The Apexus Advanced 340B Operations Certificate Program is the most advanced 340B training program available, designed to provide learners with all the education and insight they need to understand the issues, maintain compliance, and manage their entity’s 340B program effectively. According to the HRSA OPAIS website: “All 340B covered entities are required to maintain auditable records and are recommended to conduct annual audits of contract pharmacies that are performed by an independent outside auditor as a way to fulfill their ongoing obligation of compliance.” 2 The first requirement, known as the government ownership or government control requirement, mandates that the qualifying hospital — While 340B certification represents a … The first e-mail will just be a reminder; the actual re-certification e-mail will go to the Authorizing Official only. This entity’s provider number/NPI should not be listed on the HRSA Medicaid Exclusion File. We are also offering a recertification exam, based on the content of the new module, so 340B Apexus Certified Experts (ACEs) due to recertify can maintain their 340B expert status. Understand how to mitigate potential complianc… In mid-December 2020, the United States Department of Health and Human Services (HHS) finalized the long-awaited rule that sets forth the requirements and procedures for the 340B drug discount program administrative dispute resolution (ADR) process. Menu. The 340B Drug Pricing Program is an essential source of support for Community Health Centers, allowing them to stretch increasingly scarce federal resources and reinvest in patient care. Entity Sanctions for; Noncompliance Entities that cannot document compliance with 340B requirements may (1) be removed from The 340B Prime Vendor Program (PVP), defined by a contract awarded by HRSA, is responsible for supporting the 340B Drug Pricing Program. 10/15/2015 6 1. The covered entity must ensure the contacts listed in the 340B database are accurate at all times to receive all recertification notifications. 340B covered entities must annually recertify their eligibility to remain in the 340B Drug Pricing Program and continue purchasing covered outpatient drugs at discounted 340B prices. As we outlined in previous articles, many drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs (“HRSA OPA”) guidance on contract pharmacy arrangements is no longer binding. Active 340B covered entities must recertify their eligibility annually to remain in the 340B Program. Accessibility* If you use assistive technology, you may not be able to fully access information in this file. HRSA understands that many 340B Program stakeholders are concerned about the evolving impact of COVID-19. Visit the HRSA OPA website for information on registration and recertification. In addition to negotiating significant discounts for certain drugs for Prime Vendor Program participants, Apexus provides a myriad of resources and educational opportunities to covered entities, offering practical and operational information about policy application. Visit the HRSA OPA website for information on registration and recertification. The 1996 patient definition guidelines establish a test that individuals must meet to be eligible to receive 340B-priced drugs. In addition, as part of recertification, covered entities agree to self-report to HRSA when they uncover any “material breach” of 340B … The 340B program is administered by the Office of Pharmacy Affairs within the Health Resources and Services Administration (HRSA). The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations or covered entities at significantly reduced prices. The 340B software will recognize when the virtual inventory of 340B medication is depleted, dispense a non-340B pill, and then bill Medicaid for the 340B rebate. been endorsed by HRSA and is not dispositive in determining compliance with or participatory status in the 340B Drug Pricing Program. At this time the tentative re-certification dates will be February 10- March 14, 2014. Verify the HRSA 340B Database is accurate 2. Another source for 340B Program education is Apexus, the HRSA prime vendor for the 340B Drug Pricing Program. 340B Recertification for HRSA and IHS Grantees Underway Posted on February 14, 2014 by Tim Vroman - News The Health Resources and Services Administration (HRSA) and Office of Pharmacy Affairs (OPA) has announced that re-certification for Tribal and Urban Indian entities, HRSA grantees, and CDC STD/TB grantees is scheduled to begin on February 10, 2014. (2) the covered entity meets 340B Program eligibility requirements; (3) the covered entity will comply with all requirements of Section 340B of the Public Health Service Act and any accompanying regulations including, but not limited to, the prohibition against duplicate discounts and diversion (section 340B(a)(5)(A) and (B) of the Public Health According to HRSA, drug purchases at 340B prices totaled approximately $12 billion in 2015. According to 340B Health, more than 50% of diversion findings are related to contract pharmacies.
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