Certificate Program Goals
The Apexus Advanced 340B Operations Certificate Program goals/learning objectives are the following:
- Provide in-depth review of policy around 340B requirements and guidance on how to apply that policy in support of 340B operational integrity
- Discuss best practices for ensuring 340B operational integrity
- Explain how to mitigate potential compliance challenges
- Discuss how to improve audit preparedness initiatives
The original program curriculum is composed of 24 self-study modules available for viewing online. Topics, learning objectives, and length of time to complete each self-study module are noted on the outline below.
Module 1: Levels of 340B Policy
(ACPE UAN: 0221-9999-22-163-H04-P/T, Knowledge-based, 0.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Explain the Health Resources and Services Administration’s (HRSA’s) role in policy-making regarding the 340B Program.
- Outline HRSA’s policy making mechanisms.
- Apply policy resources in support of well-informed decision-making.
Module 2: Use of 340B Savings
(ACPE UAN: 0221-9999-22-164-H04-P/T, Knowledge-based, 0.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Explain the congressional intent of the 340B Program and review corresponding landmark reports.
- Demonstrate how you may calculate your 340B savings and align savings with the program intent.
- Review examples of hospitals and clinics that use 340B savings effectively.
Module 3: Eligibility for Hospitals
(ACPE UAN: 0221-9999-22-165-H04-P/T, Knowledge-based, 1.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Outline eligibility requirements for hospitals and their outpatient facilities in the 340B Program.
- Discuss the use of the Medicare cost report in determining eligibility of parent and offsite child locations.
- Determine how hospital eligibility may be evaluated in an audit to ensure compliance.
Module 4: Eligibility for Grantees and Designees
(ACPE UAN: 0221-9999-22-166-H04-P/T, Knowledge-based, 1.25 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Describe the statutory eligibility requirements for federal grantees and designees and their related clinics.
- Review unique considerations for federal grantees or designees to ensure that only eligible organizations are registered in the HRSA 340B Database, with particular focus on health center grantees.
- Review auditing processes HRSA may use to evaluate 340B eligibility to ensure compliance and identify strategies for self-auditing to ensure that all parts of an organization meet 340B eligibility requirements.
Module 5: Diversion
(ACPE UAN: 0221-9999-22-167-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Review the definition of diversion and its statutory and policy context.
- Apply the principles of avoiding diversion to practice and evaluate considerations for their application related to an eligible setting and locations.
- Apply the principles of preventing diversion to practice and evaluate considerations for their application related to meeting the patient definition.
- Determine components of a HRSA audit that examine compliance in preventing diversion and strategies for self-auditing those components.
Module 6: Covered Outpatient Drugs
(ACPE UAN: 0221-9999-22-168-H04-P/T, Knowledge-based, 0.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Explain the definition of a covered outpatient drug.
- Describe the decision points to consider when applying this definition in practice.
- Identify strategies for auditing the application of a covered outpatient drug interpretation.
Module 7: 340B Pricing
(ACPE UAN: 0221-9999-22-169-H04-P/T, Knowledge-based, 0.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Define the components of 340B Program drug pricing and associated requirements.
- Discuss 340B pricing requirements and operational considerations from the perspective of pharmaceutical manufacturers and wholesalers or distributors.
- Determine program integrity elements around 340B pricing, including handling disputes and audits.
Module 8: Verifying the 340B Price
(ACPE UAN: 0221-9999-22-170-H04-P/T, Knowledge-based, 0.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Describe the legal basis for the provision of a 340B drug price.
- Determine whether a particular drug product should have a 340B price available, as required by the 340B statute.
- Describe a process for determining and obtaining correct pricing on 340B drugs, if a 340B price is unavailable for a covered outpatient drug.
- Establish an ongoing quality management program to monitor for accuracy of 340B drug prices.
Module 9: 340B & Distributor Accounts
(ACPE UAN: 0221-9999-22-171-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Explain policy surrounding distributor (or wholesaler) ordering accounts.
- Describe the steps that occur to link distributor ordering accounts to the prime vendor contracts.
- List the steps the covered entity should take to ensure that all the applicable PVP contracts have been loaded to its ordering account.
- Identify steps that should be considered when returning product to an entity distributor and returning expired medication.
- Describe best practices in monitoring entity purchases through distributor accounts to ensure pricing integrity.
Module 10: Chargeback Disputes
(ACPE UAN: 0221-9999-22-172-H04-P/T, Knowledge-based, 0.5 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Define the chargeback process and its purpose in the 340B Program.
- Provide an overview of the operational considerations in chargebacks from a manufacturer’s and distributor’s perspective.
- Determine the role of chargebacks in 340B Program transparency and integrity, including the dispute resolution process.
Module 11: Medicaid Perspectives & 340B
(ACPE UAN: 0221-9999-22-173-H04-P/T, Knowledge-based, 1.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Describe the policy context for the Medicaid Drug Rebate Program and corresponding program requirements and their intersection with the 340B Program.
- Explain the application of Medicaid rebate collection policies and their interface with state 340B policies.
- Describe audit scenarios of covered entities by state Medicaid programs regarding 340B and Medicaid rebates.
Module 12: Duplicate Discount Prevention
(ACPE UAN: 0221-9999-22-174-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify and explain the various federal and state policies regarding duplicate discount prevention and the implications for covered entities.
- Explain the Medicaid agency, managed care organization, manufacturer, and covered entity perspectives regarding duplicate discount prevention.
- Explain how the Medicaid Exclusion File and other marketplace solutions function to prevent duplicate discounts in various entity scenarios.
- Evaluate an entity’s carve-in versus carve-out decision using a checklist of considerations.
- Conduct an audit to ensure prevention of duplicate discounts.
Module 13: Medicaid Reimbursement & 340B
(ACPE UAN: 0221-9999-22-175-H04-P/T, Knowledge-based, 1.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify federal and state policy regarding Medicaid reimbursement.
- Explain the Medicaid agency, managed care organization (MCO), manufacturer, and covered entity perspectives in 340B Medicaid reimbursement.
- Explain 340B Medicaid reimbursement scenarios that exist in the marketplace.
- Describe how to start a discussion with a state Medicaid agency or a Medicaid MCO about 340B reimbursement options.
Module 14: Replenishment & Separate Physical Inventory Models
(ACPE UAN: 0221-9999-22-176-H04-P/T, Knowledge-based, 2.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify policy regarding inventory management and the key considerations in identifying the optimal inventory model for various settings.
- Explain how to manage the available inventory models.
- Identify audit components that should be implemented to support compliance.
Module 15: GPO Prohibition
(ACPE UAN: 0221-9999-22-177-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Explain policies that govern the GPO Prohibition.
- Identify when and where GPO purchased products can be used in compliance with the GPO Prohibition.
- Describe contracting and purchasing practices as well as operational considerations to help support compliance with the GPO Prohibition.
- Describe audit best practices to assess appropriate GPO use.
Module 16: Split-billing Software Vendor Selection & Setup Considerations
(ACPE UAN: 0221-9999-22-178-H04-P/T, Knowledge-based, 2.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Describe the functionality and role of split-billing software in managing a replenishment inventory model.
- Discuss initial considerations when selecting a vendor and setting up split-billing software for an institution.
- Assess split-billing software capabilities in diversion and duplicate discount prevention.
- Outline other considerations when selecting a vendor that help ensure compliant inventory management.
Module 17: Split-billing Software Maintenance & Compliance
(ACPE UAN: 0221-9999-22-179-H04-P/T, Knowledge-based, 1.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Demonstrate compliant approaches when making manual adjustments to accumulators.
- Outline split-billing software auditing best practices and utilization of software reports to assess compliance.
Module 18: Optimizing Purchasing in the WAC Account
(ACPE UAN: 0221-9999-22-180-H04-P/T, Knowledge-based, 1.5 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify circumstances when purchasing products at WAC is necessary to be compliant with the GPO Prohibition.
- Identify decision points of a hospital subject to the GPO Prohibition that may affect the entity’s WAC expenditures.
- Discuss the use of split-billing software to identify and minimize unnecessary WAC expenditures.
- Discuss inventory management strategies that minimize the financial impact of the GPO Prohibition.
Module 19: Entity-owned Pharmacies
(ACPE UAN: 0221-9999-22-181-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Determine the costs associated with operating an entity-owned pharmacy, in comparison to the alternatives.
- Determine the revenue associated with operating an entity-owned pharmacy, in comparison to the alternatives.
- Identify key considerations in operating the entity-owned pharmacy.
- Identify audit components that may be implemented to support compliance.
Module 20: Contract Pharmacy and Vendor Selection Standards
(ACPE UAN: 0221-9999-22-182-H04-P/T, Knowledge-based, 1.75 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Outline contract pharmacy requirements for covered entities in the 340B Program.
- Discuss considerations in establishing contract pharmacies.
- Review key considerations in selecting 340B vendors and discuss components involved in 340B contract pharmacy negotiations.
- Demonstrate how covered entities may evaluate eligibility of contract pharmacy(ies) and contract appropriateness as a part of audit readiness.
Module 21: Contract Pharmacy Inventory Management & Compliance
(ACPE UAN: 0221-9999-22-183-H04-P/T, Knowledge-based, 2.25 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify HRSA’s essential elements for 340B contract pharmacy program management and compliance.
- Discuss inventory models used in contract pharmacies and considerations for compliant operations.
- Describe dispensing models existing for contract pharmacies.
- Review contract pharmacy inventory management and replenishment models, including reporting used to monitor inventory.
- Determine how contract pharmacy programs may be audited to support compliance.
Module 22: Orphan Drug Exclusion
(ACPE UAN: 0221-9999-22-184-H04-P/T, Knowledge-based, 1.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Identify and explain orphan drug policy, and describe stakeholders’ roles in the implementation of the orphan drug exclusion.
- Explain factors to consider regarding orphan drugs when doing an evaluation of whether or not to participate in the 340B Program as a hospital subject to the orphan drug exclusion.
- Discuss operational challenges and solutions with the orphan drug exclusion and describe considerations in a self-audit regarding orphan drugs.
Module 23: HRSA Audit and Self-Audit Preparedness
(ACPE UAN: 0221-9999-22-185-H04-P/T, Knowledge-based, 2.5 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Discuss why accountability and oversight are integral to 340B Program integrity.
- Describe a detailed self-audit plan for the various 340B settings within a covered entity, which includes industry leading practices.
- Explain the key components of an audit by the federal government and a manufacturer, and lessons learned from those audits.
Module 24: Resolving 340B Noncompliance
(ACPE UAN: 0221-9999-22-186-H04-P/T, Knowledge-based, 2.0 contact hour, Release: 7/2/2022, Exp: 7/1/2025)
- Review 340B Program policy requirements related to resolving and reporting noncompliance.
- Discuss how covered entities may define what constitutes a material breach and how to detect instances of noncompliance.
- Discuss how covered entities may correct instances of noncompliance and the considerations associated with each of those options.
- Outline the role of self-disclosures, corrective action plans, and repayment in resolving noncompliance.
Accreditation Statement and Continuing Education Credit
Practice Activity Number 0221-9999-19-226-H04-P/T
Initial Date of Release: July 1, 2019 | Date of Expiration: July 1, 2025
This CE activity is jointly provided by ProCE, Inc. and Apexus. ProCE, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Certificate Program Number (CPN) 0221-22-001-CP has been assigned to this practice-based CE activity (initial release date 07-22-2022). This CE activity is approved for 33.25 contact hours (3.325 CEUs) in states that recognize ACPE providers. Statements of completion will be issued online as individual modules and an online evaluation are completed. UANs for the individual activity modules are listed above.
The Advanced 340B Operations Certificate Program is a separate Apexus offering that is not a part of the 340B Prime Vendor Program or otherwise associated with the Prime Vendor Agreement between HRSA and Apexus.
The program is provided solely for education and/or instructional purposes, and the learner assumes exclusive responsibility for using and applying the information presented therein. Successful completion of the program does not confer a professional license or other equivalent designation or qualification on the learner.
Passing score thresholds are subject to change.
For questions about the Apexus Advanced 340B Operations Certificate Program, contact Apexus at 888.340.2787 or 340BCertificate@apexus.com.
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