From initial eligibility review through registration, implementation, and launch.
Starting a 340B program requires more than completing an application.
Organizations must confirm eligibility, understand the requirements attached to their covered entity type, register correctly, establish compliant clinical and pharmacy workflows, select appropriate vendors, train staff, and ensure the program is operationally ready before eligible activity begins.
Thrive340B guides organizations through the entire process.
We help evaluate eligibility, prepare registration materials, develop the program’s clinical and operational infrastructure, coordinate vendors, establish compliance controls, and manage implementation through go-live.
One experienced partner from initial assessment through full program launch.
Start Your 340B Program
Determine Whether Your Organization Is Eligible
Section 340B of the Public Health Service Act identifies the organizations that may participate in the 340B Program. HRSA requires eligible organizations and applicable outpatient facilities to register and receive approval before participating. (HRSA)
Thrive340B helps organizations evaluate:
- Covered entity classification
- Grant or program eligibility
- Hospital eligibility
- Parent organization structure
- Child-site eligibility
- Outpatient facility requirements
- Service-location eligibility
- Grant relationships
- Organizational documentation
- Registration timing
- Supporting documentation
- Potential operational limitations
Our role is to help leadership understand whether the organization appears eligible, what documentation may be required, and what operational responsibilities will follow enrollment.
Final eligibility and registration approval remain with HRSA.
Covered Entity Types We Support
Our work may involve organizations such as:
- Federally qualified health centers
- FQHC look-alikes
- Ryan White HIV/AIDS Program recipients
- Sexually transmitted disease grantees
- Tuberculosis grantees
- Hemophilia treatment centers
- Family-planning organizations
- Urban Indian organizations
- Native Hawaiian health centers
- Disproportionate share hospitals
- Children’s hospitals
- Critical access hospitals
- Rural referral centers
- Sole community hospitals
- Free-standing cancer hospitals
- Other eligible grantees and healthcare organizations
Each covered entity type has different eligibility documentation, operational considerations, and compliance risks.
Thrive340B develops an implementation plan around the organization’s specific structure rather than applying a generic model.
Preliminary Eligibility Assessment
Before registration begins, we evaluate whether the organization appears to meet applicable eligibility requirements and whether leadership is prepared to maintain the program after approval.
The assessment may include:
- Review of federal grant documentation
- Review of hospital classification
- Medicare cost report considerations
- Parent and child-site relationships
- Outpatient facility structure
- Clinical service locations
- Provider relationships
- Patient populations
- Pharmacy strategy
- Medicaid billing considerations
- Administrative resources
- Compliance infrastructure
- Financial feasibility
- Implementation readiness
The outcome is a practical assessment of the organization’s potential path forward, known limitations, documentation needs, and next steps.
340B Registration Support
HRSA accepts registrations during designated quarterly registration periods. New covered entities and outpatient facilities must submit registration information and required supporting documentation through 340B OPAIS. (HRSA)
Thrive340B can assist with:
- Registration planning
- Registration timeline development
- 340B OPAIS account preparation
- Covered entity information review
- Parent-site registration
- Child-site registration
- Contract pharmacy registration planning
- Authorizing official coordination
- Primary contact coordination
- Medicaid billing information
- Supporting-document preparation
- Registration submission support
- HRSA reviewer response coordination
- Effective-date planning
- Post-approval verification
The organization’s authorized representatives remain responsible for reviewing and certifying information submitted to HRSA.
Child-Site and Outpatient Facility Analysis
Organizations expanding into new locations must determine whether those locations meet applicable eligibility and registration requirements.
For hospitals, HRSA’s current guidance ties off-site outpatient facility eligibility to specific Medicare cost-report treatment and associated outpatient costs and charges. (HRSA)
Our analysis may include:
- Location ownership and control
- Clinical services provided
- Provider relationships
- Medical record integration
- Billing structure
- Cost-report treatment
- Grant scope
- Outpatient status
- Proposed drug use
- Registration requirements
- Anticipated effective dates
- Operational readiness
We help organizations understand when a new location may require registration and what records should support the determination.
Program Design
Registration alone does not create a functioning 340B program.
Before launch, the covered entity needs a clearly defined operating model.
Thrive340B helps design:
- Patient eligibility processes
- Provider eligibility standards
- Prescribing workflows
- Pharmacy distribution models
- Contract pharmacy arrangements
- Entity-owned pharmacy strategies
- Medication purchasing workflows
- Inventory models
- Medicaid carve-in or carve-out decisions
- Duplicate-discount safeguards
- Diversion controls
- Provider roster processes
- Data management
- Financial reconciliation
- Compliance monitoring
- Leadership reporting
Every component is developed around the covered entity’s actual clinical and operational environment.
Pharmacy Strategy and Implementation
A covered entity may determine that pharmacy services are needed to support access for its eligible patients. HRSA permits covered entities to enter written arrangements with one or more contract pharmacies and places responsibility for oversight on the covered entity. (HRSA)
Thrive340B can assist with:
- Pharmacy-needs assessment
- Entity-owned pharmacy analysis
- Contract pharmacy strategy
- Geographic access analysis
- Pharmacy identification
- Third-party administrator evaluation
- Vendor selection
- Wholesaler coordination
- Account setup
- Data-feed development
- Accumulator configuration
- Replenishment workflows
- Claims exclusions
- Medicaid controls
- Pharmacy registration
- Launch testing
- Ongoing monitoring plans
Vendor Identification and Selection
Most new programs require relationships with multiple outside organizations.
These may include:
- Third-party administrators
- Contract pharmacies
- Wholesalers
- Split-billing vendors
- Software platforms
- Data vendors
- Audit firms
- Pharmacy benefit partners
- Specialty pharmacies
- Medication-access partners
Thrive340B helps covered entities compare vendors based on:
- Capabilities
- Fee structures
- Implementation support
- Data access
- Reporting quality
- Compliance responsibilities
- Audit rights
- Integration requirements
- Customer service
- Contract terms
- Termination provisions
- Long-term scalability
Legal review of agreements should be completed by qualified legal counsel.
Medicaid Strategy
Federal law prohibits a manufacturer from providing both a 340B discount and a Medicaid rebate for the same drug transaction. Covered entities must maintain mechanisms designed to prevent duplicate discounts. (HRSA)
Thrive340B helps organizations evaluate:
- Medicaid fee-for-service activity
- Carve-in and carve-out decisions
- Medicaid Exclusion File information
- Billing numbers and identifiers
- State Medicaid requirements
- Managed Medicaid considerations
- Contract pharmacy Medicaid exclusions
- Billing modifiers
- Vendor configuration
- Written procedures
- Ongoing monitoring
Medicaid strategy should be evaluated at the site, pharmacy, payer, and state level.
Policies and Procedures
Before launch, the covered entity should have written policies that reflect how the program will actually operate.
Policies may address:
- Program governance
- Covered entity eligibility
- Patient eligibility
- Provider eligibility
- Child-site eligibility
- Contract pharmacy oversight
- Diversion prevention
- Duplicate-discount prevention
- Medicaid billing
- Provider roster management
- Purchasing and inventory
- Replenishment
- OPAIS maintenance
- Internal auditing
- Independent auditing
- Corrective actions
- Self-disclosure
- Record retention
- Vendor oversight
- Staff responsibilities
We develop policies around the organization’s real systems and workflows instead of providing a generic manual that employees cannot implement.
Staff Education and Launch Training
A compliant program requires more than one knowledgeable employee.
Thrive340B provides role-specific training for:
- Executive leadership
- Authorizing officials
- Primary contacts
- Compliance personnel
- Pharmacy staff
- Clinical staff
- Providers
- Billing teams
- Finance teams
- Information technology staff
- Patient navigation teams
- Vendor-management personnel
Training may address:
- Program purpose
- Individual responsibilities
- Patient and provider eligibility
- Diversion prevention
- Duplicate-discount prevention
- Medicaid processes
- Contract pharmacy oversight
- Documentation
- Reporting concerns
- Corrective-action escalation
- Record retention
Pre-Launch Testing
Before eligible activity is processed, Thrive340B helps test whether the program is functioning as designed.
Testing may include:
- Provider roster validation
- Location validation
- Patient matching
- Prescription matching
- Data-feed testing
- TPA configuration
- Contract pharmacy configuration
- Claims exclusions
- Medicaid controls
- Accumulator testing
- Replenishment testing
- Wholesaler account verification
- Reporting validation
- Exception review
- Staff workflow testing
The purpose is to identify implementation errors before they affect live transactions.
Post-Launch Validation
Program approval and go-live are only the beginning.
After launch, Thrive340B can provide:
- Early transaction testing
- Claims reconciliation
- Provider roster review
- Pharmacy performance review
- Data-feed validation
- Exception monitoring
- Financial reconciliation
- Staff support
- Policy updates
- Corrective-action assistance
- Leadership reporting
- Growth planning
Build the Program Correctly From the Beginning
A poorly planned implementation can create years of operational inefficiency, missed eligible activity, unreliable data, and compliance exposure.
Thrive340B helps organizations move from eligibility analysis to a fully operational program with the necessary people, systems, vendors, workflows, controls, and reporting in place.
Confirm eligibility. Complete registration. Build the infrastructure. Launch with confidence.
Discuss Your 340B Implementation