House Lawmakers Drill Down On Use Of AI In Health Care

Wednesday’s (Nov. 29) House Energy & Commerce health subcommittee hearing on the use of artificial intelligence in health care raised new issues on CMS’ reimbursement of the technology and possible new ways for lawmakers to wrap their heads around AI, while refining existing questions on the tech like the need for a national data privacy framework and ensuring demographic representation in the training of the models to promote health equity. At E&C’s fourth hearing this year on artificial intelligence, lawmakers...
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House Lawmakers Drill Down On Use Of AI In Health Care

Wednesday’s (Nov. 29) House Energy & Commerce health subcommittee hearing on the use of artificial intelligence in health care raised new issues on CMS’ reimbursement of the technology and possible new ways for lawmakers to wrap their heads around AI, while refining existing questions on the tech like the need for a national data privacy framework and ensuring demographic representation in the training of the models to promote health equity. At E&C’s fourth hearing this year on artificial intelligence, lawmakers...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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Bumpus To Become FDA Principal Deputy Commissioner As Woodcock Retires

FDA Chief Scientist Namandjé Bumpus will replace Janet Woodcock as the agency’s principal deputy commissioner when Woodcock retires next year after spending decades at the agency and building a reputation as a medical regulation icon, Commissioner Robert Califf announced Wednesday (Nov. 29). Bumpus, who has sought to combat health misinformation and advocated for advisory committee reform, steps into her new role with major changes in progress at FDA. Califf announced the pending promotion in a social media post. Bumpus assumed...
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FDA Week - 12/01/2023
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Vol. 29, No. 48
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AMA Floats Principles To Steer Its Lobby Efforts On AI/ML Oversight

The nation’s leading physician lobby on Tuesday unveiled a series of principles to guide its discussions with the administration, Congress and industry stakeholders on policies to regulate the development, deployment and use of health care artificial intelligence and machine learning. The American Medical Association calls for development of comprehensive national policies that mitigate the quickly evolving technology’s risks to patients and physicians while also maximizing AI’s benefits in health care, and says third-party AI developers and data holders, payers and...
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AMA Floats Principles To Steer Its Lobby Efforts On AI/ML Oversight

The nation’s leading physician lobby on Tuesday unveiled a series of principles to guide its discussions with the administration, Congress and industry stakeholders on policies to regulate the development, deployment and use of health care artificial intelligence and machine learning. The American Medical Association calls for development of comprehensive national policies that mitigate the quickly evolving technology’s risks to patients and physicians while also maximizing AI’s benefits in health care, and says third-party AI developers and data holders, payers and...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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Consumer Advocates, CareQuest Celebrate NBPP Adult Dental Proposal

A proposal in the 2025 draft exchange rule that would allow states to add adult dental services as an essential health benefit (EHB) is being cheered by advocates who have been calling on the administration to boost oral health care coverage. The draft rule doesn’t add a requirement for plans or states, but it would remove a prohibition on adding adult dental as an EHB that had been in effect for the last decade. Several sources point out that while...
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Senators To HHS: Probe Insurers’ Use Of Generic Drug Price Hikes To Evade MLR

A bipartisan Senate duo have asked the HHS Office of Inspector General to look into how three major health insurers are using vertically integrated specialty pharmacies to get around the Medical Loss Ratio (MLR) requirement that they spend at least 80% or 85% of health care premium dollars on medical claims. Sens. Elizabeth Warren (D-MA) and Mike Braun (R-IN) want the HHS OIG to investigate the extent to which Cigna, CVS Aetna and UnitedHealth Group are hiking up the prices...
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Four In 10 MA Plans Offering Supplemental Benefits in 2024

About 2,300 of the 5,800 MA plans, or 40%, are offering supplemental benefits in 2024, according to recent data analyzed by ATI Advisory. The overall number and percentage of plans offering SSBCI has increased, but not at the same rapid pace as in prior years. The data for 2024 are contextualized by ATI’s ongoing concerns with a scarcity of data on supplemental benefits. Tyler Cromer, a principal at consulting firm ATI Advisory, along with Sara Rayel, director of health care...
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CMS Issue: 
Inside CMS - 11/30/2023
CMS Volume: 
Vol. 26, No. 48
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Generic Drug Lobby To CMS: Mandate Hospitals Buy Generics Through Long-Term Contracts

As CMS continues to explore its idea of increasing reimbursement for hospitals that stockpile “buffer” supplies of essential medicine, the generic drug lobby urges the agency to mandate hospitals procure generic medications through stable, long-term contracts with fixed volumes to ensure a resilient supply chain. This comes after the Association for Accessible Medicines (AAM) raised concerns on whether the agency’s proposal to pay hospitals extra to set up “buffer stocks” of essential drugs to avert shortages would be enough to...
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FDA Issue: 
FDA Week - 12/01/2023
FDA Volume: 
Vol. 29, No. 48
CMS Issue: 
Inside CMS - 11/30/2023
CMS Volume: 
Vol. 26, No. 48
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FDA Quits China-Led Device Harmonization Group

FDA announced it is withdrawing from the Asia-led international organization that works on medical device regulatory coordination, the Global Harmonization Working Party (GHWP), citing concerns about the lack of representation for international regulators, decision-making processes dominated by industry stakeholders, and use of documents duplicated from other groups. The announcement indicates that the United States will focus instead on international regulatory efforts through the International Medical Device Regulators Forum (IMDRF), of which it is a founding member. FDA’s top medical device...
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FDA Week - 12/01/2023
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Vol. 29, No. 48
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