340B Coalition Update:
An Eventful 2017

By: Michael Cook, PharmD,

It has been a very eventful past few months in the 340B space. Here is what we think you need to know about what has transpired on capitol hill since the 340B Summer Coalition and insights on what we can expect for 2018.

What has happened since the last 340B Coalition?

A lot.

  1. The Energy & Commerce Committee held two 340B oversight hearings to better understand if 340B covered entities (CEs) were being good stewards of the program. Between the two hearings, the Energy & Commerce Committee sent detailed letters to covered entities requesting data on their 340B savings.
  2. CMS proposed and passed the final rule which slashes Medicare Part B reimbursements by nearly 30% and took effect on January 1, 2018. The rule will also require all 340B hospitals to use modifiers to identify 340B drugs billed under the Outpatient Prospective Payment System (OPPS).
  3. There have been significant and successful advocacy efforts in Washington to block the CMS payment cuts. There have been 228 signatories from the House and 57 from the Senate sent to CMS to block proposed Part B cuts to hospitals. As a result of these efforts, an appeal hearing will be held in April 2018.
  4. The 340B Pause Act was introduced in late December 2017 which would place a 2-year freeze on new DSH hospitals and new child sites for existing DSH hospitals. This legislation would be burdensome and initiate problematic reporting requirements for CEs.

What you can except in 2018?

340B will be under a microscope.

  1. Already in 2018, the Energy & Commerce Committee issued report that recommends significant changes to 340B program. These changes include re-evaluating the purpose of the program, assessing changes to DSH hospital eligibility, and directing program focus on charity care levels.
  2. Also introduced this year was the “HELP Act.” This would place a freeze on new DSH hospitals and child sites, add reporting requirements similar to PAUSE Act with the addition of claim modifiers, and change eligibility requirements for new DSH, children’s, and cancer hospitals and their child sites. If enacted, the implications of the legislation will be retroactively applied as of December 31, 2017.
  3. President Trump released FY19 budget that includes proposed changes to the 340B program. These changes include regulatory authority, increased enforcement, and a Medicare payment policy.

Stay tuned for more updates on what we are hearing from the 340B Coalition.