There has been a lot of movement around federal 340B reform this year, but two proposals have started to stand out: the SECURE 340B Act and the SUSTAIN 340B Act.
At a high level, both bills are trying to address many of the same longstanding issues within the 340B Program, including contract pharmacy access, patient definition, duplicate discounts, manufacturer restrictions, child sites, reporting, and oversight. The biggest difference is how they get there.
Both would bring more structure and federal oversight to the program, but SUSTAIN generally gives covered entities stronger protections around the traditional 340B model, while SECURE places more requirements around how hospitals operate and demonstrate patient benefit.
Where SECURE and SUSTAIN Are Similar
There is a lot of overlap between the two bills. Both proposals would create a clearer federal framework around areas that have historically relied heavily on HRSA guidance, litigation, or manufacturer-specific policies.
Both bills would:
- Establish a federal definition of a 340B patient
- Protect covered entities’ ability to use contract pharmacies
- Limit manufacturer restrictions on contract pharmacy access
- Create a national claims clearinghouse
- Increase claims-level data sharing to help prevent duplicate discounts
- Add more requirements around hospital child sites
- Increase reporting and transparency
- Expand HRSA audit and enforcement authority
- Add patient financial assistance requirements
Even if neither bill passes exactly as written today, Congress seems to be moving toward a model where covered entities receive stronger protections from manufacturers, but in exchange are expected to provide more data, documentation, and transparency.
Contract Pharmacies
This is one of the strongest areas for covered entities under both bills. Both SECURE and SUSTAIN would formally protect a CE’s ability to use contract pharmacies and would prevent manufacturers from simply refusing 340B pricing because a drug is dispensed through a contract pharmacy.
Both proposals also avoid placing a strict numerical or geographic cap on contract pharmacy relationships. That would be a significant shift after years of manufacturer-specific rules, exceptions, data requirements, and pharmacy limits.
There is a tradeoff, though. CEs should still expect more formal oversight of those relationships, including registration, written agreements, data reporting, and auditing.
Rebate Models: SUSTAIN Has the Advantage
The rebate model is probably one of the biggest differences between the two proposals.
SECURE would protect the traditional upfront 340B discount for four years, generally preventing manufacturers from forcing CEs into a retrospective rebate structure during that period. That is meaningful protection, but it still leaves the door open to a different model later.
SUSTAIN takes a stronger position by reinforcing 340B as a point-of-purchase discount program rather than a rebate-based model.
For covered entities, that matters. Rebate models can create additional cash-flow pressure, reconciliation work, delayed savings, and more opportunities for claims to be denied or disputed. Because of that, SUSTAIN is the stronger proposal for CEs when it comes to preserving the traditional 340B purchasing model.
Patient Definition
Both bills would create a statutory patient definition, which could finally bring more consistency to an area that has remained unclear for decades. However, that clarity could also narrow how some covered entities currently identify eligible 340B claims.
Both proposals focus on demonstrating a clear relationship between the CE and the patient, including recent outpatient encounters and documentation around referrals.
For CEs, this could mean taking a closer look at encounter windows, referral capture, provider relationships, prescription origin, TPA qualification logic, and medical record documentation. Entities currently using broader qualification methodologies may see more change here than those already using a more conservative patient definition.
Child Sites and Financial Assistance
Both proposals increase oversight of hospital child sites, but SECURE appears more restrictive.
SUSTAIN would add ownership, registration, and integration requirements, while SECURE goes further with more detailed standards around provider-based status, Medicare participation, financial integration, cost report treatment, financial assistance, and community need.
For hospital CEs with multiple off-campus locations, SECURE could create a much larger compliance review. Existing child sites may need to be reassessed, and future acquisitions or clinic expansions may require more analysis before assuming a site will qualify for 340B.
The bills also place more focus on demonstrating how 340B supports patients. SUSTAIN would establish financial assistance requirements for certain patients at or below 200% of the federal poverty level, while SECURE goes further for some hospital covered entities, with requirements that could extend financial assistance or sliding-fee protections to patients up to 400% of the federal poverty level.
For hospitals, this is another area where SECURE could create more financial and administrative responsibility.
The National Clearinghouse
Both SECURE and SUSTAIN would establish a national clearinghouse intended to address duplicate discounts and standardize 340B claims data.
In theory, that could reduce some of the fragmentation CEs are currently dealing with across ESP, Truzo, manufacturer portals, rebate models, and other manufacturer-specific requirements.
However, centralized does not necessarily mean less data. Claims information, payer data, NDCs, prescriber information, pharmacy identifiers, wholesaler data, purchasing information, and other records could all become more important under a standardized federal process.
Regardless of which proposal moves forward, covered entities need to know where their data is coming from, whether it is accurate, and whether their vendors can support increasingly detailed reporting requirements.
Which Bill Is Better for Covered Entities?
Overall, SUSTAIN appears to be the more favorable proposal for covered entities right now.
That does not mean it is light on compliance. SUSTAIN would still bring more reporting, more audits, more data requirements, a defined patient standard, additional child-site requirements, and more formal oversight of contract pharmacies.
However, it also provides several protections that are especially important for CEs:
- Stronger protection of the traditional upfront 340B discount
- A clearer position against manufacturer rebate models
- Federal protection for contract pharmacy relationships
- No strict numerical or geographic contract pharmacy cap
- A national approach to duplicate discount data
- Less aggressive financial assistance requirements than SECURE for some hospitals
SECURE also offers meaningful protections, especially around contract pharmacies and manufacturer restrictions. The concern is that those protections come with more detailed operational requirements, particularly for hospitals with multiple child sites or more complex 340B structures.
For smaller and rural covered entities, SUSTAIN may strike the better balance between protecting 340B access and adding federal oversight.
What Should Covered Entities Be Watching?
Neither bill is law yet, and both could change significantly before anything reaches the finish line. Still, the similarities between SECURE and SUSTAIN give CEs a good idea of where federal reform may be heading.
Covered entities should be paying particular attention to patient eligibility, contract pharmacy documentation, claims and purchasing data, child-site structure, financial assistance policies, and vendor readiness.
The biggest takeaway is not necessarily to change operations today. It is to make sure current processes are documented, data is reliable, vendors are prepared, and leadership understands where future federal reform could create the biggest impact.
The Bottom Line
SECURE and SUSTAIN are different bills, but both point toward the same general direction: more protection for covered entities, paired with more oversight.
SUSTAIN currently provides the stronger framework for preserving the traditional 340B model, particularly around point-of-purchase discounts and contract pharmacy access. SECURE offers many of the same protections, but with more extensive requirements around hospital operations, child sites, and patient financial assistance.
For covered entities, the impact will come down to how well either proposal balances stronger protections with the added compliance and reporting requirements. As reform continues to develop, the focus should be on understanding what changes operationally and making sure current 340B processes are prepared to adapt.