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Your Exclusive Client Update
NEWSLETTER
Date: January 14, 2026
By: RxX Consulting
What’s New
We’re launching a 340B educational video series in 2026! The training videos will highlight our Rx|X Way for 340B teams. Stay tuned and follow us on LinkedIn for more
What’s Coming Up
📅 Are you attending the Winter 340B Coalition Meeting in San Diego? Message us by replying to this email and we can schedule time to get together!
340B News & Updates
340B Rebate Model Update: What Changed, Why It’s Stalled, and What May Come Next
We entered 2026 with the good news that HRSA’s 340B Rebate pilot program was paused after the AHA/Maine Hospital Association suit versus HHS was successful. But, after 6 months of crazed preparation and tons of unknowns, where are we now as an industry?
HRSA has officially paused implementation, noting on its website that the agency is “evaluating feedback and next steps.”
“In accordance with the December 29, 2025, U.S. District Court for the District of Maine order in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.) and the subsequent January 7, 2026, U.S. Circuit Court of Appeals for the First Circuit order in American Hospital Association et al. v. Kennedy et al., No. 25-2236 (1st Cir.), HRSA’s Office of Pharmacy Affairs (OPA) is pausing the implementation of the 340B Rebate Model Pilot Program for all covered entity types at this time.
Manufacturers who were approved for participation in the Pilot to effectuate 340B pricing through a rebate mechanism will now be required to continue to offer all of their covered outpatient drugs to 340B covered entities at the 340B ceiling price as an up-front discount. OPA will update stakeholders on developments regarding the Pilot as they arise.”
Predicting What HRSA May Do Next
While paused, the model is not going away. In fact, several signals suggest HRSA is recalibrating rather than retreating. Based on HRSA’s initial challenges to the district court’s ruling, legal landscape, and the timing of the Inflation Reduction Act implementation, here is what I think could happen:
1. Begin Building an Administrative Record (Possibly Immediately)
To avoid further APA challenges, HRSA may begin:
Creating a formal rulemaking record
Documenting rationale
Collecting comments, data, and legal foundations
Why? This would allow HRSA to reintroduce the model in a procedurally defensible way.
2. Use 2026 to Prepare for a 2027 Relaunch Aligned With Maximum Fair Price (MFP) Drugs
The next group of drugs selected for Medicare Maximum Fair Price (MFP) will take effect in 2027.
HRSA may time a revised rebate model to align with:
MFP implementation
Manufacturer reporting cycles
CMS data-sharing timelines
Why? This would allow HRSA to position the rebate model as part of a synchronized federal drug-pricing strategy.
3. Manufacturers Will Likely Increase Their Focus on Duplicate Discounts
Even during the pause, we fully expect manufacturers to:
Strengthen duplicate-discount detection
Request more detail on 340B/MFP overlap
Seek additional payer, modifier, or claim-level data
Use ESP or similar platforms to validate eligibility
Why? The rebate model may be stalled, but manufacturer data collection is accelerating.
Rx|X will be on the Watch for…
More scrutiny of Medicaid secondary/tertiary billing
Additional manufacturer audits or data requests
New expectations around cost and submission clarification codes
Increased emphasis on NDC-11 level matching
More intervention from CMS
Client Question: have you noticed any issues with:
Communicating transaction-level details?
Determining cost or clarity around net pricing?
Submission clarification codes (SCCs) or modifier use?
Your real-world experience helps us keep our guidance sharp and we have ways to communicate in the aggregate to HRSA and CMS, so please share!
How are we Responding to the OPPS Survey??
CMS has opened its OPPS Drug Acquisition Cost Survey, requesting hospitals — including 340B hospitals — to report net outpatient drug acquisition costs for July 1, 2024 through June 30, 2025. The survey covers separately payable drugs and requires reporting of total units and total net costs, broken out by 340B vs. non-340B purchases. Submissions are due March 31, 2026.
CMS has openly stated that it cannot require hospitals to respond. However, CMS also signaled that it intends to use whatever data it receives to inform future OPPS drug payment rates. With the way this administration has been making decisions, we are a little surprised they are actually doing the survey. We know it is why the Supreme Court overturned the prior OPPS cuts, but what is stopping them from “doing” the survey but just using the 340B ceiling price. Is that too cynical??
Risks of Responding vs. Not Responding
Responding may create:
Administrative burden and resource strain
Possible consistency questions if survey data diverge from Medicare cost reporting, data that both CMS and HRSA have
Consistency issues among hospitals period - Suzanne and I have tried to collect similar data in the past and the answers vary much more wildly than it would appear
The risk that submitted costs could influence future OPPS reimbursement levels
Not responding carries other considerations:
CMS may rely on alternative datasets or assumptions to impute your cost, which could disadvantage non-responding hospitals
A complete absence of response could be interpreted as lack of engagement, depending on future CMS rulemaking
Is there a Practical Middle-Ground Option?
Some hospitals are considering a balanced approach where they submit a response explaining why the survey is burdensome, detailing resource limitations or data constraints. This approach acknowledges the request without committing to full cost reporting. We don’t know if this is where the majority will go, but it is something to consider.
Hospitals should also monitor guidance from AHA, 340B Health, and outside counsel, all of whom have raised concerns about:
The voluntary nature of the survey
The significant operational load
The potential payment implications of incomplete or skewed data
Rx|X Recommendations
Because strategic and legal implications vary by hospital, we strongly recommend each organization:
✔ Consult with in-house counsel and external legal advisors before deciding whether — and how — to respond
✔ Ensure alignment between finance, pharmacy, and compliance teams
✔ Document internal reasoning and resource considerations
HRSA Notice: Proposed Updates to 340B Registration & Recertification Requirement
Yesterday, HRSA released an updated Information Collection Request (ICR) proposing revisions to the forms used for 340B registration, recertification, and change requests (OMB No. 0915-0327). Comments on the revised version are due February 9, 2026.
These changes build on an earlier 60-day notice published in the Federal Register on August 7, 2025 (90 FR 38167–38169). Fourteen public comments were submitted during that period, and HRSA reviewed and responded to each one before issuing this updated notice.
This is an important example of HRSA establishing a clear administrative record by:
Requesting public comment
Reviewing stakeholder input
Publishing its responses
Issuing a refined proposal
This is the type of minimum administrative process stakeholders expected for the 340B Rebate Pilot, which HRSA placed on pause without developing or publishing a similar public record.
Key Proposed Changes
1. Shipping Address Clarifications
New fields will distinguish whether each shipping address is a pharmacy, health care delivery location, or other receiving site. This is intended to prevent processing delays and classification issues.
2. STD & TB Grantees – Required Documentation
Entities must upload supporting Notices of Award and subrecipient agreements to verify eligibility.
3. Title X Programs
Updated questions will document the period during which the entity received Title X assistance.
4. Physical Address Change Requests
Entities must confirm whether the new location continues to be grant-funded and whether the prior location remains operational.
5. Tribal and Urban Indian Health Programs
Forms will now capture the Tribal Agreement number to support eligibility validation.
6. Hospital Registration Clarifications
Terminology alignment with CMS, including:
“File Date” → “Date/Time Prepared”
“Medicare Provider Number” → “CMS Certification Number”
7. Hospital Trial Balance Instructions
Revised instructions clarify that a unique trial balance demonstrating outpatient reimbursable costs is required for each new registered service.
What This Means for Covered Entities
Operational requirements are not changing, but recertification and registration workflows will include more precise data fields and documentation prompts, particularly for federal grantees and hospitals adding new outpatient departments.
Rx|X Recommendations
Flag upcoming recertification cycles for small workflow adjustments.
Ensure program documentation for STD, TB, and Title X sites is organized and accessible.
Coordinate with compliance, finance, and legal teams to determine your plan for responding.
Consider submitting comments by the February 9 deadline if the changes create operational burdens.
What Working with Rx|X Means
Rx|X is built on higher standards.
While HRSA audits don’t require Yellow Book standards, Rx|X voluntary incorporates them. This means:
Stronger planning and documentation
Clear, transparent reporting
Evidence-driven conclusions
Learn about Rx|X’s new tool Avanti340B, a major driver in this standard.
Need help?
If any additional team members would like to receive these updates directly, please have them either fill out the form using the button below or email us directly at info@rxxconsulting.com.