Lilly CEO says weight-loss drug Zepbound weekly prescriptions hit 25,000 in December

By Patrick Wingrove - Eli Lilly (LLY.N) CEO David Ricks on Monday said the company's powerful weight-loss drug Zepbound hit 25,000 new prescriptions per week at the end of December and that its 2024 supply may not be enough to meet demand. Read Full Article…

VBA Article Summary

1. Lilly's CEO, David Ricks, highlighted the importance of setting expectations while addressing the demand for their weight-loss drug, Zepbound Lilly, at the JPMorgan health conference. However, he did not disclose specific production figures or forecasts for 2024 demand and supply.

2. The company emphasized its commitment to meeting dynamic patient demand by investing in manufacturing. In 2023, Lilly announced plans to expand its North Carolina plant and construct a new facility in Germany to support production.

3. Ricks expects significant coverage for Zepbound from pharmacy benefit managers (PBMs), with at least one major PBM likely to recommend coverage for the drug in 2024. Nevertheless, the CEO cautioned that employer decisions not to cover weight loss drugs in their health plans could impact demand. Lilly also launched a website for direct drug orders with coupons to reduce costs, discouraging the use of counterfeit versions. Additionally, the company has been working to combat the sale of fake weight-loss drugs online. Lilly is in discussions with UK health officials for the use of their weight-loss medicine in Britain and intends to rejoin the UK's voluntary medicines pricing agreement with new terms.

10 healthcare names get Shkreli Awards for bad behavior

By Molly Gamble - Ten individuals and organizations are recognized in the name of a "pharma bro" with the release of Lown Institute's Shkreli Awards.  Read Full Article…

VBA Article Summary

1. Shkreli Awards by Lown Institute: The Lown Institute, a nonpartisan think tank, organizes the annual Shkreli Awards, highlighting the most egregious examples of dysfunction and profiteering in healthcare. A panel of 19 judges, including patient activists, clinicians, health policy experts, and journalists, select the recipients. These awards aim to expose unfair practices and lack of integrity in the U.S. healthcare system.

2. Examples of Award Recipients: The 2023 Shkreli Awards recognized various entities for their questionable actions. For instance, Columbia University and its affiliated hospital were highlighted for minimal intervention in a case involving a physician's sexual assaults. CommonSpirit Health was noted for its CEO's excessive compensation. Additionally, pharmaceutical companies were called out for challenging Medicare's drug price negotiations on constitutional grounds, and hospitals were criticized for partnering with private equity to offer predatory medical credit cards.

3. Impact and Coverage: The awardees, which include hospitals, pharmaceutical companies, and individual healthcare practitioners, were extensively covered by local and national news outlets throughout 2023. These stories not only highlight specific incidents of misconduct but also reflect broader systemic issues in the U.S. healthcare system. The Lown Institute underscores the need for increased fairness and integrity in healthcare, as these cases cease to be mere anecdotes and start representing a larger, more troubling narrative.

Walgreens to pay $360 million to Humana in drug pricing settlement

By Mike Scarcella - Walgreens (WBA.O) has agreed to pay $360 million to healthcare insurer Humana to settle a lawsuit claiming that the retail pharmacy giant for years overcharged for prescription drug reimbursements. Read Full Article…

VBA Article Summary

1. Walgreens and Humana Settlement: U.S. District Judge Ana Reyes dismissed a lawsuit in the Washington, D.C., federal court after Walgreens disclosed a settlement with Humana. This settlement, the amount of which was revealed in a filing with the U.S. Securities and Exchange Commission, resolves a dispute stemming from 2022 when Walgreens sued Humana to overturn a $642 million award. Humana had accused Walgreens of filing "millions of falsely-inflated" prescription drug prices for over a decade.

2. Walgreens Declines Comment on Settlement Terms: While Walgreens confirmed the settlement with Humana, the company declined to comment on its specific terms. Based in Deerfield, Illinois, and a subsidiary of Walgreens Boots Alliance, Walgreens had previously denied the allegations made by Humana. In a related development, Walgreens also announced plans to resolve a lawsuit against U.S. law firm Crowell & Moring, which represented Humana during the arbitration, citing a conflict of interest due to Crowell's past representation of Walgreens.

3. Ongoing Legal Challenges for Walgreens: Despite settling with Humana and planning to resolve the lawsuit against Crowell & Moring, Walgreens continues to face other legal challenges related to drug-price overcharge claims. Some Blue Cross Blue Shield plaintiffs in Chicago federal court have withdrawn their claims against Walgreens, with Walgreens dropping counterclaims in response. However, Walgreens still confronts similar pending claims from other Blue Cross plaintiffs and has stated its intention to “vigorously defend” itself in these ongoing cases.

Claim denied? Health insurers must promptly hand over records, but most don’t

By Maya Miller - Just outside public view, the American health insurance industry’s algorithms, employees and executives process tens of millions of claims for people seeking medical care. Read Full Article…

VBA Article Summary

1. Insurers Not Complying with Legal Requirements: The article highlights instances where health insurers made mistakes or based their decisions on company profits rather than patient health. In some cases, they denied treatments due to misapplying guidelines or misreading surgery types. Although federal laws and regulations mandate that insurers must provide claim files within 30 days upon request, some insurers are failing to comply. ProPublica's investigation found that insurers often did not turn over files as required, with some improvement only after ProPublica's intervention.

2. Issues with Accessing Claim Files: Patients and advocates face challenges when requesting claim files, which are crucial for crafting successful appeals. The article notes that more than 120 people have sought their claim files, but many encountered obstacles such as missed deadlines and incorrect information from insurers. For instance, insurers like Cigna and Anthem incorrectly told members they needed subpoenas for access. Some insurers also confused claim file requests with appeals, further complicating the process.

3. Insurers' Acknowledgment and Steps Towards Improvement: Upon ProPublica's inquiry, all involved insurers admitted that patients were entitled to the requested material. Following this, some insurers began sending the files and are updating policies to better handle future requests. Anthem Blue Cross Blue Shield and Cigna acknowledged the need for better staff training and policy communication. The article also emphasizes the importance of timely responses, as stated by a Department of Labor official, emphasizing that delays are contrary to regulations.

Clinician accuracy suffers from biased AI, even with mitigation, study finds

By Emily Olsen - AI has the potential to help providers find abnormalities in imaging results and analyze patient data to find patterns and make predictions on outcomes. Read Full Article…

VBA Article Summary

1. AI in Healthcare Diagnostics: A study published in JAMA revealed that while artificial intelligence (AI) can enhance diagnostic accuracy for clinicians, particularly in cases of acute respiratory failure, the presence of bias in AI models can significantly decrease this accuracy. The study involved clinicians assessing patient vignettes with the assistance of AI models, demonstrating an increase in diagnostic precision when AI was used. However, the introduction of systematically biased AI models, which could misdiagnose certain patient subpopulations, resulted in a notable decrease in accuracy.

2. Limitations of Model Explanations: The research found that providing explanations for AI models' logic did not substantially aid clinicians in overcoming the errors introduced by bias. This challenges the assumption that explanatory mechanisms can help healthcare professionals understand and compensate for AI recommendations. Despite FDA guidance emphasizing the value of such explanations for interpretability, the study suggests they might be insufficient in mitigating the harm caused by biased AI models.

3. Challenges in AI Literacy and Model Understanding: The study highlights a significant gap in AI literacy among clinicians, with many unaware of the potential for systematic biases in AI models. This lack of awareness, combined with the potential inadequacy of image-based explanations, suggests a need for more effective training and experience in interpreting AI models. The study suggests exploring alternative methods, such as text descriptions, to better convey the AI models' reasoning and improve their safe and effective use in clinical diagnostics.

3 health plan mergers through the lens of new DOJ/FTC rules

By Laura Beerman - Would the final 2023 merger guidelines from the U.S. Department of Justice and the Federal Trade Commission have affected this year’s biggest deals? Here’s a look at the key guideline takeaways and the deals in question. They include one that’s still on the table following a state justice request to the DOJ. Read Full Article…

VBA Article Summary

1. Unified Guidelines for All Merger Types: The Department of Justice (DOJ) and the Federal Trade Commission (FTC) have introduced new, comprehensive guidelines that apply universally to all types of mergers. This includes horizontal mergers (between companies offering similar services), vertical mergers (involving different types of service providers), and cross-market mergers (across various geographical areas). These guidelines aim to simplify and standardize the rules for merger evaluations.

2. Stricter Criteria for Horizontal Mergers: The updated guidelines have established more stringent criteria for the evaluation of horizontal mergers. Now, such mergers are considered "presumptively unlawful" if they result in a combined market share of 30% or a market concentration level exceeding 1,800 on the Herfindahl-Hirschman Index (HHI). The HHI measures market concentration, ranging from 0 to 10,000, and helps identify markets that are moderately (HHI 1,500-2,500) or highly concentrated (HHI above 2,500). This change signals that even moderately concentrated deals might face increased scrutiny and potential blockage.

3. Rejecting Efficiency as a Defense and Emphasizing Comprehensive Analysis: The final merger guidelines dismiss the argument of cost savings and efficiencies as a general defense against mergers that are deemed illegal and anti-competitive. Only under narrow conditions, such as unique benefits that are provable and do not harm market competition, can this defense be used. Additionally, the guidelines have elevated the importance of economic and competitive analysis in merger evaluations. This includes considering the impact on the labor market and other potential harms, demanding a more comprehensive and rigorous evidentiary approach from companies involved in mergers.

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

By Fred Schulte and Holly K. Hacker - Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream. Read Full Article…

VBA Article Summary

1. Insulin Pump Malfunction and Legal Action: Carlton "PeeWee" Gautney, a dispatcher from Opp, Alabama, died in May 2020, and his family attributes his death to a malfunction of his Medtronic MiniMed insulin pump, which they believe delivered a fatal overdose of insulin. His daughter, Carla Wiggins, has filed a wrongful-death lawsuit against Medtronic, claiming the pump was defective and dangerous. Medtronic, however, denies these allegations and has sought a court motion for summary judgment. This case is part of a broader pattern where numerous FDA-cleared medical devices, including implants and chronic disease treatment tools, are suspected of contributing to injuries and patient deaths.

2. FDA and Medical Device Regulation Challenges: The FDA faces significant challenges in ensuring the safety of medical devices. Many devices, including implants, are cleared for sale without rigorous tests for safety or effectiveness, relying instead on demonstrating "substantial equivalence" to existing products. This process, though less costly and quicker, has been criticized for potentially overlooking safety concerns. Additionally, the FDA struggles to track malfunctions and adverse events effectively, and patients face legal barriers in holding manufacturers accountable for defects. Despite FDA's claims of a rigorous evaluation process, cases like Gautney's raise concerns about the effectiveness and speed of FDA responses to device malfunctions.

3. Broader Issues in Medical Device Industry: The investigation highlights broader issues in the medical device industry, including delayed actions and warnings about device hazards, underreporting of adverse events, and challenges in legal accountability for manufacturers. Examples include the MiniMed insulin pump recall due to a potentially fatal flaw, and the PB 980 ventilator recall for dangerous malfunctions. Additionally, the 510(k) clearance process used by the FDA for medical device approval is under scrutiny for not adequately evaluating the safety and effectiveness of new devices, relying instead on comparisons to previously approved devices. This has led to concerns about patient safety and the effectiveness of the FDA's regulatory processes.

Private equity is buying up health care, but the real problem is why doctors are selling

By Yashaswini Singh and Christopher Whaley  - Who owns your doctor’s office? More and more often nowadays, the answer is a private equity firm — a type of investment fund that buys, restructures, and resells companies. Read Full Article…

VBA Article Summary

1. Rising Influence of Private Equity in Health Care: Over the past decade, private equity firms have significantly invested in the health care sector, with nearly $1 trillion spent on approximately 8,000 health care deals. This trend includes a wide range of practices from fertility clinics to hospices. While this increases prices and aims for high returns, many physicians are selling their practices to these firms due to the unsustainability of running a private practice and the unattractiveness of alternative employment options like hospital work.

2. Impact on Healthcare Costs and Quality: Consolidation in health care, driven by both hospitals and private equity, is not a new phenomenon. Studies suggest that consolidation generally leads to higher healthcare costs without improving the quality of care. In the case of private equity, the need to deliver high returns to investors often results in inflated charges and cost-cutting measures, such as high turnover of physicians and increased hiring of non-physician staff.

3. Addressing the Underlying Causes and Potential Solutions: To combat the growing influence of private equity in health care, it's crucial to understand why physicians feel the need to sell their practices. Key factors include the need for higher reimbursement rates, access to capital, and the desire for a better work-life balance. Solutions proposed include increasing transparency in consolidation activities, addressing monopolistic behavior, easing the financial burden of running independent practices, and reforming Medicare to better support primary care practices.

Editor's Corner—Fierce Healthcare's 10 most-read stories of 2023

By Heather Landi - Physician pay and workforce issues were top of mind for Fierce Healthcare readers in 2023. Read Full Article…

VBA Article Summary

1. Physician Compensation and Economic Pressures: The article highlights the decline in average physician pay by 2.4% from 2021 to 2022, as reported by Doximity's annual physician compensation report. This decline is attributed to various challenges faced by U.S. healthcare workers, including economic strains, a growing physician shortage, and high rates of work-related burnout.

2. Increasing Layoffs in Healthcare: The article notes a significant increase in layoffs among hospitals and health systems in 2023, with a 99% increase in healthcare company layoffs year over year. This trend reflects the financial difficulties faced by these organizations, leading to over 100 layoff announcements, news reports, and regulatory filings from hospitals and health systems throughout the year.

3. Major Mergers and New Technology in Healthcare: The article discusses Kaiser Permanente's acquisition of Geisinger Health and the launch of a new multisystem value-based care platform, Risant Health. Additionally, it mentions the introduction of a beta version of a ChatGPT tool for doctors by Doximity, aimed at streamlining administrative tasks, indicating a growing interest in applying AI technology in healthcare.