White House orders HHS to collect reports on healthcare AI safety

By Nick Paul Taylor - Regulatory scrutiny of AI has increased over the past year. The European Union is developing the AI Act, legislation that it claims will be the first comprehensive AI law, and the FDA is drafting guidance on AI-enabled device software functions. Now, the White House has set out its stance on AI in an executive order. Read Full Article…

VBA Article Summary

1. Establishment of an AI Safety Program: The directive mandates the Department of Health and Human Services (HHS) to form an AI safety program within a year. This program is tasked with developing a unified framework to identify and document clinical errors caused by AI, including those related to bias or discrimination. It also aims to establish a central database to track incidents that result in harm to patients, caregivers, or others.

2. Data Analysis and Development of Best Practices: The HHS is responsible for analyzing the data collected from the central tracking repository. Using this analysis, the department will synthesize evidence to create and disseminate best practices, recommendations, or guidelines. These resources are intended to mitigate potential harms associated with the use of AI in healthcare settings.

3. Formation of an AI Task Force and Strategic Planning: The order requires the HHS to collaborate with the Secretaries of Defense and Veterans Affairs to form an AI Task Force within 90 days. This task force has a subsequent year to formulate a strategic plan focusing on the responsible implementation and utilization of AI. This plan should include policies for monitoring AI technologies' safety and performance in the real world, integrating equity principles, and embedding safety, privacy, and security standards throughout the software development lifecycle.

17 health care groups urge Congress to pass value-based care bill, extend 5% incentive

By Dan Cook - Support from health care professionals and their representatives is growing for the The Value in Health Care Act. The bill, which promotes value-based health care, was reintroduced in the House of Representatives in late July. It now comes with a resounding endorsement from 17 health stakeholder groups. Read Full Article…

VBA Article Summary

• Introduction of Accountable Care Model: The Value in Health Care Act is a pivotal legislative step aimed at transforming the healthcare system from a volume-based fee-for-service structure to an outcome-driven Accountable Care Model. This shift intends to incentivize medical professionals to focus on the quality of patient outcomes rather than the quantity of services provided. The act is a response to extensive research indicating that the fee-for-service model promotes overutilization of medical interventions, while accountable care encourages physicians to dedicate more time to patient care, maintain independence, and integrate performance-based compensation.

• Improvements and Endorsements: The reintroduced bill, receiving strong backing from 17 health groups, seeks to enhance the original act by making several key improvements to the current value-based care programs administered by the Centers for Medicare & Medicaid Services (CMS). These improvements include a two-year extension of 5% advanced alternative payment model incentives, adjustments in payment thresholds to support diverse medical practices, the removal of revenue-based distinctions that disadvantage rural providers, transparent financial targets for Accountable Care Organizations (ACOs), and additional support for clinicians transitioning to these models. The bill also includes provisions to address health equity and studies to balance the payment models within traditional Medicare and Medicare Advantage plans.

• Potential Impact and Support for Passage: With ACOs having saved Medicare billions and improved care for millions, the Value in Health Care Act is recognized as a necessary advancement to solidify and enhance the shift towards value-based care initiated by the Medicare Access and CHIP Reauthorization Act (MACRA). The legislation aims to overcome the slow progress of the transition by solidifying incentives and support structures for physicians. Various medical associations and groups, including the Medical Group Management Association (MGMA), have expressed that this bill is crucial, especially in the face of proposed Medicare reimbursement cuts, to support practices in the move towards a sustainable, patient-centered care model. The widespread industry support underscores the bill’s significance in advancing value-based care within the healthcare system.

How does the quality of the U.S. health system compare to other countries?

By Imani Telesford, Emma Wager, Krutika Amin, and Cynthia Cox - Despite spending more money per capita on healthcare than any similarly large and wealthy nation, the United States has a lower life expectancy than peer nations and has seen worsening health outcomes since the onset of the COVID-19 pandemic.  Read Full Article…

VBA Article Summary

1. Long-Term Health Outcomes: The United States observed a decline in life expectancy in 2021, further widening the gap with peer nations where life expectancy rebounded. While both the U.S. and comparable countries have made strides in reducing years of life lost and overall mortality rates since 1980, the progress has been more pronounced in peer nations. The U.S. notably experienced a higher increase in premature deaths during the pandemic in 2020 and 2021, partially driven by racial disparities, and continues to have higher rates of disease burden as measured using disability adjusted life years (DALYs).

2. Treatment Outcomes: The U.S. showed better outcomes in 30-day mortality rates for ischemic strokes compared to an average of similar countries in 2020. However, the country has seen rising maternal mortality rates, which are significantly higher compared to peer nations, alongside a notable racial disparity in maternal mortality rates. Furthermore, higher hospital admission rates for chronic conditions like congestive heart failure and complications due to diabetes were observed in the U.S., indicating a potential lack of preventive services or adequate primary care.

3. Patient Safety and Experiences: Rates of obstetric trauma during vaginal deliveries with instruments and post-operative complications like pulmonary embolism or deep vein thrombosis were higher in the U.S. compared to most peer countries. However, post-operative sepsis rates were lower in the U.S. Also, higher rates of reported medication and treatment errors were noted, while the U.S. had the lowest rate of retained surgical items or unretrieved device fragments in 2020. Patient experiences highlighted a higher rate of missed consultations due to cost in the U.S., which may lead to worsened health outcomes and increased costs in the long run.

Defunct direct contracting model saved Medicare $372M last year

By Rebecca Pifer - The defunct Global and Professional Direct Contracting Model allowed physicians offer more flexible benefits than traditional Medicare and accept either full or partial capitation as payment for coordinating patients’ care. Read Full Article…

VBA Article Summary

1. Improved Savings in 2022: The Direct Contracting Entities (DCEs) involved in Medicare witnessed a significant enhancement in savings in 2022 compared to 2021, attributed to having a full year for patient care management unlike the disrupted nine months in 2021 due to the pandemic. The total savings approached $870 million, with the CMS compensating DCEs $484 million in shared savings, showcasing the fiscal potential with adequate time for patient care management.

2. Notable Net Savings Achievements: Various organizations achieved remarkable net savings; Iora, a subsidiary of Amazon, led with $37.7 million, followed by VillageMD with $40.4 million, which is majority-owned by Walgreens and operated six DCEs across different states. Other entities like the CVS division Oak Street Health and a DCE operated by Intermountain Healthcare also secured high net savings of $31 million and $34.3 million respectively, illustrating the lucrative and competitive nature of managing medical costs in Medicare.

3. Transition to ACO REACH Model: Post the 2022 performance year, a transition to a new model, ACO REACH, has been initiated following concerns from lawmakers about Medicare privatization. This new structure, emphasizing provider-led organizations and addressing health disparities, aims to further streamline the management of care for Medicare seniors. The National Association of ACOs lauded the savings achieved, asserting that these results reinforce the importance of investing in alternative payment models, encouraging continued participation despite the structural shift.

Is exercise more effective than medication for depression and anxiety?

By Robby Berman - An expansive analysis of existing research concludes that physical activity should be viewed as a first-choice treatment for people living with mental health issues. The analysis distills the conclusions of nearly 100 meta-reviews of randomized controlled trials. Read Full Article…

VBA Article Summary

1. Superior Efficacy of Exercise: Dr. Ben Singh, the study's lead author, suggests that physical activity is 1.5 times more effective than medication or cognitive behavior therapy for alleviating mild-to-moderate symptoms of depression, stress, and anxiety. Although widely acknowledged as beneficial for mental health, physical activity is not employed as frequently as it should be for the management of depression and anxiety, the study highlights. All types of exercise have a positive impact on mental health, with the study revealing that higher-intensity activities yield the most significant benefits.

2. Optimal Duration and Intensity: The research indicates that short-term exercise programs are more beneficial than longer ones, with the greatest advantages diminishing with more extended exercise regimens. The findings underscore that individuals with mental health challenges do not need to engage in long-term, intensive exercise routines to reap maximum therapeutic benefits. According to the study published in BJM Sports Medicine, 150 minutes of physical activity per week, including activities like brisk walking, weightlifting, and yoga, can significantly reduce depression, anxiety, and psychological distress.

3. Global Mental Health Crisis and Non-Pharmacological Interventions: The World Health Organization (WHO) reports that nearly one billion people worldwide suffer from mental disorders, primarily anxiety and depression, with a projected increase in these conditions following the COVID-19 pandemic. The extensive study reviewed 97 meta-analyses of 1,039 randomized controlled trials, concluding that exercise can be as effective, if not more so, than traditional psychotherapy and pharmacotherapy for treating mental health issues. Dr. Singh advocates for the inclusion of exercise as a primary treatment modality for mental health concerns and encourages collaboration between mental health and physical activity professionals to create comprehensive treatment plans for patients.

Ozempic, Wegovy, and Mounjaro: A Bargain or Too Expensive?

By George Citroner - While Ozempic, Wegovy, and Mounjaro have gained attention for their significant weight loss effects, the drugs' domestic cost has raised some eyebrows. Read Full Article…

VBA Article Summary

1. Pricing Discrepancies between the U.S. and Other Nations: The costs of semaglutide-based weight loss drugs such as Ozempic and Wegovy are significantly higher in the United States compared to other developed nations. For example, a month’s supply of Ozempic costs $936 in the U.S., while it's priced under $200 in countries like Germany, Switzerland, and the United Kingdom. These disparities highlight the financial burden faced by Americans, even in light of the reductions made possible through insurance coverages and manufacturer rebates.

2. Insurance Coverage and Affordability: Insurance coverage significantly lowers the price of these anti-obesity drugs, but the costs remain high. Manufacturer Novo Nordisk emphasizes the importance of insurance coverage, advocating for government and commercial insurance plans to cover these drugs to enhance affordability. Despite these measures, insured individuals not covered for these drugs still face high out-of-pocket expenses, illustrating the persistent affordability issue.

3. Impact on Medicaid and Low-Income Groups: Concerns about Medicaid solvency arise as more states consider covering semaglutide. With 86 million individuals enrolled in Medicaid, the financial strain is apparent. Loren Anthes from Yuvo Health suggests that the cost-saving aspect of preventing obesity-related diseases should be weighed against the high costs of these drugs. For low-income groups, the intertwined challenges of obesity, diabetes, and food insecurity further complicate the affordability and accessibility of these crucial medications.

Corporate Wellness Market Worth USD 138.1 Billion by 2031

By Transparency Market Research - The latest research study released by Transparency Market Research on "Corporate Wellness Market Forecast to 2023-2031 ″ research provides accurate economic, global, and country-level predictions and analyses. It provides a comprehensive perspective of the competitive market as well as an in-depth supply chain analysis to assist businesses in identifying major changes in industry practices. Read Full Article…

VBA Article Summary

1. Market Growth and Projections: The Corporate Wellness market is anticipated to reach a valuation of US$ 138.1 billion by the end of 2031, expanding at a CAGR of 8.4% from 2023 to 2031, according to Transparency Market Research (TMR). A comprehensive SWOT analysis within the industry points to growth drivers, restraints, and a spectrum of financial and economic factors influencing the market. The availability of a sample market research report for stakeholders through a dedicated link demonstrates the commitment to provide tailored insights for strategic business decisions.

2. Competitive Landscape and Segmentation Analysis: Key players such as Anthem, Inc., Virgin Group Ltd., and Alphabet Inc., among others, are profiled with detailed business overviews, financial data, and strategic analysis. The market has been extensively segmented by type and application, with revenue forecasts provided for each segment to offer a granular view of the market. The report provides a competitive intelligence that includes business models, product/service analysis, recent developments, and strategic growth initiatives.

3. Regional Insights and Strategic Recommendations: The Corporate Wellness market is broken down by regions, with North America, Europe, Asia-Pacific, South America, and the Middle East & Africa analyzed for market consumption, growth opportunities, and trends. Strategic recommendations are provided for both new entrants and existing market players to navigate the competitive landscape and capitalize on growth opportunities. The report employs a robust research methodology, encompassing both primary and secondary data sources, ensuring a comprehensive market analysis for stakeholders.

FDA says the decongestant in your medicine cabinet probably doesn't work. Now what?

By Dr. Jeffrey Singer - Just before cold and flu season is set to kick off, the Food and Drug Administration's advisory panel last month reported that an oral decongestant Americans have relied on for nearly 20 years is no better than a placebo. Read Full Article…

VBA Article Summary

1. Regulatory Impact on Decongestants: In 2005, the Combat Methamphetamine Epidemic Act (CMEA) forced pseudoephedrine, an effective oral decongestant found in products like Sudafed, behind the counter to curb the manufacturing of methamphetamine. To avoid regulatory hurdles and the stigma associated with purchasing pseudoephedrine, many drugmakers, such as the makers of Sudafed PE and Nyquil Sinex, switched to phenylephrine, leaving pseudoephedrine-based medications like Claritin-D, Zyrtec, and Allegra behind the counter.

2. Efficacy Concerns and FDA Response: Subsequent studies, including those by two academic pharmacists from the University of Florida in 2007 and later by Merck, indicated that phenylephrine was no more effective than a placebo when taken orally. These findings were due to the breakdown of phenylephrine by digestive enzymes before it could be absorbed effectively. Despite these findings and petitions to the FDA, it took until 2023 for an advisory panel to confirm the ineffectiveness of oral phenylephrine, decades after the initial approval.

3. Legislative Repercussions and Market Reactions: The CMEA has been criticized for not only restricting access to effective cold and allergy relief but also failing to prevent a rise in methamphetamine production, which has surged due to methods developed by Mexican cartels. As drug-related deaths increased dramatically, the law's effectiveness came into question. With CVS's decision to remove phenylephrine-based decongestants from its shelves, the FDA faces pressure to respond. Lawmakers are now urged to repeal the CMEA to restore access to effective medications like Sudafed and Claritin-D and to address the unintended consequences of the act.