№ files_lp_3_process_7_053850
Guidance framework outlining recommended practices for defining material breach, establishing internal assessment thresholds, and formalizing self-disclosure procedures within the 340B Drug Pricing Program compliance structure.
Year: 2024
Program: 340B Drug Pricing Program
Subject: Compliance policy and self-disclosure procedures
Document Type: Guidance framework
Issuing Organization: Apexus
Related Authority: Health Resources and Services Administration (HRSA)
Intended Audience: 340B covered entity leaders and stakeholders
Scope: Definition of material breach and self-disclosure to HRSA and manufacturers
Key Components: Threshold indicators, policy criteria, sample statement, review procedures
Compliance Focus: Diversion and duplicate discounts
Copyright: © 2024 Apexus
Usage Rights: Permitted for use, copying, and distribution by 340B covered entities and Medicaid agencies
Price: 8 / 10 USD
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