Monthly GP Update: December 2025
Dec 4, 2025
For many in GP, it’s “the most wonderful time of the year!" Public Law for your Federal Supply Schedule should be wrapped up, there are no quarterly calculations due until the end of January, and things always seem to be a little quieter during the second half of the month as people take time off.
We wanted to draw your attention to a few things to keep in mind since things to get compressed into a shorter amount of time in December:
November calculations are due December 30
Q3 Part D (MDP) Payment Due December 9 to HPMS
PHS/340B Ceiling Pricing Due to your wholesalers/distributors by December 15
ASP Discarded Drug Refund Due to HPMS by December 31
The bulk of Medicaid invoices should have been received already but a few are likely to trickle in between now and the end of the month, along with supplemental rebates
(Remember, you can always find upcoming GP deadlines, conferences, and related activities at The Pricing Group’s online calendar or reach out to us if you have any questions.)
We’ve had a lot of other activity in the GP/Pharma world recently which seems to be the norm for 2025. A few highlights:
On November 6, CMS released the GENEROUS Model (GENErating cost Reductions fOr U.S Medicaid Model) which is a 5-year model where CMS will negotiate supplemental rebates with manufacturers for participating states, tying the GNUP to Most Favored Nation (MFN) which has been redefined as the average net price in all G-7 countries except the U.S. plus Denmark and Sweden. CMS will negotiate the coverage criteria for all participating states including utilization management such as step therapy, quantity limits, and other terms for prior authorization. It is voluntary for manufacturers and will apply to all products within a company’s portfolio for those that choose to participate. The model is effective January 1, 2026 and manufacturers have until March 31, 2026 to apply.
CMS released the 2026 Medicare Physician Fee Schedule Final Rule related to the Average Sales Price (ASP) calculation. Included is a new requirement of manufacturers to submit to CMS a “Bona Fide Service Fee (BFSF) Certification” or Warranty letter for current, new, and renewed customer contracts effective January 1, 2026 including the methodology used to determine fair market value with service fees deemed BFSFs.
Each quarter, manufacturers will be required to submit any reasonable assumptions used in calculating ASP as part of the submissions to CMS. (If you need the template provided by CMS, please let me know and I will be happy to provide it to you.)
On November 21, CMS released a final rule with changes to the Hospital Prospective Payment System. Of note to manufacturers is that reimbursement through Medicare Part B (ASP) will no longer take place if the manufacturer does not have a Medicaid National Drug Rebate Agreement. This has been in the statute but has not been enforced previously.
CMS released the Medicare Part D Maximum Fair Price list of 15 drugs, effective Jan. 1, 2027, with the “negotiated price” of each.
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.