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  • Writer's pictureLyssa Limbrecht

5 Best Practices for 340B Compliance

Updated: Dec 8, 2023

Imagine checking your email on a Friday afternoon right before you leave work. An email from HRSA suddenly pops up on your screen…

It's a HRSA notification you that your 340B Program is being audited.

Will your palms sweat and your heart race under this type of pressure? Or will you remain calm because your organization has your 340B program under control?

Truth be told, to stay compliant, it starts with a strong culture built around 340B compliance and the right partnerships in the industry.

Here are five best practices for running a compliant 340B program.

1. Create a 340B Compliance Team

Create a 340B team to start and monitor your program. Choose 3-5 staff members dedicated to making sure your 340B program is running smoothly. The best 340B teams include participation from multidisciplinary team members and senior leadership.

Some responsibilities for your compliance team will include:

● Developing and approving 340B policies and procedures

● Providing 340B self-audit oversight and sharing findings

● Working with 340B partners and Vendors to resolve non-compliance.

Essentially, your team will be the front line to help your organization stay compliant and promote a culture of 340B compliance.

2. Conduct Self-Audits

Routine audits will help you make lasting improvements to your 340B compliance. Not to mention that they are a HRSA program requirement. Conduct audits monthly to quickly uncover and fix any issues.

Conducting an in-depth review of all of your OPAIS and 340B records before your annual recertification will help you ensure that nothing has been missed.

Finally, keep detailed records of any and all self-audits performed. These records should include steps taken to fix compliance issues that arose during said audits. Find out more about performing self-audits in a prior post here and here

3. Keep HRSA’s Database Up to Date

Make sure your organization is up to date on HRSA’s OPAIS database at all times.

It is crucial to note which 340B eligible sites are closing, if a site becomes ineligible and when new sites become eligible. This holds true for contract pharmacy locations as well.

Additionally, your Primary Contact and Authorizing Official information must be kept up to date at all times. With the increasing turnover rate in healthcare, this is often overlooked but is crucial to 340B compliance.

The best rule of thumb is to check for OPAIS updates during your monthly self-audits. Find out a little more here

4. Educate Your Staff

Share helpful resources like technical help from HRSA and the 340B prime vendor program (Apexus) 340B University On-Demand with staff engaged with your 340B program.

Understanding how the 340B program works for your specific organization through clear 340B Policies and Procedures and staying up to date on new changes within 340Bwill help you stay compliant.

5. Improve Your Communication with Contract Pharmacies

The oversight of your 340B contract pharmacies is ultimately your responsibility.

That being said, regular communication with them will help you keep tabs on how your program is operating, and makes it easy to engage pharmacy staff to resolve compliance concerns when necessary.

Keeping the lines of communication open with your contract pharmacies will benefit your 340B program in more than just compliance. Learn a little more here

Quick Tips:

● Know your 340B eligible patients, providers, and locations to prevent diversion.

● Know your state and nearby state's Medicaid payor information (BIN/PCN/Group#) to prevent duplicate discounts.

● Make sure 340B program policies and procedures and other compliance-related documents are easily accessible for internal staff and outside auditors.

● Conduct monthly or at least quarterly self-audits to find any concerns in your program.

Every facility can use these best practices as a framework to encourage and promote 340B compliance internally.

Managing a compliant 340B program doesn’t need to be a full-time job for you or your staff, though. It pays to have a team of 340B experts on hand to assist with and be a resource for engaging and guiding your staff, partners and vendors.

Discover how our 340B industry expertise helps organizations to stay compliant and maximize savings.

Get in touch with us to learn more about how Optimal340B can help your facility with your 340B Program.

Call us at 1-866-OPT340B(678-3402) , Schedule a time to chat or reach our CEO by email at

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