Pharmaceutical Policy Experts™


Comprehensive 340B Compliance Review

The 340B Drug Discount Program offers qualified safety-net entities a federally-mandated reduction on the cost of pharmaceuticals; however, any savings associated with participation in 340B are contingent on compliance. According to HRSA guidelines, 340B entities are expected to maintain fully auditable records and conduct routine audits of their operations, including contract pharmacy relationships. Recent attention from Congress, the Inspector General, interest groups and manufacturers on program integrity has reinforced the need for a compliant 340B program.

Rx|X’s 340B Comprehensive Program review is based on three elements that are essential to an entity’s compliance and efficient operations:

1) A demonstrated understanding of program requirements that are appropriately documented and defensible;

2) Consistent application of ordering, tracking, inventory, and billing practices;

3) Appropriate design of the data that feeds 340B qualifications.

Information collected from document review, interviews, pharmacy walk-through, systems demonstration, and technical specifications are evaluated across covered entity eligibility criteria, compliance with the GPO prohibition and/or the orphan drug exclusion, procurement and distribution of 340B drugs, patient definition, prevention of duplicate discounts and level of audit documentation.

The cornerstone of our program review is transaction testing of a sample of qualified 340B claims against the medical record.  In this test, Rx|X mimics the HRSA audit process to trace prescription origination, provider eligibility and patient eligibility.  While the universe of 340B-qualified data is reviewed to test for consistencies in data and identify outliers, reviewing a sample of patient records is essential to uncover issues with data feeds, inconsistent application of interpretations, or unidentified risk areas.

Rx|X then works with IT, Billing, Finance, and Pharmacy to discuss file specifications supplied to in-house systems, split-billing vendors, and/or third party contract pharmacy administrators for 340B qualification. We test inputs versus outputs, review your accumulator(s), crosswalks, and other data to validate that the program design matches your intent.  Often times we identify missing or incomplete data that is contributing to missed 340B opportunity.

The deliverables for the Rx|X Comprehensive 340B Compliance Review includes a report on the state of compliance at the entity and an Implementation Table that summarizes all findings, discussions and recommendations for the team to use as a working guide post-review.  The report will also include steps to address any IT issues and best practices for program optimization within a compliant framework.  Rx|X can also assist with the creation and/or editing of 340B Policies and Procedures.