OPA-CMS Webinar Focuses on Preventing 340B Duplicate Discounts

by Admin | December 15, 2011 1:40 pm

December 15, 2011—With 340B covered entity audits just over the horizon, providers that use 340B drugs for Medicaid patients should double-check the accuracy of their information in the Office of Pharmacy Affairs (OPA) database lest they find themselves on the hook for a duplicate discount violation, the office’s director recommended during a recent webinar.

Also, auditors aren’t the only ones who will soon be examining the accuracy of 340B providers’ entries in OPA’s Medicaid Exclusion File, Director Krista Pedley said. The office itself will be asking that question as part of the new annual recertification of all entities’ eligibility to participate in 340B.

OPA and the Centers for Medicare and Medicaid Services (CMS) co-hosted the Dec. 8 webinar, which drew more than 600 listeners, to describe the workings of the Medicaid exclusion file, a subset of OPA’s covered entity database.

Under federal law, drug manufacturers are to be protected against paying 340B discounts and Medicaid rebates on the same products. When covered entities enroll in 340B, they must decide whether they are going to purchase drugs for their Medicaid population at the 340B price or through a separate, non-340B account. Those that choose to use 340B drugs for Medicaid patients (i.e., those that “carve in”) are required to submit their Medicaid billing numbers which, in turn, are listed in the Medicaid exclusion file. Those that choose to “carve out” their Medicaid drugs from 340B are not listed in the file.

State Medicaid agencies are supposed to use the Medicaid exclusion file to ensure that rebates are not collected on 340B drugs billed to Medicaid under the submitted billing numbers. Failure to use the file exposes manufacturers to a duplicate discount risk (i.e., giving an up-front 340B discount and a back-end Medicaid rebate on the same drug).

During the webinar, Pedley reminded covered entities that it is ultimately their responsibility to ensure accurate reporting of Medicaid billing of 340B drugs to OPA and the state Medicaid agency.

“If you’re a covered entity and you’re on the call today, you want to make sure your Medicaid billing practices are listed accurately in the exclusion file or you could be violating the duplicate discount prohibition,” she said. “If the appropriate Medicaid billing number is not listed in the exclusion file and 340B drugs are used to fill Medicaid prescriptions, contact OPA immediately to make sure that the correct number is in the file.”

Entities in violation of the duplication discount prohibition, she noted, “can be found liable to the manufacturer in the amount equal to the reduction in the price of the drug.”

Pedley also reminded providers that carve their 340B drugs into Medicaid that they “cannot choose which drugs you will bill Medicaid for and which you will not.”

“It’s either all in or all out,” she said.

Pedley also observed that the majority of providers that contract with one or more pharmacies to dispense 340B-purchased drugs exclude Medicaid prescriptions from such arrangements to eliminate the possibility of duplicate discounts.

OPA, she said, was surprised to learn in June that more than half of all state Medicaid agencies had developed alternatives to the exclusion file, including 10 that said they did so because of inaccurate data in the file. The finding was part of a Department of Health and Human Services Office of the Inspector General (OIG) report[1] on state Medicaid agencies’ oversight of reimbursement for drugs bought under the 340B program.

“It opened our eyes to realizing that improvements had to be made to the file,” Pedley said. OPA is inviting stakeholders to email their concerns about the file and suggestions for improvements to opaexclusion@hrsa.gov[2].

The PowerPoint slides from the webinar are available here[3].

Source URL: https://340binformed.org/2011/12/opa-cms-webinar-focuses-on-preventing-340b-duplicate-discounts/

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