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Navigating HRSA 340B Program Audits

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A Step-by-Step Guide

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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 turn to Kristin Andolfo, a seasoned expert in navigating HRSA audits. Kristin is a 340B ACE Senior Consulting Advisor at The Craneware Group.

With over 300 HRSA audits under its belt, along with extensive experience in handling manufacturer, state, and external audits, The Craneware Group is uniquely positioned to offer valuable insights on how covered entities can effectively prepare for HRSA audits.  See our step by step below guide below:

1. Alert and Gather All Key Players  

The first step in preparing for a HRSA audit is to ensure that all relevant stakeholders within the organization are informed and engaged. This includes representatives from pharmacy, finance, compliance, and any

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

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Join us Wednesday, May 15, 11:00 – 12:00 ET

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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 findings from a HRSA audit. People and processes are often insufficient to fully recognize and address compliance risks. At the same time, lawmakers at the federal and state levels are increasing attention on ensuring that providers are good program stewards.

340B program managers should employ multiple strategies to ensure effective risk management programs are in place. Automation and technology tools can enable a comprehensive approach to managing compliance risk. Processes can fail, and people can miss critical compliance elements, but technology mitigates the gaps in risk management.

This webinar will emphasize how non-compliance is not an option, examine the benefit of a proactive compliance approach vs. a reactive one, and

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Advanced 340B Education: Staying Informed and Empowered

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Access New Content Developed by the Apexus Advanced 340B Operations Certificate Program

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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 program, the Apexus Advanced 340B Operations Certificate Program is excited to introduce our new advanced 340B education offerings! These programs aim to provide you with comprehensive and up-to-date information on the latest trends and hot topics in the 340B landscape.

Master Classes: A Sneak Peek into Advanced 340B Education

Stay ahead of the curve by signing up for our master classes presented by the Apexus Advanced 340B Operations Certificate Program, held quarterly at no charge. Each master class is designed to cover the most relevant and timely developments and challenges facing 340B stakeholders. Whether you are a covered entity or a non-covered entity stakeholder, these

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Guidance on 340B ESP Use and Management

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Quality Assurance Tips to Maximize Your Contract Pharmacy Savings

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Since 2020, select drug manufacturers have begun deploying restrictions or limitations on the sale of their products through the 340B program. This has proven to be a marketplace disruptor that has shifted the landscape of the 340B contract pharmacy program, as covered entities have experienced a loss of savings and have had to increasingly rely on entity-owned retail and/or specialty pharmacy operations to help in their mission. The issue of manufacturer restrictions has endured several legal challenges as well with some states, such as Arkansas, Louisiana, West Virginia and Mississippi having measurable success with combating the manufacturer restrictions.

Regardless, manufacturers continue to impose restrictions with the assistance of 340B ESP, a drug industry vendor that facilitates 340B claim management and oversees implementation of drug maker policies.  In many cases, the restrictions made by the manufacturers will be applied to the covered entity for all contract pharmacies unless the covered entity has created

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340B Webinar—340B Legislation: Navigating Changes, Championing a Better Future

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PharmaForce webinar April 18, 2024

Join us Thursday, April 18th, 11:30 – 12:00 ET

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Attention 340B Covered Entities: The 340B drug pricing program is entering an exciting phase of evolution. The SUSTAIN 340B Act and the 340B Patients Act demonstrate a strong commitment to refining the program, ensuring it serves patients effectively while maintaining accountability. This active legislative engagement, alongside legal discussions and state-level initiatives, signals a healthy process of improvement. Covered entities (CEs) now have a unique opportunity to collaborate with policymakers and shape the 340B program to best serve those in need.

This webinar will help you understand the potential changes, and equip you to advocate for your interests. Here’s what we’ll cover:

  • Manufacturer Restrictions: Analyze recent limitations and their potential impact on CEs.
  • Understanding Key Legislation: Compare and contrast the SUSTAIN 340B Act and the 340B Patients Act.
  • Examining the Arkansas Victory: Learn how this legal win could affect challenges to manufacturer restrictions.
  • Tracking State-Level Legislation: Discover which states support or
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Spring Cleaning of Your 340B Program

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Essential Updates and Checks

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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, we outline essential steps and checks to maintain the excellence of your 340B program as we transition to this new season.

1. Review Your State’s Medicaid Website for New BIN/PCN/Group Updates

It’s essential to regularly check the Medicaid website for your carve-in states, looking for any updates related to Billing Identifier Number (BIN), Processor Control Number (PCN), and group numbers. These details are crucial for accurately processing pharmacy claims and securing appropriate 340B discounts. Often, at the beginning of the year, Medicaid agencies will update their websites with the latest BIN/PCN/Group numbers based on recent contracting information with Medicaid Managed Care organizations.

2. Fiscal Year-End Specific Checks

For

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Bridging the primary care gap: The role of in-house pharmacies in today’s healthcare marketplace

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Holly Russo, Maxor 340B
Removing the Headache of Running an On-Site Pharmacy

SPONSORED CONTENT

Healthcare leaders have a lot on their plates. Today’s healthcare landscape requires health care organizations to compete in attracting and retaining qualified employees, remain up to date on reimbursement changes, select and employ technologies to serve more patients in convenient ways, and adhere to quality standards to serve their communities.

With the need for pharmacy to become an integrated part of health care organizations and for leaders to be successful in achieving their objectives, organizations are turning to Maxor, a national provider of pharmacy services. Maxor’s been helping healthcare leaders tackle pharmacy challenges for more than 90 years.

Maxor partners with hospitals, health systems and grantee organizations (e.g. Community Health Centers, Ryan White Clinics, STD Clinics, FQHC and FQHC look-a-likes) to create fully customized solutions, allowing clients to realize clinical and financial benefits without the headache of running an onsite pharmacy. Not to mention, Maxor is a leading expert in 340B

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