340b audit preparation software

After an initial search is completed, narrow the search results by clicking on one of the categories or. Rphi helps to make sure covered entities are ready in the event of a hrsa audit. To ensure continued 340b program compliance, covered entities are now required to submit to an increasing number of hrsa, manufacturer and thirdparty audits. The audience for this tool is intended to be the 340b steering committee. Self audit can be part of the pre audit negotiation with the software vendor. As the only 340b certified sales staff in the pharmaceutical return service industry, we have developed the first return processing system to specifically address the audit guidelines of the hrsa 340b program. The software helps users maintain 340b program compliance with comprehensive audit preparation and support services, and creates standard and userdefined reports to demonstrate the impact of the hospitals 340b. Identify staffother participants necessary for the selfaudit. While the pharmacy department should lead the program and direct the rfp process, the rfp committeein particular team members from legal, the internal audit or compliance departments, and finance andor business servicesare key to the software selection process. The objective of a mock audit is to assess the organizations preparedness for a hrsa audit. From contracting through monthly management to regulatory preparation we have been impressed with the support we have received from hudson headwaters. By reading this paper, you will better understand 340b internal audit procedures. Designed by administrators to assure complete compliance. We use our signature 340b program audit to test your entitys hrsa audit.

Through continuous enhancements, our integrity system enables us to manage all facets of the 340b. Preparing for 340b drug pricing program audits with self. As the 340b drug pricing program expands, its under continued scrutiny for payment reform and legislative changes. The program was enacted in 1992 to help eligible providers stretch resources to. The 340b program launched in 1992 to stretch scarce fed eral resources in order for participating entities to increase accessibility to care eg, medications, clinical services, etc for. You can untangle operational, financial and regulatory knots using our pioneering software and services. Medications purchased through the 340b program are dispensed pursuant to a prescription written by. It should not be construed or relied upon as legal advice. Preaudit engagement letter from hrsa auditor will schedule a presite visit conference call audit objectives, logistics, scheduling, space needs, and initial data requests data request includes. About 340b audits getting started with 340b solution manager and consultants helping pharmacies get the most out of 340b.

Our 340b architect software simplifies the complexities of managing a 340b so you can focus on the health of your patients and your organization. Turnkey pharmacy solutions has significant experience i. Audit of 340b tech solution successfully completed prweb. Oct 19, 2015 practical tips for preparing for a 340b hrsa audit 1. Choose a partner that understands your 340b reality. An annual independent 340b audit is exactly what hrsa recommends in addition to your own internal audits.

A risky venture todays blog is about managing 340b in mixeduse areas without using a split billing software. Our software is a proprietary system that offers realtime management of patients and inventory. Additional faqs may be available to address specific. Total 340b program oversight with ongoing, autonomous audit preparation.

Psg also offers robust 340b consulting services that include traditional compliance and audit. Your pharmacy partner is critical to operating a successful 340b program. This can be performed by the software vendor, a trade association or a thirdparty accounting firm. The program should be tailored to address the unique needs and characteristics of an organization. Sentry data systems sentinel hospital pharmacy solution. Under section 340b a1 of the public health service act, manufacturers of covered outpatient drugs that participate in the 340b drug pricing program 340b program must offer all covered outpatient drugs at no more than the 340b ceiling price to a covered entity listed on hrsas public 340b database if such drug is made available to any other purchaser at any price. This is your opportunity to invest in a complete look at all of the keystone pillars of compliance.

Find 340b tools such as templates for policies and procedures, registration, audit and compliance plans, and additional resources to ensure 340b program. If youre looking to maximize 340b drug pricing program participation, look to macro helix. Presented by 340b hrsa audit toolkit practical tips to prepare covered entities 2. With the click of a button, covered entities can determine whether they are fully. Frequently asked questions 340b prime vendor program. Policies and procedures related to 340b most recently filed medicare cost report 340b drug orders or prescriptions. The purpose of this tool is to provide covered entities with a framework for monitoring and communicating 340b oversight based on best practices.

But program participation comes with complex regulatory and audit requirements that must be managed carefully to maintain compliance. October and november have been busy for us because of 340b audits. This is achieved by conducting an indepth evaluation of all crucial 340b program compliance and management elements, once the mock audit is complete, you should then be provided with strategies for remediation if necessary. Find 340b tools such as templates for policies and procedures, registration, audit and compliance plans, and additional resources to ensure 340b program integrity. Apexus pvp is communicating these hrsa faqs with the intention of improving program compliance. Pharmacy solutions pharmaceutical strategies group. Apr 09, 2020 to help maintain 340b program integrity, hrsa has the authority to audit covered entities for compliance with the program requirements. The 340b program is an existing program that allows certain eligible hospitals and other providers to purchase outpatient drugs at a discount from pharmaceutical manufacturers. Attention on the 340b program by government officials, government agencies eg, the government accountability office, and organizations eg, air340b, coupled with the initiation of hrsa audits, has caused many covered entities to become more aware and focused on the management of the 340b program. Audit preparation is the best starting point to cover areas of 340b program compliance and gain insight into areas where program performance can be improved. Our contractrx software helps covered entities and contracted pharmacies make the most of the 340b.

This understanding led hudson headwaters health network through a successful hrsa audit in 2015, with no adverse findings. Verity has installed its auditready, compliant 340b solutions in hundreds of facilities. Thanks to turnkey, we identified and addressed those risk areas and are now better prepared for a hrsa audit. The advanced 340b operations certificate program is a separate apexus offering that is not a part of the 340b prime vendor program or otherwise associated with the prime vendor. Nov 09, 2010 the audit performed, statement on auditing standards sas no. Review reports of purchased, dispensed, administered 340bnon 340b medications. At its core, the audit looks for accuracy of the office of pharmacy affairs information system opais, record keeping, compliance with program prohibitionsgroup purchasing organization gpo, diversion, and duplicate discounts. Integrated informatics hrsa audit results 2018 hrsa audit results 2019 u. Hrsa began auditing covered entities in 2012 and currently. The software helps users maintain 340b program compliance with comprehensive audit preparation and support services, and creates standard and userdefined reports to demonstrate the impact of the hospitals 340b program. Frequently asked questions 340b prime vendor program apexus. In 2006, we began offering 340b third party administrative services to other health care providers using our proprietary integrity software system. Objectives 2 overview of 340b drug discount program define the purpose of the hrsa audits identify key practice areas to regularly ensure compliant programs describe methods to prepare a 340b entity for internal andor external audits. Office of inspector general overview of the 340b drug pricing program the 340b drug discount program 340b prime vendor program.

Built under the watchful eye of a former pharmacy owner. How to prepare for a software audit biztech magazine. If the 340b software is powered by a custom query with extensive data. The hudson headwaters 340b team understands the critical value of systems focused on ensuring compliance and mitigating risk. Understanding the 340b drug pricing program audit process. The 340b statute explicitly authorizes hrsa to audit covered entities to make sure they are compliant with the program. Post audit the auditor will not provide any determination on compliance or gaps in compliance at the end of the audit. Indepth audit preparation, including webinars, compliance checklists and audit reports preaudit, onsite and postaudit support for hrsa, manufacturer and thirdparty audits one complimentary auditcheckup per year with our audit support services team.

With hrsa audits increasing annually and continued focus on compliance, preparation, and oversight demands commitment and expertise. Audit software regularly be involved in building the logic verification that contract pharmacy arrangements comply with the 340b program requirements and are properly listed in the opa 340b database 19. Review reports of purchased, dispensed, administered 340b non 340b medications. Sentry data systems the healthcare intelligence company. Consultant experts in 340b, including mckesson s pharmacy optimization can provide a structured and. Authorizing official, primary contact, 340b coordinator, director of pharmacy, contract pharmacy representatives, consultants, it support identify location of or how to access pre audit data. We are assisting four 4 hospitals with 340b hrsa audit preparation yes, they.

Rph innovations, llc audit, 340b rph innovations, llc. As you will read, with advance preparation, an audit can be planned strategically for success. Develop a routine auditing and monitoring process to validate that 340b programcovered drugs werent resold or otherwise transferred to an. Todays 340b environment includes everchanging regulatory requirements and close governmental scrutiny of program participation. Assent offers a variety of consulting services that are a valuable added asset to any healthcare entity. Medications purchased through the 340b program are not supplied to any non340b eligible patients. Backed by our sophisticated qualification engine, our splitbilling and contract pharmacy solutions lead the industry in compliance while maximizing savings.

Conduct a compliance assessmentexternal audit to determine areas for improvement. Sometimes, a formal audit requires that a vendor enter the workplace to access computer systems and verify compliance status. They identified potential risk areas for our organization and provided us with the necessary corrective action. A well thoughtout and detailed audit program is critical to an audit initiative. Audits of the 340b drug pricing program by health resources and services administration hrsa, a department of the u. With the click of a button, covered entities can determine whether they are fully hrsacompliant or at risk with 340bests cloudbased audit and compliance tools. The prime vendor has developed a number of tools to help covered entities operationalize 340b program compliance guidelines. Understanding the requirements for participation in 340b is critical. Following the us government accountability offices gao recently releas ed report gao20108on the 340b drug discount program 340b program, participating organizations covered entities should consider taking steps to prepare for increased procedures during a health resources and services administration hrsa program audit as well as the annual recertification process. Since the programs inception, 340b health has worked to protect the program by providing our members educational, networking, and advocacy opportunities. Adequate controls to prevent diversion of 340b drugs were not in place.

Audit the eligible provider list within the splitbilling software to ensure that eligibility matches the provider criteria set by the covered entity. Under section 340ba1 of the public health service act, manufacturers of covered outpatient drugs that participate in the 340b drug pricing program 340b program must offer all covered outpatient drugs at no more than the 340b ceiling price to a covered entity listed on hrsas public 340b database if such drug is made available to any other purchaser at any price. Preparing for a 340b audit audit preparation is the best starting point to cover areas of 340b program compliance and gain insight into areas where program performance can be improved. It is essential to have continuous self auditing processes and have your internal audit team to evaluate the results of the self audits to identify any systematic issues in your 340b program. Complete the form below to download a case study and see why you can expect more with sentry. Visit the 340b aisle in rxinsiders virtual pharmacy trade show. Has the entity practiced obtaining data to support 340b compliance in the event of an hrsa or manufacturer audit. When we began researching how to open up a 340b pharmacy program, the management of such a program seemed too great for a small health center to do on its own. Audit action plan identifies who within and outside of the organization needs to be contacted upon receipt of a hrsa audit notification key resources. Disclaimer the information contained in this presentation is for informational purposes only. Sentry data systems is a healthcare intelligence company, offering software applications to maintain 340b compliance, pharmacy management and contract pharmacy solutions. Audit software regularly be involved in building the logic verification that contract pharmacy arrangements comply with the 340b program requirements and are properly listed in the opa 340b.

Review the accuracy of 340b sites listed in the hrsa database for any additions, deletions, and corrections. Assent expert staff are constantly informed and abreast of all policy and industry expectations and changes. With hrsa audits increasing annually and continued focus on compliance, preparation and. Preparing for a 340b audit family planning council of iowa.