TOP 5 COMPLIANCE TIPS
1. Policies and Procedures
It is essential that covered entities have detailed policies and procedures in place that accurately reflect their processes. Policies and procedures provide a blueprint for best practices and promote a consistent approach across covered entities.
These should include guidelines, objectives, and a detailed description of processes. They should be readily available to anyone involved in the program and need to be reviewed annually and updated as necessary to reflect process changes. HRSA will review policies and procedures as part of their audit process.
Sample policy and procedure manuals can be found on the Apexus tools website.
2. Robust self-auditing process
HRSA holds covered entities accountable for compliance with the 340B requirements. Self-auditing is the best way for a covered entity to identify areas of non-compliance. This process should cover all elements of the program at your entity and include mixed use areas, child sites, entity owned pharmacies, and contract pharmacies. The audits should test for appropriate OPAIS registration/eligibility, diversion, duplicate discounts, GPO prohibition for example. Split-billing software configuration should also be reviewed.
The audits should be performed on a regular basis and the results collated. These can often be used to identify systemic problems. Audit results should be reported to Senior Management and to the 340B Oversight Committee.
3. 340B Oversight Committee
A multi-disciplinary 340B oversight committee promotes accountability and compliance within an organization, and provides general oversight of the 340B program. This committee should include members from multiple departments within the covered entity such as finance, credentialing, legal, IT, supply chain and compliance, in addition to pharmacy. At least one member of the C-Suite should be included on the committee, and they should meet periodically to review all aspects of the 340B program. The oversight committee should also be involved in determining material breach and self-disclosures.
4. 340B Education
It is crucial that 340B stakeholders have an in-depth understanding of the 340B program requirements to promote compliance. In order for a 340B program to be successful, it is imperative that all involved, including senior leadership, have appropriate education and access to resources. All associates involved in the day to day running of the program should have periodic training to allow them to stay current with any changes in requirements.
5. Annual Independent Audit
While HRSA does not mandate that an annual independent audit is performed, it is an expectation for contract pharmacies and will be requested by HRSA auditors. An annual independent audit brings an outside perspective that can help identify issues that are often overlooked during the self-monitoring process.
It is essential that covered entities have detailed policies and procedures in place that accurately reflect their processes. Policies and procedures provide a blueprint for best practices and promote a consistent approach across covered entities.
These should include guidelines, objectives, and a detailed description of processes. They should be readily available to anyone involved in the program and need to be reviewed annually and updated as necessary to reflect process changes. HRSA will review policies and procedures as part of their audit process.
Sample policy and procedure manuals can be found on the Apexus tools website.
2. Robust self-auditing process
HRSA holds covered entities accountable for compliance with the 340B requirements. Self-auditing is the best way for a covered entity to identify areas of non-compliance. This process should cover all elements of the program at your entity and include mixed use areas, child sites, entity owned pharmacies, and contract pharmacies. The audits should test for appropriate OPAIS registration/eligibility, diversion, duplicate discounts, GPO prohibition for example. Split-billing software configuration should also be reviewed.
The audits should be performed on a regular basis and the results collated. These can often be used to identify systemic problems. Audit results should be reported to Senior Management and to the 340B Oversight Committee.
3. 340B Oversight Committee
A multi-disciplinary 340B oversight committee promotes accountability and compliance within an organization, and provides general oversight of the 340B program. This committee should include members from multiple departments within the covered entity such as finance, credentialing, legal, IT, supply chain and compliance, in addition to pharmacy. At least one member of the C-Suite should be included on the committee, and they should meet periodically to review all aspects of the 340B program. The oversight committee should also be involved in determining material breach and self-disclosures.
4. 340B Education
It is crucial that 340B stakeholders have an in-depth understanding of the 340B program requirements to promote compliance. In order for a 340B program to be successful, it is imperative that all involved, including senior leadership, have appropriate education and access to resources. All associates involved in the day to day running of the program should have periodic training to allow them to stay current with any changes in requirements.
5. Annual Independent Audit
While HRSA does not mandate that an annual independent audit is performed, it is an expectation for contract pharmacies and will be requested by HRSA auditors. An annual independent audit brings an outside perspective that can help identify issues that are often overlooked during the self-monitoring process.
