No products in the cart.
Certified Compliance Pharmacist – 340B Focus (CCP-340B)
Official Examination Content Outline
This document provides the official content outline for the Certified Compliance Pharmacist – 340B Focus (CCP-340B) examination. The exam certifies that a candidate possesses the expert-level knowledge required to develop, manage, and maintain a compliant 340B Drug Pricing Program, ensuring program integrity and adherence to all federal regulations.
Examination Specifications
| Name of Credential | Certified Compliance Pharmacist – 340B Focus (CCP-340B) |
|---|---|
| Certification-Issuing Body | The Council on Pharmacy Standards (CPS) |
| Designation Awarded | CCP-340B |
| Target Population | Pharmacists, compliance officers, and program managers responsible for 340B program oversight. |
| Examination Length | 120 multiple-choice items |
| Administration Time | 3.0 hours |
Examination Content Outline
The CCP-340B examination is weighted according to the five domains listed below, which cover the full spectrum of 340B program management, from foundational compliance and operations to strategic oversight and digital transformation.
| Domain 1: Program Integrity and Compliance | 30% |
| Domain 2: Operations, Inventory, and Dispensing | 20% |
| Domain 3: Audits, Finance, and Program Optimization | 20% |
| Domain 4: Policy, Advocacy, and Stakeholder Management | 15% |
| Domain 5: Health IT, Data Analytics, and Digital Compliance | 15% |
Domain 1: Program Integrity and Compliance (30%)
Task 1: Manage covered entity eligibility and registration.
- Verify that the covered entity and its child sites meet all statutory eligibility requirements for their specific entity type.
- Manage the annual HRSA recertification process and ensure the accuracy of the OPAIS database.
- Assess the impact of organizational changes (e.g., mergers, acquisitions, changes in service lines) on 340B eligibility.
- Develop and maintain policies and procedures that govern all aspects of program registration and maintenance.
- Maintain a comprehensive and auditable file of all documentation that supports the covered entity's eligibility.
Task 2: Apply and audit the 340B patient definition.
- Interpret and apply all three prongs of the HRSA patient definition to diverse and complex clinical scenarios.
- Design and implement auditable processes to verify that a patient has an established relationship with the covered entity.
- Ensure that dispensing records are linked to an eligible patient encounter with a qualified provider.
- Develop policies that clarify the application of the patient definition in challenging areas like telehealth and emergency services.
- Conduct regular sample audits of dispensing records to test for and identify potential diversion.
Task 3: Prevent duplicate discounts across all payer types.
- Design and manage a system to prevent duplicate discounts for both Medicaid fee-for-service and managed care plans.
- Ensure the entity's Medicaid Exclusion File (MEF) is accurate and reflects the organization's billing strategy.
- Implement workflows and technology to identify and segregate Medicaid claims from 340B accumulations.
- Conduct regular reconciliations of billing data to ensure Medicaid claims were not filled with 340B-purchased drugs.
- Address the complexities of duplicate discount prevention for specialty drugs billed to multiple payers.
Task 4: Maintain auditable records and program documentation.
- Design a system for maintaining all 340B-related records in a readily retrievable and auditable format.
- Ensure all purchasing, dispensing, and inventory records are maintained for the required period.
- Document all policies, procedures, and staff training related to the 340B program.
- Maintain detailed records of all internal and external audit activities, findings, and corrective actions.
- Ensure that data from split-billing software or a third-party administrator (TPA) is regularly backed up and accessible.
Task 5: Prevent and respond to fraud, waste, and abuse (FWA).
- Design and implement a compliance program based on OIG guidance to prevent and detect FWA.
- Utilize data analytics to monitor for anomalous patterns in purchasing, dispensing, or billing that may indicate FWA.
- Develop and manage internal policies for FWA reporting, including whistleblower protections.
- Lead internal investigations into potential compliance violations in coordination with the compliance department.
- Coordinate with legal counsel to respond to external FWA inquiries or investigations from government agencies.
Domain 2: Operations, Inventory, and Dispensing (20%)
Task 1: Manage 340B drug procurement and inventory systems.
- Establish and maintain separate 340B and non-340B (WAC/GPO) purchasing accounts and inventory models.
- Manage the operational use of split-billing software to track drug accumulations in mixed-use settings.
- Ensure compliance with the GPO Prohibition for disproportionate share hospitals and other applicable entities.
- Reconcile purchase orders, invoices, and dispensing records to ensure inventory integrity.
- Design and manage a compliant drug replenishment process based on actual dispensations to eligible patients.
Task 2: Design and manage a compliant contract pharmacy program.
- Evaluate and select contract pharmacy partners and third-party administrators (TPAs).
- Negotiate contract terms that define services, fees, compliance responsibilities, and risk-sharing models.
- Implement a robust oversight program, including regular independent audits of contract pharmacy operations.
- Oversee the compliance and performance of third-party administrators (TPAs) to ensure accurate claims qualification and data integrity.
- Develop and implement corrective action plans to address any identified compliance issues at a contract pharmacy.
Task 3: Manage specialty pharmacy and limited distribution drug workflows.
- Develop workflows to manage the unique procurement and tracking challenges of 340B specialty medications.
- Navigate manufacturer requirements to gain access to 340B pricing for limited distribution drugs.
- Ensure proper tracking of 340B eligibility for high-cost specialty drugs dispensed via internal or external pharmacies.
- Address manufacturer-imposed restrictions on the use of contract pharmacies for certain drugs.
- Ensure patient assistance programs for 340B-eligible specialty drugs are managed compliantly.
Domain 3: Audits, Finance, and Program Optimization (20%)
Task 1: Manage internal and external compliance audits.
- Design and implement a comprehensive annual self-audit plan for all aspects of the 340B program.
- Serve as the primary point of contact and coordinator for external audits from HRSA and manufacturers.
- Prepare and organize all requested data and documentation for auditors.
- Develop a comprehensive and timely Corrective Action Plan (CAP) for any adverse audit findings.
- Manage the process for repaying manufacturers if a compliance breach is confirmed.
Task 2: Analyze and report on the financial value of the 340B program.
- Develop a methodology to calculate and track the savings generated by the 340B program.
- Analyze how 340B savings are used to support the organization's mission and patient care services.
- Create regular financial reports for the 340B oversight committee and executive leadership.
- Model the financial impact of potential program changes or new legislative and regulatory policies.
- Articulate the program's financial value to support advocacy and stakeholder education.
Task 3: Develop and sustain long-term financial and operational strategies.
- Assess the role of the 340B program in the organization's overall financial health and sustainability.
- Develop strategies for the reinvestment of 340B savings into patient care services.
- Evaluate the cost-benefit of various program models, such as in-house versus contract pharmacy networks.
- Collaborate with pharmacy and executive leadership to align 340B program goals with organizational strategy.
- Identify and implement opportunities to compliantly optimize the program for long-term growth and value.
Domain 4: Policy, Advocacy, and Stakeholder Management (15%)
Task 1: Monitor and interpret the 340B legislative and regulatory environment.
- Track proposed legislation and regulations at the federal and state levels that could impact the 340B program.
- Analyze the potential operational and financial impact of proposed changes on the organization.
- Interpret final rules and guidance documents from HRSA to ensure ongoing compliance.
- Utilize resources from national advocacy organizations to stay informed about the evolving policy landscape.
- Summarize key policy changes for leadership and the 340B oversight committee.
Task 2: Evaluate and manage manufacturer, payer, and PBM policies.
- Monitor the landscape of manufacturer-imposed restrictions on contract pharmacy arrangements.
- Assess the clinical and financial impact of these restrictions on the organization and its patients.
- Analyze payer and PBM policies that result in discriminatory reimbursement for 340B drugs.
- Develop and implement operational strategies to mitigate the impact of adverse manufacturer and payer policies.
- Collaborate with legal counsel and advocacy groups to respond to restrictive policies.
Task 3: Manage internal and external stakeholder engagement.
- Develop and lead a multidisciplinary 340B oversight committee to ensure enterprise-wide accountability.
- Provide regular education to executive leadership on the value, risks, and strategic importance of the 340B program.
- Engage with federal and state policymakers to advocate for the integrity of the 340B program.
- Collaborate with payers, PBMs, and wholesalers to address 340B-related operational and reimbursement challenges.
- Develop organization-wide messaging on the 340B program's benefit to the community and patient care.
Domain 5: Health IT, Data Analytics, and Digital Compliance (15%)
Task 1: Manage 340B-related software and technology platforms.
- Evaluate, select, and manage the implementation of split-billing and replenishment software.
- Oversee the performance and compliance of third-party administrator (TPA) platforms.
- Ensure the accurate maintenance of the drug formulary crosswalk, provider files, and location maps within the software.
- Implement and monitor cybersecurity safeguards to protect 340B data and prevent breaches.
- Manage user access, roles, and training for all 340B technology platforms.
Task 2: Integrate EHR and pharmacy systems for eligibility tracking.
- Design workflows that leverage EHR and pharmacy system data to determine patient eligibility in real-time.
- Ensure the reliable extraction and transfer of data required for 340B qualification.
- Collaborate with IT and clinical informatics to validate the integrity of data used for 340B compliance.
- Assess how changes in the EHR or pharmacy system may impact 340B operations.
- Automate the identification of Medicaid and other third-party claims to prevent duplicate discounts.
Task 3: Apply data analytics to monitor and audit program integrity.
- Design and maintain a dashboard of key performance and compliance indicators (KPIs).
- Utilize data analytics to conduct continuous monitoring and sample audits of 340B claims.
- Analyze purchasing and dispensing data to identify trends, anomalies, and potential compliance risks.
- Generate comprehensive data reports to support internal reviews and external HRSA audits.
- Use data to validate the accuracy of TPA services and contract pharmacy performance.
