More Americans could get dental coverage under Biden proposal

By Maya Goldman - Dental care could soon become more widely available to adults who buy health insurance on the Affordable Care Act marketplaces under a new federal proposal that aims to narrow a long-standing coverage gap in the 2010 health care law. Read Full Article…

VBA Article Summary

1. Significance of Oral Health in Overall Well-being: The Biden administration's proposal emphasizes the importance of dental health as an integral part of general health. It highlights how conditions like gum disease are associated with serious health issues, including cardiovascular diseases and diabetes. This proposal is particularly beneficial for individuals with lower incomes and people of color, who are more likely to suffer from poor oral health.

2. Proposed Changes and Implications: The Centers for Medicare and Medicaid Services (CMS) recently proposed allowing states to classify adult dental services as an "essential health benefit" for Affordable Care Act (ACA) health plans. This marks a significant shift from the initial federal health standards derived from employer health plans, where adult dental care was typically offered separately from medical benefits. States, under this proposal, could integrate dental coverage into medical plans or offer it as a standalone service, enhancing accessibility and comprehensiveness of dental care.

3. Potential Impact and Legislative Actions: The proposed change has received support from various health and consumer advocacy groups, citing the importance of recognizing the connection between oral health and overall health. However, the adoption of this benefit by states remains uncertain, as they must weigh the impact on insurance costs. Concurrently, separate legislative efforts, like the bipartisan bill proposed by Senators Maggie Hassan and Roger Marshall, aim to facilitate the purchase of standalone dental plans through the federal ACA marketplace. This comes alongside the Biden administration's efforts to extend dental services to Medicare beneficiaries when necessary for other medical treatments, further underscoring the commitment to improving oral health care access.

What would a Desantis Presidency look like for healthcare?

By Romy Ellenbogen, Tampa Bay Times and Christopher O'Donnell, Tampa Bay Times - On the presidential campaign trail, Republican Ron DeSantis touts himself as a champion of medical freedom, outlawing vaccine mandates and protecting doctors who refuse to provide certain medical treatments on moral grounds. Read Full Article…

VBA Article Summary

1. Public Health and COVID-19 Response: As Florida's governor, DeSantis initially followed federal health guidance on COVID-19, but quickly shifted towards reopening the state. He banned mask mandates and later diverged from mainstream scientific consensus on COVID-19 prevention and treatment, notably not preordering vaccines for young children and contradicting CDC guidance on vaccinations. His approach to public health suggests a potential presidency that would prioritize state autonomy over federal guidance in health emergencies.

2. Abortion and Gender Dysphoria Care Policies: DeSantis has enacted significant anti-abortion legislation in Florida, including a 15-week abortion ban with limited exceptions. His administration has also restricted treatments for transgender minors, such as puberty blockers and hormone therapy, diverging from the recommendations of major medical organizations. These actions reflect a presidential campaign that might heavily restrict such medical services at the federal level.

3. Medicaid and Healthcare Coverage: Despite national trends towards expanding Medicaid under the Affordable Care Act, Florida under DeSantis remains one of the few states resisting expansion. This has led to high uninsured rates, particularly among children. DeSantis' stance reflects his belief in limiting government assistance programs, suggesting a presidency that might not prioritize expanding federal healthcare coverage, although he has approved some Medicaid expansions based on specific needs.

4.5M have signed up for coverage on the ACA exchanges so far in open enrollment: CMS

By Paige Minemyer - Open enrollment on the insurance marketplaces began on Nov. 1, and more than 4.5 million people have selected plans in the early weeks of the process, according to new federal data. Read Full Article…

VBA Article Summary

1. Enrollment Snapshot: The Centers for Medicare & Medicaid Services' first snapshot report on Affordable Care Act plans indicates a significant enrollment. About 920,000 (20%) are new enrollees, while the remaining 3.7 million (80%) are returning users who had active coverage in 2023 and are renewing or selecting new plans for 2024.

2. Administrator Comments: CMS Administrator Chiquita Brooks-LaSure highlighted an increase in plan selections and a significant rise in new enrollees compared to previous years. She emphasized the agency's commitment to providing quality, affordable healthcare, noting the strong early showing in enrollment and encouraging individuals seeking coverage to visit HealthCare.gov.

3. Enrollment Trends and Affordable Options: The report notes a rise in ACA exchange enrollments throughout 2023, with about 1.5 million more people signing up between March and September compared to 2022. This includes shifts from Medicaid and the Children's Health Insurance Program. HHS Secretary Xavier Becerra pointed out that four out of five enrollees can obtain coverage for $10 or less monthly after subsidies, underscoring the administration's efforts to offer affordable healthcare and the positive start to this year’s enrollment season.

What Healthcare Cybersecurity Leaders Should Know About the FDA's Section 524B Guidelines

By Bill Reid - Recently, the Food and Drug Administration (FDA) issued updated regulations regarding medical devices, specifically related to the cybersecurity requirements of those devices. These new requirements are found in Section 524B, Ensuring Cybersecurity of Devices, of the Food, Drug, and Cosmetic Act (FD&C Act). Read Full Article…

VBA Article Summary

1. Scope of the New Regulations: The new FDA regulations, effective from October 1, 2023, impact anyone submitting a premarket application for a "cyber device," defined as a device with software authorized by the sponsor, internet connectivity, and potential cybersecurity vulnerabilities. These rules don't apply retroactively but do cover new applications and significant updates to existing devices.

2. Purpose and Requirements of the Regulation: Aimed at recognizing cybersecurity's critical role in medical device safety and effectiveness, the regulation requires manufacturers to demonstrate adherence to cybersecurity standards. This involves a documented plan for addressing cybersecurity vulnerabilities, processes to ensure device and system security, and providing a software bill of materials. It emphasizes integrating security throughout the device's lifecycle, from design to decommissioning.

3. Implications for Medical Device Companies: Affected companies must integrate security considerations into device design and operations, often requiring collaboration between security and engineering teams. This shift may necessitate acquiring new skills and tools, possibly involving partnerships with experienced security providers. The regulation underlines the importance of security in the medical device industry, linking it to the overall market success of the products.

Why Long-Term Care Insurance Falls Short for So Many

By Jordan Rau and JoNel Aleccia - For 35 years, Angela Jemmott and her five brothers paid premiums on a long-term care insurance policy for their 91-year-old mother. But the policy does not cover home health aides whose assistance allows her to stay in her Sacramento, California, bungalow, near the friends and neighbors she loves. Her family pays $4,000 a month for that. Read Full Article…

VBA Article Summary

1. Inadequate Insurance Coverage and High Costs: The article highlights the shortcomings of the private insurance market in providing affordable and adequate long-term care insurance. Many older Americans find themselves unable to afford the escalating costs of home health aides, assisted living, or nursing home care. Premiums for long-term care insurance have soared, and many policies do not cover the full range of care needed today. For instance, Laura Lunceford's experience illustrates the significant increase in premiums and the inadequacy of older plans, which often only covered nursing home care.

2. Industry Challenges and Policyholder Struggles: The long-term care insurance industry has faced numerous challenges, including underestimating the longevity of policyholders and the cost of care. This has led to insurers exiting the market, increasing premiums, and offering less generous policies. The situation is compounded by high denial rates for insurance applications and claims. The industry's financial instability and the resulting impact on policyholders are exemplified through cases like Alice Kempski, who discovered her insurer was insolvent when she needed to claim benefits.

3. The Need for a Sustainable Solution: The article suggests that relying solely on the private insurance market to cover long-term care costs is untenable. It discusses the potential for government-subsidized programs or public alternatives, similar to systems in countries like the Netherlands and Singapore. However, efforts to establish such programs in the U.S. have yet to gain significant traction. The story of Jeffrey Tanck, who had to resort to crowdfunding to cover his parents' care, underscores the urgency for a more effective and accessible solution for long-term care financing.

US patients believe generative AI can improve healthcare access, affordability, survey finds

By Heather Landi - As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs. Read Full Article…

VBA Article Summary

1. Consumer Optimism and Generative AI in Healthcare: A Deloitte survey revealed that 53% of U.S. consumers believe generative AI could enhance medical care access and reduce wait times. Additionally, 46% see potential in making healthcare more affordable. Consumers are already using AI tools like ChatGPT for health-related purposes, with 69% finding the information very reliable. There's a notable optimism among patients about AI's role in revolutionizing healthcare delivery, with 71% of current AI users holding this view.

2. Challenges and Opportunities in Healthcare: The healthcare sector is grappling with increasing costs, high interest rates, inflation, and clinician burnout. Despite these challenges, patients are hopeful that technology, especially generative AI, can provide solutions. There's a growing acceptance of AI among consumers for obtaining information about health conditions and treatments, with a significant portion of patients using AI to learn about medical conditions (20%), understand treatment options (16%), and decipher technical language (15%).

3. Government and Consumer Readiness for AI Integration: The U.S. government is preparing for the widespread adoption of AI in healthcare, highlighted by a recent executive order from the White House. Consumers show a preference for AI being used by healthcare providers to supplement information about their conditions and treatment options. However, there is some hesitation regarding AI's role in critical decision-making aspects of care, such as diagnosis and treatment nature. Deloitte researchers emphasize the need for transparent processes and regulatory frameworks to align with consumer concerns and expectations.

The big question about obesity drugs: Can people ever stop taking them?

By Tina Reed - ​There's an emerging debate around a popular class of anti-obesity drugs: whether patients who go on them can ever expect to stop taking them. Read Full Article…

VBA Article Summary

1. Revolutionary Treatment, Costly Implications: The use of GLP-1 agonists, initially for Type 2 diabetes and now increasingly for weight loss, marks a significant shift in treating obesity as a chronic disease. This shift is not without its challenges, as it involves long-term treatment plans that raise concerns about cost, especially for insurers and clinicians prescribing them.

2. Debates and Dilemmas in Long-Term Use: The long-term efficacy of these drugs is under scrutiny. Patient advocates highlight the need to treat obesity as a biological condition rather than a lack of willpower. However, questions remain about the duration of treatment, especially since many patients discontinue use within 24 months due to side effects and coverage limits. The debate extends to whether obesity treatment should involve lifetime medication or if alternative strategies can be effective.

3. Balancing Effectiveness and Accessibility: The conversation includes arguments for treating obesity like other chronic diseases, which would mean continuous medication. Yet, there are voices advocating for exploring ways to use these drugs more effectively and affordably, such as tapering doses, switching to cheaper medications, or intermittent use. This approach could make treatment more accessible and palatable, especially for children and those hesitant about lifelong medication. Overall, there is a consensus on the need for robust patient support services to enhance the success of these treatments.

Telehealth could strengthen military’s mental health care, report says

By Meghann Myers - The military has struggled to provide adequate access to mental health care for years. And even as it has worked to reduce the stigma and consequences of seeking help, provider shortages have created appointment logjams and long wait times — if an appointment is even available at all. Read Full Article…

VBA Article Summary

1. Expanding Telehealth Access for Military Members and Dependents: The RAND Corp. report emphasizes the benefits of increased telehealth access for service members and their dependents, who often face challenges in maintaining consistent behavioral health (BH) care due to frequent relocations. The report highlights the issue of provider shortages, with 35% of service members living in areas with limited access to psychiatric care, and suggests that virtual visits could help alleviate this problem by distributing access more evenly.

2. Challenges and Considerations in Telehealth Implementation: The report outlines several considerations for the successful implementation of telehealth in the military context. This includes addressing digital literacy among patients, ensuring privacy and quiet for sensitive conversations, and equipping providers for effective virtual care. It notes that during the pandemic, many providers reverted to in-person care, indicating a need for better training and comfort in delivering high-quality virtual BH services.

3. Developing a Strategic Implementation Plan for Virtual Care: The RAND report recommends that the Department of Defense (DoD) develop a comprehensive plan for implementing virtual behavioral health services. This plan should include minimum requirements for equipment and infrastructure, recommended software programs, and guidelines for training and competency of the BH workforce. It also stresses the importance of creating consistent policies across military and civilian TRICARE providers and conducting studies to understand the specific needs and effectiveness of virtual care for the military community.

Will Ozempic lawsuits be the next big thing in mass litigation?

By Jenna Greene - When a product is wildly successful, lawsuits – meritless or not – tend to follow like flies to honey. To date, however, the makers of Ozempic and similar drugs have been spared a deluge of litigation by people who claim the blockbuster weight loss medications caused serious and unexpected side effects. Read Full Article…

VBA Article Summary

1. Pending Federal Cases and Potential Increase in Litigation: Currently, there are nine federal cases pending against Novo Nordisk's Ozempic and Eli Lilly's Mounjaro, with Morgan & Morgan representing over 13,000 clients under retainer. Despite millions of prescriptions for these drugs, the current litigation seems minimal, but the high number of clients suggests an impending increase in legal actions. Litigator Paul Pennock anticipates filing more cases regularly as individual claims are investigated.

2. Serious Side Effects and Labeling Concerns: Plaintiffs claim that Ozempic and similar drugs cause severe gastrointestinal side effects, including persistent vomiting leading to emergency room visits or hospitalization. There is an ongoing debate over whether drug labels sufficiently warn about these risks, with critics arguing that the labels fail to mention specific risks like gastroparesis. Both Novo Nordisk and Eli Lilly assert that known risks are reflected in the FDA-approved labeling.

3. Historical Context and Marketing Ethics: Comparisons are drawn between the current situation and past lawsuits against weight loss drugs, most notably the fen-phen litigation, which resulted in payouts exceeding $21 billion. The lawsuits allege that companies like Novo Nordisk fail to disclose full side effects, emphasizing the importance of adequately informing patients about potential risks associated with weight loss medications.