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Case Study – Certified Compliance Pharmacist – 340B Focus (CCP-340B)
CCP-340B Interactive Case Studies
Certified Compliance Pharmacist - 340B Focus (CCP-340B)
The Scenario: Imminent HRSA Audit
"Metropolis Health," a Federally Qualified Health Center (FQHC), has just received an audit notification letter from HRSA, with the audit scheduled in 45 days. Their 340B Manager resigned last month, and you have been hired as the new CCP-340B to lead the preparation. The previous manager left behind disorganized files. Your first task is to perform a rapid risk assessment to identify potential findings before the auditors arrive.
Data Sets (Excerpts from Files)
Provider Credentialing File
- Dr. Alice Chen, MD: Employed, full-time at main FQHC site.
- Dr. Ben Carter, DO: Contractor, works 1 day/week at main FQHC site. Also has a private practice.
- Dr. David Wells, MD: Employed, primarily works at the hospital's non-340B eligible surgical center.
- Sarah Page, NP: Employed, credentials expired 2 months ago.
Patient Dispensing Records
- Patient A: Saw Dr. Chen on 7/15/2025. Drug dispensed from in-house pharmacy on 7/15/2025.
- Patient B: Encounter on 7/18/2025 was for a flu shot administered by an RN only. A 340B drug was dispensed.
- Patient C: Last visit with Dr. Carter was 6/1/2024. A refill was dispensed from a 340B accumulator on 7/20/2025.
- Patient D: A 340B drug was administered during a procedure at the non-eligible surgical center.
Your Task
1. From the provider file, identify two individuals whose prescriptions create a potential diversion risk if filled with 340B drugs. Why?
Answer:
- Dr. David Wells: Prescriptions written from the non-eligible surgical center are not 340B eligible. Dispensing them with 340B drugs would be a clear instance of diversion.
- Sarah Page, NP: A provider must be currently credentialed and privileged. Since her credentials have expired, she is not an eligible provider, and her prescriptions are not 340B eligible until her status is rectified.
2. From the patient records, which two dispenses are likely HRSA audit findings? Justify your answer.
Answer:
- Patient B: The patient did not have an encounter with an eligible provider that resulted in a documented medical record. A service with a nurse only does not meet the patient definition criteria.
- Patient D: Drugs administered at a non-eligible site (the surgical center) cannot be replenished with 340B inventory. This constitutes diversion. Patient C is also a risk, as a refill over a year after the last visit may fall outside the entity's policy for an established relationship.
3. What are the three most critical policy documents you must locate and review immediately?
Answer:
The three most critical documents are:
- 340B Policies and Procedures Manual: This is the playbook for the entire program. You must ensure it accurately reflects current operations.
- Most Recent OPAIS Database Record: You must verify that all sites and providers listed are accurate and match reality. Any discrepancies are major findings.
- Internal/Independent Audit Reports: Reviewing past audits will quickly reveal known compliance gaps and whether corrective action plans were implemented and completed.
The Scenario: Mixed-Use Reconciliation
"Unity Hospital," a DSH covered entity, operates a mixed-use oncology infusion clinic. You, the CCP-340B, are performing the monthly reconciliation for a high-cost oncology drug, "OncoVex." Your split-billing software shows a significant discrepancy between the expected inventory and the actual physical count. You must perform a root cause analysis to identify the source of the variance.
Data Sets (for OncoVex 100mg vial)
Inventory Summary - July 2025
- Starting Physical Inventory: 15 vials
- 340B Purchases Received: 50 vials
- GPO Purchases Received: 20 vials
- Total Dispenses (from EMR): 68 vials
- Software Expected Ending Inv: 17 vials
- Actual Physical Ending Inv: 12 vials
Dispense Log Snippets (Problematic)
- Transaction #101: Patient John Smith, Location: Inpatient Room 402. Dispensed 1 vial. Accumulated to 340B.
- Transaction #102: Patient Jane Doe, Location: Oncology Clinic. Prescribed 150mg. Dispensed 2 vials (200mg). The 50mg of documented waste was not entered into the software.
- Transaction #103: Patient Robert Paulson, Location: Oncology Clinic. Dispensed 1 vial. Service line was incorrectly coded as "GPO," so it did not accumulate to 340B.
Your Task
1. Calculate the total inventory discrepancy in units (vials).
Answer:
The discrepancy is 5 vials.
Methodology:
$$\text{Discrepancy} = \text{Software Expected Inventory} - \text{Actual Physical Inventory}$$
$$17 \text{ vials} - 12 \text{ vials} = 5 \text{ vials}$$
2. From the dispense log, identify three transactions that explain the 5-vial discrepancy and how they contributed.
Answer:
- Transaction #101 (Inpatient): This vial was incorrectly accumulated for 340B. It should have been a GPO dispense. This accounts for +1 vial error in the 340B accumulator.
- Transaction #102 (Waste): The system thinks only one vial was used for the 150mg dose, but two were physically removed. The undocumented waste accounts for +1 vial discrepancy (physical is one less than system expects).
- Transaction #103 (Wrong Code): This was an eligible 340B dispense that was incorrectly coded as GPO. The software failed to accumulate it to 340B. This accounts for -1 vial error in the 340B accumulator.
The net impact of these errors does not fully explain the 5-vial gap, indicating there are more systemic issues to uncover, but these are the starting points.
3. What is the most severe compliance risk identified in this reconciliation?
Answer:
The most severe risk is the GPO Prohibition violation from Transaction #101. For DSH hospitals, using 340B drugs for inpatients is a major violation of the statute, as inpatient drugs are typically covered under Medicare Part A and subject to GPO pricing. This can lead to significant repayment liabilities and requires immediate corrective action.
The Scenario: Contract Pharmacy Oversight
A Ryan White HIV/AIDS Program grantee uses three contract pharmacies: a large national chain ("ChainRx"), a local independent ("IndyPharm"), and a mail-order pharmacy ("MailRx"). As the CCP-340B, you are reviewing the monthly report from your Third-Party Administrator (TPA) and notice several concerning patterns that require investigation to ensure program integrity.
Data Sets (TPA Report Excerpts)
Claim Analysis by Pharmacy
- ChainRx: High volume of claims for drugs not on the grantee's formulary (e.g., dermatologicals, statins) are being matched to 340B-eligible NDCs.
- IndyPharm: Multiple claims for the same patient, same drug, same day. One patient had a Medicaid Fee-for-Service (FFS) plan.
- MailRx: Several dispenses were sent to patients in states where the grantee has no eligible providers or sites.
Compliance Files
- Medicaid Exclusion File: Your entity carves-out Medicaid FFS. The OPAIS database correctly lists your entity as "N" for Medicaid FFS.
- Provider File: Contains only providers physically located at your single, eligible site in Georgia.
- Formulary: Primarily consists of HIV/AIDS medications and related supportive care drugs.
Your Task
1. What is the primary compliance risk presented by the ChainRx claims?
Answer:
The primary risk is diversion through improper "NDC mapping." The pharmacy may be filling prescriptions unrelated to the grantee's scope of service and then mapping those dispenses back to a 340B-purchased drug in the TPA system to profit from the spread. The prescription must originate from an eligible encounter at the covered entity.
2. The IndyPharm claim for a Medicaid FFS patient is a major finding. What is this violation called, and why is it prohibited?
Answer:
This violation is a duplicate discount. It is prohibited because the manufacturer would be giving two discounts on the same drug: one to the state Medicaid agency through a rebate, and a second to the covered entity through the upfront 340B price. Since the entity carves-out Medicaid FFS, this claim should have been blocked by the TPA.
3. What immediate action must be taken regarding the MailRx out-of-state dispenses?
Answer:
You must immediately investigate each out-of-state dispense to ensure it resulted from an eligible encounter with one of your providers (e.g., a valid telehealth visit). If the prescription originated from a non-entity provider, it is a clear case of diversion. The TPA's logic must be reviewed to understand why these claims were not flagged, and any improper replenishments must be reversed.
