In HHS Reorganization, ONC to Take Bigger Role

By David Raths - In a significant reorganization within the U.S. Department of Health and Human Services, ONC will be renamed the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), with Micky Tripathi, Ph.D., in the new role of Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology. Read Full Article…

HVBA Article Summary

1. Reorganization of Responsibilities: Oversight of technology, data, and artificial intelligence policy and strategy within the U.S. Department of Health and Human Services (HHS) will be centralized under the ASTP/ONC. This shift includes the integration of roles such as the Chief Technology Officer, Chief Data Officer, and Chief AI Officer into ASTP/ONC. Additionally, a new Office of Digital Services will be established to further enhance digital and technological capabilities across the department.

2. Cybersecurity Consolidation: The 405(d) Program, a public-private cybersecurity initiative between the health sector and the federal government, will transition to the Administration for Strategic Preparedness and Response (ASPR). This move aims to consolidate health sector cybersecurity activities within ASPR’s Office of Critical Infrastructure Protection, supporting the goal of creating a unified healthcare cybersecurity policy hub.

3. Institutional Changes and Commitments: The ASTP/ONC will establish an Office of the Chief Technology Officer and reinstitute the role of Chief Technology Officer to lead HHS’s department-level and cross-agency technology, data, and AI strategy and policy. Micky Tripathi, in a blog post on ONC’s website, highlighted the formalization of ONC’s role in shaping technology and data policy, which is expected to enhance synergy across health IT and other divisions, ensuring optimal use of technology and data in health services.

3 Big Pharma cancer drugs facing inflation penalties

By Amy Baxter - Big Pharma will need to pony up for some of its biggest price hikes. The industry expects invoices from the government later this year as a penalty for raising drug prices faster than the rate of inflation. Read Full Article…

HVBA Article Summary

1. Inflation Penalties and Rebates for Drug Companies Under the IRA: The Inflation Reduction Act mandates that pharmaceutical companies pay penalties when their drug prices increase faster than inflation. As of the latest announcement, 64 drugs are affected, including several from major pharmaceutical companies. These drugs are separate from those under direct price negotiation with Medicare, which is another aspect of the IRA. The penalties aim to stabilize costs by requiring companies to refund the excess amount charged over the inflation rate, based on average sales price and units sold to Medicare. This money is then deposited into the Medicare Trust Fund, helping reduce coinsurance rates temporarily for beneficiaries.

2. Implications for Big Pharma’s Top Treatments: Among the drugs listed for inflation rebates are three notable cancer treatments: Pfizer’s Adcetris, and Bristol Myers Squibb’s Abecma and Breyanzi. Adcetris, primarily used for Hodgkin lymphoma, has seen its coinsurance percentage adjusted downward, offering temporary cost relief for patients. Abecma and Breyanzi, both CAR-T cell therapies, face similar financial adjustments due to the penalties, even as they navigate a competitive market and new approvals that could boost future sales.

3. Specific Case Study - Pfizer and Padcev: Pfizer’s handling of Padcev, a treatment for bladder cancer, exemplifies the financial implications of the IRA’s inflation penalty provision. After acquiring Padcev through the purchase of Seagen, Pfizer has been subject to additional scrutiny as the drug's price has consistently risen faster than inflation, leading to adjusted coinsurance rates for Medicare recipients. Despite these penalties, Padcev’s strong sales performance contributes significantly to Pfizer’s revenue, highlighting the complex interplay between regulatory impacts and pharmaceutical pricing strategies.

Celebrating Medicare’s 59th Birthday Amidst Troubling Trends

By Wendell Potter - [On Tuesday], we celebrate[d] the 59th birthday of Medicare, a cornerstone of American health care that has provided critical services to millions of seniors since its inception in 1965. This historic program was a watershed moment in our nation’s history, transforming the landscape of health care and ensuring that older Americans and the disabled could access necessary medical services without facing financial ruin. Medicare’s legacy is one of promise and protection, grounded in the belief that no American should go without the health care they need. Read Full Article…

HVBA Article Summary

1. Deviation from Original Medicare's Mission: Medicare Advantage plans, primarily operated by for-profit insurers, have significantly diverged from the original intent of Medicare, which was to provide a simple and efficient government-managed healthcare solution for seniors. These plans prioritize profits over patient care, often resulting in higher costs and more restrictive provider networks for enrollees, which complicates their access to necessary medical services.

2. Financial Drain on Medicare Trust Fund: Reports from MedPac and Physicians for a National Health Program this year highlighted severe overpayments to Medicare Advantage plans, estimating excess payments of $83 billion and $140 billion, respectively. These overpayments, often attributed to questionable risk adjustment practices by insurers, siphon funds from traditional Medicare, threatening the program's sustainability and the quality of care available to all beneficiaries.

3. Regulatory Response to Protect Medicare: The growing scrutiny by regulators towards the manipulative practices of Medicare Advantage plans is a positive development. By focusing on reducing these overpayments and ensuring that Medicare funds are used efficiently, lawmakers and regulators are taking essential steps to safeguard the program for future generations, ensuring it remains a viable healthcare solution for seniors.

Nearly a third of adolescents getting mental health treatment, federal survey finds

By Alexander Tin - Close to 1 in 3 adolescents in the U.S. received mental health treatment in 2023, the Substance Abuse and Mental Health Services Administration reported Tuesday, which works out to around 8.3 million young people between the ages of 12 and 17 getting counseling, medication or another treatment. Read Full Article…

HVBA Article Summary

1. Increase in Mental Health Treatment Accessibility: The survey revealed a noticeable uptick in individuals accessing mental health services, particularly among adolescents. In 2023, 13.9% of adolescents aged 12 to 17 received prescription medication for mental health issues, a slight increase from 12.8% in 2022. This upward trend is consistent with efforts to destigmatize mental health treatment and make it more accessible, as emphasized by SAMHSA and the Biden-Harris administration.

2. Substance Use Trends among Adolescents and Adults: Traditional cigarette use continued to decline in 2023, falling to 13.7% among adolescents and adults. Conversely, nicotine vaping rose to 9.4% from 8.3% in 2022. Marijuana use remained stable overall, with 21.8% of adolescents and adults using marijuana, although underage use showed a marginal decline to 18.4%.

3. Changes in Alcohol Consumption Patterns: Alcohol consumption experienced a statistically significant reduction in 2023, with 47.5% of adults and adolescents reporting alcohol use in the past month, down from 48.7% in 2022. Despite the decrease in general alcohol consumption, the prevalence of alcohol use disorder and binge drinking rates remained largely unchanged, underscoring the ongoing challenges in addressing alcohol-related health issues.

Pennsylvania Bans Healthcare Practitioner Noncompete Agreements Longer Than 1 Year

By Jennifer Betts, Zachary V. Zagger, and Yuliya Khromyak - In a major noncompete development for the Commonwealth of Pennsylvania, beginning January 1, 2025, certain noncompete agreements with doctors, registered nurses, and other healthcare practitioners will no longer be enforceable in Pennsylvania. Read Full Article…

HVBA Article Summary

1. Restrictions on Noncompete Agreements: Starting January 1, 2025, the "Fair Contracting for Health Care Practitioners Act" in Pennsylvania will render noncompete agreements unenforceable if they restrict healthcare practitioners from practicing their profession for more than one year after leaving an employer. This law reflects a broader trend across various states seeking to limit the duration and enforceability of noncompete clauses, particularly in the healthcare sector.

2. Patient Notification Requirements: Under the new legislation, healthcare employers must inform patients within ninety days if their healthcare practitioner leaves the practice. This notification must include information on how patients can transfer their records and the option to be reassigned to a new practitioner within the same practice. This measure aims to enhance transparency and continuity of care for patients undergoing a change in their healthcare provider.

3. Scope and Exceptions of the Act: The Act only affects noncompete agreements entered into after its effective date and includes specific exceptions. For example, noncompete agreements valid for up to one year will still be enforceable if the practitioner was not terminated by the employer. Additionally, the law does not interfere with contracts that involve recovery of costs directly related to the practitioner, nor does it affect noncompete clauses linked to the sale of a business.

Semaglutide May Help Smokers Quit, Study Suggests

By Elizabeth Short - Among patients with type 2 diabetes and tobacco use disorder (TUD), use of the GLP-1 receptor agonist semaglutide (Ozempic, Wegovy) was associated with a reduced risk of medical encounters for TUD compared with other diabetes medications, according to an emulation target trial. Read Full Article…

HVBA Article Summary

1. Strongest Association with Semaglutide: The study reported the strongest association with reduced risk of medical encounters for tobacco use disorder (TUD) diagnosis, smoking cessation medication prescriptions, and smoking cessation counseling when semaglutide was compared with insulins, showing a hazard ratio (HR) of 0.68. This finding underscores semaglutide's potential as a smoking cessation aid, particularly notable across patients with and without obesity, and was observed within 30 days of prescription initiation.

2. Comparison with Other Medications: While semaglutide showed a statistically significant yet weaker association when compared with other GLP-1 receptor agonists (HR 0.88), its effects were consistent and superior across various diabetic medications. It was linked to lower risks for TUD diagnosis and related medical encounters when compared with a broad spectrum of diabetes medications including insulins, metformin, and DPP-4 inhibitors, suggesting its broader applicability in diabetic patients who smoke.

3. Implications for Smoking Cessation and Limitations: Patients on semaglutide reported a reduced desire to smoke, supporting its utility as a smoking cessation tool. However, the study was retrospective and observational, which limits the ability to make causal inferences. The authors caution against off-label use for smoking cessation without further research, highlighting the need for randomized clinical trials to confirm these findings and fully understand semaglutide’s benefits beyond glycemic control.

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

By Emily J. Cook - On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. Read Full Article…

HVBA Article Summary

1. CMS Proposals for 340B Drugs: The Centers for Medicare and Medicaid Services (CMS) have outlined proposals to ensure claims-level information reporting for Medicare Part D 340B drugs and to employ claim modifiers for excluding Part B claims. These proposals, effective from January 1, 2024, mandate that all 340B-covered entities report claim-line modifiers for separately payable Medicare Part B drugs. This aligns with CMS's ongoing efforts to streamline reporting and reduce overpayments in the Medicare system.

2. Stakeholder Engagement and Legal Considerations: Given the significant implications of the CMS proposals and recent judicial rulings such as the end of the Chevron doctrine, stakeholders in the 340B program are encouraged to submit comments by September 9, 2024. The input from these comments is anticipated to be crucial in shaping the final rules and may also influence the outcomes of potential legal challenges to CMS's regulations.

3. Methodologies for Drug Cost Management: CMS is adopting differentiated methodologies to identify and exclude 340B drugs from inflation rebate calculations for Part B and Part D. For Part D, a new estimation methodology will be introduced in 2026, based on the ratio of 340B units purchased to the total units sold. For Part B, initial methods will include the use of specific modifiers on claim lines, transitioning to a unified modifier approach by 2025. These methods aim to accurately track and manage 340B drug costs within the Medicare framework.

When's the Best Time to Eat to Reduce Diabetes Risk?

By Antara Ghosh - Higher energy intake and glycemic load in the late morning are associated with a lower risk for type 2 diabetes (T2D) in Hispanic/Latino adults. Read Full Article…

HVBA Article Summary

1. Study Design and Participant Demographics: Researchers conducted a comprehensive prospective cohort study involving 8,868 Hispanic/Latino adults without diabetes, aged on average 38.7 years, including 51.5% women. The study spanned across four U.S. communities from 2008 to 2011, with a follow-up clinic examination from 2014 to 2017. Participants' meal timings were categorized into five distinct periods, with comprehensive assessment of energy intake and glycemic load for each period through two 24-hour dietary recalls.

2. Key Findings and Risk Associations: The study found that each 100-kcal increase in energy intake and each 10-unit increase in glycemic load during the late morning (9:00-11:59 AM) were associated with a 6% and 7% lower risk of type 2 diabetes (T2D), respectively. These associations were statistically significant and remained robust after adjusting for total energy intake, diet quality, and other potential confounders. Notably, no such protective associations were observed for meal timings in the early morning, afternoon, evening, or night.

3. Practical Implications and Recommendations: This research supports the potential benefits of aligning meal times with the natural diurnal rhythm of glucose tolerance to mitigate diabetes risk. By shifting just 100 kcal of energy intake or 10 units of glycemic load from early morning, afternoon, or evening meals to the late morning, individuals could potentially reduce their risk of developing diabetes by 5% to 9%. These findings advocate for dietary adjustments that consider not just what but when we eat, aligning our eating patterns more closely with our biological clocks.

Eco-Anxiety and Patients' Need for Mental Health Support

By Stéphanie Lavaud - It is no secret that the accelerating climate change increasingly threatens patients' mental health and psychosocial well-being, leading to psychologic distress, anxiety, depression, grief, and suicidal behavior. This relationship is evidenced by the emergence of new terms such as "eco-anxiety." Read Full Article…

HVBA Article Summary

1. Global Warming and Mental Health Correlation: Professor Martin Beniston highlighted the significant rise in global temperatures since the industrial era, notably more than 1°C over the last century, with a more pronounced increase in Europe. This change, according to Beniston, has direct and indirect impacts on mental health, ranging from vulnerability due to natural disasters like floods to the rise of new diseases via pollution and invasive species. He raised concerns about these climate consequences occurring earlier than predicted by the Intergovernmental Panel on Climate Change.

2. Disproportionate Impact Among Vulnerable Populations: Professor Philippe Conus discussed the varying effects of climate change on mental health across different demographic groups, emphasizing that the impact is more severe among vulnerable populations, such as those with existing mental illnesses. He referenced a specific example from the 2021 North American heatwave that led to a significant increase in deaths among patients with schizophrenia in British Columbia, showcasing the acute effects of extreme weather conditions on vulnerable groups.

3. Addressing Eco-Anxiety and Promoting Resilience: Conus elaborated on the psychiatric consequences of climate change, classifying them into direct, gradual, and indirect impacts. He specifically focused on the widespread issue of eco-anxiety among younger generations, providing advice on managing this anxiety through connection with nature, sharing experiences, and taking actionable steps at an individual level to regain a sense of control over environmental issues. This approach aims to help individuals cope with the psychological strain caused by climate change and promote mental resilience.