Justice Department 'upping its game' on healthcare antitrust enforcement with new task force

By Heather Landi - The U.S. Department of Justice (DOJ) announced Thursday it has established a new task force to take on healthcare monopolies and collusion. Read Full Article…

HVBA Article Summary

1. Formation and Goals of the HCMC: The newly established Healthcare Market Competition Taskforce (HCMC) aims to direct enforcement strategies and policies in the healthcare sector, addressing widespread competition concerns. These concerns include payer-provider consolidation, serial acquisitions, and issues related to labor, quality of care, medical billing, healthcare IT services, and the use and misuse of healthcare data.

2. Leadership and Composition: The task force, led by experienced antitrust prosecutor Katrina Rouse, combines a diverse team of civil and criminal prosecutors, economists, healthcare industry experts, technologists, data scientists, investigators, and policy advisers. This multi-disciplinary team will tackle antitrust problems in healthcare markets, ensuring a comprehensive divisional and governmental approach to antitrust enforcement.

3. Strategic Focus and Public Concerns: The HCMC's mission is to identify and eliminate monopolistic and collusive practices that could lead to increased costs and decreased quality of healthcare. Assistant Attorney General Jonathan Kanter emphasized the urgency of addressing these antitrust issues, highlighting their impact not only on economic factors but also on the quality of healthcare services critical to American lives.

Ascension expects IT outages 'for some time'

By Molly Gamble - A cybersecurity incident has left 140-hospital Ascension with its EHR disabled, some appointments and surgeries postponed, and the expectation that the 19-state health system will operate on downtime procedures "for some time." Read Full Article…

HVBA Article Summary

1. Cybersecurity Breach Detection and Response: On May 8, Ascension, based in St. Louis, reported detecting unusual activity on its network, signaling a cybersecurity incident. Subsequently, on May 9, the organization confirmed the incident and initiated a comprehensive response plan.

2. Impact on Operations and Patient Care: As a result of the cybersecurity incident, Ascension's electronic health records (EHR) system, MyChart, and certain phone systems are inaccessible. Consequently, the health system has implemented downtime procedures, leading to the postponement of non-emergency elective procedures, tests, and appointments. Patients are advised to provide detailed symptom notes and medication lists for continued care.

3. Response and Engagement of External Support: Ascension has mobilized internal and external resources to address the breach. The organization is collaborating with cybersecurity firm Mandiant, known for its involvement in major cyber incidents such as the SolarWinds attack and the Colonial Pipeline ransomware attack. Despite the ongoing investigation and restoration efforts, Ascension anticipates a prolonged reliance on downtime procedures, affecting hospital operations and patient services.

FTC Puts Pharmacy Benefit Managers, Private Equity in the Crosshairs

By Jeremy Faust, MD, MS, MA and Emily Hutto - In Part 2 of this exclusive video interview, MedPage Today editor-in-chief Jeremy Faust, MD, and Lina Khan, JD, chair of the Federal Trade Commission (FTC), discuss the agency's role in healthcare, including its actions on pharmacy benefit managers (PBMs) and private equity in medicine. Read Full Article…

HVBA Article Summary

1. Incentives in Pharmaceutical Innovation: The current patent system incentivizes pharmaceutical companies to focus on profitable drugs rather than those addressing less prevalent conditions. This dynamic potentially discourages research and development for drugs targeting diseases like cystic fibrosis or sickle cell anemia, which may not yield high profits.

2. Antitrust Measures to Promote Innovation: The Federal Trade Commission (FTC) intervenes to ensure fair competition in the pharmaceutical market. For instance, the FTC sued Sanofi to prevent exclusive access to drugs for Pompe disease, enabling innovative companies like Maze to bring more affordable and convenient treatments to patients.

3. Scrutiny of Middlemen in Healthcare: Pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) wield significant influence over drug access and pricing. The FTC is investigating opaque practices, such as rebate systems favoring branded drugs over generics, and the impact of PBMs on independent pharmacies, aiming to safeguard fair competition and patient access to essential medications.

House Bill Would Extend Telehealth, Hospital-at-Home Payments

By David Raths - The U.S. House Ways and Means Committee unanimously passed a bill that would extend Medicare patients' access to telehealth services for an additional two years. The bill also includes a five-year extension of the Acute Hospital Care at Home (AHCAH) waiver, which is set to expire at the end of this year. Read Full Article…

HVBA Article Summary

1. Continuation of Telehealth Access: The introduction of the Preserving Telehealth, Hospital, and Ambulance Access Act ensures the continued availability of telehealth services for Medicare beneficiaries. Initially expanded during the COVID-19 pandemic and extended through 2024, this bipartisan legislation aims to prevent any lapse in coverage, allowing patients to receive care virtually without disruption.

2. Bipartisan Support and Advocacy: Representatives David Schweikert and Mike Thompson, from different political parties, jointly support the bill, highlighting its significance in expanding patient access to healthcare providers. Advocacy organizations, including the American Telemedicine Association and Moving Health Home, have praised the bill for its potential to safeguard millions of Medicare beneficiaries' access to critical care and extend telehealth flexibilities.

3. Rural Healthcare and Acute Hospital Care at Home Extension: The legislation not only addresses telehealth access but also extends crucial waivers and payment designations, benefiting rural providers and patients. The inclusion of a five-year extension for the Acute Hospital Care at Home (AHCAH) waiver particularly stands out, enabling Medicare beneficiaries to access innovative care programs with proven clinical outcomes, higher patient satisfaction, and reduced healthcare costs.

HSA Limits to Rise for 2025

By Paul Mulholland - The Internal Revenue Service issued inflation adjustments for 2025 for health savings accounts in connection with high-deductible health plans in Revenue Procedure 2024-25. Read Full Article…

HVBA Article Summary

1. Triple Tax Privilege: HSAs offer a unique tax advantage by allowing pre-tax contributions, tax-free growth of funds, and tax-free distributions for qualified medical expenses. This triple-tax privilege makes HSAs a powerful tool for managing healthcare costs efficiently.

2. High-Deductible Health Plans (HDHPs): To utilize an HSA, individuals must be enrolled in a high-deductible health plan (HDHP). For 2025, an HDHP is defined as a plan with an annual deductible of at least $1,650 for self-only coverage or $3,300 for family coverage, with corresponding increases from previous years. Additionally, HDHPs must maintain maximum out-of-pocket limits, which have also been raised for 2025.

3. Increased Contribution Limits: The maximum HSA contributions have been raised for 2025, providing individuals with greater opportunities for tax-advantaged savings. For self-only coverage, the annual contribution limit is now $4,300, up from $4,150 in 2024, while for family coverage, it is $8,550, increased from $8,300. Individuals aged 55 and older can make an additional catch-up contribution of $1,000, enhancing their ability to save for future medical expenses.

CHS sues MultiPlan

By Andrew Cass - Franklin, Tenn.-based Community Health Systems is the latest health system to sue MultiPlan over allegations the data analytics firm conspired with major payers to underpay providers by tens of billions annually. Read Full Article…

HVBA Article Summary

1. Pattern of Allegations: MultiPlan faces its third lawsuit within a year from various health systems, with allegations of price-fixing. AdventHealth and Allegiance Health Management previously filed similar lawsuits, indicating a trend of discontent within the healthcare industry regarding MultiPlan's practices.

2. Collusive Practices: The lawsuit accuses MultiPlan of orchestrating agreements with major payers to collectively suppress out-of-network reimbursements to healthcare providers. It alleges that MultiPlan's repricing tools make negotiation or dispute resolution practically impossible for providers, leading to underpayments and benefiting insurance companies, investors, and executives instead of patients.

3. Cartel Allegations and Response: CHS's lawsuit portrays MultiPlan as the orchestrator of a cartel agreement with competing health insurance companies, resulting in significant financial losses for healthcare providers annually. MultiPlan refutes these claims, asserting its role in reducing healthcare costs across the ecosystem. However, the lawsuit reflects broader concerns about MultiPlan's practices, including calls for investigation by Senator Amy Klobuchar and recent reports of insurers profiting from MultiPlan's fee structures.

Ascension Hospitals Across Several States Are Offline Following Cyberattack

By Katie Adams - Cybercriminals don’t seem like they will stop using healthcare institutions as target practice anytime soon, as another major organization fell victim to a cyberattack this week. Read Full Article…

HVBA Article Summary

1. Immediate Impact on Patient Care: Ascension's detection of hacker activity has led to disruptions in clinical operations across its extensive network of hospitals. The health system is actively working to mitigate these disruptions, highlighting the critical role of cybersecurity readiness in maintaining patient safety and care delivery.

2. Collaborative Response and Investigation: Ascension has engaged with cybersecurity firm Mandiant to investigate the incident, demonstrating a proactive approach to addressing the cyberattack. The involvement of a reputable cybersecurity firm underscores the seriousness of the situation and the need for a comprehensive response strategy.

3. Broader Implications for Healthcare Security: The cyberattack on Ascension is emblematic of a larger trend in the healthcare sector, with numerous organizations facing similar threats. Experts emphasize the importance of adopting advanced security measures, such as AI-powered tools, to detect and mitigate evolving cyber threats, while also advocating for greater collaboration between regulatory agencies and healthcare leaders to strengthen overall cybersecurity resilience.

What will the DOL rule mean for advisors?

By Susan Rupe - The Department of Labor has several objectives in issuing its latest iteration of the fiduciary rule and one of them is expanding the scope of fiduciary activities, a Washington attorney said. Read Full Article…

HVBA Article Summary

1. Expansion of Fiduciary Responsibility: The fiduciary rule, as outlined by the National Association of Insurance and Financial Advisors, signifies a significant expansion of fiduciary responsibility within the financial advisory sector. Under the rule, almost all advisors will be classified as fiduciaries, necessitating compliance with new standards and review processes, thereby impacting sales, marketing, and customer service procedures.

2. Compliance and Disclosure Requirements: Advisors must adhere to extensive new disclosure and compliance requirements, exposing them to heightened litigation liability. The rule mandates disclosure of fiduciary status to customers, opening the door to potential common-law fiduciary duty claims. Additionally, advisors must satisfy prohibited transaction exemptions and adapt their practices to comply with the evolving regulatory landscape.

3. Transition Period and Implications for Advisors: While the rule's effective date is set for September 23, there exists a one-year transition period for certain aspects of the rule. Advisors deemed fiduciaries must meet conditions of prohibited transaction exemptions to receive commissions or compensations. Notably, changes to PTE 84-24 under the rule signify a significant shift in regulatory oversight, with insurers assuming a more prominent role in monitoring and ensuring compliance among independent producers.

Slow Responders to Zepbound Achieve Meaningful Weight Loss Eventually

By Ed Susman - The vast majority of patients with obesity who responded slowly to the once-weekly injectable tirzepatide (Zepbound) achieved meaningful reductions in body weight a year later, a post hoc analysis of the SURMOUNT-1 trial showed. Read Full Article…

HVBA Article Summary

1. Extended Treatment Duration Yields Significant Weight Loss: Participants who failed to achieve a 5% reduction in body weight after 12 weeks of tirzepatide treatment saw substantial weight loss over a longer period. More than 90% of these slow responders achieved the clinically meaningful 5% weight loss at 72 weeks, with 30% achieving a 15% reduction in body weight.

2. Patience and Persistence with Tirzepatide Treatment: The study suggests that patients may benefit from prolonged treatment beyond the initial 12-week period, as tirzepatide takes around 20 weeks to reach its highest effective dose. Switching medications prematurely, as suggested by current guidelines, may overlook the potential for significant weight loss with continued tirzepatide use.

3. Tailored Treatment Approach: While guidelines typically recommend changing medications if a 5% weight loss isn't achieved at 12 weeks, findings from the SURMOUNT-1 trial indicate that a personalized approach may be more appropriate. Assessing individual progress over a longer timeframe and adjusting treatment accordingly could optimize outcomes for patients undergoing tirzepatide therapy.

For every million-dollar gene therapy, Peter Marks gets an email from FDA chief Robert Califf

By Annalee Armstrong - After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. Read Full Article…

HVBA Article Summary

1. Exorbitant Costs of Gene Therapy: Each new gene therapy approval comes with staggering price tags, with recent examples like Orchard's Lenmeldy costing $4.25 million. Despite not factoring prices into approval decisions, the FDA recognizes the implications of such costs on healthcare sustainability.

2. Challenges in Accessibility and Affordability: The astronomical prices of gene therapies raise concerns about global accessibility and affordability. Director Marks emphasizes the necessity of reducing costs to expand access and potentially replace conventional therapies. However, achieving this goal requires significant changes and improvements in manufacturing technologies.

3. Importance of Long-Term Follow-Up and Real-World Data: Post-approval, long-term patient follow-up becomes crucial for understanding continued benefits and adverse effects, especially for rare diseases. The FDA is contemplating incentives for collecting real-world data to demonstrate value for payers. Despite their high costs, gene therapies for rare diseases are unlikely to match the expenditure on treatments for more common conditions like the GLP-1 weight loss/obesity craze.