CMS Creates New Online Portal For EMTALA Complaints

CMS is launching a new portal that would allow patients to easily file a complaint under the Emergency Medical Treatment and Labor Act (EMTALA), an effort to step up EMTALA protections as the Supreme Court considers a case over whether the law requires hospitals to provide abortions to patients in need. The web portal is accessible through CMS.gov, the agency announced Tuesday (May 21) . “HHS is committed to protecting access to emergency medical care for everyone in America and...
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CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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Cutting Foreign Ties Could Lead To Drug Supply Chain Disruptions, Industry Warns

As House committees advance bills that would bar American companies from working with some foreign-owned biotechnology companies in the future, industry experts warn ending pharmaceutical relationships with China could lead to drug shortages and supply chain disruptions. Darius Lakdawalla, director of research at University of Southern California Schaeffer Center for Health Policy and Economics, said at the U.S. Pharma and Biotech Summit Thursday (May 16) that cutting ties with foreign companies could worsen supply chain issues in the United States...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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Colorado Gov. Polis Signs AI Bill To Inform National Debate, While Calling For Federal Law

Colorado Gov. Jared Polis (D) has signed legislation “concerning consumer protections in interactions with artificial intelligence systems,” hailed as the first of its kind in the country, while asserting the need for federal legislation that would govern all states. “Should the federal government not preempt this with a needed cohesive federal approach,” Polis said in a May 17 signing statement , “I encourage the General Assembly to work closely with stakeholders to craft future legislation for my signature that will...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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Group Chaired By Former USPTO Directors Questions Office’s AI Guidance Over ‘Human Contribution’

The Council for Innovation Promotion, a group co-chaired by former U.S. Patent Office directors, says draft USPTO guidance on artificial intelligence would inject uncertainty into the process of obtaining patent protection for inventors using AI, and urges that the document be withdrawn or substantially rewritten. “C4IP is concerned that the Office’s artificial intelligence (AI) inventorship guidance will ultimately hurt humans, human creativity, and flourishment; the very opposite of what the Office set out to do,” the group says in comments...
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Key Lawmakers Float Doc Pay Reforms, Congress Examines Consolidation

Key lawmakers are floating ideas on Medicare physician payment reforms ahead of the Memorial Day break, with Senate Finance Leaders Ron Wyden (D-OR) and Mike Crapo (R-ID) unveiling a white paper Friday (May 17) , the same week senators unveiled proposals to create a hybrid payment policy and to address prior authorization for drugs. Health care consolidation will be front and center on Thursday (May 23) when the House Budget Committee holds a hearing on Breaking Up Health Care Monopolies:...
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Maryland PDAB Gives Thumbs Up To Cost Reviews For Six Drugs

Updated Story Maryland’s prescription drug affordability board (PDAB) voted Monday (May 20) to move forward with cost review studies for six drugs, including the blockbuster drug for diabetes and obesity Ozempic. The drugs are AbbVie’s Skyrizi, Eli Lilly’s Trulicity, Novo Nordisk’s Ozempic, Boehringer Ingelheim’s Jardiance, AstraZeneca’s Farxiga, and Sanofi’s Dupixent, with the cost review of Dupixent scheduled to come after the others. Senate Bernie Sanders (I-VT), chair of the Senate health committee, is campaigning to lower the...
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Industry Praises CMS For Punting ‘Stacking’ Change For Medicaid Best Price

In a move applauded by the health care industry, CMS has decided to hold off finalizing a proposal that would have required drug makers aggregate, or “stack,” all manufacturer price concessions to determine a final best price for a covered outpatient drug in Medicaid’s Drug Rebate Program (MDRP), including discounts, rebates or other arrangements made to different best price-eligible entities throughout the drug supply chain, the agency said Friday (May 17) in an update on a proposed rule related to...
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CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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Industry Praises CMS For Punting ‘Stacking’ Change For Medicaid Best Price

In a move applauded by the health care industry, CMS has decided to hold off finalizing a proposal that would have required drug makers aggregate, or “stack,” all manufacturer price concessions to determine a final best price for a covered outpatient drug in Medicaid’s Drug Rebate Program (MDRP), including discounts, rebates or other arrangements made to different best price-eligible entities throughout the drug supply chain, the agency said Friday (May 17) in an update on a proposed rule related to...
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IDP Issue: 
Inside Drug Pricing - 05/27/2024
IDP Volume: 
Vol. 7, No. 22
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