340B for Hospitals &
Health Centers

Program intent. HRSA describes 340B as enabling covered entities to stretch scarce federal resources to reach more eligible patients and offer more comprehensive services. (HRSA)

Cooper Strategy helps Disproportionate Share Hospitals (DSH), Children’s Hospitals, Free‑Standing Cancer Hospitals, Rural Referral Centers (RRC), Sole Community Hospitals (SCH), Critical Access Hospitals (CAH), and FQHCs/FQHC look‑alikes capture more compliant 340B value—without adding burden to already stretched teams. Our blend of FQHC consultants, technologists, and former CE operators improves cash flow and audit readiness while expanding access for vulnerable patients.

What Counts: The 340B Hospital Definition

"340B hospital definition" refers to the hospital categories defined in statute that qualify for 340B participation (for example: DSH, CAH, RRC, SCH, Children's, and Free‑Standing Cancer hospitals). Each type has distinct eligibility and registration rules, and a hospital eligible in multiple categories must enroll under one category and follow that category's requirements.

If you're unsure where you fit—or how child sites/clinics, cost reports, or the GPO prohibition apply—we'll map your status and next steps using current HRSA guidance and FAQs.

Our 340B Growth System for Hospitals & FQHCs

1

Purpose‑Built FQHC Revenue Cycle Management for 340B

We align FQHC revenue cycle management with pharmacy operations so finance, pharmacy, and population health pull in the same direction. Outcomes include cleaner eligibility determinations, better accumulator hygiene, faster reconciliation, and fewer reversals—supported by dashboards your CFO will actually use.

2

Referral Capture with Unique Walgreens Access

Cooper Strategy is one of only two sources available to Covered Entities for Walgreens referral capture assistance. Because Walgreens processes a large share of U.S. prescriptions, unlocking these referrals can materially affect 340B revenue. Our direct access and data pipelines raise qualified capture rates while reducing manual work for your team.

3

Pharmacy Network Development (We Do the Heavy Lifting)

We analyze claims density, prescriber geography, payer mix, and leakage to add the right contract pharmacies—then handle the paperwork and HRSA registrations. Example: we discovered a client had no CVS contracts in an area with clear overlap; we coordinated and registered 18 CVS locations, which now generate $200,000+ per month to the health center through CVS/Wellpartner.

4

Telehealth‑Enabled Patient Procurement (Compliant by Design)

We coordinate with self‑insured employers and their PBMs to steer new, unique patients to your health center or hospital—without overwhelming staff. Built‑in compliance via our partner MakoRx includes: CE‑provider contracting, CE ownership of health records, grant‑scope alignment for FQHCs/look‑alikes, and delivery of actual health services beyond drug dispensing via telemedicine.

Typical financial model:
  • Year 1: net just under $2M as volume ramps to protect quality.
  • Years 2+: approximately $7M net annually at steady state.

(Results vary by market size, payer mix, and network configuration.)

HRSA 340B Audits: Build "Audit-Ready by Design"

HRSA conducts audits of covered entities and manufacturers to verify eligibility, prevent duplicate discounts, and prevent diversion. Findings can trigger corrective action plans, repayments, and—in egregious cases—removal from the program. We operationalize the audit process and documentation standards end-to-end so you're ready any day.
100% Success Rate

Our comprehensive audit services include:

Mock Audit Package — Patient definition testing, prescriber/location eligibility, Medicaid carve-in/out alignment, contract pharmacy oversight.
Fielding HRSA/Manufacturer/TPA Audits — Curated document rooms, secure exchange, real-time response.
Policy & Training — SOP refreshers and "what auditors actually ask."
Technology — One-click bundles for auditors, CFOs, and your compliance committee.

Compliance Corner (Hospitals & FQHCs)

Patient definition (what auditors look for)

HRSA's 1996 Patient Definition Guidelines continue to guide audits. Documentation should show a clinical relationship (encounter notes, orders), CE responsibility for care, and CE‑maintained records. HRSA has noted that the Genesis v. Becerra decision is applicable solely to that case; your safest posture remains robust encounter documentation.

Dispensing‑only isn't enough

To minimize diversion risk, ensure the patient received health services beyond drug dispensing from or on behalf of the CE and that you maintain auditable records.

Maintain auditable records

Inadequate documentation can lead to findings, repayments, or termination.

How we implement this for you

Record the referral

In the EHR with the referring and referred‑to providers, diagnosis, therapy plan, and dates.

Verify provider encounters

On both sides of the referral with source notes (or patient care summaries from our platform) and prescriber/location eligibility.

Define and enforce your encounter window

A CE‑specific, clinically defensible timeframe to support medical necessity and continuity.

Store all documentation

At the CE's registered site with secure, role‑based access.

Audit records regularly

Our proprietary system flags gaps; one button assembles the regulatory package for authorized viewers (CFO, Cooper, or HRSA auditor).

Why Cooper Strategy?

  • FQHC consultants with operator‑level experience in pharmacy + finance.

  • Walgreens referral capture is not widely available elsewhere.

  • AI + human review on every claim for higher accuracy and lower overhead.

  • Proof of impact: multi‑million‑dollar pharmacy network expansions and telehealth‑driven patient growth.

  • Mission alignment: maximize shared savings to reinvest in underserved communities.

Reminder: To participate, covered entities must enroll and comply with all program requirements. HRSA's site lists eligible entity types and current program updates.

Ready to Take the Next Steps?

Request a 340B Readiness Review

Eligibility, child sites, and risk mapping.

Schedule a Referral Capture Workshop

Walgreens + network yield.

Book an Audit Simulation

HRSA 340B audits prep with findings remediation.

FAQs

Q1: What is the 340B hospital definition?
A: It refers to the statutory hospital categories eligible for 340B (DSH, Children's, Free‑Standing Cancer, CAH, RRC, SCH). A hospital eligible in multiple categories must choose one and follow that category's rules.
Q2: How do HRSA 340B audits work—and how do you prepare us?
A: HRSA (and manufacturers) audit for eligibility, duplicate discounts, and diversion. Findings can require CAPs and repayments. We build "audit‑ready by design" operations with mock audits, document rooms, and staff training.
Q3: Does dispensing‑only qualify a person as a 340B patient?
A: HRSA's audit posture is still anchored in the 1996 Patient Definition Guidelines—auditors look for clinical services delivered beyond drugdispensing and CE‑maintained health records.
Q4: What do FQHC consultants actually do for 340B revenue cycle management?
A: We align eligibility, pharmacy, and finance workflows; improve accumulator hygiene; raise referral capture; optimize contract pharmacy networks; shorten reconciliation; and reduce reversal risk.
Q5: Can you help us decide between hospital categories or register child sites?
A: Yes—our team translates HRSA rules and FAQs into step‑by‑step actions for registration, category selection, child‑site setup, and ongoing compliance.