340B Compliance Consulting and Audit Support
Supporting 340B Compliance, Audit Readiness, and Program Oversight
Managing a 340B program today requires more than staying compliant with baseline requirements. Increased regulatory scrutiny, evolving manufacturer restrictions, and growing operational complexity have made it more difficult for covered entities to maintain compliance while protecting program savings.
Draffin Tucker provides 340B compliance consulting and audit support to help healthcare organizations strengthen oversight, reduce risk, and confidently manage their programs. Our team of experienced 340B consultants works alongside your staff to improve documentation, prepare for audits, and build processes that support long-term compliance. Our work often aligns closely with broader healthcare advisory services, helping organizations connect compliance efforts with financial and operational strategy.
Whether you are preparing for an HRSA audit, navigating staffing gaps, or looking to improve program performance, we provide the guidance and structure needed to move forward with clarity.
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340B Compliance Is Complex. You Do Not Have to Manage It Alone.
The 340B Program continues to evolve, and with that comes increased expectations around documentation, oversight, and audit readiness. Many covered entities face challenges such as:
- Maintaining accurate and up-to-date OPAIS records
- Monitoring contract pharmacy arrangements for compliance
- Preventing duplicate discounts and diversion risks
- Keeping policies and procedures aligned with actual operations
- Preparing for HRSA audits with limited internal resources
Our team helps you address these challenges with a structured, proactive approach to 340B program compliance. Many of these compliance areas also impact reimbursement accuracy and reporting, which is why organizations often pair 340B oversight with healthcare reimbursement support.
We work with your organization to:
- Prepare for HRSA audits and reduce compliance risk
- Strengthen policies, procedures, and supporting documentation
- Improve contract pharmacy compliance and oversight
- Maintain accurate OPAIS registration and recertification records
- Support ongoing program management with clear reporting and accountability
Our 340B Consulting Services
Our 340B consulting services are designed to support compliance, audit readiness, and day-to-day program management.
340B Risk Assessments
A 340B risk assessment provides a comprehensive review of your program to identify areas of vulnerability and opportunity.
We evaluate your processes based on current regulatory expectations, common compliance pitfalls, and real-world audit findings. The result is a clear, prioritized roadmap that helps reduce risk and improve program integrity.
Mock Audits and HRSA Audit Preparation
Preparing for an HRSA audit requires more than a checklist. Our team provides structured mock HRSA audits and audit readiness support to help you identify issues before they become findings.
We assist with:
- Documentation review and validation
- Transaction testing and compliance checks
- Staff preparation and audit response readiness
- Guidance throughout the audit process
Our goal is to ensure your team is prepared, confident, and aligned well before an audit occurs.
OPAIS Registration, Recertification, and Update Support
Accurate OPAIS records are critical to maintaining eligibility and avoiding audit findings.
We provide support for:
- Initial registration and recertification
- OPAIS updates and change requests
- Alignment with cost report documentation
- Ongoing validation of program eligibility
This helps reduce risk tied to outdated or unsupported records and ensures your program remains in good standing.
Policies and Procedures Review and Development
Strong documentation is the foundation of 340B compliance.
We help develop and refine 340B policies and procedures so they accurately reflect your operations and meet regulatory expectations. This includes:
- Full policy and procedure manual development or updates
- Alignment between written procedures and actual workflows
- Staff training and role clarity
Corrective Action Plan (CAP) Support
If compliance issues are identified, a clear and structured response is critical.
We assist with corrective action plan (CAP) development, implementation, and documentation to ensure findings are addressed effectively and sustainably.
Outsourced 340B Monthly Coordinator Services
For organizations needing ongoing support, we offer outsourced 340B coordinator services to help manage program operations consistently.
This includes:
- Monthly program monitoring and reporting
- Claims sampling and compliance reviews
- Trend analysis for purchasing and dispensing activity
- Project tracking and prioritization support
- Ongoing training and knowledge transfer
Our approach goes beyond temporary support. We help build internal understanding so your team can sustain compliance long-term.
What You Receive When You Work With Our 340B Team
We focus on delivering clear, actionable outcomes that support both compliance and program performance.
- A prioritized risk assessment with recommended next steps
- Audit readiness guidance and supporting documentation structure
- Updated or newly developed policies and procedures
- OPAIS support and documentation alignment
- Monthly oversight reporting and insights (if applicable)
- Practical recommendations your team can implement immediately
Talk With a 340B Consultant
If you are looking to strengthen compliance, prepare for an audit, or improve how your 340B program operates, our team is here to help.
Request a Consultation or Contact the 340B Team to start the conversation.
Who We Support
Covered Entities
We work with a range of covered entities participating in the 340B Program, including hospitals, health systems, and community-based organizations.
Internal Teams
Our work typically supports:
- Compliance and regulatory teams
- Finance and reimbursement leaders
- Pharmacy and 340B program administrators
- Executive leadership and operations teams
Frequently Asked Questions About 340B Compliance
We work with a range of covered entities participating in the 340B Program, including hospitals, health systems, and community-based organizations.
