IRA Lawsuits for Days 🏛

Hannah Wolf  0:03  
Welcome to Healthcare Policy pop. I'm Hannah Wolf. It's Thursday, November 16, 2023.

Today's pop topics, multiple lawsuits against a certain part of the Inflation Reduction Act. A legal expert gives us the latest. The CMS drug price negotiations within the IRA have instigated many lawsuits. Ilana Eisenstein is the chair of us litigation at DLA Piper and says that the word negotiation is the sticking point. 

Ilana Eisenstein  0:35  
Now they say negotiate the price, but this is where the dispute comes in. Really, the negotiation involves CMS setting a maximum fair price and the manufacturers are then more or less required to agree to that price. If they don't, they have to withdraw entirely from federal health programs, or face significant other penalties. The companies have several issues with the mandates in the IRA. Eisenstein lists some of those arguments. They've raised a number of constitutional claims, including that they have important intellectual property rights and a right to sell these products and that setting the price is essentially a taking. It also they claim violates due process, the way in which they go about the negotiations. They also challenge Congress's delegation, the power to set prices without enough guidance. 

Hannah Wolf  1:28  
Many of these lawsuits are still being briefed. But one judge recently made a notable ruling. 

Ilana Eisenstein  1:35  
US District Judge Newman and the southern district of Ohio, denied the Chamber of Commerce's motion for a preliminary injunction to stop the act from going into effect. And the judge found that participation and the Medicare program is a completely voluntary choice. That's a quote from the decision. 

Hannah Wolf  1:54  
We asked Eisenstein to predict the future on these legal battles. 

Ilana Eisenstein  1:59  
So I expect that whatever the district court decisions will be will be appealed whether it be that the industry wins are the government wins. And there are cases pending in multiple circuits, which raises the question of a division of opinion between the circuits. And given the importance of this program and the novelty of the issues, I think that there is a significant chance that this goes all the way to the US Supreme Court. 

Hannah Wolf  2:26  
In the meantime, with these cases pending the IRA and the programs associated with it will continue to move forward. In a recent episode of the Healthcare Policy Pop we spoke with Bruce Altevogt about the CMS listening sessions. We'll keep you updated on the IRA and have an update on the listening sessions in a future episode.

A possible cure for sickle cell disease could be on the horizon after recent breakthroughs, and it could also be the first gene editing treatment approved by the FDA. Recently, a group of independent FDA advisors praised the treatment, which uses the gene editing technique CRISPR to treat sickle cell disease. A decision on the approval of the treatment is expected by early December. Find a link to an article on the hill and the show notes. That's all for today. We're back on Tuesday for another Healthcare Policy Pop, a resource of Patients Rising Now. I'm Hannah Wolf, have a great day.