The 340B Program was created over 25 years ago with the intent of helping covered entities stretch their resources to continue to provide care to those who otherwise wouldn’t have access to quality health care. As a covered entity you are always in search of solutions to ensure that your 340B program compliance operates at the highest level. Whether you have been in the program for many years, are just getting started or just received a HRSA 340B Audit notice, one thing seems to be constant: you always seem to have more questions than answers…
We created 340B Consulting because it became apparent that many covered entities, despite being familiar with the 340B Statute and guidelines, desire more help in operationalizing 340B rules in their organization. We are here to help create a customized 340B compliance plan that follows all the federal guidelines AND is tailored to your organization's unique set of systems and resources. As Apexus 340B Certified Experts we not only offer the highest level of 340B knowledge but also have hands on experience of working at covered entities and are intimately familiar with challenges that hospitals and grantees face in day-to-day operations.
Since the inception of the program, HRSA has had the responsibility of 340B program oversight and the authority to conduct covered entity audits. With the increased scrutiny and pressure from 340B opponents, HRSA has been steadily increasing the number of audits which means the question to ask yourself is: Am I audit ready? You can find out if you are ready by filling out our 340B Audit Questionnaire.
HRSA’s timelines from audit notification to on-site visit have been significantly shortened forcing entities to be in a constant state of audit readiness. In order to be successful in an audit, you have to be able to quickly retrieve all auditable records and any information requested by the auditor on-site. We can help put systems in place that will enable you to produce information needed on a short notice and without a need for additional resources.
As part of our compliance program we offer our clients the following services:
Independent audits utilizing HRSA’s methodology
In-depth review of the 340B program to uncover any opportunities for improvement
Review of split billing software setup to optimize your purchases
Review of policies and procedures
Ongoing support including implementation of any post-audit recommendations and corrective action plans
Contract pharmacy program design and optimization
We will be there every step of the way working with your entity and guiding your compliance efforts to make your 340B program a success!
Due to the complexity of their operations, the majority of the hospitals rely on split billing software to manage their drug inventory. How confident are you that your software is performing as designed? Are you capturing all 340B transactions or are you constantly having to purchase drugs at WAC? How well can you describe the way the data is processed and 340B patient eligibility determined? All these questions become vitally important when evaluating your 340B program.
We are familiar with all major split billing vendors, we know what works well for various EMR’s and which data elements translate best into 340B eligibility. From selecting the right vendor, implementation, optimization, and audits we can present you with options and solutions that will leave you confident and feel in charge of your compliance.
For 340B hospitals subject to the GPO Prohibition statute requirement (disproportionate share hospitals (DSH), children's hospitals (PED), and free-standing cancer hospitals (CAN), we can help maintain program integrity as well as program optimization. We can show you how to identify, measure, and reduce your WAC exposure.
We can help 340B hospitals subject to the orphan drug exclusion such as: critical access hospitals (CAH), free-standing cancer hospitals (CAN), sole community hospitals (SCH), and rural referral centers (RRC) ensure that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drugs are designated.
Has your organization been approached by a 340B vendor and presented with an exciting prospect of a significant amount of savings from 340B contract pharmacy? Or maybe you already have a number of 340B pharmacy locations you contract with?
Contract pharmacies offer a great opportunity to expand the reach of your 340B program but are associated with higher level of compliance risk. According to 340B Health, more than 50% of diversion findings are related to contract pharmacies. HRSA audits are proof of the significant opportunity for improvement in contract pharmacy transactions. 340B Consulting can provide guidance and expertise in 340B contract pharmacy relationship, compliance, and optimization. Our goal is to make sure that our clients realize 340B savings while maintaining the highest level of program integrity.
Participating in the 340B program as a grantee can bring a lot of benefits to your organization but also comes with a set of unique challenges. Knowing how to successfully navigate your setting will position your entity for maximum benefits from the 340B program. To take advantage of unique opportunities available to you, you’ll need qualified resources to help with decision making and program design. If you don’t have an entire team dedicated to managing your program, why not leverage our knowledge? 340B Consulting staff have extensive first-hand experience in grantee environment and we’re here to answer your questions.