer-to-peer reviews to ensure fairness and adherence to clinical guidelines.

3. Impact and Need for Comprehensive Reform: The researchers at the center found that the success of prior authorization reforms largely depends on their careful design, implementation, and enforcement. They emphasize that without accompanying federal action, particularly for plans governed by ERISA, state-level reforms may have limited effectiveness in reducing provider burdens and improving patient access, underscoring the need for a coordinated approach to overhaul prior authorization systems both at the state and federal levels.

Record number of health data breaches reported in 2024

By Tim Broderick - Healthcare organizations have reported a record number of data breaches this year — and the full scope of the high-profile ransomware attack on Change Healthcare is still unknown. Read Full Article…

HVBA Article Summary

1. Increase in Data Breaches: In the first half of 2024, there were 387 data breaches affecting over 45 million individuals, marking the highest number of incidents reported within the first six months since the Health and Human Services' Office for Civil Rights (OCR) began publishing cases in 2010. This represents an increase from the 357 breaches reported during the same period in 2023, which impacted about 50 million people.

2. Notification Delays and Responses: The OCR has allowed for delays in the 60-day breach notification period under specific circumstances, as seen with United HealthGroup's Change Healthcare after their February data breach. The process of notifying affected entities only began several months later, highlighting challenges in timely communication post-breach. UnitedHealth Group has emphasized its commitment to rapid notification, claiming that over 90% of files have been reviewed to date.

3. Major Breaches and Ongoing Risks: The largest breach reported in the first half of 2024 involved the Kaiser Foundation Health Plan, affecting 13.4 million individuals, with compromised data potentially shared with major tech companies like Google and Microsoft. Looking forward, experts like Lee Kim from the Healthcare Information and Management Systems Society express concern over the increasing sophistication of cyber threats, including those potentially aided by AI, and emphasize the need for enhanced collaboration and investment in cybersecurity frameworks within healthcare organizations.

Study: LLMs Identify Mental Health Crises with Accuracy Comparable to Clinicians

By Marissa Plescia - Large language models (LLMs) can identify and predict mental health crises with comparable accuracy to clinicians, but in a significantly shorter amount of time, a new study shows. The findings indicate the potential AI has in supporting clinicians at a time when there is a severe shortage of behavioral health providers. Read Full Article…

HVBA Article Summary

1. Study Overview and Methodology: The peer-reviewed study by Brightside Health, published in JMIR Mental Health, investigated the application of AI in predicting suicidal ideation among patients. It analyzed deidentified patient data from 460 individuals, focusing on their responses and past suicide attempts. Both clinicians and OpenAI's GPT-4 were tasked with predicting whether patients would develop suicidal ideation with a plan, comparing their accuracy and speed.

2. Findings on AI and Clinician Performance: The findings revealed that clinicians predicted suicidal ideation with a plan with an accuracy of 55.2% to 67%, while GPT-4 achieved a 61.5% accuracy rate. Notably, GPT-4 processed the evaluations significantly faster, taking less than 10 minutes to analyze the 460 samples, compared to over three hours for clinicians.

3. Implications for Mental Health Care: Dr. Mimi Winsberg, co-founder and chief medical officer at Brightside Health, emphasized the potential of generative AI to support mental health care. She highlighted its utility in efficiently triaging patients and supporting clinical decisions, particularly for those at high risk of suicide. The study underscores the need for a collaborative approach between AI tools and human clinicians to enhance patient care, especially in regions facing a shortage of mental health professionals.