Why the Supreme Court's overrule of Chevron has major implications for the FDA

By Lia DeGroot - The Supreme Court on Friday overruled a longstanding legal doctrine that gives federal agencies latitude to interpret federal law, which legal scholars and industry have warned could destabilize the FDA. Read Full Article…

HVBA Article Summary

1. Supreme Court Overturns Chevron Doctrine: In a 6-3 decision, the Supreme Court overturned the Chevron doctrine, a 40-year-old legal principle that allowed regulatory agencies to interpret ambiguous federal statutes without consulting Congress or the courts. Chief Justice John Roberts, writing for the majority, argued that the doctrine gave agencies excessive interpretive power and emphasized that statutory ambiguities should be resolved by the courts.

2. Dissenting Opinion Highlights Need for Expertise: Justice Elena Kagan, writing for the minority, opposed the majority's view, stressing that courts lack the specialized knowledge necessary for complex regulatory decisions. She cited the FDA's authority to regulate biological products as an example, arguing that agencies have the expertise required to make informed decisions on technical matters.

3. Implications and Concerns: Experts expressed concerns about the decision's impact on regulatory processes. Reshma Ramachandran warned of potential delays and inconsistencies in the FDA's regulatory authority, while Rachel Sachs noted that the ruling lacks clarity on what will replace Chevron. Holly Fernandez Lynch highlighted the challenges of interpreting vague statutes, especially as technologies like AI evolve. The FDA and DOJ have yet to comment on the ruling.

4 healthcare takeaways from the presidential debate

By Kelly Gooch and Erica Carbajal - President Joe Biden and former President Donald Trump spent a small portion of their 90-minute presidential debate June 27 highlighting issues affecting healthcare leaders, from prescription drug costs to the opioid crisis. Read Full Article…

HVBA Article Summary

1. Prescription Drug Costs: The debate briefly touched on the high cost of prescription drugs, a significant issue for nearly 40% of Americans. Both candidates discussed their roles in capping insulin costs, with Biden highlighting his administration's $35 monthly cap under the Inflation Reduction Act, and Trump noting a voluntary program from his presidency that also aimed to cap costs. The debate did not delve deeply into future plans for broader drug price negotiations or how to address affordability comprehensively.

2. Abortion Rights: Abortion was discussed for around 10 minutes, with Biden pledging to restore federal protections for abortion rights, while Trump emphasized state-level decision-making. The Biden administration's use of the Emergency Medical Treatment and Labor Act (EMTALA) to ensure emergency abortion care was mentioned, though this has led to legal ambiguities. The recent Supreme Court ruling allowing temporary emergency abortions in Idaho was noted as a momentary reprieve, not a definitive solution.

3. Medicare and Immigration: Medicare was brought up in the context of immigration and its financial sustainability. Trump accused Biden's administration of burdening Medicare by extending benefits to undocumented immigrants, a claim fact-checked by The Washington Post to highlight contributions made by undocumented workers through payroll taxes. Biden countered by accusing Trump of attempting to cut Medicare and Social Security, an assertion scrutinized by The New York Times, which noted Trump's fluctuating stance on entitlement cuts.

Is Semaglutide Anti-inflammatory?

By Liam Davenport - The anti-obesity drug semaglutide is associated with significant reductions in the inflammatory marker high-sensitivity C-reactive protein (CRP), even in patients who do not lose substantial amounts of weight with the drug, according to data from the SELECT clinical trial. Read Full Article…

HVBA Article Summary

1. Significant Reduction in CRP Levels: The research presented at the European Atherosclerosis Society 2024 demonstrated that semaglutide led to a 38% reduction in high-sensitivity CRP levels compared to placebo, regardless of various baseline factors. This reduction occurred early, with approximately 12% at 4 weeks and around 20% at 8 weeks, even among patients who experienced minimal weight loss.

2. Impact on Cardiovascular Events: The SELECT trial found that semaglutide consistently reduced major adverse cardiovascular events, including cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke, by around 20% compared to placebo. This suggests that semaglutide has a significant role in reducing cardiovascular risks in patients with established cardiovascular disease and overweight or obesity.

3. Debate on Mechanisms of Action: While the study highlights semaglutide's potential anti-inflammatory effects, experts like Naveed Sattar, MD, PhD, emphasize that the primary driver of CRP level reduction is likely weight loss. The exact mechanisms by which semaglutide affects cardiovascular events and inflammation remain speculative, with further research needed to understand the interplay between weight loss, CRP levels, and cardiovascular outcomes.

The Burden of Health Insurance Premiums on Small Business

By JP MorganChase - The U.S. Supreme Court, by a vote of 6-3, has overturned the Chevron deference, stripping power from federal agencies to interpret and enforce regulations. Read Full Article…

HVBA Article Summary

1. Increasing Burden of Premiums: Health insurance premiums are a growing part of operating expenses for nonemployer businesses. From 2018 to 2023, median health insurance expenses increased by 19%, outpacing other operating costs.

2. Impact on Small Employers: Small businesses with fewer employees face higher health insurance burdens as a percentage of compensation costs. Firms with lower revenues see a larger share of their expenses going towards health insurance premiums.

3. Stability and Variation in Premiums: Median health insurance premiums have remained stable since 2014, but the distribution of premium payments has widened, with some small business owners paying significantly higher premiums in 2023 compared to 2014.

Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies

By Noah Tong - The U.S. Supreme Court, by a vote of 6-3, has overturned the Chevron deference, stripping power from federal agencies to interpret and enforce regulations. Read Full Article…

HVBA Article Summary

1. Chevron Doctrine Overturned: The Supreme Court's decision in Loper Bright Enterprises v. Raimondo, which was combined with Relentless v. Department of Commerce, marks the end of the Chevron deference established in Chevron v. Natural Resources Defense Council (1984). This landmark ruling means that courts are no longer required to defer to agency interpretations of ambiguous laws if they are reasonable. Justice Neil Gorsuch emphasized the significance of this change, noting that Chevron's "tombstone" is now prominent.

2. Implications for Healthcare Regulation: With the Chevron doctrine overturned, agencies like the Centers for Medicare & Medicaid Services (CMS) will face increased judicial scrutiny. Courts now have the authority to decide how persuasive an agency's interpretation is rather than deferring to it by default. Healthcare attorney Richard Hughes IV predicts that this will lead to more rigorous examination of provider reimbursement cuts, drug pricing regulations, and the Inflation Reduction Act. Kelly Clearly, a former Deputy General Counsel at HHS, underscores that agencies must now demonstrate that their interpretations are not only permissible but also optimal.

3. Broad Impact on Federal Agencies: The decision shifts significant interpretive power from federal agencies to the courts, with experts from the O’Neill Institute for National & Global Health Law highlighting the potential consequences for public health, safety, and environmental policies. Critics, including Justice Elena Kagan, argue that the ruling disrupts the established framework that supported regulatory efforts across various sectors. The decision is expected to result in more legal challenges and could hinder agencies' ability to quickly adapt to new technologies and evolving policy needs.

10 numbers on prescription drug costs: GoodRx

By Paige Twenter - Between 2014 and 2024, prescription medication prices have increased 37%, according to a GoodRx, which launched a prescription cost tracker June 26. Read Full Article…

HVBA Article Summary

1. Prescription Usage and Costs: As of June 26, 1.3 billion prescriptions have been filled in the U.S., with a total out-of-pocket spend reaching $21 billion. The average out-of-pocket cost per prescription is $16.26.

2. Medicare Part D Coverage and Restrictions: 54% of drugs are covered by Medicare Part D plans, but 50% of medicines have some form of insurance restriction, such as step therapy or prior authorization. Additionally, 25% of Americans have at least one prescription that Medicare Part D does not cover.

3. Access and Availability Issues: 41 million Americans lack access to a pharmacy, and 51 million Americans leave a prescription at the pharmacy counter each month. Furthermore, 20% of Americans experienced an out-of-stock prescription in the first quarter of 2024.

Health insurers cover fewer drugs and make them harder to get

By Sydney Lupkin - Insurance coverage isn’t what it used to be when it comes to prescription drugs. Insurance companies’ lists of covered drugs, called formularies, are shrinking. In 2010, the average Medicare formulary covered about three-quarters of all drugs approved by the Food and Drug Administration, according to new research by GoodRx, a website that helps patients find discounts on prescription drugs. Now, it’s a little more than half. Read Full Article…

HVBA Article Summary

1. High Drug Prices and Limited Coverage: The GoodRx report "The Big Pinch" highlights the dual pressure on patients from high drug prices set by pharmaceutical companies and limited drug coverage provided by health insurance companies. Tori Marsh, director of research at GoodRx, emphasizes that while the high cost of prescriptions is often discussed, the issue of poor coverage is equally significant, particularly as commercial plans tend to cover fewer drugs than Medicare due to fewer federal mandates.

2. Increased Hurdles for Drug Access: The report indicates that patients face more obstacles now than 14 years ago in obtaining covered medications. Nearly half of the drugs require prior authorization, where insurers demand additional justification from doctors, leading to delays and potential deterrents for patients to fill their prescriptions. This restriction, while serving a business purpose for negotiating lower prices, ultimately complicates patient access to necessary medications.

3. Shopping for Better Coverage: Although formularies have stabilized somewhat since 2020, GoodRx’s Marsh notes that drug coverage has not expanded. For consumers seeking more comprehensive plans, shopping around for insurance that offers better drug coverage, even at the cost of higher premiums, is essential. However, the process of comparing and selecting health insurance plans can be overwhelming, as noted by health economist Jeromie Ballreich.

Walmart health centers to close June 28

By Laura Dyrda - Walmart revealed plans in April to close all 51 health centers across the U.S. this year. The retail giant recently posted the closing date, and it's fast approaching: June 28. Read Full Article…

HVBA Article Summary

1. Health Centers Closure and Patient Transition: On June 1, Walmart Health ceased accepting new patients and halted virtual care services. Patients were advised to establish connections with new providers, with Walmart stating that it could not offer contact details for providers or information about future practices. Patients were encouraged to use platforms like ZocDoc and Healthgrades to find new healthcare providers and were given the opportunity to obtain or transfer their health records.

2. Reasons for Closure: Walmart Health centers and virtual care services were closed due to an unsustainable business model, exacerbated by a challenging reimbursement environment and increasing operational costs. The retailer found these financial pressures too significant to maintain the health centers and virtual care services.

3. Industry Reactions: Health system executives were not surprised by Walmart's difficulties and subsequent decision to close the health centers. Saad Chaudhry, the chief digital and information officer of Luminis Health, highlighted the industry's ongoing focus on revenue cycle management and the challenges faced by new entrants in the provider space. He noted that similar issues had previously impacted the telehealth sector, indicating that Walmart Health's experience is a common lesson for new healthcare ventures.

FLOW: GLP-1 Kidney Benefits Seen With or Without SGLT2 Inhibitors

By Nancy A. Melville - New data from the landmark FLOW trial, which linked the glucagon peptide 1 (GLP-1) receptor agonist semaglutide with significant kidney outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), suggests that these benefits are consistent whether patients are or are not also treated with sodium-glucose cotransporter 2 (SGLT2) inhibitors. Read Full Article…

HVBA Article Summary

1. Limited Power of the FLOW Trial: The FLOW trial had limited power to test the effects of kidney outcomes among patients using SGLT2 inhibitors, as the number of such patients in the study was very low. Consequently, no clear differences were observed in kidney, cardiovascular, and mortality benefits of semaglutide with or without SGLT2i use.

2. Study Design and Findings: The study, which stratified patients based on SGLT2 inhibitor use, revealed that semaglutide significantly reduced the primary composite outcome of kidney failure, eGFR reduction, and kidney or cardiovascular death among non-users of SGLT2 inhibitors. However, there were no significant differences between semaglutide and placebo among those using SGLT2 inhibitors at baseline.

3. Implications and Future Research: The findings suggest no consistent evidence of heterogeneity in semaglutide’s benefits among patients with T2D and CKD, regardless of SGLT2 inhibitor use. Experts like Dr. Robert A. Gabbay emphasize the need for larger studies to better understand kidney outcomes and other effects of GLP-1 receptor agonists when combined with SGLT2 inhibitors, given their potential complementary benefits.

Pancreatic Gene Therapy: A 'One-and-Done' GLP-1 Treatment?

By Nancy A. Melville - An experimental pancreatic gene therapy given to a mouse model of obesity as a one-time, single-dose treatment showed improvements in body composition and fasting glucose comparable with those achieved with the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide, without the reversal of fat-loss and glycemia improvements that are a key concern with the withdrawal of GLP-1 receptor agonist drugs. Read Full Article…

HVBA Article Summary

1. Gene Therapy Design and Delivery: The adeno-associated virus-based GLP-1 pancreatic gene therapy is engineered to induce sustained production of GLP-1 peptides in the pancreas, potentially eliminating the need for regular GLP-1 receptor agonist drug injections. This gene therapy is delivered directly to the pancreas using a proprietary endoscopic method, ensuring localized delivery and minimizing systemic exposure.

2. Preclinical Testing in Mice: Building on promising preclinical results in Yucatan pigs, the researchers tested the gene therapy on mice with diet-induced obesity. The mice were divided into four groups: those receiving a single-dose pancreatic gene therapy (n = 10), daily subcutaneous semaglutide injections (n = 10), a gene therapy placebo (n = 8), and a semaglutide placebo (n = 8). After four weeks, the semaglutide group was further randomized, with half receiving gene therapy and half receiving placebo.

3. Assessment of Efficacy: At the end of four weeks, significant reductions in fat mass were observed in the gene therapy group (21%) compared to the semaglutide group (16%), both statistically significant against placebo (P < .05; both P < .0001). Lean mass preservation and fasting glucose improvements were also notable. At eight weeks, semaglutide-withdrawn mice showed a reversal of benefits, whereas those switched to gene therapy maintained significant reductions in fat mass and fasting glucose levels. No pancreatic inflammation or injury was reported in any group.