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Comprehensive

340B Consulting for Your FQHC

At Ravin Consultants, we specialize in empowering Federally Qualified Health Centers (FQHCs) and FQHC Look-Alikes to optimize their participation in the 340B Drug Pricing Program.

Through tailored strategy, compliance support, and program optimization, our team delivers white-glove consulting services that align with your mission to provide high-quality care to underserved populations. Whether you’re navigating enrollment, managing ongoing operations, or preparing for an audit, we’re your trusted partner in ensuring long-term 340B success.

Key Takeaways

What makes an organization eligible for 340B as an FQHC?

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Eligibility is based on designation as an FQHC or FQHC Look-Alike, with requirements such as Section 330 compliance, sliding fee scale policies, and HRSA OPAIS registration.

What is OPAIS and why is it important?

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OPAIS (Office of Pharmacy Affairs Information System) is HRSA’s official database of 340B covered entities. Accurate OPAIS records are required for participation and include site listings, Medicaid billing methods, and contract pharmacy relationships.

Can FQHCs use contract pharmacies?

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Yes. FQHCs may contract with external pharmacies to expand access and improve patient care. However, HRSA requires clear documentation, auditable inventory records, and precise reporting in OPAIS to maintain compliance.

How can we prepare for a 340B audit?

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We recommend regular internal mock audits, policy reviews, and data validation. Ravin Consultants supports FQHCs in preparing comprehensive audit documentation and navigating HRSA or manufacturer audit processes from start to finish.

FQHC Resources

How to get started with 340B as an FQHC?

Ravin Consultants offers a personalized strategy to help FQHCs meet eligibility requirements and understand the unique and complicated challenges in implementing and maintaining operations within the 340B program.

What Qualifies as a FQHC or FQHC Look-Alike?

An FQHC is a federally funded community health center that receives Section 330 grants under the Public Health Service Act.

These organizations provide comprehensive primary care and enabling services in underserved areas, operate under a patient-majority governing board, and offer services on a sliding fee scale, regardless of a patient’s ability to pay.
 FQHC Look-Alikes meet the same rigorous standards but do not receive Section 330 funding.

Both are eligible to participate in the 340B program as covered entities, as defined by the Health Resources and Services Administration (HRSA) through its Office of Pharmacy Affairs Information System (OPAIS). For more on eligibility and definitions, visit HRSA’s OPAIS portal.

Challenges Faced by FQHCs in the 340B Space

FQHCs and FQHC Look-Alikes face a unique set of challenges in navigating, implementing and administering a compliant and effective 340B program.

These may include:

  • Navigating complex compliance requirements and HRSA’s annual recertification process via OPAIS
  • Designing and maintaining compliant contract pharmacy arrangements
  • Managing Medicaid carve-in/carve-out declarations
  • Responding to evolving regulatory guidance and manufacturer restrictions
  • Balancing operational demands with limited administrative resources
  • Preparing for HRSA or manufacturer audits with complete documentation and defensible processes
  • Without a clear roadmap, these challenges can threaten program integrity and limit the impact of 340B savings on patient care.

How Ravin Consultants supports FQHCs

From 340B eligibility to implementation, optimization and compliance for audits, Ravin Consultants offers end-to-end support tailored to the specific needs of FQHCs and Look-Alikes.

Our services include:

Eligibility & Enrollment Guidance

We verify your entity’s eligibility and assist with OPAIS registration, Medicaid billing declarations, and accurate covered entity listings.

Program Implementation & Optimization

We develop tailored workflows, contract pharmacy strategies, and inventory management solutions that meet HRSA and Apexus standards.

Compliance Monitoring:

Our experts conduct internal reviews, develop policy and procedure documentation, and support corrective action plans.

Audit Preparation & Support

We simulate HRSA audit procedures through mock audits, review data integrity, and ensure audit readiness with confidence.

Staff Training & Education

We provide customized education sessions to help your team understand and uphold 340B program requirements.

Our consultants are certified through the Apexus Advanced 340B Operations Certificate Program, ensuring that your program operates in alignment with the most current industry best practices. Learn more at apexus.com.

Let’s Strengthen Your FQHC 340B Program

At Ravin Consultants, we believe your 340B program should be a strategic asset that amplifies your mission—not a compliance burden. We bring deep expertise, tailored solutions, and hands-on support to help your FQHC thrive within the 340B landscape. Whether you’re new to the program or looking to elevate your existing operations, we’re here to help.

Schedule Your FREE Consultation

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