340B Program Management
for covered entities.

340B program management is the ongoing operation of a covered entity's 340B program by a dedicated partner rather than by stretched internal staff. At Remy it runs as one service across six disciplines: identifying eligible patient encounters in EMR and claims data, running internal compliance reviews, administering contract pharmacy relationships, supporting procurement and split-billing accuracy, reporting savings and program health to leadership, and keeping documentation organized so the program stays audit-ready. Remy is a consultant and administrator, not a covered entity - compliance responsibility stays with the covered entity, and we work to your written policies and procedures.

340B consulting, as we use the term, is a bounded engagement: we assess an existing program, benchmark capture and savings, review documentation practices, and hand back findings and a plan your team executes. 340B program management is ongoing - Remy operates the program alongside your staff week to week, covering capture monitoring, contract pharmacy reconciliation, procurement support, reporting, and audit-readiness work. Many partners begin with a diagnostic engagement and move into full management once the gaps are clear.

The 340B Drug Pricing Program is a federal program that requires drug manufacturers to provide outpatient drugs at significantly reduced prices to eligible healthcare organizations - primarily Federally Qualified Health Centers (FQHCs), Ryan White clinics, Disproportionate Share Hospitals, and other safety-net providers. The program is administered by the Health Resources and Services Administration (HRSA).

Eligibility is set by federal statute and administered by HRSA. Qualifying covered entities include Federally Qualified Health Centers and FQHC look-alikes, Ryan White HIV/AIDS program grantees, tuberculosis clinics, black lung clinics, hemophilia treatment centers, family planning and STD clinics, and specific hospital types such as Disproportionate Share Hospitals, Critical Access Hospitals, freestanding cancer centers, sole community hospitals, and Rural Referral Centers. An organization must register with HRSA, appear on the 340B OPAIS database, and recertify annually to remain eligible. Any registered covered entity can benefit from 340B program management.

Since 2020 a number of manufacturers have imposed conditions on 340B pricing for drugs dispensed through contract pharmacies, and the resulting disputes have produced ongoing litigation and differing court outcomes. The practical effect is that contract pharmacy access varies by manufacturer, by drug, and over time. Covered entities should track manufacturer policies actively rather than assume prior arrangements still apply, and should consult counsel on entity-specific questions. This is an evolving area - verify current policy and legal status before relying on any particular arrangement.

We integrate directly with your EMR and claims systems to analyze each patient encounter against HRSA's 'patient definition' criteria - confirming the provider was employed or contracted by the covered entity, the service was within the scope of a qualifying grant or contract, and documentation exists in the covered entity's records. Our algorithms continuously tune against your specific clinical workflow to maximize capture without risking compliance.

Meeting 340B audit requirements is the covered entity's responsibility. Remy is a consultant and administrator, not a covered entity. Our role is operational: we keep the documentation trail behind purchases, dispenses, and provider and location records organized; we run internal reviews on a schedule against your policies; we track corrective actions through to closure; and we assemble the records your team needs when an audit notice arrives. We work from HRSA's current published guidance and your entity's own documents rather than from a generic template.

We build one specific to your program rather than handing over a generic template. During the diagnostic phase we map your dispensing models, contract pharmacy arrangements, provider and location records, and documentation practices, then produce a working checklist your team can run between formal reviews. It points back to your own written policies and procedures rather than replacing them, and we revise it as the program changes. Compliance responsibility stays with the covered entity; our job is to keep the evidence organized and the reviews on schedule.

HRSA conducts approximately 200 audits per year. Common findings include diversion (dispensing 340B drugs to ineligible patients), duplicate discounts (receiving both 340B and Medicaid rebates on the same drug), and inadequate documentation. Penalties range from repayment of manufacturer discounts to removal from the program. Remy's compliance-first approach includes quarterly self-audits and full audit-defense support.

Covered entities without in-house pharmacies can contract with external retail or specialty pharmacies to dispense 340B drugs on their behalf. These arrangements require formal written agreements, split-billing software, and careful reconciliation to prevent duplicate discounts. Remy manages the full lifecycle - from pharmacy selection and contracting through monthly reconciliation and revenue recovery.

For an established covered entity, our typical implementation takes 8 weeks: 3 weeks of diagnostic work (capture rate analysis, compliance review, benchmarking) followed by 5 weeks of build-out (eligibility engine configuration, contract pharmacy activation, reporting infrastructure). New 340B registrants will have a longer runway due to HRSA registration timelines.

Savings vary based on patient volume, prescribing patterns, and existing program maturity. A diagnostic assessment is the best way to benchmark your specific opportunity.

We offer both fixed-fee and savings-share structures depending on program size and complexity. Fixed-fee arrangements work well for established programs with predictable volume; savings-share arrangements align our incentives with growth for programs earlier in their maturity. We'll discuss both options during your discovery call and recommend the structure that fits your situation.