Expert Tip from SunRx

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TIP: Take time to focus on these three important fundamentals of 340B program compliance and integrity.


Update Prescriber Panels

Maintaining an accurate prescriber panel helps ensure only eligible prescriptions are captured under the 340B program. Regular updates help prevent compliance risks and optimize program savings.

  • Conduct routine reviews of prescriber panels to ensure they include only actively employed or contracted providers.
  • Verify that each prescriber meets eligibility requirements defined in your policies and procedures.


Ensure OPAIS Data Accuracy

The Office of Pharmacy Affairs Information System (OPAIS) serves as the official record for covered entities participating in 340B. Any inaccuracies can lead to compliance risks and potential disqualification from the program.

  • Perform quarterly audits to verify that all entity locations, child sites, and contract pharmacy relationships are correctly listed in OPAIS.
  • Confirm that contact information (Authorizing Official and Primary Contact), addresses, and covered entity details are accurate and up to date.
  • Ensure your most recent Medicare Cost Report (MCR) is filed with CMS and sent to HRSA. 


Review Policies and Procedures

Keeping policies and procedures current is essential for ensuring staff compliance and preparing for HRSA audits.

  • Review and update policies at least annually.
  • Ensure that policies cover key compliance areas, including patient eligibility, inventory management, duplicate discount prevention, and diversion mitigation.
  • Apexus has policy and procedure templates that can be customized – you can also use them as a guide to compare with yours.

A strong 340B program starts with the basics. By proactively managing these areas, your organization can strengthen its 340B program compliance and performance.

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