CMS Guidance on Drug Prices Under the Inflation Reduction Act

🧵Lots of interesting nuggets in the new guidance CMS released to outline how it will set drug prices under the Inflation Reduction Act

This caught my eye. CMS says all negotiation materials from CMS have to be kept secret, and then documents must be destroyed within 30 days 1/7 pic.twitter.com/ec54KS1gvv

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023

It says off label use of a drug will be considered when establishing the "fair price," but only if the use is listed in a CMS recognized compendia -- this probably means that for purposes of setting a price, CMS will only consider the off label uses for cancer drugs. 2/7 pic.twitter.com/l5vVy5Fgn7

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023

This language, where it discusses use of "therapeutic alternatives" as a reference price, suggests CMS could use generic drugs as a reference for setting the price of a branded drug, if they judge the generic to be a "therapeutic alternative" (no clear criteria is laid out) 3/7 pic.twitter.com/4FrvQBzy7j

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023

lots of nods to the use of RWE to inform negotiations. 4/7 pic.twitter.com/kpE8EXwIXH

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023

While a drug is subject to negotiation, materials from CMS must be kept confidential.

When a drug “graduates“ out of negotiation process, materials have to be destroyed

It’s a convenient way for CMS to keep manufacturers from comparing its conduct from one product to next 5/7

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023

CMS is basically saying that they believe that they can negotiate a better price if no body of precedent is able to accumulate. Add to that the statutory prohibition on judicial or administrative review, and do you have an argument that IRA negotiation violate due process? 6/7

— Scott Gottlieb, MD (@ScottGottliebMD) April 3, 2023