How to Register a Product on CMS for ASP Submissions

Pharmaceutical manufacturers participating in Medicare reimbursement programs must regularly report participating products and Average Sales Price (ASP) data to the Centers for Medicare & Medicaid Services (CMS). This is done using CMS Portal https://portal.cms.gov/portal/

This post clarifies how to register the manufacturer and products covered by Medicare Part B for ASP submission using CMS application Fee-for-Service Data Collection System (FFSDCS), and how to submit the product data.

Pre-requisites

Before any submissions can be made, take the following steps:

1. Give the account access to an application called Fee for Service Data Collection System (FFSDCS). Assign a role “ASP Role” within the FFSDCS application to the user.
2. Register manufacturer name with CMS as a company that submits ASP data. Go to a section: “Manage NDC1/ALT ID”, choose “Add New Request” and select option “New Manufacturer Name” on the right. Fill in fields “New Manufacturer Name”, “EIN” and “DUNS Number”. Take EIN from W-9 form, if available, and find DUNS number on DUNS Lookup. Just search by the manufacturer company name. Finally, click the “Send Request” button to submit the request for registration
3. Associate labeler code with the manufacturer name:

Submit to CMS a request for a new NDC1/Alternate ID. Wait for a confirmation email for the approval of the new labeler code. After that, go to the same section “Manage NDC1/ALT ID”, select manufacturer name from the list and labeler code from the list of NDC1, and press button “Assign”.

Product registration for ASP submission

Users can add products either manually using the CMS portal interface, or by uploading a formatted file built on the ASP Excel Template. The template file is available for download in the FFSDCS application.

CMS Portal manages several lists, used to validate the input: manufacturer names, product generic names, units of volume, units for strength, and FDA approval types. ASP template contains them as well.

Here are some comments about filling in the fields:

Volume Per Item – a number of extended units per NDC item.

Unit for Volume per Item – a unit of measure of the extended units: Tablet, MG, Ampule, Vial, etc.

Strength – is a numeric field on the template. Many software systems show Strength values like “16mg per pill”, etc. Therefore, split such values into “16” for Strength and “MG” for “Unit for Strength”.

FDA application number – can contain up to 6 digits. If the FDA number is stored as ANDA123456, code 123456 will go to the field “FDA application number”, and ANDA chosen among the values of the next field “FDA Approval Type”.

Template fields “First Marketing Date” and “Date of First Sale for this Product” refer to the earliest product activities under the FDA Application number, conducted by the original product manufacturer.

A tip on the ASP product file preparation

The template file uses formulas with references, and copying records or values from one file to a different excel file may lead to broken links, empty lists not showing up, etc. We recommend to start the submission with a clean copy of the template file.

It is not necessary to submit the whole template file, because the portal checks for the tab “Product Data Template” only. If file generation is automated, creating files with just one tab is the preferred approach.

Summary

Registering the manufacturer and its brand products on the CMS portal for ASP submissions is a key compliance requirement for drug manufacturers, participating in Medicare Part B program. This post explains how to do these registration steps in the right order, making the process transparent and easy.

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