House Panel OKs Bills on Obesity Drug and Breakthrough Device Coverage in Medicare

By Joyce Frieden - Bills that would mandate Medicare coverage for two categories of treatments -- anti-obesity drugs and "breakthrough" medical devices -- have cleared a House panel, making them one step closer to passage. Read Full Article…

HVBA Article Summary

1. The Treat and Reduce Obesity Act: This act aims to expand Medicare Part D coverage to include anti-obesity medications for beneficiaries currently on such treatments as they transition into Medicare. The House Ways & Means Committee passed this measure with a vote of 36-4, highlighting its importance in ensuring continued coverage for approximately 1.25 million patients over the next decade, who otherwise risk losing their medication access under the current exclusion of obesity drugs from Part D plans.

2. Ensuring Patient Access to Critical Breakthrough Products Act: Passed by the committee with a 36-5 vote, this act mandates Medicare coverage for FDA-approved breakthrough devices for a period of four years. This temporary coverage period allows for the collection of real-world evidence and development of a permanent coverage policy, addressing the significant delay in Medicare coverage implementation for breakthrough medical devices, which currently averages five years post-FDA approval.

3. CMS's Transitional Coverage for Emerging Technologies (TCET) Program: This proposed rule aims to provide temporary Medicare coverage for breakthrough devices for 3 to 5 years while gathering real-world evidence. This rule, which addresses the operational and evidentiary concerns of previous policies, is still under consideration as CMS works on finalizing it. Industry stakeholders, like AdvaMed, emphasize the need for timely action from CMS and the inclusion of diagnostic tests in the final legislation to ensure comprehensive coverage for innovative medical technologies.

How will SCOTUS Chevron ruling impact DOL’s fiduciary rule?

By John Forcucci - Saying the Framers of the U.S. Constitution envisioned that the final “interpretation of the laws” would be “the proper and peculiar province  of the courts,” the U.S. Supreme Court Friday overturned the Chevron doctrine, potentially sapping the regulating power of government agencies and transferring it to the courts. The widespread ramifications of this decision are likely to impact numerous financial regulatory bodies, including the Department of Labor and its pending fiduciary rule. Read Full Article…

HVBA Article Summary

1. Heightened Judicial Scrutiny and Legislative Clarity: The Supreme Court’s decision to overrule Chevron deference signifies that federal courts will no longer defer to agency interpretations of ambiguous statutes. This shift demands more rigorous and independent judicial review of agency actions, compelling Congress to draft clearer and more comprehensive legislation. As a result, challenges to agency decisions are expected to increase, necessitating more intensive judicial scrutiny and potentially reshaping the legislative and rulemaking processes.

2. Challenges to the DOL Fiduciary Rule: The decision poses significant implications for the Department of Labor’s (DOL) fiduciary rule, which extends fiduciary responsibilities to most annuity transactions. The diminished deference to administrative interpretations may hinder the DOL’s ability to enforce the rule, leading to potential delays or modifications. Legal experts anticipate increased litigation from corporations challenging the DOL’s interpretation of "fiduciary," and the DOL may need to revise the rule to reduce ambiguities and withstand judicial scrutiny.

3. Shift Towards Formal Rulemaking: The Supreme Court’s ruling may prompt agencies like the DOL to adopt formal rulemaking processes to mitigate legal challenges. By establishing a robust foundation for their regulations, agencies can better withstand judicial review. The decision marks the end of automatic deference to agency interpretations, signaling a more complex regulatory landscape where agencies must justify their rules with thorough cost-benefit analyses and clear statutory authority. This approach could lead to a period of legal adjustments as stakeholders navigate the new judicial standards.

Biden proposes first-ever nationwide worker protections from heat

By Rachel Frazin - As the nation sizzles, the Biden administration is proposing the nation’s first-ever standards aimed at protecting workers from extreme heat. Read Full Article…

HVBA Article Summary

1. Proposed Federal Heat Protection Standards: The Biden administration's proposal mandates employers to provide rest breaks, access to shade, and water for workers at risk of extreme heat. Employers would also need to identify heat hazards and develop heat illness and emergency response plans. Despite the proposal's potential life-saving impact, it faces uncertainty in implementation due to the possible political shift after the current administration's term.

2. Heat-Related Worker Fatalities and Susceptible Occupations: From 2011 to 2021, 436 workers died due to extreme heat exposure, highlighting the critical need for protective measures. Workers most susceptible to heat-related illnesses include those in outdoor, long-hour occupations such as farmworkers and construction workers. Currently, there are no federal heat protections, though some states have implemented their own, while Texas and Florida have restricted cities from establishing local protections.

3. Bipartisan Infrastructure Law Funding for Heat and Disaster Protection: In conjunction with the proposed heat protection standards, the Biden administration is allocating nearly $1 billion from the Bipartisan Infrastructure Law to safeguard communities from natural disasters and hazards, including extreme heat and flooding. This funding will support 656 projects nationwide, addressing the increasing threat of extreme heat exacerbated by climate change.

FTC opens investigation into Teva, escalating patent fight with pharma industry

By Dan Diamond - The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company’s refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post. Read Full Article…

HVBA Article Summary

1. FTC Investigation into Teva Pharmaceuticals: Last week, the FTC issued a civil investigative demand to Teva, requiring the company to provide internal communications, analysis, and financial data related to its patents listed in the Orange Book. The FTC alleges that pharmaceutical companies, including Teva, have made minor modifications to their products to extend patent protection and delay generic competition. Teva has until July 24 to comply with the FTC's demand, while the company asserts that its patents are valid and appropriately listed.

2. Escalation of Democratic Efforts Against Pharmaceutical Patent Practices: The FTC's investigation marks a significant intensification of Democratic lawmakers' ongoing battle with the pharmaceutical industry. The agency had previously urged Teva and other companies to voluntarily remove over 100 patents and expanded its focus in April 2024 to more than 300 patents considered "junk" listings. Prominent Democrats, including Sen. Bernie Sanders and Sen. Elizabeth Warren, have been vocal in their criticism of companies like Teva for manipulating patent laws to maintain high drug prices, particularly for inhalers.

3. Industry Response and Legal Challenges: Teva, along with other pharmaceutical companies, has resisted the pressure to remove patents, arguing that their patent listings are lawful and not intended to stifle competition or increase prices. The drug industry's largest lobbying group, PhRMA, has launched a campaign to defend intellectual property protections, emphasizing the balance between innovation and affordability. Meanwhile, Teva is also facing legal action from Amneal Pharmaceuticals, which has sought to produce a generic version of Teva's inhaler. A New Jersey District Judge recently ruled in favor of Amneal and the FTC, ordering Teva to correct or remove five patents from the Orange Book.

How health insurance may change, regardless of who wins the election

By Joe Markland - There has been little talk so far about plans either presidential candidate has for fixing a very broken health insurance and healthcare system with just months to go before the election. Read Full Article…

HVBA Article Summary

1. Employer-Based Health Insurance System Flaws: The article argues that the current employer-based health insurance system is not a true free-market approach but rather a "command and control" model dictated by employers due to historical tax laws. This system increases healthcare costs and limits consumer choice, as most people cannot choose their health insurance plan independently.

2. Individual Health Insurance Markets and Tax Advantages: Both Democratic and Republican administrations have taken steps to empower consumers by supporting individual health insurance markets. The ACA allowed access to individual markets with potential subsidies, while Trump's ICHRA enabled employees to purchase individual policies with pretax dollars, offering greater flexibility and cost-effectiveness. However, full implementation requires further legislative changes to remove remaining obstacles.

3. Proposed Legislative Changes and Bipartisan Support: A proposed Senate law, the Personalized Care Act, aims to allow individuals to purchase health insurance policies pretax without needing employer permission, using health savings accounts (HSAs). This change enjoys significant bipartisan support, and it could lead to a more equitable and simplified healthcare system by addressing progressive tax concerns, ensuring mandatory insurance purchases, maintaining employer contributions, and standardizing insurance plans to reduce administrative costs.

How the Supreme Court's Chevron deference ruling could affect healthcare

By Andrew Cass - The Supreme Court in a 6-3 ruling overturned a 40-year-old legal precedent known as Chevron deference, the Washington Post reported June 28. Read Full Article…

HVBA Article Summary

1. Chief Justice John Roberts and the Majority Opinion: Chief Justice John Roberts, writing for the majority, criticized the Chevron deference framework as "unworkable." He argued that it allowed federal agencies to alter their regulatory interpretations without Congressional approval, leading to inconsistent and unpredictable regulatory environments.

2. Concerns Over Healthcare Policy: Experts like Suhasini Ravi and organizations such as the American Cancer Society have expressed significant concerns about the potential overruling of Chevron deference. They argue that such a move could undermine the expertise of federal agencies crucial in healthcare, disrupt the administration of programs like Medicare and Medicaid, and create instability during regulatory transitions.

3. Implications for Legislation and Stakeholder Involvement: The rollback of Chevron is expected to lead to increased legal challenges to federal regulations, such as Medicare payment rules. Experts like Leigh Feldman and Jeffrey Davis suggest that Congress may need to draft more detailed legislation to guide agencies, potentially increasing the influence of external stakeholders and interest groups in shaping specific legislative provisions.

Tirzepatide Significantly Reduces Sleep Disruptions

By Alicia Ault - The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40% to 50% no longer needed to use a continuous pressure airway positive (CPAP) device, according to two new studies. Read Full Article…

HVBA Article Summary

1. Significant Improvements in OSA Management: Tirzepatide, a dual GIP and GLP-1 receptor agonist, demonstrated substantial efficacy in reducing episodes of obstructive sleep apnea (OSA), lowering systolic blood pressure, and decreasing C-reactive protein levels. Patients in the SURMOUNT-OSA studies experienced an 18% to 20% reduction in body weight and significant improvements in respiratory and metabolic complications, with up to half of the participants achieving AHI scores that might eliminate the need for CPAP therapy.

2. Promising Alternative to CPAP Therapy: The SURMOUNT-OSA studies involved 233 patients receiving tirzepatide and 234 receiving a placebo across 60 sites in nine countries. Patients taking tirzepatide reported fewer daytime and nighttime disturbances, with notable reductions in the number of apnea events per hour compared to those on placebo. Lead author Dr. Atul Malhotra highlighted that tirzepatide offers a viable alternative for individuals who struggle with or refuse CPAP therapy, potentially becoming the first FDA-approved drug for OSA.

3. Broader Implications and Concerns: While the trials showcased the potential of tirzepatide in treating OSA and associated cardiometabolic risks, experts like Dr. Sanjay R. Patel and Dr. Louis Aronne emphasized the importance of integrating obesity management into OSA treatment. They noted the drug's substantial impact on systolic blood pressure and cardiovascular risk reduction. However, concerns remain about patient adherence and racial disparities in access to GLP-1 receptor agonists, which could affect the broader applicability of tirzepatide in clinical practice.

NABIP upholds role of agents in the ACA marketplace

By Wire Reports - The National Association of Benefits and Insurance Professionals expressed its concern over the recent narrative presented in the Paragon Health Institute’s report, which portrays a broad and detrimental view of the role of agents within the Affordable Care Act marketplace. Read Full Article…

HVBA Article Summary

1. Fraudulent Enrollment Allegations: Paragon Health's paper, "The Great Obamacare Enrollment Fraud," alleges that there is an increasing trend of fraudulent enrollments in ACA marketplace plans. According to the authors, applicants are misstating their income to qualify for higher subsidies, and unscrupulous brokers are exploiting the enhanced direct enrollment feature of HealthCare.gov by enrolling people into different plans without their consent to earn commissions.

2. Role of Health Insurance Agents: NABIP CEO Jessica Brooks-Woods highlights the critical role of local health insurance agents and employee benefit advisors in helping individuals and families navigate the complexities of ACA enrollments. Agents facilitated nearly 80% of federally facilitated ACA enrollments last year, serving as indispensable advisors for individuals and employers making informed health coverage decisions throughout the plan year.

3. Impact of Policy Changes on Premiums and Coverage: NABIP warns against Paragon Health's advocacy for raising taxes on employee group benefits and removing tax credits in the individual market. Such measures, according to NABIP, could increase monthly premiums and financial burdens on American families, especially during heightened inflation. NABIP emphasizes the need for policymakers to prioritize consumer affordability and accessibility, leveraging the expertise of local health agents to enhance the healthcare system's effectiveness.

Walgreens to close 'significant' number of underperforming stores

By Laura Dyrda and Jakob Emerson - Walgreens is planning to shutter "a significant portion" of its underperforming retail stores over the next three years. Read Full Article…

HVBA Article Summary

1. Strategic Store Closures: Walgreens plans to close additional stores as part of its footprint optimization program, in response to ongoing financial challenges and changing consumer spending habits. CEO Tim Wentworth highlighted that 75% of the company’s stores generate nearly all retail profits, prompting the need to reevaluate the remaining 25% that are not contributing to long-term strategy.

2. Financial Performance and Adjustments: Despite reporting a 2.6% increase in sales to $36.4 billion and a quarterly operating income of $111 million, Walgreens continues to recover from significant early-year losses. The company's year-to-date operating loss stands at $13.1 billion, with a net loss of $5.6 billion. Nonetheless, U.S. healthcare sales showed promising growth, with a 7.6% increase driven by strong performances from VillageMD and Shields.

3. Focus on Core Business and Future Strategy: Walgreens is committed to enhancing its core business of retail pharmacy, recognizing its central role in the future of healthcare. The company is taking urgent steps to address critical issues and explore growth opportunities. Tim Wentworth expressed confidence in the company’s strategic review and the potential for a successful business turnaround, emphasizing the importance of the right team and strategy to meet customer and patient needs.

To secure the U.S.’s biotech supply chain, pay attention to domestic companies

By Josh Carpenter - Scientific breakthroughs will enable a future of personalized drug discovery, where precision medicine makes it possible to receive the right dose of the right medicine at the right time. America’s ability to lead this global frontier of medicine is contingent upon our willingness to recognize China as a competitor and respond accordingly. But often overlooked in this essential conversation is the importance of investing more in U.S. biotech firms and innovation ecosystems — including those outside of the well-recognized hubs.. Read Full Article…

HVBA Article Summary

1. Protecting and Developing Critical Ingredients for Precision Medicine: To deliver on the promise of accessible precision medicine, safeguarding genomic data and intellectual property is essential. Ethical protection of patient data and securing intellectual property from early-stage start-ups, universities, and research institutes are key to harnessing domestic ingenuity and pioneering novel disease treatments.

2. China's Threat to Genomic Data and Intellectual Property: China poses a significant risk through entities like Beijing Genomics Institute and WuXi App Tec, which have been implicated in the misappropriation of genomic data and intellectual property. This aggressive behavior underscores the necessity for stringent protections to prevent China from leveraging American genomic data for malicious purposes, including the potential development of targeted bioweapons.

3. Investing in Domestic Biotech Hubs for National Security: Bipartisan support for Senate Bill 3558 reflects the urgency to decouple American biotech from Chinese influence. Simultaneously, robust investments in domestic supply chains and emerging biotech hubs across the South, such as Birmingham, Atlanta, and New Orleans, are crucial. These initiatives will secure the national bioeconomy, reduce dependency on foreign adversaries, and leverage America's diverse population to bolster national security and biotech innovation.