340B Program Operations Certificate Practice Exam – Practice Test & Study Guide

Session length

1 / 20

What must the reporting of pricing errors align with?

FDA regulations

Medicare guidelines

Social Security Act definitions

The reporting of pricing errors must align with the definitions set forth in the Social Security Act. This is because the Social Security Act establishes the framework for the Medicaid Drug Rebate Program, which is closely linked to the 340B Drug Pricing Program. Accurate reporting of pricing errors is crucial for compliance with these regulations, as they dictate how drugs are priced under various federal healthcare programs.

Adhering to the Social Security Act ensures that entities participating in the 340B program maintain integrity in their pricing practices, which ultimately protects both the financial sustainability of the program and the access to affordable medications for underserved populations. This alignment is necessary to avoid penalties and to ensure the program's objectives are met.

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