US Supreme Court rejects challenge to $2.7 bln Blue Cross settlement

By Mike Scarcella - The U.S. Supreme Court on Monday declined to hear a challenge to a $2.7 billion nationwide class action settlement with Blue Cross Blue Shield over allegations that the insurance giant overcharged commercial and individual subscribers for years. Read Full Article…

HVBA Article Summary

1. Supreme Court Decision: The U.S. Supreme Court declined to hear Home Depot's objections to a major antitrust settlement involving Blue Cross Blue Shield, which had been accused of anti-competitive practices that raised insurance costs. This decision effectively upholds an earlier ruling by the 11th U.S. Circuit Court of Appeals that supported the settlement terms and a substantial attorney fee award.

2. Attorney Fees Controversy: The settlement includes one of the largest-ever class action attorney fee awards, totaling $667 million, approved by a lower court judge. Home Depot had challenged this fee, arguing it should be capped at $194 million, based on the attorneys' hours worked and prevailing hourly rates. The Supreme Court's refusal to review the case leaves the original fee award intact.

3. Consumer Impact and Legal Arguments: David Boies, representing the class of subscribers, highlighted the significant benefits for consumers, including billions in refunds and measures to enhance competition across the U.S. health insurance market. Lawyers for the class defended the settlement and fee, asserting the extensive litigation efforts warranted the awarded amount and emphasizing the settlement's prohibition of future claims related to the same issues.

Employers Can Trust Address Provided by Employees

By Noah Zuss - For employers, the order of a federal court in Illinois is important information to incorporate to the continuing operation of health care coverage. In Anaya v. Birck et al, the U.S. District Court for the Northern District of Illinois last month ruled that an employer fulfilled its Continuation of Health Coverage notification requirements even though it did not deliver a terminated employee’s COBRA election notice to his latest address. Read Full Article…

HVBA Article Summary

1. Notification Standard and Good-Faith Efforts: The court emphasized that the relevant standard is not whether the terminated employee actually received the notice, but whether the employer made good-faith efforts to notify the employee. Sending notices by first class mail to the employee's last known address was deemed an acceptable method, provided it was reasonably calculated to reach the employee.

2. Legal Context and COBRA Requirements: Under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), employers must notify employees of their right to continue health care coverage following termination. The court highlighted that the good faith standard does not require absolute certainty of receipt but rather a reasonable effort by the employer to send the notice.

3. Case Details and Court Ruling: The court ruled against the plaintiff, Jesse Anaya, who argued that the employer should have known the notice was sent to his old address. Despite the employer's CEO having been to Anaya's new home, the court concluded that expecting the CEO to ensure notice delivery would exceed the good faith standard. The ruling, which did not establish new law, was explained by Marcia Wagner of The Wagner Law Group following Judge LaShonda A. Hunt's memorandum opinion.

Novel GLP-1/Glucagon Drug Promising for Weight Loss

By Crystal Phend - Novel dual GLP-1 and glucagon agonist pemvidutide reduced weight and lipids with somewhat less muscle loss than expected, the phase II MOMENTUM trial showed. Read Full Article…

HVBA Article Summary

1. Weight Loss and Efficacy: Pemvidutide demonstrated significant weight loss over 48 weeks in a dose-dependent manner, with reductions ranging from 10.3% at a 1.2 mg weekly dose to 15.6% at a 2.4 mg weekly dose, all statistically significant compared to placebo. The mean weight loss of 32.2 lbs at 48 weeks suggests further potential weight reduction as trajectory curves continued downward.

2. Health Benefits and Composition of Weight Loss: Besides weight reduction, pemvidutide significantly lowered LDL cholesterol by 6.2% to 11.2% and triglycerides by 21.7% to 34.9%. In a subset of patients undergoing MRI scans, 21.9% of the weight loss was lean mass, favorably comparing to the 25% typically expected and up to 40% seen with incretin therapies. The majority of patients with obesity had comorbid conditions, such as metabolic dysfunction-associated steatohepatitis.

3. Trial Design and Adverse Events: The MOMENTUM trial, one of many at the ADA conference exploring new obesity treatments, involved 391 patients randomized to different pemvidutide doses. About 74% of pemvidutide-treated patients completed the 48-week treatment. The drug was well tolerated with no significant impact on heart rate and small decreases in blood pressure. However, higher doses led to higher incidences of nausea (52-60%), vomiting (27%), diarrhea (10-18%), and constipation (13-23%), with one serious adverse event reported.

Stop allowing MA plans to use AI to deny care without review, lawmakers urge CMS

By Casey Ross and Bob Herman - A bipartisan group of lawmakers is urging the Biden administration to prohibit Medicare Advantage insurers from using artificial intelligence tools to deny care until it completes a systematic review of their accuracy and effects on patients. Read Full Article…

HVBA Article Summary

1. Lawmakers Urge CMS to Enhance Oversight of AI Tools in Medicare: In a letter sent on Tuesday, lawmakers, including Sen. Elizabeth Warren and Rep. Jerry Nadler, called on the Centers for Medicare and Medicaid Services (CMS) to improve oversight of AI and algorithmic tools that discriminate against elderly and sick patients. They emphasized that these tools often make generalized decisions rather than individualized care, contradicting Medicare's mission.

2. Call for Systematic Review and Clear Guidelines: The letter also urged CMS to establish a process for reviewing AI products used in coverage decisions and provide clear guidelines distinguishing tools that consider individual patient circumstances from those that make generalized decisions. Lawmakers highlighted that insurers often adhere to an algorithm's initial prediction without reassessing changes in a patient's condition, leading to biased and potentially harmful outcomes.

3. Demand for Transparency and Prevention of AI-Related Harms: Highlighting findings from a STAT investigation, the letter pointed out that Medicare Advantage insurers use AI tools with no transparency, leading to coverage denials for patients with serious illnesses. Lawmakers proposed a two-week grace period before insurers can reissue a denial after an appeal and called for more detailed CMS guidance to prevent ambiguity and ensure transparency in the use of AI tools in healthcare.

The company that produces Ozempic is opening another billion dollar US factory

By Naomi Kresge - Novo Nordisk plans to invest $4.1 billion in another U.S. factory, plowing more money into its biggest market amid rising discontent there over the cost of its obesity and diabetes drugs. Read Full Article…

HVBA Article Summary

1. Expansion of Production Footprint: Novo Nordisk's new facility in Clayton, North Carolina, will double the company's U.S. production capacity, adding 1.4 million square feet dedicated to the final stages of manufacturing its medicines, including filling injector pens. This expansion will create 1,000 new jobs, significantly boosting local employment and enhancing Novo's manufacturing capabilities in the country.

2. Significant Investment in Supply Chain: The Clayton site is part of Novo Nordisk's broader strategy to increase production capacity for its popular diabetes drug Ozempic and weight-loss medicine Wegovy. The company plans to invest $6.8 billion in production facilities this year, nearly doubling its 2023 investments of $3.9 billion. This substantial investment underscores Novo's commitment to meeting growing demand and solidifying its position as Europe's largest company.

3. Challenges and Strategic Decisions: The expansion comes at a time of rising scrutiny over the high cost of Novo's drugs in the U.S., the largest market for weight-loss medicines due to the high prevalence of obesity and higher drug prices. CEO Lars Fruergaard Jorgensen is scheduled to testify before a Senate committee about drug pricing. Additionally, North Carolina's state employee health plan has dropped coverage for weight-loss drugs to avoid projected financial losses. Despite these challenges, Novo continues to strategically expand, including major projects in Denmark and France, while deciding against an expansion in Dublin.

Regulators move forward with offshore reinsurance ‘concepts’

By John Hilton - The Life Actuarial Task Force voted Thursday to expose a pair of reinsurance documents designed to move regulators closer to an actuarial guideline to tighten oversight of offshore arrangements. Read Full Article…

HVBA Article Summary

1. Focus on Reserve Adequacy and Transparency: Regulators emphasized the need for a comprehensive review of reserve adequacy, particularly in reinsurance transactions involving U.S. policyholders. The discussions highlighted the potential risks of reduced transparency and adequacy of reserves when business is ceded, especially to offshore reinsurers with lighter regulatory environments.

2. Detailed Considerations for Consensus: Fred Anderson presented eight key considerations for achieving consensus on reserve adequacy testing. These included the need for a reserve adequacy review, setting materiality thresholds, conducting rigorous analysis, and using already available information. These points aim to ensure thorough and consistent evaluations of reserve adequacy.

3. Regulatory Proposals and Future Guidelines: The initial proposal by David Wolf and Kevin Clark suggested stricter regulations to ensure that reserves meet policyholder obligations under "moderately adverse conditions." Regulators aim to develop and implement new actuarial guidelines by the end of 2025, with initial flexibility to allow for adjustments and refinements based on early experiences.

Wegovy improves functional class in patients with obesity, heart failure at 1 year

By Erik Swain - In patients with obesity-driven heart failure with preserved ejection fraction, semaglutide 2.4 mg was associated with more improvement in NYHA functional class compared with placebo, according to new data from the STEP-HFpEF trials. Read Full Article…

HVBA Article Summary

1. Improved Functional Class: Wegovy (semaglutide 2.4 mg) significantly improved the New York Heart Association (NYHA) functional class at 1 year in patients with obesity-driven heart failure with preserved ejection fraction (HFpEF) compared to placebo. Patients in the Wegovy group were more likely to improve and less likely to deteriorate in their NYHA class.

2. Consistent Weight Loss: The weight loss achieved with Wegovy was consistent across different functional classes. Both NYHA functional class II and classes III/IV patients experienced significant weight reduction, demonstrating the drug's effectiveness regardless of the severity of functional impairment.

3. Broader Clinical Benefits: Wegovy led to consistent improvements in various clinical outcomes, including the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), 6-minute walk distance, and biomarkers like C-reactive protein and N-terminal pro-B-type natriuretic peptide. These benefits were observed across all baseline functional classes, highlighting the drug's comprehensive efficacy in treating obesity-driven HFpEF.

As retirees rethink the future, many are heading back to work

By Alyssa Place - Once an employee leaves the workforce, that no longer means their work-life is over forever. In 2024, one in eight retirees plans to go back to work, due to factors like high cost of living, inflation, a lack of savings and even boredom, according to a survey by ResumeBuilder.com. Of those planning for their future now, a third expect to work part-time, according to Flexjobs. Read Full Article…

HVBA Article Summary

1. Self-Assessment and Flexibility: Retirees reentering the workforce should start by evaluating their skills, interests, and values to align with the demands of the new work environment. Jake Canull, regional director of the Americans at Top Employers Institute, suggests considering flexible work arrangements such as consulting, freelancing, gig work, or part-time positions.

2. Financial and Psychological Benefits: Returning to work can provide significant financial and psychological benefits for retirees. Many Americans nearing retirement feel unprepared, with only a quarter feeling on track, according to the Federal Reserve. Additionally, 68% of current retirees fear their savings won't last. A study in Economics and Human Biology found that retirees who returned to work reported better mental health and less loneliness.

3. Value for Employers: Employers benefit from a multi-generational workforce, as older employees bring valuable industry experience and knowledge that can be shared with younger team members. This knowledge transfer helps bridge the generation gap and fosters an inclusive work environment. Employers should accommodate the unique needs of older workers by offering flexible schedules, job-sharing opportunities, and maintaining an open dialogue to celebrate the strengths of each generation.

How employers can save $3,000 per employee on MSK care

By Lee Hafner - For the more than 120 million adults suffering from musculoskeletal (MSK) disorders in the U.S., the burden of pain hinders their ability to function normally, and increases the chance of other chronic mental and physical conditions. Read Full Article…

HVBA Article Summary

1. Employer-Sponsored MSK Benefits Drive Cost Savings and Health Improvements: Musculoskeletal (MSK) conditions are a significant driver of healthcare costs and negatively impact employee productivity and attendance. Employer-sponsored MSK benefits, such as those provided by Sword Health, not only facilitate recovery but also lead to substantial healthcare cost savings. According to an independent audit by Risk Strategies Consulting, Sword Health's digital and virtual physical therapy services have saved over $3,000 per member annually, resulting in a 301.2% return on investment for employers.

2. Technological Innovation Enhances MSK Care: Sword Health employs advanced technology, including AI-driven solutions like the AI Care Specialist Phoenix, to revolutionize MSK care. Patients engage in physical therapy at home using a monitor that tracks their movements, assesses progress, and provides feedback. This approach not only reduces unnecessary medical expenses but also improves patient outcomes, with 62% of members reporting mild to no pain after completing their program. The integration of AI and human clinicians ensures high-quality, holistic care.

3. MSK Benefits Should Be a Core Offering for Employers: Given the widespread impact of MSK conditions across all demographics, employers should prioritize MSK support in their healthcare benefits. Sword Health's services cater equally to blue-collar and white-collar workers, providing a convenient, comfortable, and flexible recovery experience at home. This approach meets the essential needs of the workforce, enhancing overall employee health and satisfaction.

Lilly becomes the latest pharma to tap OpenAI for help, this time for antibiotic work

By Max Bayer - First it was Moderna, then Sanofi, and now Lilly. OpenAI’s influence on the pharmaceutical industry has made its way to Indianapolis. Lilly Chief Information Officer Diogo Rau said Tuesday that generative artificial intelligence tech will “accelerate the discovery of novel antimicrobials and the development of custom, purpose-built technologies in the battle against drug-resistant pathogens.” Read Full Article…

HVBA Article Summary

1. Lack of Specificity in OpenAI and Lilly Collaboration: Spokespeople for OpenAI and Lilly declined to provide further details about their partnership. Unlike many companies that have announced biopharma-focused AI models, OpenAI has not yet disclosed any specific offerings in this area. Similarly, Lilly has not elaborated on how it plans to utilize OpenAI’s technology.

2. Support for Antibiotic Development through AMR Action Fund: The collaboration between OpenAI and Lilly is intended to support Lilly's $100 million contribution to the AMR Action Fund. This initiative aims to stimulate investments in antibiotic development, with a goal of producing two to four new antibiotics by 2030.

3. Broader AI Partnerships in the Pharma Industry: Other pharmaceutical giants are also integrating AI into their operations. For instance, Sanofi announced a partnership with OpenAI and Formation Bio to develop AI-powered software for accelerating drug development. Similarly, Moderna revealed an extensive partnership with OpenAI in April, expanding the use of ChatGPT in data analytics, image generation, and dose finding.