Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) - IRA

In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price of manufacturers' average sales price data submitted to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J. In the CY2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. We also initiated additional changes to the template in 2008 (73 FR 76032). In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we are now proposing revisions to the Addendum A template. Specifically, we propose to revise existing reporting fields and add new fields to the Addendum A template, as follows: o To split the current NDC column into three separate reporting fields, corresponding to the three segments of an NDC: the labeler, product, and trade package size; o To add a new field to collect an Alternate ID for products without an NDC; and o To expand the current FDA approval number column to account for multiple entries and supplemental numbers. We have also added a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission. 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. A User Guide containing general instructions on the use of the template and instructions for the reporting of dermal grafting products has also been created.

The latest form for Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) - IRA expires 2021-02-28 and can be found here.