Myth: Because the rebate model didn’t go live on January 1, there were no changes January 1 for entities.
While the rebate model is on pause, working its way through the court system, the Inflation Reduction Act (IRA) did go into effect. This legislation introduced a new price point, Maximum Fair Price (MFP). Reimbursement at MFP affects Medicare Part D payors and Medicare Part B payors, as well, in 2028. Covered entities could have an impact to their 340B Savings.
Myth: 340B compliance requirements do not apply.
According to the HRSA 340B FAQs, as with all 340B program requirements, auditable records should be maintained for both covered entities and manufacturers. OPA will incorporate compliance with the rebate model in audits of both covered entities and manufacturers.
Myth: This rebate model only applies to certain entity types.
The rebate model applies to all covered entity types, regardless of whether you are a hospital, health center, or other grantee.
Myth: This is only for contract pharmacy, not my retail-owned pharmacy or medical claims.
The rebate model will apply for all 340B program purchases. This applies to any retail or hospital owned pharmacy, any contract pharmacy within your network, and mixed-use medical claims.
Myth: This only applies to certain payors.
While the Maximum Fair Price (MFP) calculation and reimbursement only applies to Medicare Part D payors, the rebate model applies to all payors for the associated claims.
Myth: My state has contract pharmacy laws. I am protected and exempt.
State contract pharmacy laws do not supersede this requirement. States with contract pharmacy laws that are active still must participate in the rebate model.
What should covered entities be doing now?
Covered entities should be signing up for Beacon Channel Management if they did not complete that prior. It is the current vendor that has been selected by all nine manufacturers to administer the rebate model should it go back into effect. While Beacon and 340B ESP are both part of Second Sight Solutions, entities must maintain registrations with both platforms.
Covered entities should understand their payor mix, especially for IRA 2026 products, which will help them understand any financial impacts that might occur.
The IRA product list will continue to grow into 2027 and beyond with a number of products being added each year. There are 15 products being added in 2027 and covered entities can complete financial analysis to understand impact on their 340B program now as MFP pricing has been released.
The content in this blog is for informational purposes only and is not intended to be used in place of regulatory guidance. The opinions and views expressed herein are those of the authors and do not necessarily reflect the official position or opinions of SUNRx or any regulatory authority. Furthermore, some content may contain copyrighted material, the use of which has not always been specifically authorized by the copyright owner, but which we believe constitutes a "fair use" of any such copyrighted material as provided for in Section 107 of the US Copyright Law. We are making the information herein available in our efforts to advance understanding of the 340B program and its offerings. These views are always subject to change, revision, and rethinking at any time and may not be held in perpetuity.
Questions? Contact Kaitlyn Weckhorst, MHA, 340B ACE