340B Compliance
The Health Resources and Service Administration (HRSA) requires all organizations relevant to 340B keep auditable records, educate and maintain staff compliance with 340B, and strongly encourage organizations to maintain comprehensive data to protect against abuses or Noncompliance with 340B.
Consolidated Compliance provides services to cover every aspect of 340B Compliance
Comprehensive Audits (Including Preparation and Support)
Our 340B specialists are capable not only of preparing and supporting your organization during an audit, but we also conduct comprehensive audits as an external auditor. The HRSA recommends that your organization conduct independent audits regularly to avoid any difficulties when or if a full HRSA audit is conducted to ensure Compliance.
If you are aware you are going to be audited, we can help you there too. One of our experts can advise you and help you prepare for the audit before it begins, and continue to support you throughout the process as well.
Education and Training
340B is a living legal process that changes frequently, so while you might have been Compliant at one point, it is essential that you maintain education and training for every level of your organization to ensure Compliance.
We provide up-to-date training programs, newsletters, and other resources for you to ensure that you and every member of your staff are up-to-speed and protected with our 340B training and education resources.
Implementation
340B might only be one part of your vast organization, and that means it can be difficult to ensure quality Compliance with the attention you would like. Consolidated Compliance can handle that for you.
Our team has built, restructured, and guided the growth of countless 340B Compliance Programs over the years, and we can help your organization do the same. Whether you need a new Compliance Program built from the ground up, or just some help with Project Management related to it, we can help.
Monitoring
Once your organization has an effective 340B Compliance Program in place, you have to make sure you are ready for HRSA to examine it at any time, and to audit based on any relevant point of time in the past as well.
Consolidated Compliance offers 340B monitoring services that give you the data, tools, and understanding to ensure your organization’s 340B Compliance Program is effective, and you are prepared for your HRSA reports and audits.
Dispute Resolution
When there is a dispute between an organization and HRSA or a manufacturer, it is essential to act quickly to examine the evidence and data, verify Compliance and effectiveness of your 340B Program, and find a fair and equitable solution to the dispute.
Our team has over 20 years of experience with dispute resolution related to 340B Compliance, and we can bring that to bear for your organization. We work with legal counsels and all parties involved to identify the facts so you can protect your interests and maintain your organization’s reputation and status.
