Government
It has been our experience that every stakeholder, including pharma manufacturers, realize the importance of the 340B program to the USA and their role in it. By working together with accurate data and transparency we can reach consensus with all stakeholders and produce more effective 340B programs.
Government 340B Program: Policy, Oversight & Impact
The 340B Drug Pricing Program helps safety‑net providers stretch scarce resources and expand access to care. HRSA’s Office of Pharmacy Affairs (OPA) administers the program and maintains OPAIS, the official registry for covered entities and contract pharmacies.
Cooper Strategy partners with government stakeholders—state Medicaid agencies, public hospitals and health centers, and public employers—to translate policy into day‑to‑day operations that protect program integrity, prevent duplicate discounts, and measurably improve access.
What Government Stakeholders Need Most
1) Duplicate‑Discount Prevention (FFS & MCO)
2) Contract‑Pharmacy Oversight
3) Audit Readiness & Program Integrity
4) Policy Environment in Flux
What Government Stakeholders Need Most
1) Duplicate‑Discount Prevention (FFS & MCO)
Requirement: Manufacturers may not pay a Medicaid rebate on a drug already discounted under 340B. HRSA’s Medicaid Exclusion File (MEF) is the anchor for fee‑for‑service (FFS) carve‑in coordination (it does not apply to Medicaid managed care).
State/MCO complexity: CMS and GAO both highlight persistent challenges preventing duplicate discounts in MCO settings; states need reliable claim‑level identifiers and clear carve‑in/out rules. (Medicaid)
2) Contract‑Pharmacy Oversight
HRSA’s 2010 Contract Pharmacy Services notice recognizes broad arrangements but places responsibility on covered entities to prevent diversion and duplicate discounts and to maintain auditable records.
GAO has recommended stronger federal oversight due to risks inherent in mixed dispensing environments.
3) Audit Readiness & Program Integrity
HRSA audits covered entities and manufacturers to verify eligibility and compliance; HRSA also publishes resources showing how patient definition and other standards are applied in audits.
4) Policy Environment in Flux
States have tested contract‑pharmacy protections; courts have issued divergent rulings on preemption and enforcement, underscoring the need for careful state policy design and continuous monitoring.
How Cooper Strategy Helps Government Clients
A. Policy Design & Technical Guidance
FFS/MCO frameworks: We help states define carve‑in/carve‑out policies, data elements, and claim‑flagging logic that align with HRSA’s MEF for FFS and with CMS guidance for MCOs.
Contract‑pharmacy guardrails: Model contract provisions and SOPs that reflect HRSA’s 2010 notice—auditable records, diversion controls, and dispute pathways.
ADR awareness: We brief agencies on HRSA’s Administrative Dispute Resolution (ADR) regulation so they understand available pathways when disputes arise.
B. Program‑Integrity Analytics
Duplicate‑discount detection: Cross‑walk MEF data with Medicaid claims (FFS) and MCO encounter data to flag potential collisions before rebate invoicing.
Contract‑pharmacy risk scoring: Rank pharmacies by exception rates, reversal patterns, and documentation timeliness to prioritize oversight.
OPAIS alignment checks: Continuous verification that registered locations, billing identifiers, and timeframes line up across data sources.
C. Government Provider Operations (Public Hospitals & Health Centers)
Audit‑ready by design: Mock HRSA/manufacturer audit packages, policy refreshers, and on‑call support—built around how HRSA applies patient‑definition resources.
Referral capture & pharmacy network development: We identify high‑yield contract‑pharmacy adds and handle registrations and onboarding. In one engagement, registering 18 CVS locations with HRSA led to $200,000+ per month to the CE through CVS/Wellpartner.
Telehealth‑enabled patient procurement: For public providers, we coordinate with self‑insured employers to increase unique patient counts—compliantly—so more residents access care. In typical models, CEs net just under $2M in Year 1 and about $7M annually in steady state, with volume ramped to protect care quality.
Compliance reminder: A person is not considered a 340B patient if the only service received is dispensing for self‑administration. Covered entities must provide and maintain documentation of actual health services, consistent with HRSA’s patient‑definition resources (anchored in the 1996 guidance). (HRSA)
For Public Employers (State, County, Municipal, School Systems)
If you sponsor a self‑insured health plan, we can align benefit design and network strategy with nearby covered entities to improve primary care access via telehealth and local clinics. We focus on adherence and continuity while the CE maintains the medical record and clinical relationship. (We’ll coordinate with your counsel to confirm any state‑specific constraints and program‑integrity guardrails.)
Implementation Playbook (Government 340B Program)
1. Map your landscape
2. Codify FFS/MCO rules
3. Strengthen contracts & SOPs
4. Stand up analytics
5. Be audit‑ready
6. Track outcomes
Implementation Playbook (Government 340B Program)
Map your landscape
Inventory CEs, contract pharmacies, billing/claim identifiers, and MEF status; verify OPAIS details. (340B OPAIS)
Codify FFS/MCO rules
Publish a Medicaid bulletin that standardizes claim indicators and carve‑in/out policy. (Medicaid)
Strengthen contracts & SOPs
Require auditable documentation, eligibility checks, and data‑sharing consistent with HRSA’s notice. (Federal Register)
Stand up analytics
Implement duplicate‑discount surveillance across pharmacy channels; reconcile outliers before rebate invoicing. (Government Accountability Office)
Be audit‑ready
Use HRSA’s patient‑definition and audit resources to train teams and perform mock reviews. (HRSA)
Track outcomes
Monitor capture rate, exception rate, reversal rate, and documentation timeliness—plus access metrics such as new‑patient volume at public providers.
Why Cooper Strategy
Operator + policy DNA: We combine CE operations, Medicaid policy, and audit expertise.
Unique referral‑capture access: Our historic Walgreens data pipelines and retail integrations help prevent leakage and lift compliant capture.
AI + experts on every claim: Double‑review (machine + human) reduces reversals and accelerates audit responses.
Mission alignment: We help governments protect program integrity while maximizing dollars that flow to safety‑net care.
Looking for Next Steps?
Resources
Dive deeper into Cooper Strategy's 340B expertise with related guides for hospitals, government agencies, pharmacies, and TPAs.
340B Optimization, Referral Capture & Compliance
Learn More →340B for Hospitals & Health Centers
Learn More →340B for Pharmacies
Learn More →340B for Government
Learn More →340B Assistance for TPAs
Learn More →FAQs
Q1: What is the government 340B program in plain terms?
A: It’s a federal program administered by HRSA/OPA that lets eligible safety‑net providers buy outpatient drugs at statutory discounts to stretch limited resources and serve more patients. HRSA runs OPAIS, the program’s official registry and data system.
Q2: How do states prevent duplicate discounts?
A: Use HRSA’s MEF to coordinate FFS carve‑in claims (MEF does not apply to MCO) and publish MCO guidance that standardizes claim indicators and data exchange so 340B claims are excluded from rebate invoicing.
Q3: What does HRSA expect in contract‑pharmacy arrangements?
A: Written contracts, CE oversight, auditable records, and controls that prevent diversion and duplicate discounts, as outlined in HRSA’s 2010 Contract Pharmacy notice.
Q4: What resources show how HRSA applies the patient definition during audits?
A: HRSA’s patient‑definition resource hub points to the 1996 patient‑definition guidelines and audit materials used to assess compliance.
Q5: Where do state laws on contract pharmacies stand?
A: States have enacted various protections with mixed judicial outcomes; agencies should track ongoing litigation and tailor policy accordingly.