DTS-ASP-Certifier-UserGuide

Medicare Part B Average Sales Price
(ASP) Module
Certifier User Guide
Version 0.1
Date: January 22, 2024

ASP Module Certifier User Guide

Table of Contents
1. Purpose.................................................................................................................................3
2. Logging in Using MFA ...........................................................................................................4
3. ASP Homepage Menu Tabs ................................................................................................11
3.1
3.2

3.3
3.4

One Time Password (OTP) Verification .....................................................................11
Compliance Summary ...............................................................................................13
3.2.1
Missing...........................................................................................................14
3.2.2
Pending..........................................................................................................14
3.2.3
Certified .........................................................................................................17
3.2.4
New ...............................................................................................................20
3.2.5
Off Cycle ........................................................................................................21
3.2.6
Expired...........................................................................................................22
Assumptions ..............................................................................................................23
3.3.1
Create Assumption.........................................................................................24
3.3.2
Upload Assumption File .................................................................................26
Drug Certification .......................................................................................................29
3.4.1
Direct Employee .............................................................................................32
3.4.2
Contractor ......................................................................................................34
3.4.3
Drug Data Pending Certification .....................................................................36
3.4.4
All Drugs in Period .........................................................................................39

4. Technical Support Contact Information................................................................................40
Appendix A: Revision History ....................................................................................................41
Appendix B: Glossary................................................................................................................42
Appendix C: Figures and Tables ...............................................................................................44

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1.

Purpose

The purpose of this user guide is to provide guidance and instructions to financial executives of
drug manufacturing companies as they certify their federally required Medicare Part B drug
Average Sales Price (ASP) data for the Centers for Medicare & Medicaid Services (CMS). CMS
uses the Fee-for-Service Data Collection System (FFSDCS) to house various Fee-for-Schedule
modules.
The ASP Data Collection System, referred to within this user guide as the ASP Module, is one
of the modules under the FFSDCS system, and offers the following:
•
•
•
•
•

Provides users with an online-based software application for automating the collection,
editing, and processing of drug product pricing data drug manufacturers submit on a
quarterly basis.
Establishes a relationship between the manufacturers’ reported data and the billing codes
Medicare providers use to calculate a weighted average sales price for each billing code.
Establishes prices for billing codes to determine payment limits of Part B drugs on certain
Medicare claims.
Eliminates data entry errors, data formatting errors, and incomplete submitted data, and
greatly reduces the process cycle and resource time needed to provide the pricing to
contractors through automation of the manually intensive processes.
Accepts, stores, validates, and calculates drug pricing on Medicare Part B drug data
received for the Center for Medicare Management (CMM) stakeholders.

Section 303 (b) and (c) of the Medicare Modernization Act (MMA) of 2003 revised the payment
methodology for the majority of Part B-covered drugs and biologicals that are not priced on a
cost or prospective payment basis (hereafter referred to as drugs).
CMS applies the ASP methodology to the data drug manufacturers have submitted to the ASP
Module. Per the MMA, ASP methodology determines the payment limit for these drugs. Local
contractors calculate pricing for compounded drugs.

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2.

Logging in Using MFA

First time users must register and create an account in the CMS Enterprise Portal. Refer to the
ASP Module Registration User Guide for registration steps.
Once registration is complete, follow these steps to log into the Module as a Certifier using
Multi-Factor Authentication (MFA):
1.

Navigate to the CMS Enterprise Portal main page.
The ASP Module Login Page opens. Refer to Figure 1.

Figure 1: Logging in Using MFA - ASP Module Login

2.
3.
4.

Enter your login information into the required User ID and Password fields.
Click the Terms & Conditions hyperlink and review the text in the pop-up window; close
the window to move on to the next step.
Review the terms and conditions and select the I agree to the Terms & Conditions
checkbox.

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Note: By selecting this checkbox, you certify that you read and consent to monitoring
while accessing and using the ASP Module. The terms and conditions link provides
additional hyperlinks to the HHS Rules of Behavior and the CMS Privacy Act Statement.
5.

Click Login.
Note: If you forget your user ID or password, click the Forgot your User ID or your
Password? hyperlink under the Login button and follow the provided instructions. If you
still cannot access your account and need to unlock it, click the Need to unlock your
account? hyperlink under Login button.
The Multi-Factor Authentication page opens. Refer to Figure 2.

Figure 2: Logging in Using MFA - Select MFA Device Type Drop-Down

To ensure the security of high value data submitted to the ASP Module, you must authenticate
your identity using an MFA process. The first time you attempt to log in, you must choose an
authentication method. Users have various authentication options, including Interactive Voice
Response (IVR), Email, Text Message (Short Message Service (SMS)), Google Authenticator
and Okta Verify.
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6.

Click the Select MFA Device drop-down menu; select your preferred MFA device type
from the list. Refer to Figure 3. Whenever you log back into the Module through this
process, your preferred method of MFA reloads automatically.
Note: Figure 3 demonstrates MFA registration using IVR as the selected option.

Figure 3: Logging in Using MFA - Multi-Factor Authentication - (IVR) Example

7.
8.

Enter your phone number in the Phone Number field; enter your extension in the
Extension field, if necessary.
Click the Send MFA Code button to receive a six-digit code via your chosen contact
method.

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9.

Record and enter the six-digit code you received into the Enter MFA Code field. Refer
to Figure 4.

Figure 4: Logging in Using MFA - Multi-Factor Authentication - Verify MFA Code

10. Check the Send MFA code automatically and Do not challenge me on this device
for the next 30 minutes checkboxes depending on your preference.
Note: If you need help, click the Learn how to add MFA Devices beyond email and
Unable to Access MFA Devices or MFA Code? hyperlinks.
11. Click the Verify button to confirm your identity and enter the ASP Module.
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The My Portal landing page opens. Refer to Figure 5.

Figure 5: My Portal Landing Page

Note: Other CMS applications you have access to may display on the My Portal landing
page.
12. Click the Fee For Service Data Collection System (FFSDCS) box.
A Fee for Service Data Collection System (FFSDCS) drop-down menu opens. Refer to
Figure 6.

Figure 6: My Portal Landing Page - FFSDCS Drop-down

13. Click the Average Sales Price (ASP) hyperlink.
A full-page statement displays, titled ASP Data for Drugs and Biologics Covered
Under Medicare Part B. The statement details recent statutory requirements stated in
the Social Security Act (the Act), and the Consolidated Appropriations Act (CAA),

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2021.These requirements hold that manufacturers must report their ASP data to CMS
with precision on a quarterly basis without errors or miscalculations. Refer to Figure 7.

Figure 7: ASP Data for Drugs and Biologics Under Medicare Part B

14. Read the statement; select the I have read the above statement checkbox and click
Submit.
The Medicare Part B Average Sales Price homepage opens. Refer to Figure 8.

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Figure 8: Medicare Part B Average Sales Price Homepage

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3.

ASP Homepage Menu Tabs

The following sections describe the functionality of each menu tab on the ASP homepage,
including OTP Verification, Compliance Summary, Assumptions, and Drug Certification.

3.1 One Time Password (OTP) Verification
Once the Submitter has completed and submitted product data, the Submitter must share the
one-time password (OTP) with the Certifier to establish a relationship within the system. Note
the following about OTPs:
•
•
•
•
•

This step only occurs once as long as the people in both roles remain the same.
A new OTP should only be generated if the person in either role changes.
An OTP is valid for seven days. After seven days, the Submitter must generate a new
OTP.
Once the Submitter generates and provides the OTP to the Certifier, the Certifier must
verify the OTP to continue.
If the OTP is misplaced or lost, the Certifier must contact the Submitter to generate
another OTP.

Follow these steps to verify the OTP:
1.

From the Medicare Part B Average Sales Price homepage, click the OTP Verification
tab.
The OTP Verification page opens. Refer to Figure 9.

Figure 9: OTP Verification

2.

In the Manufacturer Name (required) field, begin typing the manufacturer name to
narrow down names for selection; select the appropriate manufacturer name. Refer to
Figure 10.

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Figure 10: OTP Verification - Manufacturer Name

3.

Enter the OTP code from the Submitter in the OTP Provided by Your Data Submitter
(required) field. Refer to Figure 11.

Figure 11: OTP Verification - OTP Provided by Your Data Submitter

4.

Click Verify to confirm the OTP.
A message displaying confirming you have successfully verified the OTP. Refer to
Figure 12.

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Figure 12: OTP Verification Successful

3.2 Compliance Summary
The features in the Compliance Summary section allow drug manufacturers to determine if
their products meet the current submission reporting requirements.
The Compliance Summary consists of the following sections:
•
•
•

Missing: Displays drug products that are missing financial data for the selected reporting
period.
Pending: Displays drug products that are both pending certification and pending
restatement certification, combined under one tab.
Certified: Displays previously certified drug products for the selected reporting period.
Note: Financial data will be suppressed for prior quarters.

•
•
•

New: Displays drug products with a first marketing date in the same reporting period.
Off Cycle: Displays drug products added on or after the first day of the submission
window of the current quarter.
Expired: Displays drug products that have an expired date of final lot sold. A drug
product that expired in an earlier quarter will continue to show in subsequent quarters.

Follow these steps to navigate the Compliance Summary section:
1.

From the Medicare Part B Average Sales Price homepage, click the Compliance
Summary tab.
The Compliance Summary page opens. The page displays the status for each
submitted drug product regarding the drug manufacturer’s compliance for the selected
reporting period. The page automatically defaults to the Missing tab. Refer to Figure 13.
Note: Figure 13 shows an alert message under Reporting Period stating that there are
drug products in need of attention.

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Figure 13: Compliance Summary

Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Use the drop-down to navigate a previous quarter starting with the most recent,
or the next quarter.

3.2.1

Missing

Follow these steps to review your data in the Missing tab of the Compliance Summary:
1.

Under Drug Identifiers waiting for data entry, review and identify the missing fields or
incorrect financial information to address with the Submitter.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price fields.
Note: Click the Export to Excel button to download all products under the Missing tab.

2.
3.

3.2.2

Inform the Submitter of any missing financial information or incorrect data to ensure the
accuracy of data collected in the Module.
Click the Pending tab to move on to the next page.

Pending

Follow these steps to review the Pending tab of the Compliance Summary:
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1.

From the default Compliance Summary page, click the Pending tab.
The Pending page displays. Refer to Figure 14.

Figure 14: Compliance Summary - All Pending Certification

The Module automatically selects the All Pending Certification radio button, and the
page displays the drug identifiers waiting for certification/restatement certification.
Note: Click the Export to Excel button to download all products under the Pending tab.
2.

Review the drug information under Drug Identifiers Waiting for
Certification/Restatement Certification.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, Average Wholesale Price, and Action fields.

3.
4.

Under Action, click the Go to Certification hyperlink to navigate to Drug Certification.
(Refer to Section 3.4 - Drug Certification.)
Click the Pending Certification radio button to filter only for drugs pending certification.
Refer to Figure 15.

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Figure 15: Compliance Summary - Pending Certification

Note: Click the Export to Excel box to download all products under the Pending tab.
5.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, Average Wholesale Price, and Action fields.

6.
7.
8.

Click the Pending Restatement Certification radio button to filter only for drugs that
are pending restatement certification. Refer to Figure 15.
Under Action, click the Go to Certification hyperlink to navigate to Drug Certification.
(Refer to Section 3.4 - Drug Certification.)
Click the Pending Certification radio button to filter only for drugs pending certification.
Refer to Figure 16.

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Figure 16: Compliance Summary - Pending Restatement Certification

Note: Click the Export to Excel box to download all products under the Pending tab.
9.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, Average Wholesale Price, and Action fields.

10. Under Action, click the Go to Certification hyperlink to navigate to Drug Certification.
(Refer to Section 3.4 - Drug Certification.)
11. Click the Certified tab to move on to the next page.

3.2.3

Certified

Follow these steps to review your data in the Certified tab of the Compliance Summary:
12. From the default Compliance Summary page, click the Certified tab.
The Certified page displays. Refer to Figure 17.

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Figure 17: Compliance Summary - Certified

The Module automatically selects the All Certified radio button, and the page displays
the certified/restated drug identifiers.
Note: Click the Export to Excel button to download all products under the Certified tab.
13. Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price.
3.

Click the Certified radio button to filter only for certified drugs. Refer to Figure 18.

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Figure 18: Compliance Summary - Certified

Note: Click the Export to Excel button to download all products under the Certified tab.
4.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price.

5.

Click the Restated and Certified radio button to filter only for and certified drugs. Refer
to Figure 19.

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Figure 19: Compliance Summary - Restated and Certified

Note: Click the Export to Excel button to download all products under the Certified tab.
6.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price.

7.

3.2.4

Click the New tab to move on to the next page.

New

Follow these steps to review data in the New tab of the Compliance Summary:
1.

From the default Compliance Summary page, click the New tab.
The New page displays. Refer to Figure 20.

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Figure 20: Compliance Summary - New

Note: Click the Export to Excel button to download all products under the New tab.
2.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price.

3.

3.2.5

Click the Off Cycle tab to move on to the next page.

Off Cycle

Follow these steps to review data in the Off Cycle tab of the Compliance Summary:
1.

From the default Compliance Summary page, click the Off Cycle tab.
The Off Cycle page displays. Refer to Figure 21.

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Figure 21: Compliance Summary - Off Cycle

Note: Click the Export to Excel button to download all products under the Off Cycle
tab.
2.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Wholesale Acquisition Cost, and Average Wholesale
Price.

3.

3.2.6

Click the Expired tab to move on to the next page.

Expired

Follow these steps to review data in the Expired tab of the Compliance Summary:
1.

From the default Compliance Summary page, click the Expired tab.
The Expired page displays. Refer to Figure 22.

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Figure 22: Compliance Summary - Expired

Note: Click the Export to Excel button to download all products under the Expired tab.
2.

Review the submitted drug information.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes First Marketing Date and Expiration Date of Final Lost Sold.

3.3 Assumptions
Drug manufacturers can submit comments regarding their certifications to CMS. Manufacturers
may submit these comments for either the current or prior reporting periods.
Follow these steps to submit certification assumptions to CMS:
1.

From the Medicare Part B Average Sales Price homepage, click the Assumptions
tab.
The Assumptions page opens and defaults to the current quarter and year. Refer to
Figure 23.

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Figure 23: Assumptions

Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Use the drop-down menu to navigate a previous quarter starting with the most
recent, or the next quarter.
Note: Click the Export to Excel box to download all products under the Assumptions
tab.

3.3.1

Create Assumption

Follow these steps to create an assumption:
1.

Click the Create Assumption or Upload Assumption File button.
The Create Assumption or Upload Assumption File window displays. The Module
automatically defaults to the Create Assumption radio button with a Manufacturer
Name (required) drop-down menu and empty Short Description and Text for
Assumption file fields. Refer to Figure 24.

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Figure 24: Assumptions - Create Assumption or Upload Assumption File

2.
3.

From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
Complete the Short Description and Text for Assumption file fields.
Note: The Short Description field is optional and allows for 500 characters of text to
provide a summary of the complete assumption you are submitting to CMS. The Text
for Assumption file field is required and allows for 5000 characters to provide as much
detail as possible related to the selected period’s financial submission.

4.

Click the Save button.
A message displays confirming you have successfully created your Assumption. Refer
to Figure 25.

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Figure 25: New Assumption Successfully Created

3.3.2

Upload Assumption File

Follow these steps to upload an assumption file to the Module:
1.

Click the Create Assumption or Upload Assumption File tab.
The Create Assumption or Upload Assumption File window displays. The Module
automatically defaults to the Create Assumption radio button.

2.

Select the Upload Assumption File radio button.

A Manufacturer Name (required) drop-down menu and empty File Description field display.
Refer to Figure 26.

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Figure 26: Upload Assumption File

3.

From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
As you select your manufacturer name, new fields display on the screen. Refer to Figure
27.

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Figure 27: Upload Assumption File - Expanded Fields

4.

In the File Description field, enter your assumption about a data submission. You have
500 characters of total text to comment about your submission in this section.
Note: Click the Show More tab to display all Supported File Formats available in the
Module for you to use in your Assumption File upload.

5.

Click Select File to browse your desktop and upload your Assumption File to the
Module. You may also drag your Assumption File into the Select File box. Refer to
Figure 28.

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Figure 28: Upload Assumption File - Uploading Files from Desktop

A download bar displays as your file uploads. A message opens to confirm you have
successfully uploaded your assumption file. Refer to Figure 29.

Figure 29: Upload Assumption File - Successfully Added

3.4 Drug Certification
Drug certification is the process in which a drug manufacturer certifies the accuracy of submitted
drug data. This process marks data for immediate certification or pending certification to be
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completed later. Selection may include one drug product item, a list of drugs, or all items
pending certification for a manufacturer.
The Submitter gathers the required quarterly drug data and submits it to the Module. Once the
Submitter has successfully submitted the data, they will notify the Certifier to log in to the
system to review and certify their submission.
Follow these steps to certify drug product data:
1.

From the Medicare Part B Average Sales Price homepage, select Drug Certification
tab from the Certification tab. Refer to Figure 30.

Figure 30: Certification - Drop-down

The Drug Certification page opens. Refer to Figure 31.

Figure 31: Drug Certification

Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Use the drop-down menu to navigate a previous quarter starting with the most
recent, or the next quarter.
2.

Click the -Select- box under Manufacturer Name (required) to expand the list. Refer to
Figure 32.

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Figure 32: Drug Certification - Manufacturer Name

3.

Select the appropriate manufacturer name.
The page displays two new radio buttons asking you to confirm if you are certifying as a
direct employee or contractor. Refer to Figure 33.

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Figure 33: Drug Certification - Direct Employee or Contractor

Note: In the updated ASP Data Collection System, CMS requests verification of your
contact information prior to certifying data.
The following sections describe how to complete the drug certification process as a direct
employee or contractor.

3.4.1

Direct Employee

Follow these steps to complete the drug certification process as a direct employee:
1.

Click the Direct Employee radio button.
New fields display asking for more information about the manufacturer’s address and
contact information.

2.

3.

Enter or select the required information as follows:
Enter the street address in the Street Address (required) field.
Enter the street address in the Street Address Line 2 (optional) field, if necessary.
Enter the city in the City (required) field.
Enter the state in the State (required) field.
Enter the ZIP code in the ZIP Code (required) field.
Enter the name in the Name (required) field.
Enter the email address in the Email Address (required) field.
Enter the phone number in the Phone Number (required) field.
Click the Edit button under Manufacturer’s Address and Certifier’s Contact Info if
you need to correct information already populated in a field. Refer to Figure 34.

a.
b.
c.
d.
e.
f.
g.
h.

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Figure 34: Drug Certification - Direct Employee - Fields Populated

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4.

Once you complete the fields, select the I confirm the accuracy of the information
provided above checkbox; click Confirm and Save.
A message displays confirming you have successfully confirmed the manufacturer’s
address and certifier’s email address. Refer to Figure 35.

Figure 35: Drug Certification - Direct Employee Confirmation

3.4.2

Contractor

Follow these steps to complete the drug certification process as a contractor:
1.

Click the Contractor radio button.
New fields display asking for more information about the manufacturer’s address, your
manufacturer’s point of contact (POC), and your contact information.

2.

Enter or select the required information as follows:
Enter the street address in the Street Address (required) field.
Enter the street address in the Street Address Line 2 (optional) field, if necessary.
Enter the city in the City (required) field.
Enter the state in the State (required) field.
Enter the ZIP code in the ZIP Code (required) field.
Enter the point of contact name in the Point of Contact’s Name (required) field.
Enter the point of contact email address in the Point of Contact’s Email Address
(required) field.
h. Enter the point of contact phone number in the Point of Contact’s Phone Number
(required) field.
i. Enter the certifier name in the Certifier’s Name (required) field.
a.
b.
c.
d.
e.
f.
g.

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3.

Enter the certifier email address in the Certifier’s Email Address (required) field.
Enter the certifier phone number in the Certifier’s Phone Number (required) field.
Click the Edit button under Manufacturer’s Address, Point of Contact Info, and
Certifier’s Contact Info if you need to correct information already populated in a field.
Refer to Figure 36.
j.
k.

Figure 36: Drug Certification - Contractor - Fields Populated

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4.

Once you complete the fields, select the I confirm the accuracy of the information
provided above checkbox; click Confirm and Save.
A message displays confirming you have successfully confirmed the manufacturer’s
address and certifier’s email address. Refer to Figure 37.

Figure 37: Drug Certification - Contractor Confirmation

3.4.3

Drug Data Pending Certification

Follow these steps to complete the drug data certification process and certify your products:
1.

Confirm that your preferred drug product is selected under Manufacturer Name
(required) field on the Drug Certification homepage. Refer to Figure 37 and Figure 38.
Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Use the drop-down to navigate a previous quarter starting with the most recent,
or the next quarter.
The Module displays the Drug Data Pending Certification tab by default. (Click the tab
if the Module does not automatically open the page to the default setting.)
This page also lists all drug products by Drug Identifier and Generic Name as well as
Manufacturer’s ASP, Number of ASP Units, Wholesale Acquisition Cost, Average
Wholesale Price, and Action. Refer to Figure 38.

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Figure 38: Drug Data Pending Certification

Note: Click the Export to Excel box to convert all information on this page into an Excel
file.
2.
3.

Click the plus symbol on each row of the table to expand each product’s information and
view additional categories, such as Brand Name, First Marketing Date, Volume per
Item, and all other information the Submitter previously reported. Refer to Figure 38.
Select the drug product and click the Certify box to open a new Data Certification
Statement. Refer to Figure 39.

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Figure 39: Data Certification Statement

4.

Read the statement; select the I agree to the above certification statement checkbox and
select Certify Data to confirm approval of the submitted data.
A message displays confirming you have successfully certified the drug data. Refer to
Figure 40.

Figure 40: Data Certification - Confirmation Message
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Note: Click the Export to Excel box to convert all information on this page into an Excel
file.
5.

3.4.4

Continue this process for each individual drug product until all your products have been
certified. Click Certify All to certify all products at the same time.

All Drugs in Period

Follow these steps to review all drug products and biologicals for the current reporting period:
1.

From the Drug Certification homepage, click the All Drugs in Period tab.
The All Drugs in Period page opens. Refer to Figure 41.

Figure 41: Drug Certification - All Drugs in Period

This page lists all drug products the Submitter entered for the current reporting period.
The Module organizes the full list by Drug Identifier and Generic Name, the
Manufacturer’s ASP, the Number of ASP Units, the Wholesale Acquisition Cost,
the Average Wholesale Price, and Status.
Note: Click the Export to Excel box to convert all information on this page into an Excel
file.
2.
3.
4.

Click the plus symbol on each row of the table to expand each product’s information and
view additional categories, such as Brand Name, First Marketing Date, Volume per
Item, and all other information the Submitter previously reported.
Review the information for accuracy.
Return to the Compliance Summary tab to review your certified products after they
have undergone drug certification. Refer to Section 3.2.3 - Certified.

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4.

Technical Support Contact Information

Contact the FFSDCS (ASP) Application Helpdesk for issues such as:
•
•
•
•

Account unlock
Password reset
Registration process questions
System availability escalations

Table 1 provides contact information for technical support.
Table 1: Technical Support Contacts
Email Address
[email protected]

Phone
Number
1-844-8760765

Hours
9:00 a.m. to 6:00 p.m. Eastern Standard Time (EST),
Monday through Friday

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Appendix A: Revision History
Table 2 provides a revision history for this document.
Table 2: Revision History
Version Number
0.1

Date

Author/Editor

01/22/2024

Index
Analytics

Description of Change
DTS-ASP-Certifier-UserGuide
• Initial draft following collaboration between
DCCA and Index Analytics and incorporation of
feedback from CMS
• Various font, grammatical, punctuation,
shading, formatting, date, version, pagination,
glossary, and alignment corrections

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Appendix B: Glossary
Table 3 a list of terms, acronyms, and definitions in this document.
Table 3: Glossary
Expanded Form

Acronym/Term

Definition

Average Sales
Price

ASP

ASP refers to the price at which an organization typically sells
a certain class of good or service. CMS uses manufacturerreported ASPs, based on manufacturers’ actual quarterly drug
sales, to calculate provider payment amounts for these drugs.
Federal law defines the price.

Center for
Medicare
Management

CMM

The CMM oversees the fee-for-service Medicare program.

Centers for
Medicare &
Medicaid Services

CMS

CMS is a federal agency within the U.S. Department of Health
and Human Services that administers the Medicare program
and works in partnership with state governments to administer
Medicaid, the State Children’s Health Insurance Program, and
health insurance portability standards.

Eastern Standard
Time

EST

EST is the standard time in the 5th time zone west of
Greenwich, reckoned at the 75th meridian. This time zone is in
the eastern part of the United States.

Fee-for-Service
Data Collection
System

FFSDCS

The FFSDCS is an instrument to collect cost, revenue,
utilization, and other information for FFS claims.

Interactive Voice
Response

IVR

IVR is a technology that allows a computer to detect voice and
DTMF keypad inputs.

Medicare

NA

Medicare is the federal system of health insurance for people
over 65 years of age and for certain younger people with
disabilities.

Medicare Part B

NA

Medicare Part B is the part of Medicare that covers doctor
services, outpatient hospital care, and other medical services
that Part A does not cover such as physical and occupational
therapy, X-rays, medical equipment, or limited ambulance
service.

Multifactor
Authentication

MFA

MFA is a security system that implements more than one form
of authentication to verify the legitimacy of a transaction.

Okta

NA

Okta is an enterprise-grade, identity management service, built
for the cloud, but compatible with many on-premises
applications.

One-Time
Password

OTP

An OTP is a password that is valid for only one login session
or transaction.

Point of Contact

POC

The POC identifies the contact information (i.e., name,
organization, title, e-mail, and office number) for each key
person working on a given project.

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Expanded Form

Acronym/Term

Definition

Short Message
Service

SMS

SMS is a text messaging service component of phone, web, or
mobile communication systems. It uses standardized
communication protocols to allow fixed-line or mobile phone
devices to exchange short text messages.

Social Security Act

SSA

The SSA is a law that provides income to retired workers aged
65 or older.

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Appendix C: Figures and Tables
List of Figures
Figure 1: Logging in Using MFA - ASP Module Login..................................................................4
Figure 2: Logging in Using MFA - Select MFA Device Type Drop-Down .....................................5
Figure 3: Logging in Using MFA - Multi-Factor Authentication - (IVR) Example ...........................6
Figure 4: Logging in Using MFA - Multi-Factor Authentication - Verify MFA Code .......................7
Figure 5: My Portal Landing Page ...............................................................................................8
Figure 6: My Portal Landing Page - FFSDCS Drop-down ...........................................................8
Figure 7: ASP Data for Drugs and Biologics Under Medicare Part B ...........................................9
Figure 8: Medicare Part B Average Sales Price Homepage ......................................................10
Figure 9: OTP Verification .........................................................................................................11
Figure 10: OTP Verification - Manufacturer Name.....................................................................12
Figure 11: OTP Verification - OTP Provided by Your Data Submitter ........................................ 12
Figure 12: OTP Verification Successful .....................................................................................13
Figure 13: Compliance Summary ..............................................................................................14
Figure 14: Compliance Summary - All Pending Certification .....................................................15
Figure 15: Compliance Summary - Pending Certification ..........................................................16
Figure 16: Compliance Summary - Pending Restatement Certification ..................................... 17
Figure 17: Compliance Summary - Certified..............................................................................18
Figure 18: Compliance Summary - Certified..............................................................................19
Figure 19: Compliance Summary - Restated and Certified ........................................................20
Figure 20: Compliance Summary - New ....................................................................................21
Figure 21: Compliance Summary - Off Cycle ............................................................................22
Figure 22: Compliance Summary - Expired ...............................................................................23
Figure 23: Assumptions ............................................................................................................24
Figure 24: Assumptions - Create Assumption or Upload Assumption File ................................. 25
Figure 25: New Assumption Successfully Created ....................................................................26
Figure 26: Upload Assumption File ...........................................................................................27
Figure 27: Upload Assumption File - Expanded Fields ..............................................................28
Figure 28: Upload Assumption File - Uploading Files from Desktop .......................................... 29
Figure 29: Upload Assumption File - Successfully Added .........................................................29
Figure 30: Certification - Drop-down..........................................................................................30
Figure 31: Drug Certification .....................................................................................................30
Figure 32: Drug Certification - Manufacturer Name ...................................................................31
Figure 33: Drug Certification - Direct Employee or Contractor ...................................................32
Figure 34: Drug Certification - Direct Employee - Fields Populated ........................................... 33
Figure 35: Drug Certification - Direct Employee Confirmation ...................................................34
Figure 36: Drug Certification - Contractor - Fields Populated ....................................................35
Figure 37: Drug Certification - Contractor Confirmation .............................................................36
Figure 38: Drug Data Pending Certification ...............................................................................37
Figure 39: Data Certification Statement ....................................................................................38
Figure 40: Data Certification - Confirmation Message ...............................................................38
Figure 41: Drug Certification - All Drugs in Period .....................................................................39

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List of Tables
Table 1: Technical Support Contacts ........................................................................................40
Table 2: Revision History ..........................................................................................................41
Table 3: Glossary ......................................................................................................................42

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