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TIP: Create and maintain a comprehensive crosswalk or log documenting your 340B registered sites, contract pharmacies, and all associated contract pharmacy agreements.
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Get the latest developments in the 340B program with some of the most respected experts in the field. Verity Solutions will be hosting this lively panel discussion again where you will get an up-to-the-minute report on hot button topics related to the policy, compliance, and regulatory aspects of the 340B program.
Among the topics to be covered:
· Developments on 340B contract pharmacy restrictions, state laws, and litigation
· Update from Washington, D.C., and the states on 340B legislative activity
· 340B provider reporting and transparency
· Future of 340B patient definition considering Genesis federal court ruling
Topics will be updated for any late-breaking news, and there will be opportunity
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Primary care organizations often view themselves as a “Medical Home” for their patients, focusing on resolving patient health problems through their medical services. However, a significant challenge for providers lies in the inability to monitor and influence a patient’s behavior in the time between medical visits. Surprisingly, pharmacy professional services, designed to address this need, remain underutilized and are rarely integrated into medical workflows.
Understanding Pharmacy Professional Services
Pharmacy professional services can be defined differently by practice setting, but they encompass a range of activities performed by pharmacy resources to improve the outcomes of medication therapy. Essentially, these services eliminate barriers to drug therapy failure which can be categorized into three main buckets:
- Poor access or affordability
- Educational gaps
- Clinical effectiveness and side effects
Despite the pressing need for addressing these barriers, the current primary care infrastructure does not fully integrate these aspects into a multidisciplinary approach. However, this is
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TIP: When offering repayment to manufacturers for noncompliant purchases, it helps to standardize the refund process by setting a target date for completion,
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TIP: Self audits require continuous monitoring.
As 340B compliance becomes increasingly political, the C-suite is ever
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The much-awaited decision in the Genesis Health Care patient definition case in federal district court in South Carolina provides 340B hospitals and federal grantees welcome re-affirmations of the importance of the vital safety-net care they provide as well as Congress’s intent to support that care through the 340B program. Although the court limited its decision solely to the Genesis health center, and its decision is potentially subject to appeal, the ruling provides a strong indication that future courts reviewing attempts by HRSA to enforce an overly-restrictive “patient definition” could similarly reject the agency’s restrictions.
Here are 3 things hospitals and grantees need to know regarding their 340B programs from the Genesis decision:
1. Hospitals and grantees should revisit their 340B prescription eligibility criteria.
For more than a quarter century, HRSA relied upon informal guidance to interpret the otherwise undefined term “patient” in the 340B statute to restrict prescriptions 340B hospitals and other
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TIP: Proactively keep abreast of the evolving landscape of the Inflation Reduction Act and the associated Part B Inflation Rebate Guidance. Accurate tracking
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The Centers for Medicare & Medicaid Services (CMS) has issued a final rule that goes into effect on January 1, 2024 that changes the way Direct and Indirect Remuneration (DIR) fees are collected. To understand the impact of this change, let’s review some background on DIR fees:
What are DIR Fees?
DIR fees are a type of fee imposed on pharmacies, particularly those that participate in Medicare Part D. DIR fees are a complex and often controversial aspect of the pharmacy reimbursement system.
How do DIR Fees work?
DIR fees are essentially retroactive price adjustments that are made by pharmacy benefit managers (PBMs) or Medicare Part D plan sponsors to pharmacies after a prescription has been dispensed to a Medicare beneficiary. These adjustments in almost all cases will decrease the reimbursement paid to the pharmacy for a particular prescription.
What is the purpose of DIR
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TIP: Ensure your 340B program has established ordering procedures and practices to optimize replenishment for maximum cost savings.
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The 340B program, enacted in 1992, enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.
In 2010, the 340B program was expanded under the Affordable Care Act, allowing covered entities to contract with an unlimited number of contract pharmacies such as Walgreens to provide 340B discount drugs.
Since July 2020, over 25 unique drug manufactures have imposed restrictions impacting and limiting access to contract pharmacy arrangements. A deeper dive of these 340B restrictions are shared below.
- Claims Data Upload – Most manufacturers have partnered with 340B ESP to require covered entities to upload 340B claims data to access to their contract pharmacy network. Claims upload must follow a standardized format as required by 340B ESP or the manufacturer and uploaded at a recurring cadence to avoid disruption to 340B pricing access. Covered entities who are considering this option should seek counsel from within their organization
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