Are You Prepared for an Office of Pharmacy Affairs (OPA) Audit?

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All entities who participate in the 340B program are subject to an Office of Pharmacy Affairs (OPA) audit regardless of entity type, size or volume of transactions.  For the last five years, HRSA’s OPA has been completing approximately 200 audits a year and

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Three Things Hospitals and Grantees Need to Know About HRSA’s 340B Administrative Dispute Resolution Rule

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On April 19, 2024—fourteen years after the Congressional deadline—the Health Resources and Services Administration published its final rule for the 340B Administrative Dispute Resolution process. Although HRSA restarted its stalled ADR rulemaking in 2020 after two 340B grantee organizations sued,

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Spring Cleaning of Your 340B Program

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As we welcome the fresh energy of spring, now is the perfect time for 340B covered entities to conduct a thorough review and update of their 340B program. Ensuring your program’s compliance and efficiency is akin to spring cleaning—tidying up, organizing, and preparing for the year ahead. Below,

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340B Webinar – It’s a Risky Business: Risk Mitigation and 340B Program Compliance

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Attention 340B Covered Entities:  For most covered entities, the 340B program is essential to their organization’s bottom line – so protecting it becomes necessary. 340B program risks are numerous and often not fully recognized. Duplicate discounts, diversion, and poor documentation are common

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Navigating State-Level Regulations to Safeguard Your 340B Program

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While federal laws and regulations set the foundation for 340B compliance, state-level laws introduce an additional layer of complexity. Covered entities (CEs) must be vigilant in understanding how these state laws can impact their operations to avoid potential compliance pitfalls. We have outlined a few

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Expert Tip from Hudson Headwaters 340B

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TIP: If your entity has not been submitting data to 340B ESP or designating pharmacies associated with certain manufacturers, it may be time

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SUSTAIN 340B -The Imperative for a Clearinghouse to Strengthen the 340B Program

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The 340B program remains essential in ensuring equitable access to crucial medications for vulnerable, underserved populations. The program provides safety net providers with critical resources necessary to expand health related services to low-income and uninsured individuals. Over the past decade, controversy,

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Navigating HRSA 340B Program Audits

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In the complex landscape of healthcare, compliance with the Health Resources and Services Administration’s (HRSA) 340B program is paramount for covered entities. As organizations strive to optimize their participation in the program, one critical aspect is preparing for HRSA audits. To shed light on this crucial process, we

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Expert Tip from Red Chip Enterprises

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TIP: When negotiating Single Case Agreements (SCA), it’s important to include payment terms. An SCA without terms can lead to lengthy delays in

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Advanced 340B Education: Staying Informed and Empowered

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The 340B drug pricing program is a critical resource for covered entities and stakeholders, providing access to affordable medications for vulnerable patient populations. To ensure that you are well equipped to navigate the complexities of the

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