Monthly GP Update: June 2025

As expected, the Department of Health and Human Services (HHS) submitted their PHS/340B Rebate Proposal to the Office of Management and Budget (OMB) for review. The OMB has 90 days to conduct its review but could potentially be shorter due to the Medicare Part D Drug Price Negotiations. Unfortunately, the details of HHS’s proposal will not be made public during the review period. Also of note is that the OMB’s review may not result in any final decision or guidance so even after the review has been completed, it is unclear if or when manufacturers will know what will be permitted. 

Your April calculations should have been submitted and certified by now and most likely, your Medicaid invoices are rolling in. Things that are due this month, depending on your products, include:

1. May monthly AMP is due Monday, June 30. 

2. Medicare Part D payments are due June 9th. You may also want to check the “Coverage Gap” section of the TPA portal as we’ve seen clients with an amount due from Q4 2024 because of a “catch-up entry” that was made. Remember, the penalty for late payment, even if only one day, is 25% of the amount due so make sure you get this payment submitted on time. 

3. Your PHS/340B pricing should be submitted to wholesalers/distributors by June 15. 

Besides the Rebate Proposal mentioned above, the PHS/340B Program continues to be what some might consider contentious as we see states and manufacturers continue their game of “cat and mouse.” States continue to try to limit how manufacturers can restrict access by contract pharmacies while manufacturers continue to try to implement programs to be able to identify duplicate discounts and/or diversion. A bill was recently introduced in the House that would require 340B discounts to be passed along to patients, and President Trump’s budget request contains a reorganization plan that would shift oversight of the program to CMS. 

In other news, the second round of the Medicare Part D negotiations is underway.  CMS was required to send initial offers to manufacturers by June 1, 2025 and manufacturers will have 30 days to respond. These will be effective January 1, 2027. And let’s not forget about tariffs and Most Favored Nations (MFN) which are also “hot topics" in the pharmaceutical industry right now. While both of these could be significant to manufacturers, at this time, neither are in effect and there is no indication that anything will change in the near future.

Remember, you can find always find upcoming GP deadlines, conferences, and related activities on our online calendar, or reach out to us if you have a specific question.

We say it all the time because it’s true: we LOVE Government Pricing, so if you have any questions or would like to discuss any new products or strategies, let us know. It’s what we do!

Please remember - this information is not company specific, but rather is intended to provide general guidance. Our goals are to provide industry information or context for what may be occurring in the upcoming weeks and to help our clients be more proactive. Some of it may not apply to your organization, and there may be other requirements that are not included here.

For any further questions, please contact us.