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

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Essential Current Audit Trends, Risks and Preparation Steps

SPONSORED CONTENT

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 as of May, 2024, 19 audits have been completed.  Historically, the entity types at highest risk for audit were disproportionate share hospitals and critical access hospitals, but in the past few years there has been a shift to audit more non-hospital grantees such as Federally Qualified Health Centers, STD clinics, and even specialty clinics.  No entity should consider themselves “safe” and all entities should be prepared to receive the dreaded OPA audit notice.

An OPA audit can last anywhere from 2 to 6 months and can include up to five separate phases.  The burden is unwieldy – how do you prepare for every aspect of an OPA audit?  We

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

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Key Implications of Long-Awaited ADR Rule on 340B Stakeholders

SPONSORED CONTENT

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, HRSA “encountered policy and operational challenges with implementation” and started over in November 2022.

As HRSA stated, “the purpose of the 340B ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit … that a covered entity has violated the prohibition on diversion or duplicate discounts.” In either case, the parties must engage in good faith efforts to resolve the dispute before filing.

The long-awaited final ADR rule represents a welcome development for 340B hospitals and grantees, but it is not without caveats. Here are three things

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Spring Cleaning of Your 340B Program

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Essential Updates and Checks

SPONSORED CONTENT

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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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

SPONSORED CONTENT

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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Navigating State-Level Regulations to Safeguard Your 340B Program

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Proactive Engagement in the States is Essential

SPONSORED CONTENT

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 common nuances our team has run into with CEs across the nation: 

  1. Medicaid Participation: State Medicaid programs play a crucial role in 340B operations, regardless of the state you’re in.
    • States vary in their approach to Medicaid, including differences between fee-for-service and managed Medicaid models.
    • Certain states may have specific carve-in or carve-out arrangements. For instance, in the state of New York, carve-in arrangements are no longer permitted, significantly impacting 340B programs across the state. Meanwhile, North Carolina allows a carve in option for specific plans but require a code 20 to flag the claim as 340B eligible and to avoid duplicate discounts from the manufacturer.
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340B INDUSTRY LEADER SPOTLIGHT

Troy Polan, Chief Information Officer, Avita Care Solutions

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Troy Polan

Q: Where did you grow up?

I grew up in southern Connecticut and lived there my entire childhood.

Q: What are your favorites?

Food: Indian, pizza, soft-serve

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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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Navigating HRSA 340B Program Audits

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A Step-by-Step Guide

SPONSORED CONTENT

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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Advanced 340B Education: Staying Informed and Empowered

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

SPONSORED CONTENT

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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Expert Tip from The Craneware Group

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TIP: When updating your 340B program policies and procedures, prioritize clear communication and training to ensure staff compliance and minimize errors.

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