How to Submit ASP Pricing on CMS Portal

Pharmaceutical manufacturers participating in Medicare Part B reimbursement programs must regularly report participating products and Average Sales Price (ASP) data to the Centers for Medicare & Medicaid Services (CMS). CMS Portal offers an application Fee-for-Service Data Collection System (FFSDCS). That application manages the product and pricing submissions.

Manufacturers often have questions on how to submit ASP pricing, because the submission involves people with two ASP-related roles, working in tandem. Besides, some steps of the process are not obvious.

This post explains how to submit quarterly ASP pricing data to the CMS application FFSDCS. It continues the ASP-related series, that began with “How to Register a Product on CMS for ASP Submissions”.

 

Prerequisites

Before making any submissions, please ensure that:

1. All prerequisite steps, listed in the “How to Register a Product on CMS for ASP Submissions”, are completed.
2. Application FFSDCS contains all products info.
3. One of senior financial executives of the drug manufacturing company takes a role of a certifier. This executive could be CEO, CFO, or an individual with a signing authority.
4. That financial executive has to have a CMS account with access to FFSDCS and a role of ASP Certifier.

CMS portal allows only one user with a role of ASP Role, and one user with a role of ASP Certifier. Generally, ASP Role is a technical support role. Therefore, the Certifier does not necessarily have to have both roles.

Submitting Quarterly ASP Financial Data

ASP needs to be calculated quarterly, on an NDC-11 level.

The details of ASP calculations are published at https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-414/subpart-J and https://www.cms.gov/medicare/payment/part-b-drugs/asp-reporting.

Users can load the ASP information either manually, using the CMS portal interface, or by uploading a formatted file. Either way, the pricing submission includes ASP, the number of units used to calculate ASP, Wholesale Acquisition Cost (WAC) and Average Wholesale Price (AWP).

FFSDCS application offer the template file “FinancialData Submission.xlsx ” for download.

CMS expects to see AWP taken from recognized sources, like RedBook or Medi-Span. When AWP is not available, some experts, like SmithRx and SRXAdvisors, suggest a formula AWP = WAC plus 20% margin. However, that formula is not universally accepted, and CMS does not endorse it.

The deadline for ASP Pricing submission is 30 days from the end of the quarter.

Obviously, it is a good practice to automate creation of the ASP financial data file to avoid repetitive WAC and AWP lookups for each product every quarter.

 

Generating One-Time Password (OTP)

After the ASP Submitter successfully loads pricing info, the Submitter need to generate a One-Time Password (OTP) and to communicate it to ASP Certifier. After that, the OTP remains valid for seven days.

 

Certifying Data

ASP Certifier authenticates himself/herself by choosing the company name from the list and typing OTP.

Then Certifier chooses tab “Pending”, which shows a list of product and prices, loaded by the ASP Submitter. Afterwards, column “Go to Certification” brings up another screen, that lists all pricing records pending certification. Finally, user selects records and certifies them.

Certified records get status “Certified”.

How to Submit ASP Pricing: Summary

Maintaining accurate ASP pricing records into CMS is an important step for drug manufacturers, participating in Medicare Part B program. This post explains how to do these registration steps in the right order, making the quarterly process transparent and easy.

For more details, please refer to asp certifier user guide.

Learn More

Relasoft Pharma Suite software offers drug manufacturers a sophisticated software platform. The platform automates ASP calculation and generates ASP pricing files according to the CMS-published template.

For a full overview of Relasoft’s Pharma Suite, visit: https://relasoft.net/pharma-suite/ or contact us at 727-306-1868 to learn how we can automate your ASP reporting process.