cover image: Re: Most Favored Nation (MFN) Model -(CMS-5528-IFC)

20.500.12592/nppnsp

Re: Most Favored Nation (MFN) Model -(CMS-5528-IFC)

26 Jan 2021

In the short amount of time that the rule was released, every court that has considered the propriety of the process used to issue this rule has concurred that CMS failed to provide for adequate notice to stakeholders. [...] Lastly, CMS’ justification for the rushed timeline and the waiving of the APA requirements, which invokes hardships on patients resulting from the COVID-19 pandemic, can be easily invalided by the fact that the rule specifically exempts vaccines and therapies that prevent and treat COVID-19 from being included in the model, and the pandemic itself does not justify overruling Congressional authorit. [...] 3, the Lower Drug Costs Now Act, legislation that passed in the House of Representatives in December 2019, and would establish a reference pricing mechanism (although different than the one used for this rule and including the Medicare Part D program) would fundamentally disrupt our nationwide life sciences ecosystem and uniquely harm California’s companies, which lead the world in the development. [...] 3 had been in effect from 2009 to 2019, California’s emerging companies would have brought just three new drugs to market, instead of 25.10 The same economists have released preliminary data on the impact the MFN rule would have on innovation and found that if fully implemented, the rule would reduce the U. [...] Not only would the rule harm both of those missions but it also clearly misuses the authority granted to the federal government to test demonstration models under CMMI and violates the rulemaking process requirements set forth by the APA, as repeatedly stated by judicial courts in the short time the rule was released.

Authors

Laure

Pages
5
Published in
United States of America