Tips to Ensure 340B Program Integrity

Request for Assistance Before an entity is allowed to enter the 340B federal drug pricing program, it must fully understand and comply with the Health Resources & Services Administration regulations and guidance. The entity must also be familiar with the Medicaid regulations for the avoidance of duplicate discounts for the fee-for-service program and all managed Medicaid programs. This includes both administered and dispensed medication billed through a hospital benefit. The covered entity must indicate whether it will be participating in Medicaid or not, and must adhere to all state requirements.

It also helps to maintain program integrity through education and assistance to all stakeholders. To ensure compliance with the program, it is a good idea to consult with legal counsel.

Select a 340B software solution

Without a software solution, it is very difficult to manage a program of 340B. It is essential to understand the data sources and filters used by TPAs to make qualification decisions if a third-party administrator (TPA software system) is used. Each decision taken during implementation should have a ramification for the covered entity.

A staff member should be designated to manage the entity’s 340B program. This person must have a thorough understanding of how the 340B software operates.

Each 340B management system requires regular maintenance and monitoring. The hospital’s electronic medical record (EHR) can be updated at any time and could impact 340B qualification. To ensure compliance with the program, providers, payers, as well as drugs, must be updated regularly in TPA software. The covered entity must ensure that the software is updated regularly to ensure that the outcomes meet expectations.

Avoid duplicate discounts

It is crucial that the covered entity can accurately identify which primary and secondary/tertiary plans are being used if they choose to enroll in Medicaid. Make sure the filters are correctly set to determine if a prescribed or administrated medication qualifies, based on the payer information associated with each transaction. All identifiers, such as NPI numbers or modifiers, must be included in billed transactions.

To validate the information sent to Medicaid payers, a checking procedure must be performed. A credit procedure must also be in place to correct any prescriptions that contain incorrect information. It is common for the qualification process not to be completed in time for the dispense. In such cases, ensure that Medicaid claims are billed using the correct identifiers or modifiers. Also, create edits in the software to help guide order entry to include or remove these identifiers. To minimize credit rebilling, it is important to verify the qualifications of prescriptions at the time of dispensing.

Different rules could apply depending on the state’s requirements to manage Medicaid transactions or fee-for-service. To identify all Medicaid transactions, including their qualification status and the identifiers associated with each dispense, it is prudent to create a daily report. This report will help you identify any billing transactions that have missing or incorrect data elements. This could result in a duplicate discount.

Audit and Monitor

Program integrity is dependent on a solid audit process. It is important to assign auditing staff. After a software system is implemented, it is important to audit the results to make sure they are in line with expectations. It is important to monitor the system on an ongoing basis to see if it meets the required audit frequency and criteria. Also, create a process for evaluating audit findings, responding appropriately, and reporting those findings to senior leaders. All evidence of noncompliance should be investigated immediately and rectified as soon as possible. HRSA will initiate a corrective plan if noncompliance is greater than the threshold for material breaches. All errors in prescribing prescriptions to Medicaid plans must be rectified. Collaborate with the state Medicaid program to ensure that credit rebilling is done correctly and any rebate requests are removed from the queue.

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