Hrsa 340b compliance software

Rphi helps to make sure covered entities are ready in the event of a hrsa. Hrsa s program integrity guiding principles are to maximize oversight reach and manage compliance risks. Covered entity compliance with 340b program requirements is also. Let our compliance team and our impeccable hrsa audit track record. Efforts to follow these principles include audits of covered entities and manufacturers to enforce. An organized 340b compliance oversight team promotes transparency and. Covered entities are subject to audit by manufacturers or the federal government. According to the health resources and services administration hrsa, which is responsible for administering the 340b program, enrolled hospitals and other. Efforts to follow these principles include audits of covered entities and manufacturers to enforce requirements for these stakeholders. The guide is a dynamic document intended to be used in conjunction with materials developed by the hrsa 340b peertopeer program and other resources available from the hrsa office of pharmacy affairs and the 340b prime vendor program managed by apexus.

The key, is understanding the process in advance of notification and plan ahead. Apexus pvp is communicating these hrsa faqs with the intention of improving program compliance. Our splitbilling software for 340b covered entities offers superior compliance that is configurable to meet your organizations unique needs. Unable to meet 100% audit compliance for hrsa program. Explain the health resources and services administrations hrsas role in policymaking regarding the 340b program. Guidance and audits are provided by pharmacists and pharmacy technicians to more closely resemble the current hrsa. Because compliance with the 340b program is complex, its important for ces to understand the programs primary compliance focus areas to help prepare for a hrsa audit. Split billing contract pharmacy hospitals community health centers contract pharmacy our contractrx software helps covered entities and contracted pharmacies make the most of the 340b. The office of pharmacy affairs opa, which is located within the health resources and services administration hrsa. The health resources and services administration hrsa has awarded the 340b prime vendor agreement to apexus llc after a competitive bid process. In my testimony today, i will provide an overview of the steps we have taken to strengthen oversight of the program. Services is your organization prepared to demonstrate active compliance with the 340b program. Effective administration of the 340b drug pricing program hhs. I appreciate your shared commitment to compliance with 340b program requirements.

When a covered entity undergoes an audit by hrsa and has findings or evidence of non compliance with a 340b program requirement, the covered entity must provide a corrective action plan cap to hrsa describing the planned and implemented actions to ensure program compliance. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid omb control number. In order to participate, entities must meet eligibility criteria and agree to comply with program requirements. Resources cover registration and implementation, requirements compliance, program integrity, and more. Rely on verity solutions to proactively foster audit compliance including program setup, administration, legal and governmental affairs. What are the common 340b program business challenges. Hrsa s office of pharmacy affairs opa is committed to educating and informing 340b drug pricing program stakeholders about the program. Overview the health resources and services administrations hrsa bureau of primary health care bphc is responsible for effective and efficient oversight of the health center program. Individuals responsible for the program should remain educated about the program so they will be informed of the current hrsa policy.

Hrsa audits are becoming more important as the scope of the 340b program increases. Cloud340b a 340b cloud automation product rctech solutions. Given hrsa s increase in 340b oversight activities, covered entities must demonstrate that their programs. Although advis consultants are primarily highly trained and skilled attorneys, our staff also includes pharmacists. Protect your 340b program and minimize compliance risk delivering the highest level of 340b expertise a vision for moving healthcare forward compliance with 340b. The 340b program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more. Bkds 340b team has the expertise to provide operational knowledge and recommendations that help covered entities increase savings and maintain compliance. With hrsa audits increasing annually and continued focus on compliance, preparation, and oversight demands commitment and expertise. The 340b program was created in 1992 by president bush, and requires drug. Their primary function involves providing software that, based on the ces data. The prime vendor has developed a number of tools to help covered entities operationalize 340b program compliance guidelines. Hudson headwaters provided invaluable assistance during our successful hrsa.

Our team of experts in pharmacy operations, implementation and software help you get up, run and maintain the 340b sm. Sentry data systems sentinel hospital pharmacy solution. Dont fear a hrsa audit of your 340b drug discount program. Name, subname, 340b id, site id, mpn, grant number, address line 1, address line 2, city. Without the correct software and compliance engine, 340b programs can be susceptible to inaccuracy, wasted manpower, penalties, and risk of non compliance from hrsa health resources and services administration and the office of pharmacy affairs opa. Rph innovations, llc audit, 340b rph innovations, llc. Contract pharmacy oversight official web site of the u. Understanding the requirements for participation in 340b is critical. Maintain policies and procedures to remain in compliance with hrsa. Scl 340b care a complete 340b administrative solution.

Any covered entity that fails to comply with 340b program requirements may be liable to manufacturers for refunds of the discounts obtained. Apexus 340b update and medicaid managed care what you. This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this government system, which includes 1. The 340b drug pricing program plays a critical role in helping eligible facilities. Is your organization prepared to demonstrate active compliance with the 340b program. Dont fear an hrsa audit of your 340b program advis. Both insured and uninsured patients may receive 340b drugs. A national leader in 340b compliance requirements and program optimization. Hrsa and 340b drug manufacturers submitting audit plans to opa may audit. How can i use the 340b compliance improvement guide. Atria 340b by hudson headwaters 340b program compliance.

Chris hatwig, ms, rph, fashp president jason atlas, rph, mba manager, 340b education and compliance support apexus 340b update and medicaid managed care what you need to know. Split billing contract pharmacy hospitals community health centers contract pharmacy our contractrx software helps covered entities and contracted pharmacies make the most of the 340b program. The 340b program demands compliance in multiple areas of your organization and across multiple levels of leadership. Hrsa targeting 340b program compliance at specific contract. Hudson headwaters 340b will customize your 340b program to optimize management, auditing and compliance assessments. Compliatric gives you easy, centralized control over complex health center compliance management efforts through a comprehensive compliance software platform. Serves as the institutional compliance expert on 340b regarding program details, policies, and procedures of the virtual inventory processes required for mixeduse and retail areas. The health resources and services administration hrsa has recently created a covid19 resources page and is encouraging covered entities to reach out to the 340b prime vendor with any. For your reference, hrsa has compiled the chart below outlining contract pharmacy oversight requirements and links to resources offered by our contracted 340b prime vendor program. Given hrsas increase in 340b oversight activities, covered entities. Maintain auditable records documenting compliance with 340b program requirements. Expanded flexibility for 340b stakeholders in the covid19. Protect your 340b program and minimize compliance risk.

The 340b prime vendor will continue to support the distribution of covered outpatient drugs through the 340b drug pricing program and as a resource to 340b stakeholders. The health resources and services administration hrsa urges 340b drug discount program covered entities to adequately monitor the. Frequently asked questions 340b prime vendor program. Verity solutions 340b program administration and compliance.

Among the most important members of the 340b team of a covered entity ce are the software vendors. The tool can support both mixeduse and retail pharmacy. Both use third party software to track dispensing of eligible claims. Hrsa recognizes the importance of third party billing to entitiesif. In response to 340b administrative challenges, we developed scl 340b care. Several manufacturer audits of covered entities have taken place, although far fewer than the number of audits performed by hrsa. But before i get into the meat of the article, so to speak, i must honor the curmudgeon coalition and. Getting started with 340b compliance 340bpvp document. A mock hrsa 340b audit can help you confidently prepare for an audit and identify potential areas of exposure that could compromise participation in the 340b program. Opas website provides information on all areas of the 340b program. Hrsa has the authority to audit covered entities for compliance with 340b drug pricing program 340b program requirements 42 usc 256ba5c. The removal of an faq from the website does not imply that the faq is no longer supported by hrsa.