Washington Update, November 2020

Washington Update

By Johanna Gray
It’s been another busy month in Washington! Here are a few quick updates:

  • Committee Leaders Seek Input on 340B Modernization: I shared last month that Senate HELP Chairman Lamar Alexander (R-TN) and House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) recently put out a request for information seeking policy ideas from stakeholders about 340B reform. See here for the letter that the Alliance submitted – telling the positive story of how the 340B program enables HTCs to serve their patients and opposing any policies that would impede that.
     
  • Trump Administration Regulations: In the last week, the Trump Administration has released several new regulations related to drug pricing for Medicare Parts B and D, and physician anti-kickback rules, and other topics. Issie wrote above about the physician anti-kickback rules, and we are currently analyzing the potential impact of the Most Favored Nation rule, which seeks to limit spending on some Medicare Part B drugs to the much lower prices paid in other countries. Our initial take is that this controversial model (which may not even take effect!) will not have a large effect, since no bleeding disorders treatments will be included in the first year of the model, and since drugs dispensed at home are exempt. We will be able to provide a summary of the rules and their potential impact on December’s webinar. We expect that there will be a number of additional regulations released, as President Trump seeks to tackle various issues before his term ends in January.
     
  • ACA Lawsuit: On November 10th, oral argument was heard in the US Supreme Court on the California v. Texas lawsuit concerning the constitutionality of the Affordable Care Act. While it is always tricky to anticipate a final ruling based on the questions asked by Justices during the oral argument (sometimes they ask questions to serve as the Devil’s advocate, for example), there were hopeful signals that the Supreme Court will not find the entire ACA to be unconstitutional if they find that the individual mandate currently is, due to the lack of penalty. Again, we don’t expect a final ruling in the case until the spring or possibly as late as June 2021. We’ll update the community as we learn more.
     
  • Federal Funding: Because it was unable to pass the regular federal funding bills before the start of fiscal year 2021 on October 1st, Congress passed, and President Trump signed into law a continuing resolution (or CR) to extend last year’s funding levels until December 11, 2020. Congressional leaders are negotiating this right now, and we are hopeful they will reach agreement before the deadline to prevent a government shutdown. We will provide an update in the December Newsletter.

Also in this Issue…

Notes from Joe
· The Light at the End of the Tunnel

Legal Update
· HHS Continues Its “Regulatory Sprint”

Payer Update
· Payer Update: 35 and Growing!

Notes from the Community
· Plasminogen Deficiency Foundation Launched

Alliance Update
· Announcing Our New Board Member
· 2021 Meeting Schedule