Questions About Your 340B/Medicaid Dispute?

Introduction

What is going on?

Through a thorough review of data CiiTA identified prescriptions that may have triggered a 340B-Medicaid duplicate discount.  Those claims were then confirmed to have been filled using 340B inventory and then submitted for a Medicaid rebate by your state.

Are you saying we did something wrong?

Not at all. It is our experience that duplicate discounts generally occur in through simple processing errors and mitigating these duplicate discounts is just part of the reconciliation process.

Why did this happen?

No one party in the 340B chain has all the information necessary to ensure with completeness that duplicate discounts are not occurring, hence this dispute following a review of the disparate elements. Basically, it is really complicated, and wires can get crossed.

How were these claims identified as triggering a duplicate discount?

Duplicate Discount Prevention is a three-step process

  • Identification
    • Identification of claims which have or are likely to trigger a Duplicate Discount
  • Confirmation
    • Confirmation of claim as triggering a Duplicate Discount
  • Mitigation
    • Actual steps necessary for prevention of potential Duplicate Discounts or recovery of existing Duplicate Discounts

What occurs during the Identification step?

There are two processes for identifying possible duplicate discount claims: the Prescriber Risk Analysis and the Medicaid Exclusion File Analysis.

For Prescriber Risk analysis existing Manufacturer Claims-Level Data (CLD) and other data is mapped against existing data maintained by CiiTA.

  • If the following are matched from CLD, a potential Duplicate Discount is inferred:
    • Prescriber NPI associated with CE, and
    • Dispensing NPI associated with CE and eligible for 340B, and
    • Product NDC consistent with CE scope of service, and
    • Date of Service within eligible CE dates

For Medicaid Exclusion File Analysis Manufacturer-supplied Claims Level Data (CLD) is mapped against the Office of Pharmacy Affairs-managed Medicaid Exclusion File for overlap.

  • If the following are matched from CLD, a potential Duplicate Discount is inferred:
    • Dispensing NPI associated with CE and eligible for 340B, and
    • Date of Service within eligible CE dates

But my state doesn’t use the Medicaid Exclusion File!

We understand that many states utilize methods other than the MEF for preventing duplicate discounts.  The MEF is only used to flag transactions that may have triggered a duplicate discount.

So how do we know that these claims are actually 340B?

That is where the Confirmation step occurs.  Upon identification of potential duplicate discounts, CiiTA initiates a Good Faith Inquiry (GFI) with the identified Covered Entity. Working with the Covered Entity, the GFI allows us to confirm the 340B status of the claim set in question. The GFI is a collaborative approach to preventing Duplicate Discounts that is neither putative nor onerous. When confirmation of a Duplicate Discount is made, a determination is then made as to the party responsible based upon Federal and State laws, regulations, and procedures.

So how did this happen?

Duplicate Discounts remain an issue due to the fundamental conflict between 340B purchasing and Medicaid rebating. Think of it as a translation issue between packaging (the 340B purchasing) and dispensing (the Medicaid processing and rebating). This translation issue inevitably leads to errors even when the program is run effectively and precisely.

Preventing Duplicate Discounts is difficult and consumes a great deal of time and energy. We know that this is just one of many things that you must manage, and we appreciate the work that you are putting in regarding this issue.

Who is CiiTA, Inc?

CiiTA is a performance services company for pharmaceutical manufacturers.

What is CiiTA’s relationship to the manufacturer?

CiiTA is under contract with the manufacturer to complete this cooperative evaluation on their behalf.

What are CiiTA’s qualifications?

CiiTA is fortunate to have an extensive bench of on-demand subject matter expertise regarding the 340B program, including having formed the nation’s first 340B third party administrator.

How does CiiTA ensure bias-free findings?

Our process is designed to be entirely transparent, and confirmation of 340B status is ultimately made by your organization. It is our belief that transparency ensures a lack of bias.

Where is CiiTA located?

CiiTA is located in Portland, Oregon.

Who do I talk to if I have more questions?

Feel free to reach out to our evaluation team to schedule an appointment.

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