FDA Approves Interchangeable Biosimilars For Ophthalmology Drug Eylea

The competition is on for Regeneron’s costly eye disorder treatment Eylea as FDA on Monday (May 20) approved Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercecpt-yszy), the first two interchangeable biosimilars available for the brand drug, meaning either biosimilar can be substituted for Eylea without the need to consult a prescriber. Kaiser Family Foundation reported in March 2022 that the average Medicare beneficiary liability for Eylea, the top-spending Part B drug in 2019 and used by 270,300 traditional Medicare...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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AdvaMed: FDA Should Oversee Health AI, But Narrow ‘Device’ Definition

Leading medical device industry group AdvaMed says FDA should remain the government entity charged with overseeing health care uses of artificial intelligence (AI), but urged the agency to narrow its definition of which AI tools qualify as a device to capture fewer clinical decision support (CDS) software tools used by providers and health systems. The organization also says CMS should develop an approach to pay for AI uses in health care, specifically clinical analytical services regulated by FDA, so that...
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FDA Issue: 
FDA Week - 05/24/2024
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Vol. 30, No. 21
CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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WebTPA Reports Breach Of Sensitive Information, S.S. Numbers

WebTPA, a third-party administrator, detected a data breach on benefit plans and insurance companies that may have included Social Security numbers and birthdays. The cyberattack marks the third major health care data breach in recent months as lawmakers scramble to draft legislation and put pressure on regulatory agencies to prevent future cyberattacks. Meanwhile, Senate Finance Committee Chair Ron Wyden (OR) recently told Inside Health Policy his office is drafting legislation to beef up HIPAA’s privacy protections to prevent future...
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WebTPA Reports Breach Of Sensitive Information, S.S. Numbers

WebTPA, a third-party administrator, detected a data breach on benefit plans and insurance companies that may have included Social Security numbers and birthdays. The cyberattack marks the third major health care data breach in recent months as lawmakers scramble to draft legislation and put pressure on regulatory agencies to prevent future cyberattacks. Meanwhile, Senate Finance Committee Chair Ron Wyden (OR) recently told Inside Health Policy his office is drafting legislation to beef up HIPAA’s privacy protections to prevent future...
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CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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Activists Warn Of Inherent AI Biases In Wake Of Schumer’s Legislative ‘Roadmap’

Labor and public interest activists are warning about the inherent racial and other biases in artificial intelligence in response to Senate Majority Leader Charles Schumer’s (D-NY) recently released “roadmap” for drafting legislation, arguing the Schumer strategy woefully downplays those risks in favor of business interests. “And the report today inadequately deals with the elephant in the room, bias in AI. Because foundation models are optimized to reflect their training data…we should expect them to reinforce stereotypes,” said George Washington University...
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Activists Warn Of Inherent AI Biases In Wake Of Schumer’s Legislative ‘Roadmap’

Labor and public interest activists are warning about the inherent racial and other biases in artificial intelligence in response to Senate Majority Leader Charles Schumer’s (D-NY) recently released “roadmap” for drafting legislation, arguing the Schumer strategy woefully downplays those risks in favor of business interests. “And the report today inadequately deals with the elephant in the room, bias in AI. Because foundation models are optimized to reflect their training data…we should expect them to reinforce stereotypes,” said George Washington University...
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CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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Senate Finance Leaders Unveil Potential Medicare Physician Pay Reforms, Telehealth Expansion In White Paper

Senate Finance Committee Chair Ron Wyden (D-OR) and ranking Republican Mike Crapo (ID) released a white paper on Friday (May 17) seeking feedback on possible reforms to the Medicare physician payment system, which they potentially could push to include in an end-of-year health care package alongside permanent telehealth expansion. The paper proposes linking the conversion factor (CF) for physician payments to the Medicare Economic Index (MEI), expanding incentives for Alternative Payment Models (APMs) like Accountable Care Organizations (ACOs), exploring hybrid...
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CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21
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Sanders’ Dental Bill Offers Medicare, Medicaid, Exchange Coverage, Boosts Workforce

Senate health committee Chair Bernie Sanders (I-VT) unveiled a comprehensive dental reform package Friday (May 17) meant to address each of the five drivers of the oral health care crisis by increasing access to coverage across federal health programs, establishing more places to obtain dental care, investing in the oral health profession, educating non-dental health professionals about the importance of oral health, and funding research on prevention and disease management. Sen. Sherrod Brown (D-OH) is the bill’s cosponsor. Sanders announced...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21

Senators Draft Bipartisan Bill Streamlining Rx Drug Prior Auth Requirements

A bipartisan group of five senators are continuing to focus on ensuring prior authorization requirements aren’t used to ration coverage to care, announcing Friday (May 17) they are introducing a bill that would streamline access to prescription drugs that require a health plan's approval. The joint announcement from Sens. Roger Marshall (R-KS), Ben Ray Luján (D-NM), Roger Wicker (R-MS), Sheldon Whitehouse (D-RI) and Joe Manchin (D-WV) doesn’t go into details about the bill, but senators say the proposal would digitalize...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/23/2024
CMS Volume: 
Vol. 27, No. 21

FDA Official: Supply Chain Could Suffer If EtO Sterilizers Close

An FDA official said the potential of sterilizers who contract with medical device manufacturers closing their doors in the wake of new restrictions on the chemical ethylene oxide (EtO), often used to sterilize devices, is worrisome for the medical supply chain. “There is a finite amount of overall sterilization capacity through any method in the U.S. or even globally, and those devices would have to go somewhere,” Ryan Ortega, regulatory policy advisor at the Center for Devices and Radiological Health,...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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