Federal judge sides with providers, nixes online tracker guidance

By Emily Olsen - Online trackers, or technologies that gather information about user behavior, are extremely common on hospital websites. Regulators have raised concerns about the use of trackers among entities covered by HIPAA, especially how the technologies can share users’ health information with third parties, like marketing vendors or social media companies. Read Full Article…

HVBA Article Summary

1. Legal Victory for Hospitals: The American Hospital Association, alongside other provider groups, successfully challenged federal regulators in court regarding the guidance issued by the Health and Human Services (HHS) that restricted the use of third-party tracking technologies on their websites. A judge in the Northern District of Texas ruled that the HHS had overstepped its authority under the HIPAA health privacy law, striking down the guidance.

2. Concerns Over Privacy: The lawsuit stemmed from a 2022 investigation by Stat and the Markup, which revealed that some hospital websites were inadvertently sharing sensitive patient data, such as health conditions and medical appointments, with Facebook through trackers like the Meta Pixel. This prompted the HHS Office for Civil Rights to issue restrictive guidance on the use of such trackers, deeming them potentially in violation of HIPAA if they disclosed protected health information.

3. Implications and Responses: Despite the court's decision to vacate the guidance, the HHS did not issue a permanent injunction as requested by the hospital groups, reflecting ongoing concerns about the privacy of health information. Hospitals defended their use of trackers, arguing they enhance the user experience on their websites by providing vital services such as analytics, translations for non-English speakers, and helping users locate healthcare services. The case highlights the tension between improving digital health services and protecting patient privacy.

Court keeps ACA preventive care mandate in place

By Rylee Wilson - A federal court kept the ACA preventive care mandate in place for now but raised questions about its constitutionality. The 5th U.S. Circuit Court of Appeals issued a decision in Braidwood Management v. Becerra on June 21. The judges called their decision a "mixed bag," and the case is likely to be litigated further. Read Full Article…

HVBA Article Summary

1. Appeals Court Ruling on PrEP Coverage: In a 2021 lawsuit by Braidwood Management, the company claimed that the requirement to cover preexposure prophylaxis (PrEP) for HIV prevention violated its religious freedom. The appeals court ruled that Braidwood Management cannot be compelled to pay for PrEP for its employees but reversed a lower court decision that prevented the federal government from enforcing requirements to cover preventive services.

2. ACA Preventive Services Coverage: The Affordable Care Act (ACA) mandates that payers cover over 100 preventive health services without copays, benefiting more than 100 million people annually. In March 2023, U.S. District Judge Reed O’Connor ruled that recommendations made by the U.S. Preventive Services Task Force post-2010 do not need to be followed and temporarily blocked the federal government from enforcing these recommendations. However, HHS later preserved the mandate while the case was under appeal.

3. Authority of the Task Force and Future Legal Proceedings: The appeals court agreed with Judge O’Connor that the authority of the U.S. Preventive Services Task Force is unconstitutional due to its members not being confirmed by the Senate. However, it disagreed with the lower court’s decision to vacate all enforcement of preventive-care mandates. The case, with its implications for only Braidwood Management, will be sent back to a lower court to decide on the task force’s authority. Legal experts predict that both plaintiffs and the government will be dissatisfied with the narrow ruling, potentially leading the case to the Supreme Court.

Appeals court upholds ACA’s preventive services mandate, but opens door to future challenges

By Rebecca Pifer - Two Christian-owned companies in Texas, Braidwood Management and Kelley Orthodontics, sued the federal government in 2020 over the ACA’s requirement that their health plans cover contraception, HPV vaccines and medicines to prevent HIV for free, arguing the services violated their religious beliefs. Read Full Article…

HVBA Article Summary

1. Federal Appeals Court Ruling on ACA Preventive Services Mandate: The 5th Circuit Court of Appeals upheld the Affordable Care Act's mandate requiring private insurance to cover preventive services at no cost to patients. However, the court allowed a group of Christian companies to be exempt from this mandate, indicating a potential for broader legal challenges in the future that could undermine the mandate nationwide.

2. Constitutional Authority and the USPSTF: The appellate panel ruled that the U.S. Preventive Services Task Force (USPSTF), responsible for determining free preventive services, lacks constitutional authority as its members are not confirmed by Congress. Moving forward, the court mandated that USPSTF members must be nominated by the president and confirmed by the Senate. The ruling questioned the authority of other groups, such as the Advisory Committee on Immunization Practices and the Health Resources and Services Administration, to recommend free vaccines and contraceptives, referring this issue back to the lower court.

3. Implications for Preventive Health Services and Future Legal Challenges: While the decision maintains access to free preventive services for now, benefiting approximately 164 million Americans with employer-provided insurance, it sets the stage for potential future lawsuits. Patient advocacy and health policy groups expressed relief but also concern over the long-term impact, as the ruling may pave the way for challenges that could limit access to essential preventive health care services.

SELECT: Semaglutide Reduces CV Events and Diabetes Risk

By Alicia Ault - The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Wegovy, Ozempic) reduced cardiovascular events and reduced the risk of progression to diabetes by 73% in people with established cardiovascular disease and obesity compared with placebo, regardless of baseline A1c levels, according to two new analyses of the SELECT trial. Read Full Article…

HVBA Article Summary

1. Semaglutide's Impact on Glycemic Control and Diabetes Progression: The study presented at the ADA 84th Scientific Sessions highlighted semaglutide's efficacy in improving glycemic control in individuals with cardiovascular issues and overweight or obesity but without diabetes. Notably, fewer participants with pre-diabetes progressed to diabetes, and a greater number returned to normal A1c levels compared to those taking a placebo. However, semaglutide did not significantly slow glycemic progression over time.

2. Cardiovascular Risk Reduction Across Glycemic Levels: Another study conducted by Ildiko Lingvay and her team demonstrated that semaglutide significantly reduces cardiovascular events, such as major adverse cardiovascular events (MACE), regardless of the baseline A1c levels. This suggests that even individuals with normal A1c can benefit from semaglutide for cardiovascular risk reduction, emphasizing its effectiveness across the glycemic continuum.

3. Call for Cautious and Equitable Use: While semaglutide shows promising results in glycemic control and cardiovascular risk reduction, experts like Shivani Misra stress the need for caution and equitable distribution. Misra highlights the importance of understanding the comprehensive effects of semaglutide, including its impact on body weight, cholesterol, blood pressure, and renal function. Additionally, she emphasizes the necessity of developing strategies to ensure that these benefits reach low- and middle-income countries and younger adults at risk for cardiovascular consequences.

US uninsured rate to increase over next decade: CBO

By Jakob Emerson - The U.S. uninsured rate is projected to increase to 8.9% by 2034, according to new estimates published by the Congressional Budget Office in June. Read Full Article…

HVBA Article Summary

1. Uninsured Rate and Projections: In 2023, the nation's uninsured rate hit a record low of 7.2%, according to the Congressional Budget Office (CBO). A preliminary survey by the National Center for Health Statistics found the uninsured rate to be 7.6%, representing 25 million people. However, the CBO projects an increase in the uninsured rate over the next decade due to Medicaid redeterminations, the expiration of ACA premium subsidies after 2025, and increased immigration.

2. Demographic Impact: The largest increase in the uninsured population between 2024 and 2034 is expected to occur among adults aged 19 to 44. This demographic shift highlights the need for targeted policies to address insurance coverage gaps within this age group.

3. Health Insurance Coverage Trends: By 2034, commercial health insurance will remain the largest source of coverage, with enrollment ranging between 164 million and 170 million. Medicaid and CHIP enrollment is projected to decrease from 92 million in 2023 to 79 million in 2034, while Medicare enrollment is expected to rise from 60 million in 2023 to 74 million in 2034. The proportion of Medicare beneficiaries enrolled in Medicare Advantage is projected to increase from over half in 2023 to nearly two-thirds by 2034. ACA enrollment is anticipated to peak at 23 million in 2025 before declining by 7 to 8 million post-2025.

FTC Backs PTO’s New Patent Settlement Rules for Enhanced Antitrust Oversight

By Cora Lewis and Linley Sanders - Janille Williams wants to buy a house someday — but first, he has to pay down tens of thousands of dollars in medical debt. “I was hospitalized for a blood infection for three months more than ten years ago, and the bill was for more than $300,000,” said Williams, 38, a Fairbanks, Alaska, resident who works as a retail sales manager for AT&T. “I was in the middle of changing jobs, the only time in my life I haven’t had health insurance.” Read Full Article…

HVBA Article Summary

1. Impact on Individuals: Medical debt forgiveness could substantially improve credit reports and stop collection calls, as exemplified by Williams, who faced a lowered yet still unpayable debt of $50,000 after his medical bills went to collections. Many Americans support this initiative, with a significant portion viewing it as extremely or very important for the government to provide debt relief for unpaid medical treatments.

2. Local and Federal Efforts: In response to the growing burden of medical debt, numerous cities and states, including Connecticut, New York City, New Orleans, and Chicago, have implemented their own medical debt forgiveness programs. Additionally, the Biden administration has proposed a rule to remove consumer medical debt from most credit reports, reflecting a broader trend towards addressing this issue at both local and national levels.

3. Public Opinion and Political Divide: The AP-NORC poll reveals a strong bipartisan agreement on the need for medical debt forgiveness in cases of healthcare fraud, with about two-thirds of U.S. adults supporting it. However, there are partisan differences in other scenarios, with Democrats generally more supportive of debt relief for those experiencing financial hardship or having substantial debt relative to their income, compared to Republicans.

Proposed rule change threatens mental health care access

By Melissa Bartlett - This year marks the 50th anniversary of the Employee Retirement Income Security Act (ERISA), which has helped ensure that millions of Americans, and their families, receive high-quality health and retirement benefits through their employers. Based on the 2020-2022 Census, 86% of private-sector employees received employer-sponsored health insurance. ERISA only improves with age. Read Full Article…

HVBA Article Summary

1. The Evolution of Mental Health Coverage under ERISA: The 1974 enactment of the Employee Retirement Income Security Act (ERISA) marked a pivotal moment in expanding healthcare access, primarily focusing on medical and surgical care while excluding mental health treatment. This gap was partially addressed in 1996 with the Mental Health Parity Act (MHPA) and further expanded by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). While these laws did not mandate mental health and substance use disorder coverage, they required that if such benefits were offered, they had to be on par with medical and surgical benefits, significantly impacting ERISA self-insured health plans.

2. Current Mental Health Crisis and Policy Challenges: The United States is currently facing a severe mental health crisis, with increasing numbers of individuals needing mental health and substance abuse care. This situation underscores the importance of ERISA preemption, allowing for consistent and comprehensive health coverage across multi-state employers. However, proposed changes to MHPAEA regulatory standards threaten to destabilize this infrastructure by potentially lowering quality and safety standards for providers and complicating patient-focused treatment plans, which could lead to improper treatment utilization.

3. Policy Recommendations and ERIC’s Commitment: To address the mental health crisis effectively, policy efforts should focus on increasing the number of qualified mental health professionals and improving early intervention through primary care training. Additionally, regulatory barriers to telehealth should be reduced, and long-term incentives should be provided to attract and retain mental health workers. ERIC is dedicated to collaborating with regulators and stakeholders to develop practical policy solutions that enhance patient access to mental health and substance use disorder treatment, emphasizing the need to invest in healthcare professionals rather than implementing short-sighted regulatory changes.

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. Efficacy of Tirzepatide in OSA Treatment: The SURMOUNT-OSA studies demonstrated that tirzepatide significantly reduces obstructive sleep apnea (OSA) events, with patients experiencing 27 to 30 fewer apnea-hypopnea index (AHI) events per hour compared to only 4 to 6 fewer events per hour for those on placebo. Up to half of the patients treated with tirzepatide had fewer than 5 events per hour, indicating a substantial improvement in their condition.

2. Additional Health Benefits: Beyond addressing OSA, tirzepatide also led to notable health benefits, including an 18% to 20% reduction in body weight, a decrease in systolic blood pressure (9.7 mm Hg in study 1 and 7.6 mm Hg in study 2), and lower C-reactive protein levels. These improvements suggest that tirzepatide could be a valuable treatment for patients with obesity and metabolic complications.

3. Potential as a CPAP Alternative: While continuous positive airway pressure (CPAP) therapy is effective, many patients struggle with adherence. Tirzepatide offers a promising alternative for those who cannot tolerate CPAP, with the added benefit of addressing obesity and associated cardiometabolic risks. However, concerns remain about long-term adherence to tirzepatide therapy outside of clinical trials and ensuring equitable access to this new treatment option.

FTC Backs PTO’s New Patent Settlement Rules for Enhanced Antitrust Oversight

By CPI - This week, the Federal Trade Commission (FTC) announced its endorsement of the U.S. Patent and Trademark Office’s (PTO) newly proposed regulations aimed at increasing transparency and antitrust oversight in patent dispute settlements, particularly within the pharmaceutical industry. Read Full Article…

HVBA Article Summary

1. Mandated Disclosure of Pre-Institution Agreements: In April 2024, the PTO proposed amendments requiring the disclosure of all pre-institution agreements and any collateral deals between disputing parties before the Patent Trial and Appeal Board (PTAB) initiates a trial. This move aims to provide greater transparency and oversight at the early stages of patent disputes.

2. Enhanced Antitrust Oversight by FTC: The FTC supports these changes, stating that they will significantly improve the ability of both the FTC and the Department of Justice to monitor and address potentially anticompetitive settlement agreements. This includes identifying "reverse payment settlements," which are particularly problematic in the pharmaceutical industry as they delay market entry and maintain high drug prices.

3. FTC's Increased Focus on Pharmaceutical Patents: Reflecting its intensified scrutiny of pharmaceutical patents, the FTC unanimously voted in favor of the proposed rules. This follows the FTC's actions in November 2023, where it challenged over 100 listings in the FDA’s Orange Book, targeting companies like GSK, AstraZeneca, and AbbVie for allegedly improper listings, thus underscoring the FTC's commitment to fostering a competitive market environment and protecting consumer welfare.

What’s the evidence for the surgeon general’s proposed social media warning?

By Annalisa Merelli - United States Surgeon General Vivek Murthy wants to add a warning label on social media. “It is time to require a surgeon general’s warning label on social media platforms, stating that social media is associated with significant mental health harms for adolescents,” he wrote in an op-ed published on Monday in the New York Times, calling on Congress to take action to add the warning, which would be along the lines of the ones issued against tobacco and alcohol consumption. Read Full Article…

HVBA Article Summary

1. Murthy's Advisory on Social Media and Youth: Last year, Dr. Murthy published an advisory highlighting the lack of sufficient evidence on the safety of social media for children. While acknowledging some benefits, he emphasized the need to "maximize the benefits and minimize the harms." Recently, Murthy's call for stricter social media controls was praised by advocates, with NYU social psychologist Jonathan Haidt supporting the stance that social media is unsafe for children and teens.

2. Experts' Diverging Views on Social Media Harm: Several experts, including Michaeline Jensen and Candice Odgers, argue that the evidence linking social media to significant mental health harms in adolescents is inconclusive. Jensen points out that most research in this field is correlational and not strong enough to support Murthy's sweeping statements. The National Academies of Science also noted that the available research shows only small effects and weak associations between social media use and health outcomes.

3. Balancing Risks and Benefits: While acknowledging potential harms such as cyberbullying, exposure to discrimination, and sleep disruptions, experts like Jensen also highlight the benefits of social media for youth, including social support and information seeking. A Pew Research Center survey from 2023 found that a significant portion of teens view social media positively. Experts caution that a nuanced understanding of the research is crucial for effective public health warnings, as overly strong statements without robust evidence could undermine future public health interventions.