Don’t Leave Your 340B Compliance to Luck: 5 Items Every Program Needs

Compliance is the center of any optimized 340B program. Participating covered entities know there are numerous rules, constant regulations, and changing legislation that impact how programs are operationalized. The driving factor for program success is the understanding that the 340B program, which is funded by manufacturers and not taxpayers, is a vital lifeline of funding for hospitals and grantees nationwide.

Now more than ever it is important to protect, optimize, and maximize your 340B program so that patients can maintain access to the care they need.  There are several important elements that covered entities should have to guarantee they are on the right track:

  1. Policy and Procedures – The Policy and Procedure document is crucial because it serves as the guidebook for how your 340B program is operationalized. This document will be a critical element of a HRSA audit or independent audit, as assessors will try to verify that the documented information matches the actual practices of each entity and pharmacy/dispensing model relationship. The Policy and Procedures should contain outlines of enrollment/recertification processes, important definitions and key terms, program intent and savings, inventory management, duplicate discount and diversion prevention, and more. The HH340B team understands how important this document can be for a programs success and is offering a limited time FREE Policy and  Procedure review. Email and mention this article to learn more.
  2. Well Versed Key Contacts – The main contacts of your 340B program must be well-versed and have binding authority over the program. When setting up your entity in OPAIS, it will be necessary for the Authorizing Official and Primary Contact to be two separate individuals within the organization that can be responsible for enrollment, registration, and recertification. These contacts would also be responsible for their overall program compliance and management, because compliance lies with the entity.
  3. Independent External Review – It is a requirement in the HRSA audit process to prove adequate oversight of your 340B program, which includes routine monitoring and a recommended external review. The external review process may look different depending on the type of reviewer that you contract with and could be named something like “Mock HRSA Audit”, “Independent Audit”, or “Consulting 340B Review”. To get the most out of your independent review, make sure you are contracting with a company that can answer your entity-specific questions and adequately review all areas of your program operation. The HH340B team can be a great resource for audits, compliance assessments, or ad-hoc consultant arrangements, as we serve clients of varying entity types nationwide.
  4. Positive Partner Relationships – Customer service and timely communication are important elements of your relationship with external partners, pharmacy contracts, auditors, or third party administrators. Make sure that you know exactly who to contact from each company so that you always have a resource when there are questions, concerns, or situations that need addressed in your program. These positive partner relationships can only benefit your overall compliance and program management.
  5. Advocacy  Toolkit – Conveying your 340B story to representatives is an important step in the longevity of the program. The best narrator of the 340B story is a participating covered entity that has experienced expanded patient access first hand. As the program changes and there are additional threats from manufacturers and insurance companies, it is important to stay up to date on the latest efforts to mobilize for program preservation. Resources like NACHC and 340B Health provide timely news about advocacy opportunities, and a variety of tangible resources like the 340B impact profile.

Is your 340B program missing one of these five elements and you don’t know where to start? Hudson Headwaters 340B is here to help! As a leading third party administrator, auditor, consultant, and educator, our team is well versed on the ins and outs of program management and optimization. Contact us today to start a conversation about your covered entity’s 340B compliance.


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