340B is back on deck in Congress after Chevron, but hurdles loom

By Michael McAuliff - What looked like one of the more promising efforts to update the 340B drug discount program took a step backward at the start of the month, suggesting stakeholders are in for a protracted battle if they hope to see an overhaul. Read Full Article…

HVBA Article Summary

1. Legislative Ambiguity and Rapid Expansion: The 340B drug pricing program, created by Congress in 1992, was never fully detailed in terms of its operational mechanisms. Over the years, it has expanded significantly, now involving over 2,600 hospitals and managing more than $50 billion in discounted pharmaceutical sales annually. This lack of detailed guidance from Congress has resulted in numerous legal challenges, shifting significant control over the program's rules to the courts and the Health Resources and Services Administration.

2. Supreme Court Decision and Legislative Responses: Recent legal developments, including the Supreme Court's decision to overturn the Chevron deference—a doctrine that mandated judicial deference to agency interpretations—have intensified the need for clear legislative action. In response, Congress has seen proposals such as the SUSTAIN Act, aimed at reforming various aspects of the 340B program to increase transparency, accountability, and proper utilization, though progress on these bills has been slow.

3. Challenges in Reaching Consensus: Efforts to reform the 340B program have revealed significant partisan and stakeholder divides, complicating the path to comprehensive legislative reform. Discussions have been mired in debates over key issues like the definition of a "patient," the role of contract pharmacies, and the operational scope of "child sites." Despite bipartisan interest in refining the program, disagreements and the complexity of the issues at hand have delayed the finalization of reforms, with stakeholders expressing urgency as the program narrows due to external pressures from pharmaceutical companies and others.

Health care's perfect storm: Tech, costs, and political battles

By Lucy Peterson - As the 2024 presidential election approaches, thought leaders are considering the potential changes that consumers will see within many sectors – including health care. The latest Axios Pro Report examines what health care-related issues will be most important over the coming year. Read Full Article…

HVBA Article Summary

1. Renewed Investment in Healthcare Technology: Following a period of stagnation, stakeholders are re-engaging with healthcare technology, driven by challenges and innovations born from the pandemic. Technologies like telemedicine have gained traction, and as new treatments and medications emerge, financial investments and legislative decisions are poised to significantly influence the pace and direction of healthcare transformation in the U.S.

2. Legislative Focus on Drug Pricing and Programs: Lawmakers are particularly concerned with the operations of pharmacy benefit managers (PBMs) and their role in driving up drug costs due to market incentives. There's also an ongoing legislative effort to reform the 340B discount-drug program to enhance its transparency and define eligibility more clearly, although this has triggered disputes among various healthcare stakeholders.

3. Addressing Prescription Drug Shortages and Entitlement Program Reforms: The Axios Pro Report highlights that House Democrats are advocating for pharmaceutical companies to resolve shortages of essential medications, including those for cancer, ADHD, and antibiotics. Additionally, there are potential modifications on the horizon for major healthcare entitlement programs like Medicare and Medicaid, which could alter both the cost and availability of these services.

ACA premiums set to rise in 2025

By Adriel Bettelheim - Growing demand for GLP-1 drugs like Ozempic and Wegovy and hospital consolidation could help drive up the cost of Affordable Care Act coverage next year by 9% or more, according to a preliminary review by the Peterson Center on Healthcare and KFF. Read Full Article…

HVBA Article Summary

1. Impact of Premium Increases on Federal Spending: Although the majority of individuals enrolled in the market receive subsidies and are not directly affected by premium hikes, such increases typically lead to greater federal expenditure on these subsidies. This trend emphasizes the broader economic implications of rising healthcare costs, beyond the immediate impact on consumers.

2. Factors Contributing to Rising Premiums: Analysis of rate filings from 61 insurers across 10 states and D.C. highlights several key drivers of premium increases for 2025. Hospital consolidations and workforce shortages are inflating costs, as are surging demands for diabetes treatments and weight loss drugs like GLP-1s. Despite limited coverage under ACA plans for drugs approved solely for weight loss, their influence on premium costs is significant, compounded further by the growing use of expensive specialty drugs and biologics.

3. Regulatory and Economic Influences: Insurers report that factors like state Medicaid redeterminations, COVID-19 related costs, and the federal surprise billing ban are not significantly affecting premiums for 2025. This contrasts with the notable rise in medical inflation which now surpasses the growth of non-medical prices, prompting insurers to adjust premiums upward to reflect increased costs and overhead, marking a significant shift from the trends observed from 2021 to 2023.

Virtual diabetes programs aim to prove themselves to insurers

By Gabriel Perna - Diabetes care has emerged as an expense to be reckoned with as health insurers and employers plan 2025 benefit programs. The cost of treating diabetes, including medications, appointments and ongoing care, has risen 35% in the past decade, to $412 billion annually, according to a November analysis from the nonprofit American Diabetes Association. Read Full Article…

HVBA Article Summary

1. Growing Concerns Over Diabetes Management and Costs: As the number of people with diabetes in the U.S. has increased from 30 million in 2017 to approximately 38 million, there has been a corresponding rise in per capita spending on diabetes-related healthcare, including inpatient hospital stays and prescription medications. This surge in cases and costs has prompted employers and insurers to explore more effective management strategies to control expenses and enhance patient outcomes. Despite high hopes for virtual diabetes care programs leveraging technology like smartphone apps and continuous glucose monitors, these solutions have often failed to significantly lower costs or improve key health metrics such as Hemoglobin A1c levels.

2. Challenges with Virtual Diabetes Care Programs: Initial findings from a Peterson Health Technology Institute report indicate that popular virtual diabetes care programs did not substantially reduce Hemoglobin A1c levels and, in some instances, increased spending by health plans and employers. This has led stakeholders to reassess the value of purely digital solutions. Key criticisms include low patient engagement and insufficient returns on investment, prompting a shift in strategy towards more integrated or hybrid care models that combine both virtual and in-person elements to provide more comprehensive care.

3. The Shift Towards Hybrid Care Models: In response to the limitations of purely virtual programs, entities like CareFirst are pioneering hybrid models that blend in-person consultations with digital monitoring to enhance patient management and retention. These programs, which require initial in-person visits for setting up continuous glucose monitors, aim to provide more thorough care and better integrate with patients' existing healthcare teams. This approach addresses the challenges of scaling virtual care and seeks to improve crucial health outcomes such as blood pressure control, annual eye exams, and overall diabetes management.

Uninsured Americans Now More Than 27 Million: CDC Report

By Aldgra Fredly - The percentage of uninsured Americans rose to 8.2 percent in the first quarter of this year, according to survey findings published by the Centers for Disease Control and Prevention (CDC) on Aug. 6. Read Full Article…

HVBA Article Summary

1. Increase in Uninsured Americans: As of March this year, 27.1 million Americans lacked health insurance, marking an increase from the previous year's 25.5 million. This trend is particularly pronounced among those earning below the federal poverty level, where the uninsured rate rose from 13.9 percent to 15.7 percent.

2. Impact of Immigration and Policy Changes: The Congressional Budget Office (CBO) forecasts a rise in the uninsured rate to 8.9 percent over the next decade, influenced by ongoing high immigration levels and the cessation of temporary healthcare policies established during the COVID-19 pandemic, such as extended Medicaid eligibility and enhanced marketplace subsidies.

3. Shift in Health Insurance Policies Under Different Administrations: President Biden has recently reversed a policy from the Trump era that allowed for the extension of short-term, limited-coverage health insurance plans up to 36 months. The Biden administration has restored the limit to three months to align with the original framework set during Obama's presidency, addressing concerns over the adequacy of coverage provided by these so-called "junk" health insurance policies.

Novo Nordisk goes after more compounders, expanding GLP-1 lawsuit campaign

By Nicole DeFeudis - Novo Nordisk is turning up the heat on compounding pharmacies making versions of its blockbuster. Late last week, the company filed 11 new lawsuits against med spas, weight loss clinics and telehealth companies advertising compounded versions of its semaglutide products for diabetes and weight loss. Read Full Article…

HVBA Article Summary

1. Legal Actions Across States: Novo Nordisk has escalated its legal efforts by filing lawsuits in multiple U.S. states including Oklahoma, California, Michigan, New Jersey, Pennsylvania, Washington, and Florida. These legal actions target compounders allegedly involved in misleading marketing practices, suggesting that their products are FDA-approved or proven safe and effective, which is not the case for compounded drugs.

2. Ongoing Litigation and Enforcement: To date, Novo Nordisk has initiated a total of 34 lawsuits against various compounders, achieving permanent injunctions in six cases. The company's commitment to patient safety drives its continued pursuit of legal actions against entities that engage in similar deceptive practices, signaling an ongoing strategy to protect their product integrity and consumer trust.

3. Industry Trends and Competitor Actions: The lawsuits highlight a growing trend where businesses, including prominent health tech companies like Ro and Hims, capitalize on the demand for weight loss drugs by offering compounded versions. This practice has gained traction even amidst drug shortages, with some companies, such as Hims, acquiring their own compounding pharmacies to sustain production. Meanwhile, availability issues continue to affect Novo Nordisk’s Wegovy, while Eli Lilly’s Zepbound is fully available but still listed as in shortage by the FDA.

No-Prescription Online Semaglutide Poses Multiple Risks

By Miriam E. Tucker - Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found. Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Read Full Article…

HVBA Article Summary

1. Quality and Safety Concerns: The study highlighted significant risks associated with purchasing semaglutide online without a prescription. Of the three vial products received by the researchers, one was potentially contaminated with endotoxins, and all contained 29%-39% more semaglutide than labeled, significantly increasing the risk of overdose. These findings underscore the dangers of buying and using unregistered and unlicensed pharmaceuticals from online vendors.

2. Market of Counterfeit Pharmaceuticals: The persistent issue of counterfeit pharmaceuticals is exacerbated by online platforms that facilitate the sale of these products without adequate regulatory oversight. The study's findings, including the fraudulent activities around customs clearance and the use of unlicensed vendors, illustrate the evolving and enduring challenges in combating the online sale of counterfeit medications like semaglutide.

3. Regulatory and Health Advisories: In response to these risks, health experts and regulatory bodies, including the FDA, are intensifying warnings and enforcement actions against unauthorized sellers. Health professionals are advised to educate their patients about the dangers of procuring medications online and to encourage purchasing from legitimate, licensed sources only, ensuring safety and adherence to prescribed dosages.

How to Increase Nitric Oxide Production to Encourage Healthy Aging

By Avery St. Onge - Nitric oxide has several anti-aging benefits on cardiovascular, immune, and neurological health. However, according to Christopher Bump, DC, MS, IFMCP, CNS, DABCN, nitric oxide production decreases over time. Read Full Article…

HVBA Article Summary

1. Importance of Nitric Oxide: Dr. Bump emphasized the crucial role of nitric oxide in maintaining vascular health and immune response. He highlighted its significance in regulating blood pressure through the elasticity of blood vessels, its function as a signaling molecule for immune cells, and its involvement in cognitive processes like memory and learning as a neurotransmitter and neuromodulator.

2. Decline with Age and Lifestyle Factors: The natural decline of nitric oxide production as people age, due to decreased efficiency of enzymes like nitric oxide synthase (NOS), was a key point. Dr. Bump also noted that conditions such as hypertension, diabetes, and atherosclerosis, along with certain lifestyle choices, can impair the synthesis of nitric oxide, further complicating health issues in older adults.

3. Strategies to Boost Nitric Oxide Levels: Dr. Bump proposed several natural methods to enhance nitric oxide levels:

   • Dietary Changes: Increasing intake of vegetables like spinach, arugula, and beets to boost dietary nitrates.

   • Reducing Mouthwash Use: Avoiding mouthwash to preserve oral bacteria essential for converting nitrates to nitrites, and ultimately nitric oxide.

   • Increasing Physical Activity: Regular exercise to stimulate endothelial cells to produce more nitric oxide.

   • Minimizing Acid Blockers: Limiting acid blocker medications which can interfere with nitric oxide production.

   • Supplementation: Using supplements such as L-arginine and L-citrulline to provide substrates necessary for nitric oxide production.

Texas Heart Institute implants first BiVacor Total Artificial Heart

By Cassie McGrath - On July 9, the Texas Heart Institute of Houston performed the first-ever successful implant of a BiVacor Total Artificial Heart (TAH) on a 57-year-old man—making for a heartfelt moment. Read Full Article…

HVBA Article Summary

1. Critical Illness and Innovative Solutions: The patient, in cardiogenic shock and unable to get a donor heart due to the high demand for transplants, was given a cutting-edge alternative: the BiVacor Total Artificial Heart (TAH). This device, made from titanium and using magnetic technology, replaces both ventricles and can pump blood effectively, mimicking the function of a human heart.

2. Promising Early Results and Future Prospects: During an FDA early feasibility study, the TAH demonstrated its potential by allowing the patient to perform physical activities shortly after surgery, showing a capability similar to that of a natural heart. The success of this initial surgery paves the way for further tests, with plans to conduct four more surgeries to refine and evaluate the TAH’s performance and safety before the next year.

3. Long-term Goals and Biocompatibility: The ultimate aim for the TAH is to offer a durable, long-term heart replacement that does not require anti-rejection medication, unlike traditional transplants which often fail after a decade due to rejection. The choice of titanium for the TAH enhances its biocompatibility, with the body recognizing it similarly to natural tissue, thus potentially extending the quality and duration of life for recipients beyond current transplant options.