CMS-10110 Crosswalk

CROSSWALK DOCUMENT FOR CMS 10110

CHANGE

RATIONALE

Deleted 1 data element to Addendum A to remove the 11 digit NDC information

Three additional data elements were added to split the NDC number into three components, NDC1, NDC2, and NDC3

Added 3 data elements to Addendum A to identify the labeler, product, and package size, respectively.

NDC1

NDC2

NDC3

Entering each NDC component in a separate field allows CMS to better identify information about each product.

Added 1 data element to Addendum A to identify an Alternate ID for the drug product

Alt ID

To provide identification for a product when an NDC is not available.

Added 6 data elements to Addendum A to identify the FDA approval for the drug product.

FDA Application Supplement Number

Additional FDA Application Number #1

Additional FDA Application Supplement Number #1

Additional FDA Application Number #2

Additional FDA Application Supplement Number #2

Description of FDA Approval Type

To appropriately determine payment amounts under Section 1847A of the Social Security Act, CMS must identify and associate the FDA approval number of a product with the applicable ASP data. The FDA approval number at the drug product level is not available to CMS from an existing source. Therefore, CMS must collect these data directly from manufacturers. Additional columns have been added in the case that the product has more than one FDA Application number. We are also adding a column to obtain a description on the FDA approval type.

Added Macro to validate data entered in spreadsheet

This will help verify that data are complete and submitted to CMS in the correct format, thereby minimizing time and resources spent on identifying mistakes or errors.