SCOTUS Asks DOJ To Weigh In On Teva Skinny Label Case

The Supreme Court has asked the Justice Department to weigh in on a so-called skinny label case over whether brand drug makers can patent new uses of their drugs in a bid to keep generic drugs from entering the market. There are few details about the request on the high court’s case docket, Teva Pharmaceuticals USA Inc. v. GlaxoSmithKline LLC (No. 22-37). The docket simply says the solicitor general is invited to file a brief “expressing the views of...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/07/2022
FDA Volume: 
Vol. 28, No. 40
Author: 
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FDA Launches Interchangeable Biosimilars, Rare Disease Pilot Programs

FDA on Tuesday (Oct. 4) announced the launch of three new pilot programs: one to advance development of biosimilars and interchangeable biosimilars, one to develop and identify endpoints that can be used to study treatments for rare diseases, and another to expedite reviews and approvals for novel uses of existing therapies that meet an unmet medical need. The programs were agreed to by FDA and industry stakeholders as part of the biosimilar and prescription drug user fee reauthorization package that...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/07/2022
FDA Volume: 
Vol. 28, No. 40
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CMS Faces New Pressure To Reject Co-Pay Accumulators

A coalition of patient and provider groups urges CMS to bar insurers from exempting drug manufacturer coupons from cost-sharing limits in the 2024 exchange rule, and stakeholders also urge HHS to consider the so-called “co-pay accumulators” discriminatory in its final rule on Section 1557 of the Affordable Care Act. Although Medicare bans the use of drug manufacturers’ co-pay coupons, they are allowed in the private market, including Affordable Care Act plans. Insurers say the coupons encourage high drug prices and...
Article Type: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/06/2022
CMS Volume: 
Vol. 25, No. 40
HEA Issue: 
Health Exchange Alert Weekly Report - 10/05/2022
HEA Volume: 
Vol. 10, No. 40
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BLS Data Should Not Be Used In Hospital Wage Index, AHA Tells MedPAC

The American Hospital Association is objecting to a policy the Medicare Payment Advisory Commission is considering that would use compensation data from the Bureau of Labor Statistics in the calculation of the Medicare hospital wage index, and told the commission such a policy could worsen the financial difficulties hospitals have faced since the beginning of the COVID-19 pandemic. “AHA has conducted extensive policy work on the wage index,” AHA says in a letter to the commission . “As a result...
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Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/06/2022
CMS Volume: 
Vol. 25, No. 40
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