Guidance For COVID Drug Development Encourages Diverse Trial Enrollment

Final FDA guidance on the development of drugs for the treatment and prevention of COVID-19 encourages sponsors to ensure they are including diverse populations in their clinical trials, including older populations in nursing homes that are most vulnerable to COVID-19, children, and pregnant or lactating patients. The document also notes that COVID-19 variants continue to evolve and genetic changes may impact the effectiveness of antiviral drugs. “Using an antiviral drug to treat COVID-19 may contribute to the emergence of viruses...
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FDA Week - 12/01/2023
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AMA To Study Effect Of AI, LLMs On Health Policy

The American Medical Association’s House of Delegates took steps in early November to further examine the benefits and risks of some artificial intelligence technologies on health policy decision making. Documentation from the interim meeting cited instances of large language models and generative pre-training transformers providing biased and misleading information on topics that could be involved in health care policy decision making, like scope of practice and training requirements. The delegates discussed a resolution that says that while AMA already has...
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AMA To Study Effect Of AI, LLMs On Health Policy

The American Medical Association’s House of Delegates took steps in early November to further examine the benefits and risks of some artificial intelligence technologies on health policy decision making. Documentation from the interim meeting cited instances of large language models and generative pre-training transformers providing biased and misleading information on topics that could be involved in health care policy decision making, like scope of practice and training requirements. The delegates discussed a resolution that says that while AMA already has...
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FDA Week - 12/01/2023
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Vol. 29, No. 48
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Health Leaders Eshoo, Burgess And Wenstrup To Leave Congress Next Year

The top Democrat on the House Energy & Commerce health subcommittee, Rep. Anna Eshoo (D-CA), announced this week that she will retire at the end of her current congressional term in 2025, joining several members of the House in both parties who have been leaders on health issues and plan to leave Congress. Two prominent Republican health leaders and co-chairs of the GOP Doctors Caucus also will not seek reelection. Rep. Brad Wenstrup (R-OH) announced he will retire after 10...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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States Preserve HCBS Flexibilities, Researchers Parse Caregiver Support

Half of states are planning to extend the home and community-based services flexibilities established during the COVID-19 public health emergency, including nine looking to add relatives and family caregivers as reimbursable services providers. But some researchers are also seeking ways to improve support for family caregivers under Medicare as demand for home-based care increases. To help support HCBS recipients and families during the COVID-19 public health emergency, state Medicaid programs were given the temporary authority to offer additional HCBS flexibilities,...
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Manhattan Institute To Congress: Stem Drug Shortages Via Generic Imports, FDA Accountability

The public policy think tank Manhattan Institute says the drug shortage problem is worse than it appears and Congress should take two steps: Allow imports of high-risk generic drugs in shortage from trusted foreign counties and require better accounting of FDA’s efforts to identify and stem shortages. There are several bills floating in Congress that address drug shortages, but the think tank says the proposals only offer meager solutions to the crisis. It also says FDA’s actions haven’t solved the...
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Advocates: AZ Proposal To Expand CHIP Reveals Issues With Process

Arizona’s proposed 1115 waiver to expand Children’s Health Insurance Program eligibility to families with incomes up to 225% of the federal poverty level highlights how slow and inconvenient the current process is for states to expand CHIP, children’s health advocates say as they urge Congress to create in the next legislative package a simpler pathway to let states expand CHIP eligibility. Meanwhile, the American Academy of Pediatrics would like to see lawmakers combine Medicaid and CHIP into one program. The...
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Inside CMS - 11/30/2023
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Admin Touts 4.6 Million ACA Plan Sign-Ups

Around 4.6 million people have selected a plan year 2024 Affordable Care Act plan through healthcare.gov or a state-based exchange from the start of open enrollment, including 920,000 new enrollees, according to CMS’ ACA enrollment snapshot released Tuesday (Nov. 21). The data also underscore the impact of Medicaid redeterminations and the special enrollment period for those losing coverage, with CMS reporting that 1.5 million more people enrolled nationwide from March to September compared to the same period last year, which...
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