House Committee Divided on Whether Changes are Needed in 340B Drug Discount Program

By Joyce Frieden - House members generally expressed support Tuesday for the 340B drug discount program that serves hospitals and clinics treating low-income patients, but disagreed on whether the program needs tighter regulation. Read Full Article…

HVBA Article Summary

1. Oversight and Accountability: Representative Griffith highlights the importance of Congressional oversight in ensuring that hospitals appropriately utilize 340B program funds. Instances of abuse, such as significant markups on drugs, underscore the necessity for monitoring to prevent exploitation of the system.

2. Vital Lifeline for Hospitals: Testimonies from hospital representatives, like Matthew Perry, emphasize the critical role of 340B discounts in sustaining healthcare institutions. These savings bridge the gap created by underpayment from government health programs, enabling hospitals to provide essential care, including millions of dollars in free or discounted prescriptions and uncompensated care.

3. Impact on Access and Competition: Concerns raised by Representative Schakowsky and others highlight the adverse effects of recent restrictions on contract pharmacies. Limiting access to nearby pharmacies disrupts medication accessibility for low-income patients and contributes to financial losses for healthcare systems, potentially leading to closures or consolidations that limit patient choice and competition.

AMA considers legal action against Change Healthcare

By Giles Bruce - The American Medical Association is exploring the possibility of filing a class-action lawsuit against Change Healthcare to help physicians recoup losses from the cyberattack on the Optum subsidiary. Read Full Article…

HVBA Article Summary

1. Legal Action for Unfair Enrichment: The American Medical Association (AMA) is considering legal action against Change Healthcare, alleging "unfair enrichment profits" during the February ransomware attack. This potential lawsuit aims to distribute profits gained during the attack, which AMA claims were unjustly withheld from practices and other entities.

2. Investigation into Premium Collection: The resolution highlights Optum and its parent company United Health Group's continued collection of premiums during the cyberattack period when no claims were being paid. AMA questions whether this allowed them to retain significant amounts of money, potentially earning interest and investment gains on funds that should have been disbursed to affected practices, raising concerns of unjust enrichment.

3. Scrutiny of Acquisition Practices: AMA plans to investigate Optum's acquisition of practices following the ransomware attack. It aims to determine whether these acquisitions were made opportunistically during a period of vulnerability for the practices. The resolution seeks to explore the possibility of returning these acquired practices to independence once they recover from the cyberattack's disruption.

The Senate Attacks on Pharma Put the Industry in Jeopardy and Consumers at Risk

By Rita Numerof - In his latest foray into drug pricing, Senator Bernie Sanders launched an investigation into the “unacceptable, outrageously high” prices of Ozempic and Wegovy, two GPL-1 weight loss and diabetes medications that have soared in popularity since they were approved by the FDA in 2021. Read Full Article…

HVBA Article Summary

1. Discrepancies in Drug Costs: Sanders highlights the stark contrast in drug pricing between the United States and other countries like Canada and Germany, emphasizing the unaffordability of medications for millions of patients. His scrutiny extends to recent Senate Hearings where pharmaceutical CEOs were pressed to explain these international pricing differences, suggesting a need for transparency and accountability in the industry.

2. Manufacturing Costs vs. Market Value: Sanders' argument centers on the vast disparity between the estimated manufacturing cost of certain drugs, such as GPL-1s at $5, and their retail price, often exceeding $1,000 for a four-week supply. However, the article challenges the notion that pharmaceutical pricing should be solely determined by production expenses, asserting that market forces and the value of innovation should also be considered.

3. Navigating Risk and Innovation: The pharmaceutical industry operates within a landscape of considerable risk and uncertainty, with high costs associated with research, development, and commercialization. While addressing concerns about unfair pricing practices is warranted, the article stresses the importance of understanding the intricate cost-risk-benefit equation and the broader dynamics shaping patient access to essential medicines. Simply targeting the pharmaceutical sector without comprehensive insight may risk undermining industry legitimacy and hindering progress towards viable solutions for healthcare affordability.

Excess Weight Over Time Increases Risk for Heart Attack

By Lucy Hicks - Individuals who lived with obesity over a 10-year-period were 23%-60% more likely to experience a cardiovascular event than those who maintained a relatively healthy body mass index (BMI), according to new research presented at the 2024 Annual Endocrine Society annual meeting, held in Boston. Read Full Article…

HVBA Article Summary

1. Long-term Excess Weight Raises Cardiovascular Risk: The study found that maintaining excess weight over time, rather than one-time elevated BMI measurements, significantly increased the risk of cardiovascular events such as heart attack and stroke.

2. Opportunity for Intervention: Dr. Alexander Turchin suggests a positive outlook, emphasizing that individuals with excess weight have an opportunity to decrease their cardiovascular risk by lowering their weight. This underscores the importance of interventions aimed at weight reduction.

3. Age and Duration of Obesity: The research highlights that the impact of excess weight on cardiovascular risk is more pronounced in younger individuals. Specifically, the highest cardiovascular risk was observed in women under 35 years and men aged 35-50 years who had obesity for over a decade, indicating the importance of early intervention strategies.

J&J must pay $260 million in latest talc trial, Oregon jury says

By Brendan Pierson - Johnson & Johnson (JNJ.N), opens new tab must pay $260 million to an Oregon woman who said she got mesothelioma, a deadly cancer linked to asbestos exposure, from inhaling the company's talc powder, a jury found on Monday. Read Full Article…

HVBA Article Summary

1. Legal Verdict and Financial Ramifications: The 4th Judicial District Circuit Court in Portland delivered a significant verdict against Johnson & Johnson (J&J), awarding $260 million in total damages in a case involving talc-related health issues. This verdict, comprising $60 million in compensatory damages and $200 million in punitive damages, highlights the ongoing legal battles the company faces amidst its pursuit of a $6.48 billion settlement through bankruptcy. The verdict's impact extends beyond the financial realm, raising questions about J&J's product safety assertions and its legal strategy in addressing mounting lawsuits.

2. Health Allegations and Scientific Disputes: Kyung Lee's case, diagnosed with mesothelioma, underscores the contentious claims linking J&J's talc products to asbestos exposure and cancer development. Lee's assertion that her decades-long talc usage contributed to her illness contradicts J&J's stance that its talc is asbestos-free and non-carcinogenic, supported by purportedly extensive scientific research. This legal battle not only questions the safety of talc-based products but also challenges the credibility of scientific evaluations provided by the company.

3. Litigation Landscape and Bankruptcy Settlement Challenges: J&J's legal woes extend beyond Lee's case, with over 61,000 plaintiffs, predominantly women with ovarian cancer, pursuing legal action against the company over talc-related health concerns. While J&J has settled most mesothelioma cases, its proposed bankruptcy settlement faces hurdles, requiring approval from 75% of remaining plaintiffs. Past rejections of similar settlement attempts and opposition from some plaintiffs underscore the complexities and uncertainties surrounding the resolution of J&J's talc litigation saga.

AHA pushes back on noncompete ban

By Naomi Diaz - A coalition of 230 national associations, including the AHA, is pushing back against the Federal Trade Commission's ban on noncompete agreements. Read Full Article…

HVBA Article Summary

1. Call for Delayed Implementation: The associations urge the FTC to postpone the implementation of the noncompete rule to allow for judicial review, citing Section 705 of the Administrative Procedure Act, which permits agencies to delay action pending judicial review when 'justice so requires'.

2. Lack of Clear Guidance: The letter highlights the absence of clear FTC guidance on key aspects of the rule, such as defining a policymaking position or applying the functional test, leading to uncertainty for businesses and employees nationwide.

3. Impact on Businesses and Employees: Businesses are facing increased legal costs as they seek alternative methods to protect investments, while employees are experiencing reduced bargaining power and missed training opportunities due to the uncertainty surrounding the enforcement of noncompete agreements.

Lawsuits pile up over state laws on discounts for hospitals' contract pharmacies

By Brendan Pierson - The pharmaceutical industry has filed at least four lawsuits this year challenging state laws requiring drugmakers to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations. Read Full Article…

HVBA Article Summary

1. Legal Battles Unfold: Novartis and PhRMA have taken legal action against laws passed in West Virginia and Mississippi, following similar lawsuits against Maryland's legislation. These lawsuits, filed in federal courts, contest the state laws enacted in March, arguing that they conflict with federal regulations governing the 340B drug-discount program.

2. Conflict Over Contract Pharmacies: A core contention in these legal disputes revolves around the role of contract pharmacies in the 340B program. While providers eligible for the program often engage outside pharmacies for drug distribution, drugmakers have raised concerns about transparency and the potential for improper discounts or duplications. This led to drug companies imposing restrictions on 340B drug sales via contract pharmacies, triggering legislative responses in several states.

3. States' Response and Legal Challenges: Maryland, West Virginia, Mississippi, Kansas, and Louisiana passed laws mandating drugmakers to offer 340B discounts on drugs dispensed by contract hospitals, in response to industry restrictions. Despite previous legal victories for the drug industry against federal guidance on contract pharmacies, states have pursued their own measures to safeguard access to discounted drugs for vulnerable populations, sparking ongoing legal battles. Arkansas's earlier enactment of such a law and a recent legal challenge rejection by the 8th U.S. Circuit Court of Appeals further underscore the complexity and significance of these legal disputes.

Cybercriminals intensify attacks on health care

By Chelsea Cirruzzo and Ben Leonard - MILLIONS HIT IN 2024 — Sixty-nine more health care data breaches have occurred in the first quarter of 2024 than in the same period in 2023, according to HHS data. Read Full Article…

HVBA Article Summary

1. Rising Breach Frequency: The first quarter of 2024 witnessed a surge in health data breaches compared to the same period in 2023, with 226 breaches affecting 17.2 million patients. This represents a notable increase from the 157 breaches in 2023, which affected 17.6 million patients. Notable incidents include cyberattacks at Concentra Health Services, INTEGRIS Health, and Medical Management Resource Group, LLC, impacting millions of individuals.

2. Impact on Healthcare Infrastructure: Cybercriminals targeting healthcare institutions have disrupted services, extorted millions in ransoms, and compromised patient data security. These attacks have forced hospitals, health plans, and providers to divert resources, pay ransoms, and deal with the aftermath of compromised data access, affecting patient care and privacy.

3. Challenges in Cybersecurity Preparedness: The healthcare sector faces challenges in bolstering cybersecurity measures, lagging behind other industries despite warnings of targeted attacks from foreign hackers. While the HHS has issued voluntary cybersecurity guidelines for hospitals, plans are underway to mandate specific practices. However, OCR Director Melanie Fontes Rainer emphasizes the need for proactive investments in preventive care, including basic risk analysis, to mitigate vulnerabilities and protect patient data privacy before breaches occur.

AI cancer screening programs are booming, but you’ll likely have to pay for them yourself

By Bertha Coombs - Artificial intelligence for cancer screening has taken off. Yet most of those new programs aren’t covered by Medicare or private insurers, which creates headwinds for companies looking to boost adoption and for patients who could benefit from the new technology. Read Full Article…

HVBA Article Summary

1. Challenges of Reimbursement: Traditional reimbursement processes for medical devices, including AI-enabled ones, often take up to seven years after FDA approval. This delay poses significant hurdles for companies like Avenda Health in getting coverage for their innovative products, leaving patients to potentially bear the cost burden.

2. Lack of Billing Codes: Despite the FDA's authorization of over 800 AI and machine learning-enabled devices and programs, nearly 600 of them, particularly in radiology, lack billing codes necessary for reimbursement. This absence of codes prevents widespread adoption, especially among smaller hospitals and physician practices, and limits patient access to potentially beneficial AI technologies.

3. Patient Impact and Access Concerns: The absence of insurance coverage for AI screenings can lead to patients paying out of pocket or facing limited access to innovative technologies. While some patients, like UCLA neurology professor Josh Trachtenberg, may afford these expenses and benefit significantly from AI-enabled screenings, others, particularly those without financial means, may be at risk of poorer health outcomes due to limited access to these advancements. Moreover, uncertainty surrounding reimbursement may deter funding for further innovation in AI healthcare solutions, potentially impeding progress in the field.

GLP-1 Coverage Often Denied for Teens With Obesity

By Lucy Hicks - Insurance companies frequently deny insurance coverage of glucagon-like peptide-1 (GLP-1) receptor agonists for adolescents, according to a new analysis. Read Full Article…

HVBA Article Summary

1. Adherence Challenges: Despite GLP-1 prescriptions being covered by insurance, a significant portion of patients failed to adhere to their treatment plans, with many unable to reach their prescribed dose within the specified timeframe.

2. Access Disparities: Medicaid coverage for GLP-1 prescriptions was notably lower for patients with obesity but without a type 2 diabetes (T2D) diagnosis, highlighting disparities in access to treatment based on medical conditions.

3. Side Effects and Discontinuation: Gastrointestinal issues were the most common reason for discontinuing GLP-1 medications, with some severe cases of pancreatitis reported, underscoring the importance of monitoring and weighing potential side effects against the medication's benefits in shared decision-making between patients and physicians.