Financial Oversight Calculation Background: HRSA Policy Does Not Address Topics in This

340B Oversight Best Practices

Purpose:The purpose of this tool is to provide covered entities with a framework for monitoring and communicating 340B oversight based on best practices. Although the 340B statute does not specify how 340B Program savings must be used, the intent of the program is to provide savings to the safety net organizations that participate in the program. Therefore, as a best practice, dashboards can be a helpful way for an organization to identify and depict the role the 340B Program may play in supporting an organization’s mission as a safety-net provider. The audience for this tool is intended to be 340B Steering Committee staff. The metrics to include can be customized for C-suite.This template is based on best practices shared by covered entities; it is not an exhaustive list, and can be customized according to the covered entity’s specific circumstances. Historical time periods may be incorporated to provide benchmarking and trends. This framework can be transferred to a Microsoft Excel spreadsheet for tracking data, or covered entities can also automate the dashboard monitoring through software. The 340B Oversight Dashboard is followed by additional background information.

COMPLIANCE OVERSIGHT
COMPLETION / GOALS: / DASHBOARD VIEW
Quarterly HRSA 340B OPAIS review by ____ [date]. / Date: / Date: / Set due dates and/or targe metric for each review element. Assign color for each goal. Designate color on dashboad view based on completion in comparison to goal.

Quarterly Medicaid Exclusion File accuracy review by _____ [date]. / Date: / Date.
Monthly self-audit transaction sampling completion by ______[date]. / Date: / Date:
Quarterly account load pricing spot check completion by ______[date]. / Date: / Date:
Annual independent contract pharmacy audit completion by _____ [date]. / Date: / Date:
Annual 340B policy and procedure review by ______[date]. / Date: / Date:
Quarterly/Annual DSH% tracking in preparation for Medicare cost report filing by _____ [date]. / Date: / Date:
Percentage of staff completing required 340B education by ____ [date]. / X% / >X% completion rate by ___ date.
>X%: green
X% yellow
<X%: red
FINANCIAL OVERSIGHT
*Refer to examplesbelow for corresponding calculations
340B Benefits
Add the following three metrics together for total 340B benefit.
TOTAL: $ / MINUS
- / 340B Compliance Maintenance Costs
TOTAL: $ / EQUALS
= / 340B Net Financial Impact
$ / GOALS (Net Financial Impact): / DASHBOARD VIEW:
Physician-administered/clinics savings / $ / Summation of split-billing software fees; education; dedicated FTEs and contractors; legal fees; external auditor fees; consultant fees / $ / Set annual target financial impact. Assign color goal. Designate color on dashboad view based on net financial impact in comparison to goal.
Entity-owned retail pharmacy savings / $
Contract pharmacy revenue / $

Financial Oversight Calculation Background: HRSA policy does not address topics in this tool; this information is shared for reference.

340B Savings: physician-administered/clinics, entity-owned retail pharmacies

There are several ways to calculate 340B savings. The following is an example:

For hospitals subject to the GPO Prohibition; and entity-owned retail pharmacies subject to the GPO Prohibition:

Step 1: Calculate 340B savings by reviewing the purchase history report from the 340B account and identify the unit price for each NDC when purchasing those NDCs at 340B price and GPO price. 340B savings will be equal to the GPO total minus the 340B total.

Step 2: Calculate WAC variance by identifying purchase history in the non-GPO/WAC account and what those purchases would have cost at GPO pricing. WAC variance will be equal to the non-GPO/WAC total minus the GPO total.

Step 3: Calculate net savings. The net savings is equal to 340B savings calculated in Step 1 minus the WAC variance calculated in Step 2.

All other entities; and entity-owned retail pharmacies not subject to the GPO Prohibition: 340B savings may be calculated by looking at the difference between 340B pricing and customary pricing for all outpatient purchases.

Contract pharmacy revenue: Reimbursement received - (drug AAC +dispensing fees to contract pharmacies + administrative fees to vendor + DIR fees charged by PBMs + entity costs of sliding fee subsidization)

This tool is writtento align with Health Resources and Services Administration (HRSA) policy, and is provided only as an example for the purpose of encouraging 340B Program integrity. This information has not been endorsed by HRSA and is not dispositive in determining compliance with or participatory status in the 340B Drug Pricing Program. 340B stakeholders are ultimately responsible for 340B Program compliance and compliance with all other applicable laws and regulations. Apexus encourages all stakeholders to include legal counsel as part of their program integrity efforts.

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