Reminder: Pharma Manufacturers Now Required to Report Average Sales Price (ASP) Data for Part B Drugs Via New System
As discussed in a prior blog post, pharmaceutical manufacturers whose drugs are reimbursed under Medicare Part B must now report certain product and financial data (including Average Sales Price, or ASP) to the Centers for Medicare & Medicaid Services (CMS) through the Fee-for-Service Data Collection System (FFSDCS). In a teleconference on March 27, 2018, representatives from CMS explained the processes required to register individuals and assign roles within the FFSDCS. Specifically, users must obtain an Enterprise Identity Management (EIDM) username and password (or, to the extent that the individual already submits data to CMS electronically, link their current EIDM username to the FFSDCS) and then select their appropriate role as either an “ASP End User” or an “ASP Certifier.”
There are two methods by which manufacturers may submit the required product and financial data in FFSDCS: manual data entry on a product-by-product basis, or, in the event that the report contains a large amount of drug data, by compiling all required data in template spreadsheets provided by CMS and submitting via file transfer. CMS representatives indicated that CMS has already uploaded product information that manufacturers have previously reported into FFSDCS, and that the manufacturer should first review the product information in the system for accuracy. Reporting product data should only be necessary to the extent the manufacturer is adding a new product. However, the financial reports must be filed each quarter.
For the first reporting period that the FFSDCS is active (which ends on April 30, 2018), CMS is requiring manufacturers to report the required product and ASP data both through the FFSDCS, and the method that the manufacturer currently uses to submit data. CMS’s ASP webpage contains the template spreadsheets that must be used in the event of a file transfer and a detailed User Manual with step-by-step instructions regarding the entire process.
The Arent Fox Health Care Group actively monitors CMS’s changes to the ASP reporting system. If you have any questions about this topic, please contact Stephanie Trunk or Erin Atkins in our Washington, DC office, or the Arent Fox professional who regularly handles your matters.