Cuban Ready To Distribute Generic Drugs If CMS Agrees To March-In Alternative

Updated Story Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, tells Inside Health Policy he could take on the role of distributing the drugs should CMS back drug-pricing advocates’ proposed march-in alternative to license entities to make generic versions of expensive drugs like Xtandi. The advocates tell IHP the proposal they shared with CMS this week could be used beyond Xtandi for other expensive drugs developed in part with taxpayers’ funding. Cuban...
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CMS Issue: 
Inside CMS - 04/18/2024
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Vol. 27, No. 16
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Balderson’s Move To E&C Health Panel Brings Digital Focus

House Energy & Commerce Chair Cathy McMorris Rodgers (R-WA) announced that Rep. Troy Balderson (R-OH) will shift to the E&C health subcommittee, a move that brings a digital health advocate onto the health panel as lawmakers grapple with whether to permanently extend telehealth waivers , and how HHS should regulate digital therapeutics and artificial intelligence. Balderson is the co-chair of a recently formed bipartisan Congressional Digital Health Caucus. The caucus is initially focusing on AI, and members hope to help...
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FDA Issue: 
FDA Week - 04/19/2024
FDA Volume: 
Vol. 30, No. 16
CMS Issue: 
Inside CMS - 04/18/2024
CMS Volume: 
Vol. 27, No. 16
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Balderson’s Move To E&C Health Panel Brings Digital Focus

House Energy & Commerce Chair Cathy McMorris Rodgers (R-WA) announced that Rep. Troy Balderson (R-OH) will shift to the E&C health subcommittee, a move that brings a digital health advocate onto the health panel as lawmakers grapple with whether to permanently extend telehealth waivers , and how HHS should regulate digital therapeutics and artificial intelligence. Balderson is the co-chair of a recently formed bipartisan Congressional Digital Health Caucus. The caucus is initially focusing on AI, and members hope to help...
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Brookings: No Surprises IDR Process May Hike Costs, Premiums

The No Surprises Act’s independent dispute resolution (IDR) mechanism that Congress’ scorekeeper had believed would reduce costs over the first decade may end up raising in-network prices and premiums, according to a recent Brookings Institution report analyzing the first tranche of IDR outcome data released by CMS in February, which suggest lawmakers’ goal of ending surprise billing without increasing rates is in jeopardy. It’s a pretty shocking outcome considering congressional committee leaders, the Congressional Budget Office and other experts believed...
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CMS Issue: 
Inside CMS - 04/18/2024
CMS Volume: 
Vol. 27, No. 16
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FDA Seeks Patient, Provider Input As It Drafts Device AI Guide

FDA hopes to get input from patients and providers as it creates new draft guidance for artificial intelligence (AI) lifecycle management and content marketing submissions for AI-enabled devices, an agency official said Wednesday (April 10). The call comes as FDA works to strengthen its purview of AI. “I'm also hopeful that we'll hear feedback from patients and providers who can best tell us what kinds of information they'd like to know about AI-enabled devices in their performance, including their continued...
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Inside CMS - 04/18/2024
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Vol. 27, No. 16
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Sanders Unveils Long COVID Discussion Draft, Uncovering Divisions Among Patient-Advocates

Senate health committee Chair Bernie Sanders (I-VT) is seeking feedback from the long COVID community on a draft legislative proposal that would appropriate $10 billion in mandatory funding for the National Institutes of Health over the next decade to bolster its response to the condition through several new initiatives. However, the reactions to Sanders' draft reveal significant and enduring divisions among long COVID advocacy groups. This draft bill, unveiled Tuesday (April 9), follows the Senate health committee's January hearing on...
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FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
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Jones: FDA Budget Could Mean Reduction In State Food Safety Dollars

FDA Deputy Commissioner for Human Foods Jim Jones is warning that the lack of a significant budget increase for the agency in fiscal 2024, likely to be repeated in fiscal 2025, will endanger food-related priorities and reduce the amount of money FDA is able to send to states for food safety efforts. “We have long faced a gap between what is needed and what is available, and each year that gap grows larger,” Jones said at a webinar hosted by...
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FDA Issue: 
FDA Week - 04/12/2024
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Vol. 30, No. 15
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CMS Tailors Drug Buffer Stock Idea To Small, Rural Hospitals

The Biden administration is revisiting the idea of offering Medicare add-on payments to incentivize hospitals to create buffer stocks of essential medicines to avert shortages, but it is tailoring the plan to small, independent hospitals in its calendar year 2025 inpatient payment proposal out Wednesday (April 10). CMS last year proposed applying the buffer stock plan to all hospitals but punted the idea after hospitals complained it could be administratively burdensome, especially for rural and safety-net hospitals. As part of...
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Inside CMS - 04/18/2024
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Vol. 27, No. 16
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Hospitals Slam CMS’ Proposed 2.6% Hospital Inpatient Pay Bump For 2025

CMS’ proposal to increase Medicare hospital inpatient payments by less than 3% for 2025 is deficient and disregards the increased inflation and operational costs, on-going labor shortages and aging patient population that hospitals are facing, hospitals say after CMS unveiled the proposed pay rule Wednesday (April 10). The 2.6% pay increase for 2025 reflects a 3% market basket update reduced by a 0.4 percentage point productivity adjustment. The proposed rates, and other changes, will increase hospital pay by $3.2 billion,...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 04/18/2024
CMS Volume: 
Vol. 27, No. 16

E&C Lawmakers Weigh Permanent Versus Temporary Telehealth Extension

Key lawmakers on the House Energy & Commerce Committee are still weighing whether to pursue a temporary or permanent extension of pandemic-era telehealth policies to avoid a “telehealth cliff” at the end of the year. The ultimate collection of provisions -- either temporary or permanent -- will likely be included in a larger health care package expected to be taken up in a lame-duck session. Discussions about telehealth permanency versus temporary extensions of Medicare waivers dominated a Wednesday (April 10)...
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