Ascension Health, largest Catholic hospital chain in the U.S., hit by cyberattack, disrupting patient care

By Rob Wile - Ascension Health, the nation's largest chain of Catholic hospitals, said Thursday it was responding to a cyberattack that was disrupting its operations. In a press release on its website, Ascension said the attack had caused "disruption to clinical operations" as access to some systems had been interrupted. Read Full Article…

HVBA Article Summary

1. Preparedness in Action: Ascension's care teams have undergone specialized training to navigate disruptions like cyberattacks. They've implemented robust procedures to ensure that patient care remains safe and operational despite challenges, emphasizing the organization's proactive approach to crisis management.

2. Engagement of Expert Support: Ascension has taken decisive steps to address the cyber incident by enlisting the expertise of Mandiant, a reputable cybersecurity consulting firm. This strategic partnership underscores the company's commitment to swiftly investigating and mitigating the breach, prioritizing the security and privacy of patient data.

3. Collaboration with Authorities: In response to the cyberattack, Ascension has not only initiated internal investigations but has also involved law enforcement authorities. By promptly notifying relevant agencies, including the FBI, Ascension demonstrates transparency and a willingness to cooperate in resolving the matter, reflecting a broader commitment to safeguarding healthcare infrastructure and combating cyber threats in collaboration with governmental agencies.

Pfizer agrees to settle over 10,000 Zantac lawsuits, Bloomberg News reports

By Reuters - Pfizer (PFE.N), has agreed to settle more than 10,000 lawsuits about cancer risks related to the now discontinued heartburn drug Zantac, Bloomberg News reported on Wednesday, citing people familiar with the deal. Read Full Article…

HVBA Article Summary

1. Partial Resolution: The recent agreements made by Pfizer regarding Zantac claims specifically address cases within U.S. state courts, signaling a step towards resolving legal disputes. However, it's noted that these agreements do not comprehensively resolve the entirety of the company's exposure to Zantac-related litigation.

2. Financial Disclosure Gap: While the agreements signify progress in managing legal liabilities, the specific financial terms of these deals remain undisclosed. This lack of financial transparency adds uncertainty regarding the exact impact on Pfizer's financial standing and future obligations.

3. Ongoing Legal Landscape: Despite these recent developments, Pfizer's legal journey concerning Zantac is far from over. The company's exposure to lawsuits stemming from the presence of NDMA in Zantac, as highlighted by the FDA's actions in 2020, indicates a prolonged legal battle ahead. This legal saga extends beyond Pfizer, involving other pharmaceutical giants like GSK, Sanofi, and Boehringer Ingelheim, underlining the complexity and scope of the issue.

N.C. State Treasurer report says that some hospitals overcharged state employees for drugs

By Ashley Balsavias - North Carolina State Treasurer Dale Folwell, CPA, released a report Wednesday saying that several hospitals billed state employees for over 5 times the acquisition cost for cancer drugs. Read Full Article…

HVBA Article Summary

1. Misuse of the 340B Program: Hospitals participating in the 340B Drug Pricing Program, initially designed to aid low-income and rural communities, are exploiting it for profit. Instead of passing on discounts to patients or investing in vulnerable areas, some hospitals are making substantial profits, with claims revealing average earnings of up to $13,617 per claim on cancer drugs funded by the NC State Health Plan for Teachers and Employees.

2. Expansion into Wealthier Neighborhoods: Despite its intended purpose, data indicates that hospitals are extending their 340B program involvement into affluent neighborhoods where insured patients can afford higher drug prices. This expansion not only deviates from the program's original mandate but also exacerbates healthcare cost disparities.

3. Urgent Need for Transparency and Accountability: High healthcare costs in North Carolina, ranked as the most expensive state in the country for healthcare, underscore the necessity for greater transparency and accountability. Researchers emphasize the burden on patients, citing alarming statistics such as one in five families in North Carolina being in collections for medical debt. The report reveals egregious disparities, particularly in cancer drug pricing, with NC 340B hospitals billing over five times the discounted acquisition costs and marking up prices by an average of 84.8 percent compared to non-participating hospitals.
   
   You can read the full report below:

   Overcharged - State Employees Cancer Drugs and the 340B Drug Pricing Program by Jamie Boulet on Scribd

Private equity investing in healthcare continues to slow

By Rebecca Pifer - News of the ongoing slowdown is likely welcomed by patient advocates and regulators opposed to PE firms ramping up their presence in the healthcare sector, due to concerns the companies raise costs and worsen the quality of care in the pursuit of profits. Read Full Article…

HVBA Article Summary

1. Declining Private Equity Activity: Private equity investment in healthcare services continues to decline, with just below 160 deals announced or closed in the first quarter of the year. This trend, even slower than 2023, reflects a significant drop of almost a third from the previous quarter, indicating a chilling effect exacerbated by heightened antitrust scrutiny.

2. Challenges Hindering Investment: Despite increased interest from sponsors and improved financing availability, several factors hinder high private equity investment in healthcare. These include discrepancies between buyer and seller pricing expectations, anticipation of prolonged higher interest rates by the Federal Reserve, and stricter regulatory oversight, particularly regarding anticompetitive practices.

3. Regulatory Uncertainty and Impact: The regulatory landscape, characterized by stricter guidelines, antitrust inquiries, and state-level restrictions, creates considerable uncertainty around deal reviews and processes, chilling overall investment sentiment. Recent research highlighting negative outcomes associated with private equity ownership in healthcare further amplifies regulatory scrutiny and investor caution, leading to challenges in exiting investments and potential waves of bankruptcies among physician practices owned by private equity firms. Despite this, certain segments like dentistry and outpatient services still offer opportunities for investment, driven by demographic shifts and evolving healthcare needs.

Utah fines UnitedHealthcare for selling unapproved health plans

By Jakob Emerson - Utah has fined UnitedHealthcare $546,500 for selling unapproved health plans to state residents. Read Full Article…

HVBA Article Summary

1. Lack of Compliance: In March 2022, it was revealed that UnitedHealthcare had sold unapproved policies to a Utah resident, failing to file appropriate forms as required by the state's insurance department. This discovery pointed to a significant oversight in regulatory compliance.

2. Extent of Noncompliance: Following an investigation prompted by the initial discovery, it was found that a large group policy, covering nearly 2,200 Utah residents since 2014, lacked proper filing of forms. Not only were forms not filed in Utah, but they were also originally filed in Illinois, indicating a broader scope of noncompliance across state lines.

3. Resolution and Commitment to Quality Care: UnitedHealthcare took corrective action by submitting new forms to Utah in May 2022, although initially facing rejection due to inaccuracies. Finally approved in July 2023, the incident underscores the importance of regulatory diligence in the healthcare sector. The company reiterated its commitment to ensuring access to quality care for its members and pledged ongoing collaboration with Utah authorities to deliver high-quality, affordable healthcare services.

Report: More Employers Are Looking To Deploy Value-Based Care

By Marissa Plescia - About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care. Read Full Article…

HVBA Article Summary

1. Top Priorities of Accountable Care: According to a report by the Milken Institute, with support from Morgan Health, key priorities for accountable care include expanding preventive care, improving access to primary care, and emphasizing whole-person health. These priorities were identified through a survey of 72 employers across various industries and sizes.

2. Challenges in Advancing Accountable Care: Despite the emphasis on accountable care, employers face significant barriers. Challenges include difficulties in setting up value-based arrangements, limitations in health system infrastructure, and issues related to capacity, bandwidth, geography, and cost.

3. Future Directions in Benefit Offerings: Employers are focusing on enhancing certain benefits in the coming years. Mental health resources, virtual primary care, and caregiver support are among the areas slated for improvement, reflecting employers' efforts to address evolving healthcare needs and priorities.

Cavazzoni: FDA wants to prevent manufacturing stoppages during inspections

By Joanne S. Eglovitch - The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER). Read Full Article…

HVBA Article Summary

1. Urgent Communication and Collaboration: Cavazzoni emphasizes the importance of continuous communication between FDA investigators, drug shortage teams, and compliance teams. Manufacturers are urged to engage with the FDA's drug shortage team immediately during inspections to mitigate potential disruptions in essential drug manufacturing. This proactive approach aims to address shortages more effectively and prevent manufacturing stoppages witnessed in recent times.

2. AI Integration Challenges: FDA's Deputy Center Director discusses the increasing use of AI elements in Investigational New Drug Applications (INDs) and the necessity for a significant overhaul of regulatory frameworks. Incorporating AI tools would demand substantial investments in high-performance computational technology for data processing and analysis. Moreover, the agency anticipates challenges in developing new policies for retaining and storing algorithmic data due to potential cost barriers.

3. Enhancing Postmarket Surveillance: Cavazzoni highlights FDA's efforts to enhance postmarket surveillance methods, particularly through the reevaluation of the Sentinel system. The agency considers integrating more electronic health record (EHR) data into Sentinel and adopting a modular approach for data collection. Despite these advancements, securing targeted funding remains a challenge, hindering the optimization of postmarket safety surveillance. Additionally, there's a push for CDER to develop a robust electronic gateway to facilitate cloud-based submissions, aiming for a more efficient regulatory process.

GLP-1s: 8 things hospital leaders should know

By Paige Twenter - A blockbuster drug class that includes Ozempic, Wegovy and Trulicity is pioneering avenues in the healthcare industry and redefining obesity care as the weight loss therapy market stretches toward $100 billion. Read Full Article…

HVBA Article Summary

1. Understanding GLP-1: GLP-1 stands for glucagon-like peptide-1 receptor agonist, a gut hormone that regulates insulin secretion, suppresses appetite, and induces a feeling of fullness. These medications mimic these physiological effects, aiding in weight management and glycemic control.

2. Available Medications: Several GLP-1 drugs have gained FDA approval for Type 2 diabetes and weight management. Notable medications include Ozempic, Wegovy, Trulicity, and Rybelsus. The popularity of these drugs surged in recent years, driven by social media trends and celebrity endorsements.

3. Impact on Hospital Care: The uptake of GLP-1 medications is reshaping hospital strategies, leading to changes in weight loss programs, transplant eligibility criteria, and elective surgery volumes. Concerns about perioperative safety and supply shortages highlight the need for hospitals to adapt their care protocols and resource allocation strategies accordingly.

Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

By Arthur Allen - When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized. Read Full Article…

HVBA Article Summary

1. Patient Struggles with High Dosage: Crosslin's experience with the cancer drug Lumakras highlights the dilemma faced by many patients. While the drug helps keep him alive, its high dosage comes with significant side effects that severely limit his quality of life. Despite his concerns, Crosslin feels compelled to follow his oncologist's guidance, illustrating the difficult choices patients often face between treatment efficacy and tolerability.

2. FDA Initiative for Optimized Cancer Drug Dosages: The FDA's Project Optimus addresses the issue of high-dose cancer drugs by emphasizing dose optimization in drug development. The initiative aims to prevent patients from experiencing unnecessary toxicity by requiring companies to conduct more thorough dosing studies before drugs reach the market. This shift represents a crucial step towards making cancer treatments both safer and more effective for patients.

3. Challenges in Implementing Lower Dosages: Despite evidence suggesting that lower dosages may be equally effective with fewer side effects, pharmaceutical companies often resist adopting them due to financial incentives. For example, Amgen's Lumakras, although shown to be more tolerable at a lower dosage, continues to be marketed at a higher, more profitable dose. This highlights the tension between medical necessity and commercial interests in drug pricing and dosing decisions.

Workplace Injury a Preventable Risk for Opioid-Related Harms

By Marilynn Larkin - Work-related injuries are a preventable risk factor for opioid-related harms, new research from Ontario, Canada, suggested. Read Full Article…

HVBA Article Summary

1. Elevated Risks Across Industries: An analysis of nearly 1.7 million formerly injured workers in Ontario's Occupational Disease Surveillance System (ODSS) revealed heightened risks of opioid-related poisonings and behavioral disorders across various industries. Surprisingly, these risks extended beyond physically demanding jobs, encompassing sectors like construction, materials handling, and processing of minerals, metals, and chemicals, among others.

2. Disproportionate Impact on Female Workers: Subgroup analyses unveiled that female workers in the ODSS faced higher risks of opioid-related poisonings and mental and behavioral disorders compared to their counterparts in the general population. This trend persisted across occupations and industries, emphasizing the need for gender-sensitive interventions to address workplace-related opioid harms.

3. Implications for Public Health and Workplace Safety: The findings underscore the significance of workplace injuries as preventable risk factors for opioid-related harms. Strategies targeting primary prevention of injuries and secondary prevention of long-term opioid use are imperative. Additionally, the study highlights the broader societal impact of this public health crisis, necessitating collaborative efforts involving employers, healthcare systems, policymakers, and communities to ensure post-injury support, safe return-to-work practices, and adherence to clinical guidelines for opioid prescriptions.