340B is not one program. It is fourteen, with different rules each.
A critical access hospital is exempt from the GPO prohibition; a disproportionate share hospital is not. A health center can often carve Medicaid in; a hospital frequently should not. Generic 340B advice is how entities get findings.
At a glance
- 01Entity categories
- 14
- 02Registered sites
- 60,000+
- 03States served
- All 50
- 04Advice model
- Entity-specific
Two broad paths: hospitals, and federal grantees.
Hospital eligibility depends on a disproportionate-share calculation or a specific statutory classification. Grantee eligibility depends on receiving one of a defined list of federal grants — the grant itself is the qualifying event.
Hospitals and health systems
Health centers, clinics and federal grantees
The same program, four different rule sets
A quick comparison of the differences that most often catch entities out. This is a simplification — full eligibility rules are set out on each entity page.
01GPO prohibition
- DSH hospital
- Applies
- Critical access
- Exempt
- FQHC
- Not applicable
- Ryan White
- Not applicable
02Orphan drug exclusion
- DSH hospital
- Not applicable
- Critical access
- Applies
- FQHC
- Not applicable
- Ryan White
- Not applicable
03Child site cost report linkage
- DSH hospital
- Required
- Critical access
- Required
- FQHC
- Scope of project
- Ryan White
- Scope of grant
04Typical Medicaid approach
- DSH hospital
- Frequently carve out
- Critical access
- Varies by state
- FQHC
- Often carve in
- Ryan White
- Often carve in
05Typical program scale
- DSH hospital
- Very large
- Critical access
- Small
- FQHC
- Small to mid
- Ryan White
- Small
06Most common exposure
- DSH hospital
- Patient definition, contract pharmacy
- Critical access
- Oversight capacity, documentation
- FQHC
- Scope of project, site registration
- Ryan White
- Manufacturer restriction concentration
Sole community hospitals, rural referral centers, children's hospitals and free-standing cancer hospitals each have further variations. Confirm your specific category before applying any of the above.
Next step
Not sure which category you fall into?
Eligibility category determines almost everything else. It is the first thing we confirm on any engagement, and we will confirm it on a call at no cost.