CMS Labeler Agreement: What You Need to Know
The Centers for Medicare & Medicaid Services (CMS) has implemented a labeler code system for prescription drugs reimbursed by the Medicare Part B program. The CMS Labeler Agreement is a contractual agreement between the manufacturer or distributor of a drug and CMS, which outlines the terms and conditions for the assignment of a labeler code.
What is a Labeler Code?
A labeler code is a unique five-character code assigned by the FDA to identify the manufacturer or distributor of a drug. It is used in drug labeling and packaging and is necessary for processing Medicare Part B claims.
Why is the CMS Labeler Agreement Important?
The CMS Labeler Agreement is important for manufacturers and distributors of drugs because it ensures compliance with the Medicare Part B program requirements and guarantees accurate reimbursement for their products. The agreement also includes provisions for the assignment of National Drug Codes (NDCs) and quarterly reporting of drug pricing.
Who Needs to Sign the CMS Labeler Agreement?
All manufacturers and distributors of drugs reimbursable under the Medicare Part B program must sign the CMS Labeler Agreement. This includes both brand-name and generic drug manufacturers and distributors.
How to Obtain a Labeler Code?
To obtain a labeler code, a manufacturer or distributor must sign the CMS Labeler Agreement and submit it to CMS along with a completed Labeler Code Request Form. The request is processed by the CMS Labeler Code Request Coordinator, and the labeler code is assigned within 10 business days.
What Happens if a Labeler Code is Not Obtained?
Failure to obtain a labeler code can result in delayed or denied claim processing, resulting in financial losses for the manufacturer or distributor. It can also lead to non-compliance with Medicare Part B program requirements and potential legal consequences.
Conclusion
The CMS Labeler Agreement is a crucial document for manufacturers and distributors of drugs reimbursable under the Medicare Part B program. It ensures compliance with program requirements and guarantees accurate reimbursement for their products. Failure to obtain a labeler code can lead to significant financial losses and legal consequences. Therefore, it is essential to understand the process of obtaining a labeler code and to comply with the CMS Labeler Agreement.