By: Heidi Larson, PharmD, 340B ACE
Do you know and understand how contracts are loaded into your wholesaler accounts? As we move into FY23 of 340B Program HRSA audits, SpendMend has seen increased scrutiny on purchasing accounts and practices. This includes mixed-use universes, clean-site universes, in-house entity-owned pharmacy, and going so far as to understand contract pharmacy replenishment and true-up processes. One of the first steps to this process is to have a clear understanding of the distributor accounts and if a CE has not already done so, enroll in the Prime Vendor Program. It is free and can provide added value to the 340B Program in additional contracted purchasing savings.
Let’s start this process with a few questions.
What is the Prime Vendor (PVP) contract load process? Which PVP contracts should be loaded to 340B or Non-GPO/WAC accounts? How does an entity verify that Prime Vendor contracts have been loaded on wholesaler accounts?
The PVP managed by Apexus helps 340B entities access the best price on covered outpatient drugs through contracting with manufacturers. Once an entity is enrolled in the PVP program, Apexus will send a welcome email with an effective date and registration instructions for access to the secure website to obtain 340B selling prices. PVP sends notifications to wholesalers/distributors to load PVP pricing which should take about 10-14 days. All PVP enrolled entities should confirm with the wholesaler/distributor that 340B/PHS, PVP Sub-340B contracts are loaded to the 340B account, PVP Sub-WAC contracts are loaded to the non-GPO/WAC account, and Apexus value-added pricing is loaded to both the 340B and non-GPO/WAC accounts. Apexus generic source program portfolio (AGP) contracts may have different price points depending on the account.
Contact the Apexus call center if you are unable to confirm that contracts were loaded. If there is a change in a wholesaler, the PVP must be notified. Any secondary and tertiary wholesalers should also be reported to Apexus for contract load. When evaluating drug pricing for accuracy you may notice that the 340B price from the wholesaler is different from the 340B price listed on the PVP secure website, or different from a colleague. The reason for this is that the 340B ceiling price is the same for all entities, but the selling price may differ among entities because wholesalers charge distribution fees and offer volume incentives for their services.
It is important to note that 340B/PHS and PVP sub-340B pricing are only loaded to 340B accounts and should only be used on qualified 340B accumulations of covered outpatient drugs (CODs). Apexus value added pricing is associated with non-covered outpatient drugs (NCODs) that cannot meet the Social Security Act definition of a COD, e.g., vaccines, blood glucose monitoring supplies, and prescription vials/labels. Although value add contracts can be loaded into either the 340B or non-GPO/WAC accounts, many entities will choose to configure their split billing software to route all Apexus value added NCODs to the non-GPO/WAC account to simplify the record keeping trail while still taking advantage of these contracts. It will take time to verify correct pricing is loaded to correct accounts and to verify the split billing vendor is splitting to the correct account, so plan staff resources accordingly.
The table below describes the contract indicator, account type, and description associated with each wholesaler.
So, what does this mean?
- Covered entities should take the time to review wholesaler loaded accounts.
- For mixed-use/clinic universe and in-house entity owned pharmacies, verify the pricing loaded matches or is in line with expected pricing. This can be completed by a review of the historical pricing, a check in OPAIS (note that the AO or PC will have to login to obtain pricing information), and a review of other pricing tools used by the covered entity.
- Don’t forget about a review of contract pharmacy pricing. Ensure that claims captured as 340B are ones in which 340B pricing or PVP pricing is applied appropriately. One may also want to consider a review of the contract terms to determine if those claims captured due to the application of PVP pricing are charged to the covered entity in those contracts that have per claim fee terms.
- If an incorrect price is discovered, the steps a covered entity should take are provided in HRSA FAQ 1239 posted in Apexus tools.
- FAQ ID: 1239
- Last Modified: 09/01/2021
- Question: If I notice an incorrect price loaded in OPAIS, how do I correct this?
- Answer: Suggested steps include:Check the labeler code on 340B OPAIS (https://340bopais.hrsa.gov/manufacturersearch ), and check the Medicaid Drug Rebate Program labeler code (https://data.medicaid.gov/dataset/0ad65fe5-3ad3-5d79-a3f9-7893ded7963a) to help determine if the drug is a covered outpatient drug in the Medicaid Drug Rebate Program and subsequently should have a 340B price.2. Validate the correct price using the 340B OPAIS pricing system:
a) Compare the price in OPAIS to the invoice purchase price using the NDC to look up the product in OPAIS.
b) Remember the following tips:
• The OPAIS Pricing Database displays the 340B ceiling price at the unit level; the covered entity may need to multiply the ceiling price by the package size (this might be the total number of mL, tablets, capsules, grams, etc.) in the package purchased.
o For Prime Vendor participants, verify the selling price by visiting the password-protected Prime Vendor Program Catalog or 340B & PVP Product Selling Price Lookup tool. Package size information is available.
• Adjust the purchase price for your wholesaler distribution charge/markdown3. If the OPAIS prices do not match, work with the entity’s wholesaler and if not resolved directly with the manufacturer to resolve the pricing issue.4. If necessary, the entity can contact OPA by completing a Template Notification Tool: Unavailable 340B Ceiling Price/Incorrect Ceiling Price for further investigation by OPA.https://www.340bpvp.com/Documents/Public/340B%20Tools/340B-ceiling-price-unavailable-incorrect-340b-ceiling-price-notification-for-hrsa.docx