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340B Pharmacy Program Audit & Consulting

AAFCPAs’ Healthcare practice has deep expertise in federal 340B program compliance. We help clients prepare, ensure program integrity, and mitigate major risks.

The Health Resources & Services Administration (HRSA) 340B Program has a myriad of regulations and compliance requirements, which often leave covered entities feeling overwhelmed and concerned. HRSA recently switched their audit focus from commercial hospital environments to nonprofit covered entities and contract pharmacy arrangements. A finding of non-compliance can result in sanctions, removal from the Program, and/or repayment to manufacturers.  Additionally, HRSA has recently clarified that covered entities utilizing a contract pharmacy are required to have an annual independent audit of the Program.

AAFCPAs’ Healthcare practice has deep expertise in federal 340B program compliance. We help clients:

  • Successfully prepare for an Office of Pharmacy Affairs (OPA) audit,
  • Ensure 340B Program integrity and maintain accurate records documenting compliance with all 340B Program requirements, and
  • Mitigate major risks associated with the 340B Program.

340B Program Audit & Consulting Solutions

Summarized Testing of Pharmacy Transactions*

 

AAFCPAs leverages our healthcare and data analytics expertise to assess your entire population of pharmacy transactions for a limited number of compliance requirements including:

  1. Potential diversion based upon patient data
  2. Potential diversion based upon provider data
  3. Trends by drug, provider and patient
  4. Trends by pharmacy, location or pricing
  5. Outlier transactions which may require investigation
  6. Pricing trends
Detailed Testing of a Sample of Pharmacy Transactions* In cases where covered entities do not have access to the entire population of pharmacy transactions, AAFCPAs selects a representative sample of pharmacy transactions and performs detailed testing of the various HRSA criteria, including:

  1. Adherence to Federal Diversion Requirements including a review of patient eligibility against patient definitions
  2. Adherence to Federal Duplicate Discount Requirements
  3. Compliance with the established internal controls
  4. Billing practices to ensure consistency with Medicaid state policy and 340B database information
  5. Verification of referrals treatment and eligibility
  6. Verification of scope of services for which covered entity status was awarded
  7. Eligibility of providers writing scripts
  8. Adherence to Federal guidelines surrounding the disposal of expired 340B drugs
Monthly Outlier Reporting* AAFCPAs performs Monthly Outlier Reporting for covered entities who have multiple contract pharmacy arrangements or a significant amount of contract pharmacy transactions. We leverage our healthcare and data analytics expertise as well as state-of-the-art data extraction software to export, summarize, review, and analyze thousands of prescription transactions in a cost-efficient manner. This analysis includes information related to:

  1. Potential diversion based upon patient data
  2. Potential diversion based upon provider data
  3. Trends by drug, provider, and patient
  4. Trends by pharmacy, location, or pricing
  5. Outlier transactions which may require investigation
  6. Pricing trends
Internal Control Policies and Procedures Assessment AAFCPAs assesses the design of your 340B pharmacy program policies and procedures and their ability to meet internal control objectives. These assessments include detailed, live walkthroughs of pharmacy transactions to determine if controls are operating as designed. AAFCPAs recommends Internal Control Policies and Procedures Assessment be performed every three years, or when there are significant changes in your pharmacy program, such as expansion of service providers or locations.
Compliance Policies and Procedures Assessments AAFCPAs assesses the design of your 340B pharmacy policies and their ability to meet compliance objectives, including but not limited to:

  1. Formal written compliance policies and procedures surrounding the Program
  2. The performance and documentation of results of internal audits
  3. Documentation of the use of 340B savings in alignment with the Program intent
  4. Inventory management
  5. Billing practices in alignment with Medicaid requirements
  6. Monitoring 340B compliance for the contract pharmacy
  7. Review of contracts with the contract pharmacy to gain an understanding of reimbursement guidelines and dispensing fees
  8. Review the agreed upon dispensing fees in relation to the integrity of the Program

AAFCPAs recommends Compliance Policies and Procedures Assessments be performed every three years, or when there are significant changes in your pharmacy program, e.g. expansion of service providers or locations.

Reporting of Data Analysis

AAFCPAs will make the results of our analysis available in a written report documenting internal control and compliance findings and a summary of testing results.  We will provide best practice recommendations to ensure OPA audit-readiness, and suggestions for future internal and external audits.  We will also meet with management to review and discuss the results of our procedures.

Why Clients Appreciate AAFCPAs’ 340B Solutions:

  • AAFCPAs’ Healthcare practice has been involved with the 340B Drug Pricing Program since the launch in 1992. We conduct regular 340B Compliance training sessions for clients and membership associations, and help covered entities avoid common pitfalls and major compliance risks associated with running your 340B pharmacy.
  • All of the Federally Qualified Health Centers (FQHCs) we work with participate in the 340B program.  Our understanding of the operations of FQHCs is integral in assessing risks related to the 340B program and pharmacy procedures.
  • Our Healthcare Practice leaders are members and active participants of the 340B University, an HRSA-endorsed training program, which provides us with the best possible knowledge to keep you informed of the latest trends and opportunities to optimize the value of the 340B program products, services, and tools. We have access to a multitude of resources through the University, ranging from your FQHC peers to pharmaceutical distributors, and we have direct access to the OPA, which we utilize as needed to help clients implement best practices.
  • We understand the unique business challenges associated with managing both in-house and contract pharmacies including increased risk of noncompliance, measurement of performance of each pharmacy, and the increased staffing and reporting burden.  We advise clients on maximizing capture rates while ensuring profits are maintained in alignment with 340B program criteria.
  • AAFCPAs leverages the specialized skills of our in-house Data Analysts, state-of-the-art technologies, and proven methodologies to extract, inspect, cleanse, and model client data to discover meaningful information that supports better decision making.
  • We leverage the deep resources of our 240+ person CPA and consulting firm, as well as national and global resources, to deliver meaningful audit and consulting engagements.
  • We believe that proactive and open communication with our clients will always be the key to success in delivering outstanding consulting services.