Bipartisan Group Of 181 Lawmakers Sides With Hospitals In 340B Dispute

A bipartisan group of 181 House lawmakers on Friday (July 15) urged HHS to stop drug makers from restricting discounts to hospitals in the 340B program by employing “steep” fines and “all available enforcement actions.” The letter is the latest development in a long-running dispute between drug companies and hospitals over the drug discount program. As of earlier this month, 18 drug companies were restricting the amount of 340B drug discounts they provide to hospitals that dispense the drug through...
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InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 07/25/2022
IDP Volume: 
Vol. 5, No. 30
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Bipartisan Group Of 181 Lawmakers Sides With Hospitals In 340B Dispute

A bipartisan group of 181 House lawmakers on Friday (July 15) urged HHS to stop drug makers from restricting discounts to hospitals in the 340B program by employing “steep” fines and “all available enforcement actions.” The letter is the latest development in a long-running dispute between drug companies and hospitals over the drug discount program. As of earlier this month, 18 drug companies were restricting the amount of 340B drug discounts they provide to hospitals that dispense the drug through...
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CMS Issue: 
Inside CMS - 07/21/2022
CMS Volume: 
Vol. 25, No. 29
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Dems Continue Reconciliation Work, Stakeholders Prep For Final Surprise Billing Rule

Democrats continue to work through their pared-down reconciliation package that includes Medicare drug-price negotiation and an extension of enhanced Affordable Care Act tax credits, as lawmakers also work through a so-called minibus that includes FDA appropriations and stakeholders watch for a surprise billing rule from the Department of Labor that could come out as early as this week. The drug-pricing aspect of the pared-down reconciliation bill is going to the parliamentarian to make sure it complies with the special Byrd...
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Health Insider
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HHS Seeks Advice On Ways To Improve Primary Care

HHS is requesting feedback from stakeholders on how to improve the U.S. primary care system as part of the department’s ongoing initiative to improve health outcomes through primary care reforms. In a recent Federal Register notice , the HHS Office of the Assistant Secretary for Health wrote that primary care is key to many of the Biden administration’s priorities, including fighting the COVID-19 pandemic, advancing health equity, and the preventing and managing chronic conditions. “However, our nation’s primary health...
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CMS Issue: 
Inside CMS - 07/21/2022
CMS Volume: 
Vol. 25, No. 29
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Group Petitions FDA To Require REMS If It Approves Hemophilia Gene Therapies

FDA should require a risk evaluation and mitigation strategy (REMS) to ensure the safety of two gene therapy treatments if it approves them for hemophilia, the National Hemophilia Foundation demands in a citizen petition filed with the agency. The two potential treatments are valoctocogene roxaparvovec, an investigational gene therapy for the treatment of severe hemophilia A made by BioMarin, and etranacogene dezaparvovec, an investigational gene therapy for hemophilia B made by CSL Behring. “We must ensure that the FDA implements...
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FDA Issue: 
FDA Week - 07/22/2022
FDA Volume: 
Vol. 28, No. 29
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FDA Warns Retailers, Manufacturers Against Selling Synthetic Nicotine

FDA will use its enforcement powers to target e-cigarette companies that are attempting to evade regulations by adding synthetic nicotine to their products instead of tobacco, the agency is warning retailers and manufacturers. A law that took effect in April clarifies that, like products containing tobacco, e-cigarettes containing synthetic nicotine cannot be sold without FDA approval. The agency announced July 13 that it had issued its first two warning letters to manufacturers marketing unapproved, non-tobacco products. FDA has also sent...
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FDA Issue: 
FDA Week - 07/22/2022
FDA Volume: 
Vol. 28, No. 29
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ULC Releases Model Legislation For Interstate Telehealth

The Uniform Law Commission introduced interstate telehealth model legislation on Wednesday (June 13) that would create a streamlined registration system for out-of-state telehealth providers amid the ongoing debate over whether the providers should be able to practice across state lines. Although interstate licensing is a divisive topic among telehealth stakeholders, the ULC intentionally incorporated feedback from a diverse array of groups and federal entities in drafting the model legislation in order to make it attractive to state legislatures. The ULC’s...
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