HRSA Audit & 340B Compliance

Be Audit-Ready Before an Audit Notification Arrives

GapRx helps covered entities strengthen 340B compliance, prepare for HRSA audits, complete internal reviews, build corrective action plans, and maintain the documentation and oversight needed for an audit-ready program.

Compliance-First Support

Reduce 340B Risk With Stronger Oversight, Documentation & Internal Controls

HRSA audit readiness should not begin after your organization receives an audit notification. A strong 340B program requires ongoing documentation, internal audits, policy review, claims testing, committee oversight, and issue resolution.

GapRx helps covered entities build a practical compliance process that supports daily operations, audit readiness, and long-term program integrity.

Where We Help

  • HRSA audit preparation and response support
  • Corrective Action Plan support after audit findings
  • Internal controls review and compliance workflow evaluation
  • Annual mock independent audit support
  • 340B Compliance Coordinator support and committee meetings
  • Policies, procedures, documentation, reporting, and audit-ready files
Audit & Compliance Services

Support for Every Stage of 340B Compliance

GapRx helps covered entities prepare before an audit, respond during an audit, and strengthen compliance after findings, internal reviews, or operational changes.

01

HRSA Audit Preparation

Review audit readiness, organize documentation, evaluate key risk areas, prepare audit files, and guide your team through expected audit requirements.

02

Corrective Action Plan Support

Support post-audit response, CAP development, remediation planning, documentation, implementation, and required follow-up activities.

03

Internal Controls Review

Evaluate policies, procedures, workflows, claims review processes, documentation, and operational controls to identify compliance gaps.

04

Mock Independent Audit

Perform mock audit reviews to test documentation, review claims, evaluate internal controls, identify gaps, and prepare staff for audit scrutiny.

05

340B Compliance Coordinator Support

Provide ongoing support for 340B program oversight, compliance questions, committee meetings, reporting, issue follow-up, and internal coordination.

06

Audit-Ready Reporting

Organize claims audits, internal review results, policy documents, financial reports, committee materials, and compliance reporting into an audit-ready process.

Our Process

A Practical Path to Audit Readiness

GapRx helps covered entities move from scattered documentation and reactive compliance work to a structured, ongoing audit-readiness process.

1

Assess Current Compliance Readiness

We review program structure, policies, procedures, OPA registrations, contracts, pharmacy relationships, audit files, committee oversight, and claims review processes.

Program Review Documentation Audit Readiness
2

Identify Gaps & Risk Areas

We evaluate internal controls, documentation gaps, claim risks, duplicate discount exposure, diversion concerns, and workflow weaknesses.

Internal Controls Claims Risk Gap Analysis
3

Build or Strengthen Documentation

We support policy updates, audit file organization, committee materials, internal reports, corrective action plans, and ongoing compliance documentation.

Policies & Procedures Audit Files CAP Support
4

Monitor, Audit & Improve

We support ongoing internal audits, mock audits, committee review, claim testing, compliance reporting, issue resolution, and continuous program improvement.

Internal Audits Monitoring Continuous Improvement
Why This Matters

Compliance Should Be Ongoing — Not a Last-Minute Audit Project

Waiting until an HRSA audit notification arrives can create unnecessary stress, rushed documentation, and avoidable risk. GapRx helps covered entities maintain a more consistent, organized, and audit-ready compliance posture.

  • Reduce audit stress with organized documentation and clear workflows
  • Identify compliance gaps before they become audit findings
  • Strengthen internal controls and committee oversight
  • Support corrective action planning and remediation tracking
  • Improve visibility into claims, pharmacy activity, and program performance
  • Protect the integrity and financial value of your 340B program
340B COMPLIANCE STRATEGY

Ready to Strengthen Your 340B Compliance Program?

GapRx can help your covered entity prepare for HRSA audits, improve internal controls, organize documentation, complete internal reviews, address compliance gaps, and maintain a more consistent audit-ready program.

Schedule a Strategy Call →
Client Testimonials

What Our Clients Say

CLIENT TESTIMONIAL
340B Analytics & Program Dashboards 340B Contract Pharmacy 340B In-House Pharmacy HRSA Audit & 340B Compliance Manufacturer Compliance & ESP
Our partnership with GapRx has been instrumental in helping us navigate the constant changes and increasing complexity of the 340B program. Their team brings a deep understanding of regulatory requirements, operational workflows, and compliance expectations, which has allowed us to stay ahead of evolving policies and industry shifts.

What truly sets GapRx apart is their responsiveness and adaptability. They are proactive in identifying potential risks, offering practical solutions, and implementing strategies that align with both compliance standards and operational efficiency. Their support has strengthened our internal processes, improved oversight, and provided confidence that we are managing our 340B program effectively.

In an environment where precision and compliance are critical, GapRx has proven to be a reliable and knowledgeable partner. I would strongly recommend them to any organization looking to enhance their pharmacy operations and ensure ongoing success within the 340B program.
CLIENT TESTIMONIAL
340B Analytics & Program Dashboards 340B Contract Pharmacy 340B In-House Pharmacy HRSA Audit & 340B Compliance Manufacturer Compliance & ESP
Working with GapRx has been incredibly valuable, particularly their proactive guidance, deep 340B expertise, and hands-on support in managing both our contract and in-house 340b programs. Their involvement has strengthened our compliance, improved operational and financial efficiency, and helped us better optimize program performance. GapRx truly acts as an extension of our team, making a meaningful impact on our 340B operations.
CLIENT TESTIMONIAL
340B Analytics & Program Dashboards 340B Contract Pharmacy 340B In-House Pharmacy HRSA Audit & 340B Compliance Manufacturer Compliance & ESP
GapRx has been and continues to be a vital part of our 340B program. We first began with GapRx only handling the implementation and ongoing operations of our contract pharmacy program, and now they handle all of our 340B program operations including in-house pharmacy as well. They have been instrumental in developing and helping to sustain our programs and we feel confident in their guidance through navigating the complexities of 340B. Having GapRx takes a tremendous workload off of us and we are so grateful for the services they provide!
CLIENT TESTIMONIAL
340B Contract Pharmacy HRSA Audit & 340B Compliance Manufacturer Compliance & ESP
AAPHC was fortunate to begin our relationship with GapRx in early 2022 with contract pharmacy management and audit services. As a result of their pharmacy and 340B expertise, we have expanded our relationship to include entity owned pharmacy auditing, contract pharmacy referral prescription capture, and claim submission services. As 340B has changed over recent years, having a proactive partner has allowed our program to continue to support expanded services for our patients. We are grateful for the stability GapRx brings to this volatile service line!
CLIENT TESTIMONIAL
340B Analytics & Program Dashboards 340B Contract Pharmacy 340B In-House Pharmacy HRSA Audit & 340B Compliance Manufacturer Compliance & ESP
GapRx 340B Consultants have been an amazing partner for Primary Healthcare Centers (PHC)! The GapRx team is honest, transparent, and highly knowledgeable with the 340B program. They provide wise guidance in maintaining compliance while maximizing PHC's savings (income) and improving patient access to affordable medications! PHC's revenue from the 340B contract pharmacies and PHC's in-house pharmacy has exceeded our expectations. I highly recommend GapRx 340B Consultants to FQHCs looking to navigate the complexity of the 340B program!