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pdfMedicare Part B Average Sales Price
(ASP) Module
Certifier User Guide
Version 2.1
Date: August 29, 2025
CMS Proprietary
ASP Module Certifier User Guide
Table of Contents
1. Purpose................................................................................................................................. 1
2. Logging in Using MFA ........................................................................................................... 2
3. ASP Homepage Menu Tabs .................................................................................................. 9
3.1
3.2
3.3
3.4
3.5
One Time Password (OTP) Verification ....................................................................... 9
Compliance Summary ............................................................................................... 11
3.2.1
Missing...........................................................................................................12
3.2.2
Pending..........................................................................................................12
3.2.3
Certified .........................................................................................................15
3.2.4
New ...............................................................................................................18
3.2.5
Off Cycle ........................................................................................................19
3.2.6
Expired...........................................................................................................20
Assumptions .............................................................................................................. 21
3.3.1
Reasonable Assumptions...............................................................................21
3.3.2
Other Assumptions (Optional) ........................................................................25
Bona Fide Service Fee Certification........................................................................... 28
Drug Certification ....................................................................................................... 29
3.5.1
Direct Employee .............................................................................................32
3.5.2
Contractor ......................................................................................................34
3.5.3
Drug Data Pending Certification .....................................................................36
3.5.4
All Drugs in Period .........................................................................................39
4. Technical Support Contact Information................................................................................ 41
Appendix A: Field Definitions .................................................................................................... 42
Appendix B: Revision History .................................................................................................... 46
Appendix C: Glossary ............................................................................................................... 47
Appendix D: Figures and Tables ............................................................................................... 49
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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-Service
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
Resource Library on the Education and Outreach page to view 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 which is prior
to the reporting period selected. 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.
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Note: Figure 13 shows an alert message under Reporting Period stating that there are
drug products in need of attention.
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 to 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 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 to ensure the inclusion of all
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:
1.
From the default Compliance Summary page, click the Pending tab.
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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 3.5 - 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.
Under Action, click the Go to Certification hyperlink to navigate to Drug Certification.
(Refer to Section 3.5 - Drug Certification.)
Click the Pending Restatement Certification radio button to filter only for drugs that
are pending restatement certification. Refer to Figure 16.
Under Action, click the Go to Certification hyperlink to navigate to Drug Certification.
(Refer to Section 3.5 - Drug Certification.)
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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 3.5 - 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:
1.
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.
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.
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 certified drugs that were
restated. 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 via the
Assumptions tab. Each quarter, manufacturers will submit these comments for the current
reporting period, or they may submit assumptions for any previous quarters they are restating
and resubmitting.
3.3.1
Reasonable Assumptions
Follow these steps to create an assumption:
Note: Certifiers cannot finalize the certification process until the Reasonable
Assumptions Form is complete. If a drug manufacturer does not have additional
information for the required response fields, enter NA.
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. Select the
appropriate reporting period before clicking the Reasonable Assumptions (Required)
tab. 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.
2.
Click the Reasonable Assumptions Form button.
The Reasonable Assumption Form window displays. The Module automatically
defaults to the Reporting Period selected on the Assumptions default page with a
Manufacturer Name (required) drop-down menu and empty required response fields.
Refer to Figure 24.
Figure 24: Reasonable Assumptions Form
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3.
4.
From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
Click View All to view all the required response fields. Refer to Figure 25.
The following response fields display:
•
•
•
•
•
•
•
•
•
•
•
•
Bona Fide Service Fees
Bundled Sales
Price Concessions and Discounts
Reporting of Products with Zero, Negative, or False Positive ASPs
Sales Excluded from Best Price
Sales to U.S. Territories
Time Value of Money
Free Goods Not Contingent on a Purchase Requirement
Value-Based Purchasing Agreements
Sales to 340B Covered Entities
Returned Goods
Billing Corrections
Figure 25: View All Required Response Fields
Note: For drug manufacturers with contractual agreements, enter comments in the
Reasonable Assumptions Form and complete the Bona Fide Service Fee
Certification. Refer to Section 3.4 - Bona Fide Service Fee Certification for instructions.
5.
Complete all the required fields. Enter NA if reasonable assumptions are not available
for a particular field.
Note: Each required field allows for 1,000 characters of text to provide a summary of the
assumption. If a response exceeds the character limit, submit or upload the additional
verbiage on the Other Assumptions tab. Refer to Section 3.3.2 - Other Assumptions
(Optional) for instructions.
6.
Click the Save Form button located at the bottom of the form. Refer to Figure 26.
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Figure 26: Save Reasonable Assumptions Form
A message displays confirming you have successfully created your Reasonable
Assumptions. The Module lists saved forms under Added Forms. Refer to Figure 27.
Figure 27: New Assumption Successfully Saved
7.
8.
To make any necessary revisions before submitting, click the Edit button.
If the submission does not require additional revisions, click the Submit button.
A message displays confirming you have successfully submitted your Reasonable
Assumptions. Refer to Figure 28.
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Figure 28: Reasonable Assumptions Successfully Submitted
3.3.2
Other Assumptions (Optional)
This section provides instructions on how drug manufacturers can submit comments regarding
their certifications to CMS via Create Assumptions or Upload Assumptions.
3.3.2.1
Create Assumptions
Follow these steps to submit certification assumptions to CMS:
1.
From the Medicare Part B Average Sales Price homepage, click the Assumptions
tab. The Module automatically defaults to the Reasonable Assumptions (Required)
tab. Click the Other Assumptions (Optional) tab. Refer to Figure 29.
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Figure 29: Create Other Assumptions
Note: Click the Reporting Period (required) tab in the top left to view previous
quarters. Use the drop-down menu to navigate to select the appropriate quarter.
2.
3.
4.
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 (required) fields. Refer to Figure 29.
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 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 1,000 characters to provide as much
detail as possible related to the selected period’s financial submission.
5.
Click the Save Form button.
A message displays confirming you have successfully created your assumption. Refer to
Figure 30.
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Figure 30: Other Assumptions Saved Successfully
3.3.2.2
Upload Assumption File
Follow these steps to upload an assumption file to the Module:
1.
Click the Other Assumptions (Optional) 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 (required)
field display. Refer to Figure 31.
Figure 31: Upload Assumptions
3.
From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
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4.
5.
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.
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. A message
opens to confirm you have successfully uploaded your assumption file. Refer to Figure
32.
Figure 32: Upload Assumption File - Successfully Added
3.4 Bona Fide Service Fee Certification
Follow these steps to submit a Bona Fide Service Fee Certification to CMS:
1.
From the Medicare Part B Average Sales Price homepage, click the Bona Fide
Service Fee Certification tab.
The Bona Fide Service Fee Certification page opens and defaults to the current
quarter and year. Refer to Figure 33.
2.
3.
4.
The Module automatically defaults to the current reporting period. Select the accurate
reporting period before proceeding.
Select the Manufacturer Name in the drop-down menu.
Download and complete the Bona Fide Service Fee Certification Form.
a. Complete Section 1 by entering all drug and manufacturer information associated
with the bona fide service fee:
• Drug Name(s)
• HCPCS code(s)
• Manufacturer name
• Manufacturer address
b. Complete Section 2 recipient of bona fide service fee information:
• Name and title of certifying individual
• Organization or entity name
• Organization or entity address
• Bona fide service
• Bona fide service fee amount (if the fee varies based on certain metrics,
describe the conditions of the fee and how it is determined)
c. Complete the Section 3 Certification Statement:
• I certify that the fee is not passed on in whole or in part to an affiliate, client, or
customer of an entity.
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5.
6.
• Manufacturer Signature
• Fee Recipient Signature
Sign the save the form; upload it to your computer.
Upload the form to the Module. Refer to Figure 33.
Figure 33: Bona Fide Service Fee Certification Submission
3.5 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
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 34.
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Figure 34: Certification - Drop-down
The Drug Certification page opens. Refer to Figure 35.
Figure 35: 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 to a previous quarter starting with the
most recent quarter.
2.
Click the -Select- box under Manufacturer Name (required) to expand the list. Refer to
Figure 36.
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Figure 36: 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 37.
Figure 37: 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.
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3.5.1
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:
a. Enter the street address in the Street Address (required) field.
b. Enter the street address in the Street Address Line 2 (optional) field, if necessary.
c. Enter the city in the City (required) field.
d. Enter the state in the State (required) field.
e. Enter the ZIP code in the ZIP Code (required) field.
f. Enter the name in the Name (required) field.
g. Enter the email address in the Email Address (required) field.
h. 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 38.
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Figure 38: Drug Certification - Direct Employee - Fields Populated
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 39.
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Figure 39: Drug Certification - Direct Employee Confirmation
3.5.2
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:
a. Enter the street address in the Street Address (required) field.
b. Enter the street address in the Street Address Line 2 (optional) field, if necessary.
c. Enter the city in the City (required) field.
d. Enter the state in the State (required) field.
e. Enter the ZIP code in the ZIP Code (required) field.
f. Enter the point of contact name in the Point of Contact’s Name (required) field.
g. 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.
j. Enter the certifier email address in the Certifier’s Email Address (required) field.
k. Enter the certifier phone number in the Certifier’s Phone Number (required) field.
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3.
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 40.
Figure 40: Drug Certification - Contractor - Fields Populated
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 41.
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Figure 41: Drug Certification - Contractor Confirmation
3.5.3
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 41 and Figure 42.
Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Use the drop-down to navigate to a previous quarter starting with the most
recent 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 42.
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Figure 42: Drug Data Pending Certification
Note: Click the Export to Excel box to download the 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 drug product fields, such as Brand Name, First Marketing Date,
Volume per Item, and all other information the Submitter previously reported. Refer to
Figure 42.
Select the drug product and click the Certify box to open a new Data Certification
Statement. Refer to Figure 43.
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Figure 43: 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 44.
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Figure 44: Data Certification - Confirmation Message
Note: Click the Export to Excel box to download the information on this page into an
Excel file.
5.
3.5.4
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 45.
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Figure 45: 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 download the 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 Drug Product data fields, 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: Field Definitions
Table 2 provides an overview of field definitions for this document.
Table 2: Field Definitions
Column/Field Name
Manufacturer Name
Format
Alphanumeric
Allowed/Sample Values
Required/Optional
Maximum of 250
characters
Required
Notes
• When entering product data for the same
Manufacturer more than once, be sure the
spelling matches.
• Special characters (comma, dash, period)
allowed.
NDC1
5-digit
number
e.g., 12345
Required
• First segment of the National Drug Code (NDC)
that identifies the labeler. Products that do not
have an NDC should only use the Alternate ID
column.
• Not required if the product has an Alternate ID.
• Leading zero allowed.
NDC2
NDC3
Alternate ID
4-digit
number
e.g., 1234
2-digit
number
e.g., 12
alphanumeric
maximum of 23
characters
Required
• Not required if the product has an Alternate ID.
• The NDC2 is the sixth through the ninth digits
of the 11-digit NDC that identifies the product.
Required
• Not required if the product has an Alternate ID.
• The NDC3 is the last two digits of the 11-digit
NDC that identify the package size.
Required
• Not required if the product has an NDC. Must
match product ID exactly as listed publicly on the
manufacturer’s website.
• Special characters (colon, dash, period)
allowed.
Alternate ID Website
URL
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e.g.,
http://www.medicare.gov
NA
Must have http:// or https:// prefix.
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
Brand Name
Alphanumeric
Maximum of 250
characters
Optional
Enter strength and package size in their
respective fields unless it is a part of the
registered brand name.
Generic Name
Alphanumeric
Maximum of 250
characters
Required
Refer to valid values in Generic Name.
Volume Per Item
Numeric
NA
Required
For Alternate ID, report the volume amount in one
item. (For instance, enter 10 for 10 ml in one vial,
and enter 1 for powders, sheets, or patches.)
Unit for Volume per
Item
NA
NA
NA
See valid value in Unit of Volume per Item. For
example, for Alternate ID, select EACH for
powders, sheets, or patches.
Number of Items Per
NDC or Alternate ID
Numeric
Maximum of 9 digits and
2 decimal places
Required
• For NDCs: Indicates the number units within
the NDC package (for instance, enter 5 for 5 vials
in a package).
• For Alternate IDs: Indicates the number of units
within the Alternate ID. (for instance, enter 5 for 5
grafts in a package).
Package Type
Alphanumeric
2 characters
Required
Enter SD, MD, or NA. (SD = Single dose, MD =
Multi dose, NA = Not Applicable)
Strength
Numeric
e.g., 300
Required
NA
Unit for Strength
NA
NA
NA
See valid values in Unit for Strength
FDA Application
Number/Registration
Number
Alphanumeric
Maximum of 6 characters
Required
• Enter FDA Application Number for NDCs and
Registration Number for Alternate IDs.
FDA Application
Supplement Number
Alphanumeric
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• Enter Facility Registration Number for Human
Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).
Maximum of 9 characters
Optional
NA
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
Additional FDA
Application Number #1
Alphanumeric
Maximum of 6 characters
Optional
NA
Additional FDA
Application Supplement
Number #1
Alphanumeric
Maximum of 9 characters
Optional
NA
Additional FDA
Application Number #2
Alphanumeric
Maximum of 6 characters
Optional
NA
Additional FDA
Application Supplement
Number #2
Alphanumeric
Maximum of 9 characters
Optional
NA
FDA
Approval/Registration
Date
MM/DD/YYYY
e.g., 01/01/2023
Required
Must be prior to the current submission period
start date.
FDA Approval Type
NA
NA
Required
Refer to valid values in FDA Approval Type.
First Marketing Date
MM/DD/YYYY
e.g., 01/01/2023
Required
• Must be on or after the FDA Approval Date.
• Must be prior to the current submission period
start date. If the date is after the current
submission period start date, it must be submitted
as an off-cycle submission.
• NDC: For drugs marketed under an FDAapproved application (e.g., Abbreviated New
Drug Application (ANDA), Biologics License
Application (BLA), New Drug Application (NDA)),
the earliest date the drug was first marketed
under the application number by any labeler. If a
drug was purchased or otherwise acquired from
another labeler, the First Marketing Date should
be equal to the First Marketing Date of the
original product.
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
First Marketing Date
(continued)
MM/DD/YYYY
e.g., 01/01/2023
Required
• Alternate ID: For products marketed under an
FDA-approved application/registration (e.g.,
510(k), HCT/P, Premarket Approval (PMA)), the
earliest date the product was first marketed under
the application/registration number by any
labeler. If a product was purchased or otherwise
acquired from another labeler, the date should be
equal to the First Marketing Date of the original
product.
Date of First Sale for
this Product
MM/DD/YYYY
e.g., 01/01/2023
Required
• Must be after the First Marketing Date.
• Must be prior to the current submission
reporting period start date unless it is an off-cycle
submission.
• NDC: The date of first sale of individual NDCs.
• Alternate ID: The date of first sale of individual
Alternate IDs.
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Appendix B: Revision History
Table 3 provides a revision history for this document.
Table 3: Revision History
Version
Number
Date
Description of Change
Author/Editor
1.0
03/15/2024
Index
Analytics/DCCA
Initial version of ASP Data Collection System
Certifier User Guide
2.0
08/08/2025
Index
Analytics/DCCA
• Updated Figure 9 and Figure 12 based on
updates to the ASP Data Collection System.
• Made various font, grammatical,
punctuation, shading, formatting, date,
version, pagination, glossary, and alignment
corrections.
2.1
08/29/2025
Index
Analytics/DCCA
• Updated Sections 3.3 and 3.4.
• Made various font, grammatical,
punctuation, shading, formatting, date,
version, pagination, glossary, and alignment
corrections.
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Appendix C: Glossary
Table 4 presents a list of terms, acronyms, and definitions in this document.
Table 4: Glossary
Expanded Form
Acronym/Term
Definition
510(k)
NA
A 510(k) submission is the mechanism through which the
majority of medical devices obtain U.S. marketing clearance.
Such devices include catheters, contact lenses, and
absorbable sutures.
Abbreviated New
Drug Application
ANDA
An ANDA is an application for a U.S. generic drug approval for
an existing licensed medication or approved drug. Authorized
generics do not require ANDAs.
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.
Biologics License
Application
BLA
A BLA is used to request permission to introduce or deliver a
biologic product into interstate commerce.
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.
Consolidated
Appropriations Act,
2021
CAA
The CAA establishes protections for consumers related to
surprise billing and transparency in health care. The No
Surprises Act (NSA) is part of the CAA.
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.
Human Cells,
Tissues, and
Cellular Products
HCT/P
HCT/Ps include human cells or tissue intended for
implantation, transplantation, infusion, or transfer into a
human recipient. The FDA Center for Biologics Evaluation and
Research (CBER) regulates HCT/Ps.
Interactive Voice
Response
IVR
IVR is a technology that allows a computer to detect voice and
DTMF keypad inputs.
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Expanded Form
Acronym/Term
Definition
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.
National Drug
Code
NDC
The NDC is a code set that identifies the vendor
(manufacturer), product, and package size of all drugs and
biologics the FDA recognizes.
New Drug
Application
NDA
An NDA is the vehicle through which drug sponsors formally
propose that the FDA approve a new pharmaceutical drug for
sale and marketing.
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 key person or group serving as the
coordinator on a given project.
Premarket
Approval
PMA
PMA is the FDA process of scientific and regulatory review to
evaluate the safety and effectiveness of Class III medical
devices. Such devices include implants, ventilators, and
pacemakers.
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 D: Figures and Tables
List of Figures
Figure 1: Logging in Using MFA - ASP Module Login.................................................................. 2
Figure 2: Logging in Using MFA - Select MFA Device Type Drop-Down ..................................... 3
Figure 3: Logging in Using MFA - Multi-Factor Authentication - (IVR) Example ........................... 4
Figure 4: Logging in Using MFA - Multi-Factor Authentication - Verify MFA Code ....................... 5
Figure 5: My Portal Landing Page ............................................................................................... 6
Figure 6: My Portal Landing Page - FFSDCS Drop-down ........................................................... 6
Figure 7: ASP Data for Drugs and Biologics Under Medicare Part B ........................................... 7
Figure 8: Medicare Part B Average Sales Price Homepage ........................................................ 8
Figure 9: OTP Verification ........................................................................................................... 9
Figure 10: OTP Verification - Manufacturer Name..................................................................... 10
Figure 11: OTP Verification - OTP Provided by Your Data Submitter ........................................ 10
Figure 12: OTP Verification Successful ..................................................................................... 11
Figure 13: Compliance Summary .............................................................................................. 12
Figure 14: Compliance Summary - All Pending Certification ..................................................... 13
Figure 15: Compliance Summary - Pending Certification .......................................................... 14
Figure 16: Compliance Summary - Pending Restatement Certification ..................................... 15
Figure 17: Compliance Summary - Certified.............................................................................. 16
Figure 18: Compliance Summary - Certified.............................................................................. 17
Figure 19: Compliance Summary - Restated and Certified ........................................................ 18
Figure 20: Compliance Summary - New .................................................................................... 19
Figure 21: Compliance Summary - Off Cycle ............................................................................ 20
Figure 22: Compliance Summary - Expired ............................................................................... 21
Figure 23: Assumptions ............................................................................................................ 22
Figure 24: Reasonable Assumptions Form ............................................................................... 22
Figure 25: View All Required Response Fields.......................................................................... 23
Figure 26: Save Reasonable Assumptions Form ...................................................................... 24
Figure 27: New Assumption Successfully Saved....................................................................... 24
Figure 28: Reasonable Assumptions Successfully Submitted ................................................... 25
Figure 29: Create Other Assumptions ....................................................................................... 26
Figure 30: Other Assumptions Saved Successfully ................................................................... 27
Figure 31: Upload Assumptions ................................................................................................ 27
Figure 32: Upload Assumption File - Successfully Added ......................................................... 28
Figure 33: Bona Fide Service Fee Certification Submission ...................................................... 29
Figure 34: Certification - Drop-down.......................................................................................... 30
Figure 35: Drug Certification ..................................................................................................... 30
Figure 36: Drug Certification - Manufacturer Name ................................................................... 31
Figure 37: Drug Certification - Direct Employee or Contractor ................................................... 31
Figure 38: Drug Certification - Direct Employee - Fields Populated ........................................... 33
Figure 39: Drug Certification - Direct Employee Confirmation ................................................... 34
Figure 40: Drug Certification - Contractor - Fields Populated .................................................... 35
Figure 41: Drug Certification - Contractor Confirmation ............................................................. 36
Figure 42: Drug Data Pending Certification ............................................................................... 37
Figure 43: Data Certification Statement .................................................................................... 38
Figure 44: Data Certification - Confirmation Message ............................................................... 39
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Figure 45: Drug Certification - All Drugs in Period ..................................................................... 40
List of Tables
Table 1: Technical Support Contacts ........................................................................................ 41
Table 2: Field Definitions........................................................................................................... 42
Table 3: Revision History .......................................................................................................... 46
Table 4: Glossary ...................................................................................................................... 47
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| File Type | application/pdf |
| File Title | Medicare Part B Average Sales Price (ASP) Module Certifier User Guide |
| Subject | ASP Module User Guide for Certifiers |
| Author | CMS |
| File Modified | 2025-08-28 |
| File Created | 2025-08-28 |