340B Automated Application System
A practical blueprint for a self-completing 340B application system that guides responsible parties through HRSA's process and produces field-ready outputs.
What the System Must Do
This is a guided completion and document-prep system—not an "auto-submit" bot—because OPAIS requires human attestation.
Determine covered entity type and prerequisites before starting the full application.
Step-by-step guidance for Responsible Party and Authorizing Official through the entire process.
Secure document uploads, identifiers, grant details, and site data with metadata tagging.
Catch common disqualifiers before HRSA entry with three-level validation system.
HRSA/OPAIS field-ready answers, checklists, and supporting documentation packets.
Complete tracking of who answered what and when, with versioning and sign-off checkpoints.
System Architecture
Intake Wizard
Role-based interface for RP, AO, Pharmacy Lead, and Compliance
Rules & Validation Engine
Encodes 340B eligibility logic by entity type (DSH, CAH, FQHC)
Document Vault
Secure uploads with metadata tagging and encryption
Output Generator
Produces OPAIS Field Map, Registration Packet, and Readiness Report
Workflow Orchestrator
Tasks, reminders, approvals, and deadline management
Admin Dashboard
Portfolio view for multi-entity systems with readiness scoring
Frontend
React / Next.js
Backend
Node / Python
Database
PostgreSQL
Storage
S3 (encrypted)
Authentication
SSO + MFA
E-Signature
DocuSign / Adobe
The Guided Flow (Wizard Screens)
Key Questions:
- Covered entity type (hospital vs. grantee vs. FQHC vs. clinic type)
- Ownership and nonprofit status
- Federal grant presence (program, award number, period)
- For hospitals: Medicare provider ID, cost report status, DSH/CAH designation
System Output: "Likely Eligible / Not Eligible / Needs Review" result with remediation checklist if not eligible
Organization Data:
- Legal name, DBA, EIN, NPI(s)
- CMS Certification Number (if hospital)
- Primary address, phone, website
- Legal structure (501(c)(3), governmental)
Key Contacts:
- Responsible Party (RP)
- Authorizing Official (AO)
- Primary 340B coordinator
- Pharmacy lead
Collect comprehensive site data including name, address, NPI, cost center designation, services provided, and relationship to parent entity.
Automatic Validation: System flags mismatched NPI/location, sites not aligned to entity type, and missing documentation
Document in-house vs. contract pharmacy use, contract pharmacy partners and locations, diversion prevention policies, patient definition alignment, and referral relationships. System generates required policy checklist and standard language templates.
Confirm all required policies exist (diversion, duplicate discounts, GPO prohibition). Responsible Party and Authorizing Official provide internal sign-off.
Readiness Gate: System produces "Readiness Report" and blocks final export until all required attestations are completed
Three-Level Validation Engine
- Entity type not eligible (e.g., for-profit)
- Missing federal grant/award when required
- Missing hospital designation/requirements
- Inconsistent legal name across documents
- Site addresses not matching source documents
- Contract pharmacy intent without required policies
- Missing supporting document for critical fields
- Unassigned RP/AO roles
- Unverified identifiers (EIN/NPI/CCN)
Output Package (What You Get)
- Organization profile summary
- Site roster
- Contact roster
- Grant/hospital eligibility evidence index
- Attestation pages (internal)
- Document appendix
Structured table with:
- Field name
- Value (copy/paste ready)
- Source document reference
- Notes/assumptions
- Owner assignment
Includes actionable gap list with assigned owners
Security, Governance, and Audit Requirements
Enterprise-grade security and compliance built into every layer
Security Controls
- Role-based access control (RP vs AO vs staff)
- Encryption at rest and in transit
- Multi-factor authentication (MFA)
- Secure document storage with access logs
Audit & Compliance
- Immutable audit log (who changed what, when)
- Version control of all outputs
- Document retention policy
- Compliance disclaimers and attestations
Important: This system prepares and guides; final HRSA/OPAIS submission requires human review and attestation.
Your "Build-First" Deliverables
These assets should be built first, in order, to create a solid foundation for the automated system.
Entity Type Decision Tree
Eligibility triage logic
Data Dictionary
All fields you collect + required docs per field
Wizard Screen Map
Phase A–E detailed flow
Validation Rules List
Hard stops + warnings
OPAIS Field Map Template
Copy/paste workbook format
Packet Generator Template
PDF structure
Workflow/Pipeline Design
Stages + tasks + reminders
Interactive Cost Calculator
Estimate your implementation costs and timeline based on your specific entity type, number of sites, and desired features.
Disproportionate Share Hospital with complex cost reporting requirements
Rural hospital with simplified eligibility requirements
Community health center with grant-based eligibility
HIV/AIDS service provider with specialized requirements
Specialized treatment center with focused patient population
Other qualifying federal grant recipient
Include all locations that will be registered in the 340B program
Guided Intake Wizard
Step-by-step data collection interface (included)
3-Level Validation Engine
Hard stops, warnings, and quality checks (included)
Secure Document Vault
Encrypted storage with metadata tagging (included)
OPAIS Field Map Generator
Copy/paste ready field completion workbook (included)
Manage contract pharmacy relationships and compliance policies
Advanced site registration and child site tracking
Task routing, reminders, and approval gates
Immutable logs with version control and e-signature integration
Multi-entity system management with readiness scoring
Connect to NPI Registry, CMS, and IRS databases for auto-fill
Custom branding and domain for your organization
Priority support with onboarding and staff training (annual)
12-16 weeks
From kickoff to production deployment
Get a detailed proposal and custom quote based on your specific requirements
Note: Pricing is estimated and may vary based on specific customization requirements, integration complexity, and support needs.
Ready to Build Your Automated System?
Tell us which covered entity type you're targeting first (hospital DSH/CAH vs FQHC/grantee), and we'll produce the complete data dictionary, validation rules, exact wizard questions, OPAIS Field Map workbook, and document checklist specific to that entity type.