cms10110.asp_user_guide_end_user_v2_3

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

cms10110.asp_user_guide_end_user_v2_3

OMB: 0938-0921

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0938-0921 can be found here:

2024-05-17 - Revision of a currently approved collection

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Centers for Medicare & Medicaid
Services

CMS eXpedited Life Cycle (XLC)

Medicare Part B Drug Average Sales Price (ASP)
User Manual
Version 2.3
01/12/23

Document Number: DCCA.CMS.ASP User Manual.V2.3
Contract Number: HHSM-500-2014-00445G
Disclosure StatementAccording to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information
unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-XXXX (Expires
XX/XX/XXXX). The time required to complete this information collection is estimated to average [Insert Time (hours or minutes)] per response,
including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information
collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure****
Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports
Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB
control number listed on this form will not be reviewed, forwarded, or retained.

CMS XLC

Table of Contents

Table of Contents
1. Introduction .............................................................................................................. 1
1.1
1.2
1.3
1.4

1.5

What is the Medicare Part B Drug Average Sales Price (ASP) Application?... 1
Purpose of the ASP Application ...................................................................... 1
ASP Business Process ................................................................................... 2
The user creates an output file to share with OIG, so they can complete ASP
comparison studies. Updates with the Average Manufacturer Price (AMP)
provided by OIG are added to the drug pricing file to replace the ASP for
some billing codes. ASP User Roles ............................................................... 3
ASP Reference Materials ................................................................................ 3

2. ASP Application Access ......................................................................................... 3
2.1
2.2

ASP Data Collection Application Access Process ........................................... 4
2.1.1
Obtaining a CMS EIDM Username and Password ............................ 4
2.1.2
Requesting ASP Application Access ............................................... 10
Points of Contact ........................................................................................... 15
2.2.1
Tier 1 Support – FFSDCS (ASP) Application Helpdesk ................... 15
2.2.2
Tier 2 Support – CM Policy Support ................................................ 15
2.2.3
Tier 3 Application/System Support (Data Computer Corporation of
America [DCCA]) ............................................................................. 16
2.2.4
Tier 4 Support .................................................................................. 16

3. ASP Application Home Page ................................................................................ 17
4. Manage NDC1/ALT ID - Submitter ........................................................................ 18
5. Compliance Summary ........................................................................................... 23
5.1
5.2

Submitter ....................................................................................................... 23
Certifier.......................................................................................................... 28

6. Product Data .......................................................................................................... 34
6.1
6.2
6.3
6.4

Add Product Data .......................................................................................... 34
Upload Product Data ..................................................................................... 39
Update Product Data ..................................................................................... 45
View Submitted Drugs ................................................................................... 50

7. Financial Data......................................................................................................... 51
7.1
7.2

Add/Edit Financial Data ................................................................................. 51
Upload Financial Data ................................................................................... 53

8. Generate One Time Password (OTP) - Submitter................................................ 59
9. Verify OTP - Certifier.............................................................................................. 61
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10. Assumptions .......................................................................................................... 62
10.1
10.2

Assumptions - Submitter ............................................................................... 62
Assumptions – Certifier ................................................................................. 65

11. Re-Statements ........................................................................................................ 68
11.1
11.2

Add/Edit Restate Financial Data ................................................................... 68
Upload Re-State Financial Data .................................................................... 70

12. Drug Certification................................................................................................... 77
Appendix A:

Record of Changes ........................................................................ 79

Appendix B:

Acronyms ....................................................................................... 80

Appendix C:

Field Definitions ............................................................................. 82

List of Figures
Figure 2-1: CMS Enterprise Portal Home Page .............................................................. 4
Figure 2-2: Step #1: Choose Your Application Page ....................................................... 4
Figure 2-3: Terms and Conditions Page.......................................................................... 5
Figure 2-4: Step #2: Register Your Information Page ..................................................... 6
Figure 2-5: Step #3: Create User ID, Password & Challenge Questions Page ............... 7
Figure 2-6: Step #3: Create User ID, Password & Challenge Questions Page Populated
................................................................................................................................... 8
Figure 2-7: Registration Summary Page ......................................................................... 9
Figure 2-8: Confirmation Message ................................................................................ 10
Figure 2-9: CMS Enterprise Portal Home Page ............................................................ 10
Figure 2-10: My Portal Page ......................................................................................... 11
Figure 2-11: Access Catalog Page ................................................................................ 11
Figure 2-12: Request New System Access Page .......................................................... 12
Figure 2-13: Identify Verification Page .......................................................................... 12
Figure 2-14: Terms and Conditions Page...................................................................... 13
Figure 2-15: Your Information Page .............................................................................. 13
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Figure 2-16: Multi-Factor Authentication Information..................................................... 14
Figure 2-17: Register Your Phone, Computer, or Email Page....................................... 14
Figure 2-18: Successful MFA Registration Message .................................................... 14
Figure 2-19: Request Acknowledgement Page ............................................................. 15
Figure 3-1: My Portal Home Page ................................................................................. 17
Figure 3-2: ASP Application Home Page – ASP Submitter ........................................... 18
Figure 3-3: ASP Application Home Page – ASP Certifier .............................................. 18
Figure 4-1: Manage NDC1/ALT ID Screen .................................................................... 19
Figure 4-2: Manage NDC/ALT ID - Filter ....................................................................... 19
Figure 4-3: Manage NDC/ALT ID – NDC1 Field Populated........................................... 20
Figure 4-4: Manage NDC/ALT ID – NDC1 Saved Successfully .................................... 20
Figure 4-5: Manage NDC/ALT ID – ALT ID Field Populated ......................................... 21
Figure 4-6: Manage NDC/ALT ID – ALT ID Saved Successfully ................................... 21
Figure 4-7: Manage NDC/ALT ID – Select NDCs/ALT IDs for Assignment ................... 22
Figure 4-8: Manage NDC/ALT ID – NDC1/ALT ID Assigned Successfully .................... 22
Figure 5-1: Compliance Summary Overview Page: Submitter ...................................... 23
Figure 5-2: Manufacturer’s Compliance Summary Report: Submitter ........................... 24
Figure 5-3: Compliance Summary: Submitter - Missing ................................................ 25
Figure 5-4: Compliance Summary: Submitter – Add/Edit Financial Data ...................... 25
Figure 5-5: Compliance Summary: Submitter – Financial Data Saved Successfully ..... 26
Figure 5-6: Compliance Summary: Submitter – Pending Certification .......................... 26
Figure 5-7: Compliance Summary: Submitter – Pending Restatement Certification ..... 27
Figure 5-8: Compliance Summary: Submitter – Total Certification ................................ 27
Figure 5-9: Compliance Summary: Submitter – Total Restatement Certification .......... 28
Figure 5-10: Compliance Summary: Submitter – Total New Drugs ............................... 28
Figure 5-11: Compliance Summary Overview Page: Certifier ....................................... 29
Figure 5-12: Manufacturer’s Compliance Summary Report: Certifier ............................ 29
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Figure 5-13: Compliance Summary: Certifier - Missing ................................................. 30
Figure 5-14: Compliance Summary: Certifier – Pending Certification ........................... 31
Figure 5-15: Compliance Summary: Certifier – Pending Restatement Certification ...... 31
Figure 5-16: Compliance Summary: Certifier – Total Certification ................................ 32
Figure 5-17: Compliance Summary: Certifier – Total Restatement Certification ........... 32
Figure 5-18: Compliance Summary: Certifier – Total New Drugs .................................. 33
Figure 6-1: Add Product Data Screen ........................................................................... 34
Figure 6-2: Add Product Data – Fields Populated ......................................................... 36
Figure 6-3: Add Product Data – Product Submission Saved Successfully .................... 37
Figure 6-4: Add Product Data – Add Fields by Alternate ID .......................................... 39
Figure 6-5: Add Product Data – Product Submission Saved Successfully .................... 39
Figure 6-6: Upload Product Data Screen ...................................................................... 40
Figure 6-7: File Directory Window ................................................................................. 40
Figure 6-8: Upload Product Data Browse Field Populated ............................................ 40
Figure 6-9: Upload Product Data Saved Successfully ................................................... 41
Figure 6-10: Upload Product File .................................................................................. 41
Figure 6-11: Upload Product Data Column Editing Dropdown ...................................... 42
Figure 6-12: Upload Product Data Format Cells Window .............................................. 42
Figure 6-13: Upload Product Data Format Cells Custom Editing Example ................... 43
Figure 6-14: Upload Product Data Format Cells Custom Editing Example ................... 44
Figure 6-15: Upload Product Data Format Cells Date Custom Editing Example ........... 45
Figure 6-16: Update Product Data Screen .................................................................... 46
Figure 6-17: Update Product Data Screen, Update by NDC Tab Fields Populated ...... 46
Figure 6-18: Update Product Data Screen – Update by NDC Saved Successfully ....... 48
Figure 6-19: Update Product Data Screen – Update by Alternate ID Updated
Successfully ............................................................................................................. 49
Figure 6-20: View Submitted Drugs Screen .................................................................. 50
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Figure 7-1: Add/Edit Financial Data Screen .................................................................. 51
Figure 7-2: Add/Edit Financial Data Screen – Fields Populated.................................... 52
Figure 7-3: Add/Edit Financial Data Screen – Financial Data Saved ............................ 53
Figure 7-4: Add/Edit Financial Data Screen – Selected Financial Data ........................ 53
Figure 7-5: Upload Financial Data Screen .................................................................... 54
Figure 7-6: File Directory Window ................................................................................. 54
Figure 7-7: Upload Financial Data Browse Field Populated .......................................... 54
Figure 7-8: Upload Financial Data Saved Successfully ................................................. 55
Figure 7-9: Upload Financial Data File .......................................................................... 55
Figure 7-10: Upload Financial Data Column Editing Dropdown .................................... 56
Figure 7-11: Upload Financial Data Format Cells Number Editing ................................ 56
Figure 7-12: Upload Financial Data Format Cells Number Custom Editing Example .... 57
Figure 7-13: Upload Financial Data Format Cells Number Editing Example ................. 58
Figure 8-1: Generate One Time Password (OTP) Screen............................................. 59
Figure 8-2: Generate OTP – Please select the Manufacturer name*: Field Populated . 59
Figure 8-3: OTP Generated Successfully ...................................................................... 60
Figure 9-1: Verify One Time Password (OTP) Screen .................................................. 61
Figure 9-2: Verify OTP – Enter OTP provided by your data submitter*: Field Populated
................................................................................................................................. 61
Figure 9-3: Verify OTP – OTP Verified Message .......................................................... 61
Figure 10-1: Assumptions Screen - Submitter............................................................... 62
Figure 10-2: Assumptions – For Reporting Period Field Populated .............................. 62
Figure 10-3: Assumptions – Comments Field Populated .............................................. 63
Figure 10-4: Assumptions Saved Successfully ............................................................. 63
Figure 10-5: File Directory Window ............................................................................... 64
Figure 10-6: Assumptions Saved Successfully ............................................................. 64
Figure 10-7: Assumptions Listed ................................................................................... 64
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Figure 10-8: Assumptions Screen - Certifier ................................................................. 65
Figure 10-9: Assumptions – For Reporting Period Field Populated .............................. 65
Figure 10-10: Assumptions – Comments Field Populated ............................................ 65
Figure 10-11: Assumptions Saved Successfully ........................................................... 66
Figure 10-12: File Directory Window ............................................................................. 66
Figure 10-13: Assumptions Saved Successfully ........................................................... 67
Figure 10-14: Assumptions Listed ................................................................................. 67
Figure 11-1: Add/Edit Restate Financial Data Screen ................................................... 68
Figure 11-2: Add/Edit Restate Financial Data – Select Re-Statement Period and Drug
Identifier ................................................................................................................... 68
Figure 11-3: Add/Edit Restate Financial Data – Add/Edit Data ..................................... 69
Figure 11-4: Add/Edit Restate Financial Data – Data Saved Successfully .................... 70
Figure 11-5: Upload Restate Financial Data Screen ..................................................... 70
Figure 11-6: Upload Restate Financial Data Screen – Select Re-Statement Field
Populated ................................................................................................................. 71
Figure 11-7: File Directory Window ............................................................................... 71
Figure 11-8: Upload Restate Financial Data Screen – Browse Field Populated ........... 71
Figure 11-9: Upload Restate Financial Data Screen – Re-Stated Financial Data
Successfully ............................................................................................................. 72
Figure 11-10: Upload Restate Financial Data File ......................................................... 72
Figure 11-11: Upload Restate Financial Data Column Editing Dropdown ..................... 73
Figure 11-12: Upload Restate Financial Data Format Cells Number Editing................. 74
Figure 11-13: Upload Restate Financial Data Format Cells Number Custom Editing
Example ................................................................................................................... 75
Figure 11-14: Upload Restate Financial Data Screen – Re-Stated Financial Data
Successfully ............................................................................................................. 76
Figure 12-1: Drug Certification Screen .......................................................................... 77
Figure 12-2: Selected Drugs to be Certified .................................................................. 77
Figure 12-3: Data Certification Statement ..................................................................... 78
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Figure 12-4: Drug Information Successfully Certified .................................................... 78

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Introduction

1.1

What is the Medicare Part B Drug Average Sales Price (ASP)
Application?

Section 303 (b) and (c) of the Medicare Modernization Act (MMA) of 2003 revised the payment
methodology for the vast majority of Part B covered drugs and biologicals that are not priced on
a cost or prospective payment basis (hereafter referred to as drugs). Per the MMA, beginning
January 01, 2005, the ASP methodology is used to determine the payment limit for these drugs.
Pricing for compounded drugs is performed by the local contractor. Additionally, the ASP
methodology is used to determine the payment limit for certain eligible outlier service drugs and
biologicals under the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), as
well as specified covered outpatient drugs, and drugs and biologicals with pass-through status
under the Outpatient Prospective Payment System (OPPS). In accordance with Section 11101
of the Inflation Reduction Act of 2022, CMS also uses the ASP methodology to establish the
inflation adjusted beneficiary coinsurance and inflationary rebates for certain single source
drugs and biologicals with prices increasing at a rate faster than the rate of inflation. The ASP
methodology is based on quarterly data submitted to the Centers for Medicare and Medicaid
Services (CMS) by drug manufacturers. CMS supplies the Medicare Fee-for-Service (FFS)
claims processing contractors with the drug pricing files for Medicare Part B drugs on a quarterly
basis.
In general, under the ASP methodology, the payment limits are based on the volume-weighted
average of the manufacturers’ ASP. However, in certain instances, the payment limits are based
on the Wholesale Acquisition Cost (WAC). Further, the payment limits for some drugs continue
to be based on the Average Wholesale Price (AWP) methodology. These data (WAC and AWP)
are published in drug pricing compendia, such as Redbook, Medi-span and First Databank. A
Medicare Contractor retrieves the data from drug pricing compendia and provides the pricing
data to CMS on a quarterly basis.
In addition, other considerations impact the ASP methodology. Under certain circumstances, the
ASP-based payment limits for certain drugs may be replaced with a payment limit identified by
the Office of the Inspector General (OIG). If errors in either the ASP data or the payment limit
calculation occur, revised drug pricing files may be implemented. If drug manufacturers do not
report ASP data or do not report timely, the accuracy of the payment limits may be impacted.

1.2

Purpose of the ASP Application

The purpose of the ASP Application is to:

•

Provide users with an Internet-based software application for automating the collection,
editing and processing of drug product pricing data received from drug manufacturers on
a quarterly basis

•

Eliminate data entry errors, data formatting errors, incomplete submitted data and to
greatly reduce the process cycle time and resource time needed to provide the pricing to
contractors through automation of the manually intensive processes

•

Accepts and stores Medicare Part B drug data received from manufacturers

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1.3

Introduction

ASP Business Process

Drug Manufacturers report ASPs by National Drug Codes (NDC), which are 11-digit identifiers
that indicate the manufacturer of the drug, the product dosage form, and package size.
Manufacturers must provide CMS with the ASP and volume of sales for each NDC on a
quarterly basis in one of two methods. Drug product data may be submitted either by uploading
a file or keying data into a predefined data entry screen. In both instances, data are edited and
saved awaiting the manufacturer to certify the accuracy of the data. During the 30-day
submission period after the end of the quarter.
Thirty days after the beginning of each quarter (calendar year), manufacturers are required to
submit pricing of their Medicare Part B (not paid on a cost or perspective payment basis)
qualifying drugs. Once drug manufacturers are registered with the Medicare Part B ASP drug
submission application, they need to choose either to submit their data online or upload the data
via file transfer. A majority of the drugs are injectable drugs furnished by physicians and other
qualified practitioners.
If the drug manufacturer decides to enter their Medicare Part B ASP drug information online,
then they log on to the secure website and enter the required drug information into the online
application. Validations and error messages ensure that the drug manufacturer is entering data
in adherence to the application requirements.
If the drug manufacturer has a large amount of drug data to report to Medicare, they may decide
to submit their Medicare Part B ASP drug information by uploading their data via file transfer. In
this case, the ASP drug data are entered into a formatted file that is in compliance with
Medicare’s specifications and it is uploaded. Along with the submission, the user can submit any
pertinent information to share with CM regarding their drug product data submissions. The user
can view and check their submitted file and resubmit, if necessary. If the file records do not
meet the file transfer validations and edits, then they are rejected, and the drug manufacturer
can resubmit the drug data through file transfer or enter it online. With both submission options,
the drug manufacturer must certify the accuracy of the data at the time of submission in order
for it to be accepted. Regardless, every instance a drug manufacturer submits data they must
submit a drug certification along with their submission and they may submit multiple times within
a submission time period. Once data have been submitted, the drug manufacturer can view all
drug data certified in the current reporting period and view whether current and previous drug
submissions are in compliance with the reporting requirements. With drug data corrections
within the current reporting period, the user can correct the drug data via data entry or upload. If
data needs to be reported after the quarter has ended, the drug manufacturer has the capability
to report restated ASP data via upload or online for any reporting period (greater than or equal
to Quarter 3 2018) to the ASP application at any time.
CM assigns each drug to one or more billing codes and determine the billing units per billing
code. The ASP for each billing code is calculated based on the weighted average of all ASPs
within a billing code. Where a billing code does not exist, users may submit a request for one to
be established.
Either users, through quality review or drug manufacturers, may identify errors in the data. The
drug manufacturer submits any corrected data so that users can re-calculate the ASP for any
affected billing code.
Once the drug manufacturer submits the Reporting Manufacturer data and it is successfully
received by CM/Division of Data Analysis and Market-based Pricing (DDAMBP) they process
and prepare the data accordingly for the ASP calculation. If the ASP Reporting Manufacturer
Data submission falls within the 30-day deadline, then, thereafter, the CM/DDAMBP runs drug

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submission reports. These reports include Impact Analysis Report, Management Reports and
Manufacturer Reports.

1.4

The user creates an output file to share with OIG, so they can complete
ASP comparison studies. Updates with the Average Manufacturer
Price (AMP) provided by OIG are added to the drug pricing file to
replace the ASP for some billing codes. ASP User Roles

The ASP Application is a role-based application. This means that certain application functions
have been linked to specific “user role profiles.” The ASP Application user roles are as follows:

•

Drug Manufacturers: Drug manufacturers can be either Submitters and Certifiers of data

•

CM Personnel: Responsible for the calculation and quality of the Part B drug prices

1.5

ASP Reference Materials

The following additional reference materials are utilized in order to successfully submit and
certify applicable data into the ASP data collection application:
•

EIDM User Guide

•

ASP Data Reporting Templates

•

Contextual Help

Click on EIDM Links for any assistance with using the application and to view applicable videos

ASP Application Access

Users are required to access the CMS Portal at https://portal.cms.gov to begin the registration
and role assignment process.
CMS has established the Enterprise Identity Management (EIDM) system to provide our
Business Partners with a means to apply for, obtain approval, and receive a single User ID they
can use to access one or more CMS applications. The EIDM Authentication System prompts
the user to create a username and password that conforms to the system’s policies; this user ID
and password is not affiliated with the user’s CMS User ID (Enterprise User Administration
[EUA]) and password. After the user successfully creates a username and password, the user
must create security questions and answers. The user must then re-log in with the new
credentials and request the specific Fee-for-Service Data Collection System (FFSDCS) ASP
Submitter or ASP Certifier role as applicable. FFSDCS is a system umbrella that houses various
Fee-for-Schedule modules. ASP is one of the modules under the FFSDCS system.
As part of the role request process the EIDM Authentication System begins the Remote Identity
Proofing (RIPD) process. RIDP is the process of validating sufficient information about the user
(e.g., credit history, personal demographic information, and other indicators) to uniquely identify
an individual. After the user’s identity is verified, the CMS Portal pushes the user’s data to CM to
review the role request and approve it.
The registration process also involves Multi-Factor Authentication (MFA). This allows the user to
authenticate their phone/tablet/PC/laptop, text message Short Message Service (SMS),
Interactive Voice Response (IVR), E-mail, and One-Time Security Code.
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For additional details on EIDM, review the EIDM User Guide.

2.1

ASP Data Collection Application Access Process

ASP users with an existing CMS Portal username and password can skip Section 2.1.1 and
continue on to Section 2.1.2 Requesting ASP Application Access. Users should allot up to 72
hours to receive access to the ASP Portal following the submission of a CMS Portal username
and password and request for access to the ASP application.

2.1.1

Obtaining a CMS EIDM Username and Password

A CMS EIDM username and password are required in order to access the ASP Application.
Perform the following steps in order to receive the required credentials:
1. Access the CMS Portal by entering the following Uniform Resource Locator (URL) in
your browser: https://portal.cms.gov.
The CMS Enterprise Portal Home Page is shown in Figure 2-1.

Figure 2-1: CMS Enterprise Portal Home Page

2. Click on the New User Registration button.
The “Step #1: Choose Your Application” page opens, as shown in Figure 2-2.

Figure 2-2: Step #1: Choose Your Application Page

3. Select “FFSDCS: Fee-For-Service Data Collection System” from the dropdown list.
The “Terms and Conditions” page opens, as shown in Figure 2-3.

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Figure 2-3: Terms and Conditions Page

Note: Read through the Terms and Conditions on the page. The page states that you
consent to monitoring while accessing and using this website. The page also details the
reasons for collecting Personal Identifiable Information (PII), which are that it is only
used to uniquely identify the new user who is registering with the application. The page
provides links to the HHS Rules of Behavior and the CMS Privacy Act Statement.
4. If you agree to the terms and conditions, click the corresponding check box and click on
the Next button.
Note: Users must agree to the terms and conditions to continue the registration process.
The “Step #2: Register Your Information” page opens, as shown in Figure 2-4.

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Figure 2-4: Step #2: Register Your Information Page

5. Enter your personal information in the required fields which are indicated by an asterisk
(the additional fields are optional but may be required for further identity verification) and
click on the Next button.
The “Step 3: Create User ID, Password & Challenge Questions” page displays as shown
in Figure 2-5.

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Figure 2-5: Step #3: Create User ID, Password & Challenge Questions Page

6. Enter your desired User ID in the “User ID” field. The User ID must be a minimum of 6
and a maximum of 74 alphanumeric characters. Allowed special characters are dashes
(-), underscores (_), apostrophes (‘), @ and periods (.).
7. Enter your desired password in the “Password” field. The CMS Portal password must
conform to the following CMS Acceptable Risk Safeguards (ARS) Password Policy:
a. Be changed at least every sixty (60) days;
b. Be a minimum of eight (8) and a maximum of twenty (20) characters;
c. Be changed only once every 24 hours;
d. Contain at least one (1) letter, one (1) number, and (1) special character;
e. Contain at least one (1) uppercase and one (1) lowercase letter;
f.

Not contain your User ID;

g. Be different from your previous six (6) passwords.
h. Not contain commonly used words; and
i.

The following special characters may not be used: ? < > ( ) ‘ “ / \ &

8. Re-enter your desired password in the “Confirm Password” field.
Note: The passwords must match before you can continue.

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9. Select a Security Question from each of the three (3) dropdown lists for which the
answer is known.
10. Enter the answers to the Security Questions in the corresponding “Answer” fields.
The fields populate as shown in Figure 2-6.

Figure 2-6: Step #3: Create User ID, Password & Challenge Questions Page Populated

11. Click on the Next button to complete the registration process.
Note: You may click on the Cancel button to exit out of the registration process. New
information or changes entered will not be saved.
The “Registration Summary” screen displays as shown in Figure 2-7.

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Figure 2-7: Registration Summary Page

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12. Review, your information, make any necessary changes, and click on the Submit User
button to complete the registration process.
A “Confirmation” message displays as shown in Figure 2-8.

Figure 2-8: Confirmation Message

13. Please wait at least 5 minutes before logging on to the CMS Portal with your new EIDM
user ID and password.

2.1.2

Requesting ASP Application Access

Perform the following steps to request access to the ASP Application:
1. Enter the address for the CMS portal
(https://portal.cms.gov/wps/portal/unauthportal/home/) into your web browser and click
on the Enter button.
The CMS Enterprise Portal Home Page is shown in Figure 2-9.

Figure 2-9: CMS Enterprise Portal Home Page

2. Enter your UserID and Password and click on the Login button.
The “My Portal” page displays as shown in Figure 2-10.

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Figure 2-10: My Portal Page

3. Click on Request/Add Apps.
The “Access Catalog” page displays as shown in Figure 2-11.

Figure 2-11: Access Catalog Page

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4. Click on the Request Access button in the “FFSDCS” section.
The “Request New System Access” page displays as shown in Figure 2-12.

Figure 2-12: Request New System Access Page

5. There are two roles that are applicable for ASP quarterly data submission:
a. ASP Submitter (who can only submit data; if you are the Submitter, select the
“ASP End User” role).
b. ASP Certifier (who can only certify data)
If your role is to submit data, click on the “Role” dropdown list and select ASP End User.
If your role is to certify, click on the “Role” dropdown list and select ASP Certifier.
6. If desired, enter any notes to the approver, and click on the Submit button.
The “Identify Verification” page displays as shown in Figure 2-13.

Figure 2-13: Identify Verification Page

7. Review the information and click on the Next button.
The “Terms and Conditions” page displays as shown in Figure 2-14.

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Figure 2-14: Terms and Conditions Page

8. Review the information, click in the box next to “I agree to the terms and conditions,” and
click on the Next button.
The “Your Information” page displays as shown in Figure 2-15.

Figure 2-15: Your Information Page

9. Review your information, complete any additional required fields, and click on the Next
button.
The “Multi-Factor Authentication Information” page displays as shown in Figure 2-16.

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Figure 2-16: Multi-Factor Authentication Information

10. Click on the Next button.
The “Register Your Phone, Computer, or Email” page displays as shown in Figure 2-17.

Figure 2-17: Register Your Phone, Computer, or Email Page

11. Select a device from the “MFA Device Type” dropdown list, enter any required
information requested for the selected device, and click on the Next button.
A message displays that your device has been registered successfully displays, as
shown in Figure 2-18.

Figure 2-18: Successful MFA Registration Message

12. Click on the OK button.
A “Request Acknowledgement” screen displays as shown in Figure 2-19.

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Figure 2-19: Request Acknowledgement Page

13. Click on the OK button.
Note: After role submission, please wait up to 72 hours to receive an e-mail notification.

2.2
2.2.1

Points of Contact
Tier 1 Support – FFSDCS (ASP) Application Helpdesk
•

Email: [email protected]

•

Phone: 844-876-0765
o

•

9AM-9PM Eastern, Peak


Jan 1st – Jan 31st



Apr 1st – Apr 30th



Jul 1st – Jul 31st



Oct 1st - Oct 31st

Tier 1 Issue examples:
o

Account Unlock

Password Reset

Policy Question escalations

2.2.2

9AM-6PM Eastern, Non-Peak

Registration process questions
System Availability escalations
Other

Tier 2 Support – CM Policy Support
•

[email protected]

•

Remedy/Service Now (SNOW) Service Tickets

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ASP Application Access

Tier 3 Application/System Support (Data Computer Corporation of America
[DCCA])
•

2.2.4

Remedy/SNOW Service Tickets

Tier 4 Support
•

Data Center SR Workflow

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ASP Application Home Page

The ASP Application is comprised of numerous pages and pop-up windows to allow drug
manufacturers to add, update, and view data entries (product data, financial data, certifications,
re-statements, and compliance). The ASP Application uses a consistent layout across pages.
The fields displayed on each page differ based on the type of user logged in and the privileges
assigned to the user role for the logged in user. You can enter data into fields in the ASP
Application unless the field displays with a gray background.
After logging into the CMS Enterprise Portal
(https://portal.cms.gov/wps/portal/unauthportal/home/), you will see your My Portal page.
Click on the Fee For Service Data Collection System (FFSDCS) icon to show the selections.
Then click on the first link Average Sale Price (ASP) [Figure 3-1].

Figure 3-1: My Portal Home Page

If the user is new to the application, the user is placed directly into the Home page (for
Submitter [Figure 3-2] or Certifier [Figure 3-3]).

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Manage NDC1/ALT ID - Submitter

Figure 3-2: ASP Application Home Page – ASP Submitter

Figure 3-3: ASP Application Home Page – ASP Certifier

Manage NDC1/ALT ID - Submitter

Before a labeler (Submitter) can begin submitting Product and Financial data for their respective
labeler codes (NDC1/ALT ID), they are required to assign those labeler codes to their unique
user account.
To assign NDC1 or Alternate ID codes, they must first be listed in the “NDC1/ALT ID Listings”
list. If the NDC1 or Alternate ID is not on the list, you must add them to the list. Once on the list,
they can then be assigned. Perform the following steps to manage NDC1s and Alternate IDs.
1. Click on Manage NDC1/ALT ID from the menu on the left side of the screen.
The “Manage NDC1/ALT ID” screen displays with the global list visible, as shown in
Figure 4-1.
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Manage NDC1/ALT ID - Submitter

Figure 4-1: Manage NDC1/ALT ID Screen

2. To search for an NDC1, enter the partial or full NDC1 in the “Search/Filter:” field.
The application filters the entered NDC1, as shown in Figure 4-2.

Figure 4-2: Manage NDC/ALT ID - Filter

3. To add an NDC1 to the global list, click on the “Add New NDC1” radio button and enter
your new NDC1 in the “NDC1:” field.
Note: the NDC1 must be 5 digits.
The “NDC1:” field is populated, as shown in Figure 4-3.

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Manage NDC1/ALT ID - Submitter

Figure 4-3: Manage NDC/ALT ID – NDC1 Field Populated

4. Click on the Add button.
A message displays confirming that the new NDC1 was added successfully and the new
NDC1 is listed at the top of the global list, as shown in Figure 4-4.

Figure 4-4: Manage NDC/ALT ID – NDC1 Saved Successfully

5. To add an Alternate ID to the global list, click on the “Add New ALT ID” radio button and
enter your new Alternate ID in the “ALT ID:” field.
Note: The ALT ID can be up to 23 alphanumeric characters including colon (:) period (.)
and dash (-).
The “ALT ID:” field is populated, as shown in Figure 4-5.

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Figure 4-5: Manage NDC/ALT ID – ALT ID Field Populated

6. Click on the Add button.
A message displays confirming that the new ALT ID was added successfully, and the
new Alternate ID is listed at the top of the global list, as shown in Figure 4-6.

Figure 4-6: Manage NDC/ALT ID – ALT ID Saved Successfully

7. To assign NDC1s and ALT IDs, select one or more items from the “NDC1/ALT ID
Listings” field.
The selected item(s) are highlighted, as shown in Figure 4-7.

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Manage NDC1/ALT ID - Submitter

Figure 4-7: Manage NDC/ALT ID – Select NDCs/ALT IDs for Assignment

8. Click on the Assign>> button.
A message displays stating that the items were successfully assigned. The selected
item(s) appear in the “Assigned NDC1/ALT ID Listings” field, as shown in Figure 4-8.

Figure 4-8: Manage NDC/ALT ID – NDC1/ALT ID Assigned Successfully

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Compliance Summary

5.1

Submitter

The Compliance Summary features allow Drug Manufacturers to view whether their drugs are in
compliance with the drug submission reporting requirements. Drug Manufacturers can access a
compliance summary for all drugs using the Compliance Summary menu tab.
1. From the menu on the left side of the page, click on Compliance Summary.
The “Compliance Summary Overview” page displays with the current reporting period as
the default, as shown in Figure 5-1.
Note: The “Compliance Summary Overview” screen lists the compliance summary for all
manufacturers assigned to a Submitter by default.

Figure 5-1: Compliance Summary Overview Page: Submitter

2. Select the desired reporting period from the “Reporting Period” dropdown list (required),
the desired manufacturer from the “Manufacturer” dropdown list (required), the labeler
code from the dropdown list (optional), and either a full or partial drug identifier
(optional), and click on the View Compliance Overview Detail button to display the
summary report.
The summary results display for the selected manufacturer for the selected reporting
period as shown in Figure 5-2.

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Figure 5-2: Manufacturer’s Compliance Summary Report: Submitter

The Compliance Summary Overview screen displays statements whether or not the
Drug Manufacturer is within compliance for the reporting period. Also listed is the
percentage of drugs assigned to the user that are certified for the selected reporting
period:
•

Missing (go to step 3)

•

Pending Certification (go to Step 6)

•

Pending Restatement Certification (go to Step 8)

•

Total Certification (go to Step 10)

•

Total Restatement Certification (go to Step 12)

•

Total New Drugs (go to Step 14)

3. To view drugs that are not compliant because the financial data for the drug have not
been submitted, click on the Missing panel.
The “Missing” report displays, as shown in Figure 5-3.

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Figure 5-3: Compliance Summary: Submitter - Missing

Drug Manufacturers have the ability to enter financial data by clicking on the “Resolve”
link for the specific drug identifier.
4. Click on the Resolve link.
The “Add/Edit Financial Data” screen displays for the drug identifier selected from the
“Compliance Summary” screen, as shown in Figure 5-4.
Note: If the reporting period selected is not the current reporting period, the “Add/Edit
Restate Financial Data” screen displays.

Figure 5-4: Compliance Summary: Submitter – Add/Edit Financial Data

5. Enter the missing financial data and click on the Save Financial Data button.
A message displays stating that the financial data were saved successfully, as shown in
Figure 5-5. The drug identifier status will now say “SAVED.”

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Figure 5-5: Compliance Summary: Submitter – Financial Data Saved Successfully

6. To view drugs that have saved financial data, but whose certifications are pending, click
on the Pending Certification panel from the “Compliance Summary Overview” screen.
The “Pending Certification” report displays, as shown in Figure 5-6.

Figure 5-6: Compliance Summary: Submitter – Pending Certification

7. Click on the Pending Certification panel to hide the drug information that is pending
certification.
8. To view drugs that have saved financial data that were restated but whose certifications
are pending, click on the Pending Restatement Certification panel from the
“Compliance Summary Overview” page.
The “Pending Restatement Certification” report displays, as shown in Figure 5-7.

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Figure 5-7: Compliance Summary: Submitter – Pending Restatement Certification

9. Click on the Pending Restatement Certification panel to hide the drug information that
is pending restatement certification.
10. To view drugs that have been certified during the selected reporting period, click on the
Total Certification panel from the “Compliance Summary Overview” page.
The “Total Certification” report displays, as shown in Figure 5-8.

Figure 5-8: Compliance Summary: Submitter – Total Certification

11. Click on the Total Certification panel to hide the certified drug information.
12. To view the information for drugs that have been restated and certified, click on the
Total Restatement Certification panel from the “Compliance Summary Overview”
page.
The “Total Restatement Certification” report displays, as shown in Figure 5-9.

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Figure 5-9: Compliance Summary: Submitter – Total Restatement Certification

13. Click on the Total Restatement Certification panel to hide the certified drug information.
14. To view the product and financial information for new drugs that have been certified or
saved, click on the Total New Drugs panel.
The “Total New Drugs” report displays, as shown in Figure 5-10.

Figure 5-10: Compliance Summary: Submitter – Total New Drugs

5.2

Certifier

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Compliance Summary

Note: The “Compliance Summary Overview” screen lists the compliance summary for all
manufacturers assigned as a default, as shown in Figure 5-11.

Figure 5-11: Compliance Summary Overview Page: Certifier

2. Select the desired reporting period from the “Reporting Period” dropdown list (required),
the desired manufacturer from the “Manufacturer” dropdown list (required), the labeler
code from the dropdown list (optional), and either a full or partial drug identifier (optional)
and click on the View Compliance Overview Detail button to display the summary
report.
The summary results display for the selected manufacturer for the selected reporting
period, as shown in Figure 5-12.

Figure 5-12: Manufacturer’s Compliance Summary Report: Certifier

The “Compliance Summary Overview” screen displays statements whether or not the
Drug Manufacturer is within compliance for the reporting period. Also listed is the
percentage of drugs assigned to the user that are certified for the selected reporting
period.
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Drugs that are listed in the panels are:
•

Missing (go to Step 3)

•

Pending Certification (go to Step 6)

•

Pending Restatement Certification (go to Step 8)

•

Total Certification (go to Step 10)

•

Total Restatement Certification (go to Step 12)

•

Total New Drugs (go to Step 13)

3. To view drugs that are not compliant because the financial data for the drug have not
been submitted, click on the Missing panel.
The “Missing” report displays with the status of “PENDING,” as shown in Figure 5-13.

Figure 5-13: Compliance Summary: Certifier - Missing

4. Click on the Missing panel to hide the drug information that needs financial data.
5. To view drugs that have saved financial data but whose certifications are pending, click
on the Pending Certification panel from the “Compliance Summary Overview” screen.
The “Pending Certification” report displays, as shown in Figure 5-14.

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Figure 5-14: Compliance Summary: Certifier – Pending Certification

6. Click on the Pending Certification panel to hide the drug information that is pending
certification.
7. To view drugs that have saved financial data that were restated but whose certifications
are pending, click on the Pending Restatement Certification panel from the
“Compliance Summary Overview” page.
The “Pending Restatement Certification” report displays, as shown in Figure 5-15.

Figure 5-15: Compliance Summary: Certifier – Pending Restatement Certification

8. Click on the Pending Restatement Certification panel to hide the drug information that
is pending restatement certification
9. To view drugs that have been certified during the selected reporting period, click on the
Total Certification panel from the “Compliance Summary Overview” page.
The “Total Certification” report displays, as shown in Figure 5-16.

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Figure 5-16: Compliance Summary: Certifier – Total Certification

10. Click on the Total Certification panel to hide the certified drug information.
11. To view the information for drugs that have been restated and certified, click on the
Total Restatement Certification panel from the “Compliance Summary Overview”
page.
The “Total Restatement Certification” report displays, as shown in Figure 5-17.

Figure 5-17: Compliance Summary: Certifier – Total Restatement Certification

12. Click on the Total Restatement Certification panel to hide the certified drug
information.
13. To view the product and financial information for new drugs that have been certified or
saved, click on the Total New Drugs panel from the “Compliance Summary Overview”
page.

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The “Total New Drugs” report displays, as shown in Figure 5-18.

Figure 5-18: Compliance Summary: Certifier – Total New Drugs

14. Click on the Total New Drugs panel to hide the certified drug information.

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Product Data

Drug manufacturers are required to submit quarterly drug data to the ASP application for ASP
pricing using a file transfer process or through online data entry. Drug data consists of product
data and financial data. The following subsections detail the steps required to submit drug
product data using online data entry and through approved file uploads.

6.1

Add Product Data

Add Product Data allows drug manufacturers the ability to manually submit drug product data
one at a time to CMS. To upload product data for multiple drugs at once from a file, skip to
section 6.2.
1. Click on Product Data from the menu on the left side of the screen, and then click on
Add Product Data.
The “Add Product Data” screen displays, as shown in Figure 6-1.

Figure 6-1: Add Product Data Screen

2. To add fields by NDC, select the “Add by NDC” tab and use the following requirements:
Note: To add fields by Alternate ID, go to step 4.
NDC1: dropdown
Note: if the NDC1 desired is not in the dropdown list, click on Manage
NDC1/ALT ID from the menu on the left side of the screen, and add and
assign your NDC1.
NDC2: numeric
required
4-digit entry

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NDC3: numeric
required
2-digit entry
Manufacturer Name: required
limited to 250 characters
Note: When entering Product Data for the same Manufacturer
more than once, be sure that the spelling is the same each
time for that Manufacturer. If data were entered through
“Upload Product Data,” the spelling must match that as well.
Has Brand Name?: checkbox
optional
Brand Name: field is only displayed if the “Has Brand Name?” box is checked
required if “Has Brand Name?” box is checked
limited to 250 characters
Generic Name: dropdown list
required
New Generic Name: displayed only if selecting “Add New Generic Name” from the
“Generic Name” dropdown list
required
limited to 250 characters
Date of First Sale:

MM/DD/YYYY format
required
cannot occur before the FDA approval date
must occur prior to the “Current Reporting Period” start date

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FDA Application Number/Registration Number: required
alphanumeric
up to 10 characters
can have up to 2 more optional
entries by clicking on the “Add New
Application Numbers” link
FDA Approval Type: required
dropdown list
FDA Application Supplement Number:

alphanumeric
optional
up to 9 characters
can have up to 2 more optional entries by
clicking on the “Add New Application
Numbers” link

The field windows populate with the entered data, as shown in Figure 6-2.

Figure 6-2: Add Product Data – Fields Populated

3. Click on the Save button.
The screen displays the confirmation that the product submission has been successfully
saved, as shown in Figure 6-3.

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Figure 6-3: Add Product Data – Product Submission Saved Successfully

4. To add fields by Alternate ID, select the “Add by Alternate ID” tab, and use the following
requirements:
Alternate ID: required
dropdown
Note: if the Alternate ID you want to use is not in the dropdown list,
you must click on Manage NDC1/ALT ID from the menu on the left
side of the screen, and add and assign the Alternate ID.
Manufacturer Name: required
limited to 250 characters
Note: When entering Product Data for the same Manufacturer
more than once, be sure that the spelling is the same each
time for that Manufacturer. If data were entered through
“Upload Product Data,” the spelling must match that as well.
Has Brand Name?: checkbox
optional
Brand Name:

field is only displayed if the “Has Brand Name?” box is checked
required if “Has Brand Name?” box is checked
limited to 250 characters

Generic Name: dropdown list
required
New Generic Name: only displayed when selecting “Add New Generic Name” from
the “Generic Name” dropdown list
required
limited to 250 characters
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Date of First Sale:

MM/DD/YYYY format
numeric
cannot occur before the FDA approval date
must occur prior to the “Current Reporting Period” start date

alphanumeric
optional
up to 9 characters
can have up to 2 more optional entries by
clicking on the “Add New Application
Numbers” link

The fields populate with the entered data, as shown in Figure 6-4.

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Figure 6-4: Add Product Data – Add Fields by Alternate ID

5. Click on the Save button.
The screen displays the confirmation that the product submission has been successfully
saved, as shown in Figure 6-5.

Figure 6-5: Add Product Data – Product Submission Saved Successfully

6.2

Upload Product Data

ASP provides drug manufacturers the ability to submit Medicare Part B drug data to CMS.
Perform the following steps to upload drug product data using the file transfer process.
1. Click on Product Data from the menu on the left side of the screen, and then click on
Upload Product Data.
The “Upload Product Data” screen displays, as shown in Figure 6-6.

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Figure 6-6: Upload Product Data Screen

2. To upload data, click on the Browse… button.
The file directory opens, as shown in Figure 6-7.

Figure 6-7: File Directory Window

3. Select a file and double-click on it.
The “Browse…” field is populated, as shown in Figure 6-8.

Figure 6-8: Upload Product Data Browse Field Populated

4. Click on the Upload button.
A message displays confirming that the product data were saved successfully, and the
drug data are listed, as shown in Figure 6-9.
Note: ASP offers a “Refresh” button for times when an upload takes longer to process;
the system will notify you to come back later while the status for the upload will say
“Processing.” If you want to know if the upload finished processing, you would click on
the Refresh button and the system will give the current status of the upload. When the
upload is finished, the status will say “Completed.”

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Figure 6-9: Upload Product Data Saved Successfully

Note: Errors will be displayed in the “Status” column detailing what you will have to
change in the Upload File.
Note: If there are errors in uploading the document where leading zeros are removed
from the NDC and date field values, the file will need to be edited and certain columns
reformatted. To do this, open your file and continue with Step 0. To be certain of file
column formatting, click on the “Click here for acceptable file formats” link, or follow the
criteria below.
5. Open the “Upload Product” file, as shown in Figure 6-10.

Figure 6-10: Upload Product File

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6. To reformat a column, right-click on a column header.
The “Column Editing” dropdown displays, as shown in Figure 6-11.

Figure 6-11: Upload Product Data Column Editing Dropdown

7. Select “Format Cells.”
The “Format Cells” window displays, as shown in Figure 6-12.

Figure 6-12: Upload Product Data Format Cells Window

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8. Make the following changes according to the below criteria:
Note: For NDC1, NDC2, and NDC3 columns, select “Number” and then “Custom.”
•

NDC1: Type 5 0s (00000), click on the OK button, and repeat from Step 6 for any
other column changes

•

NDC2: Type 4 0s (0000), click on the OK button, and repeat from Step 6 for any
other column changes

•

NDC3: Type 2 0s (00), click on the OK button, and repeat from Step 6 for any
other column changes

Figure 6-13: Upload Product Data Format Cells Custom Editing Example

Note: For the Number of Items Per NDC column, select “Number” ensure the “Decimal
places” field is set to 2, and then click on the OK button. Repeat from Step 6 for any
other column changes, as shown in Figure 6-14.

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Figure 6-14: Upload Product Data Format Cells Custom Editing Example

Note: For the Expiration Date, Date of First Sale, and FDA Approval Date columns,
select “Date” and then “Custom.”
•

Expiration Date of Final Lot Sold: Type MM/DD/YYYY, click on the OK button,
and repeat from Step 6 for any other column changes

•

Date of First Sale: Type MM/DD/YYYY, click on the OK button, and repeat from
Step 6 for any other column changes

•

FDA Approval Date: Type MM/DD/YYYY, click on the OK button, and repeat
from Step 6 for any other column changes

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Figure 6-15: Upload Product Data Format Cells Date Custom Editing Example

9. Save the file and go back to Step 2.
Note: Be sure that you do NOT change any of the column headers, as that will invalidate
the upload.
Note: Any time that you have to retrieve a file to edit, you will have to perform Steps 0
through 8 again, before you resave the file.

6.3

Update Product Data

Update Product Data allows drug manufacturers the ability to update drug product data to CMS.
1. Click on Product Data from the menu on the left side of the screen, and then click on
Update Product Data.
The “Update Product Data” screen displays with the current reporting period showing, as
shown in Figure 6-16.

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Figure 6-16: Update Product Data Screen

2. To update fields by NDC, select the “Update by NDC” tab.
Note: To update fields by Alternate ID, go to step 6.
3. Select Drug Identifier:

dropdown menu
required

All of the fields automatically populate, as shown in Figure 6-17.

Figure 6-17: Update Product Data Screen, Update by NDC Tab Fields Populated

4. Make any updates using the following criteria.
Has Brand Name?: checkbox
optional
Brand Name: field is only displayed if the “Has Brand Name?” box is checked
required if “Has Brand Name?” box is checked
limited to 250 characters
Generic Name: dropdown list
required

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New Generic Name: displayed only if selecting “Add New Generic Name” from the
“Generic Name” dropdown list
required
limited to 250 characters
Date of First Sale:

MM/DD/YYYY format
required
cannot occur before the FDA approval date
must occur prior to the “Current Reporting Period” start date

Expiration Date of Final Lot Sold: MM/DD/YYYY format
optional
Strength of the Product: required
limited to 500 characters
Volume Per Item: required
limited to 250 characters
Number of Items per NDC: numeric
required
limited to 9 digits and 2 decimal places
FDA Approval Date: required
MM/DD/YYYY format
must be prior to “Current Reporting Period” start date
FDA Application Number/Registration Number: required
alphanumeric
up to 10 characters
can have up to 2 more optional
entries by clicking on the “Add New
Application Numbers” link
FDA Approval Type: required
dropdown list
FDA Application Supplement Number: optional
alphanumeric
up to 9 characters
can have up to 2 more optional entries by
clicking on the “Add New Application
Numbers” link
The fields populate with the entered data.
5. Click on the UPDATE button.
The screen displays the confirmation that the product submission has been saved, as
shown in Figure 6-18.

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Figure 6-18: Update Product Data Screen – Update by NDC Saved Successfully

6. To update fields by Alternate ID, select the “Update by Alternate ID” tab, select an
alternate ID from the dropdown list, and use the following requirements:
Has Brand Name?: checkbox
optional
Brand Name: field is only displayed if “Has Brand Name?” box is checked
required if “Has Brand Name?” box is checked
limited to 250 characters
Generic Name: dropdown list
required
New Generic Name: only displayed when selecting “Add New Generic Name” from
the “Generic Name” dropdown list
required
limited to 250 characters
Date of First Sale: MM/DD/YYYY format
required
cannot occur before the FDA approval date
must occur prior to the “Current Reporting Period” start date
Expiration Date of Final Lot Sold: MM/DD/YYYY format
optional
Strength of the Product: required
limited to 500 characters
Volume Per Item: required
limited to 250 characters

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Number of Items per Alternate ID: numeric
required
up to 9 digits and 2 decimal places
FDA Approval Date: optional
MM/DD/YYYY format
must be prior to “Current Reporting Period” start date
FDA Application Number/Registration Number: optional
alphanumeric
up to 10 characters
can have up to 2 more optional
entries by clicking on the “Add New
Application Numbers” link
FDA Approval Type: optional
dropdown list
FDA Application Supplement Number: optional
alphanumeric
up to 9 characters
can have up to 2 more optional entries by
clicking on the “Add New Application
Numbers” link
The fields populate with the entered data.
7. Click on the UPDATE button.
The screen displays the confirmation that the product submission has been saved, as
shown in Figure 6-19.

Figure 6-19: Update Product Data Screen – Update by Alternate ID Updated Successfully

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6.4

Product Data

View Submitted Drugs

Drug manufacturers have the ability to view drug data that have been submitted during the
current reporting period. Drug manufacturers cannot update or edit drug data using this feature.
Perform the following steps to view submitted drug data:
1. Click on Product Data from the menu on the left side of the screen, and then click on
View Submitted Drugs.
The “View Submitted Drugs” window displays, as shown in Figure 6-20.

Figure 6-20: View Submitted Drugs Screen

This can be used to scroll through the list of drugs displayed on the “View Submitted
Drugs” page in order to view submitted drug data and status. This can also be used to
enter the “Drug Identifier” field and click on the Search button to filter the results to view
a particular drug’s data, using either a full or partial search of the drug identifier.

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Financial Data

Drug manufacturers are required to submit quarterly drug data to the ASP application for ASP
pricing using a file transfer process or through online data entry. Drug data consists of product
data and financial data. The following subsections detail the steps required to submit drug
financial data using online data entry and through approved file uploads

7.1

Add/Edit Financial Data

The ASP application provides the drug manufacturer the ability to submit Medicare Part B drug
financial data to CMS. Perform the following steps to add drug financial data manually using the
online data entry process. To upload financial data for multiple drugs at once from a file, skip to
section 7.2.
1. Click on Financial Data from the menu on the left side of the screen, and then click on
Add/Edit Financial Data.
The “Add/Edit Financial Data” page displays a listing of the drugs, as shown in Figure 71.

Figure 7-1: Add/Edit Financial Data Screen

2. Scroll through the list of drugs displayed on the “Add/Edit Financial Data” page in order
to locate the drug(s) needing financial data added or updated, or enter the drug identifier
in the “Drug Identifier” field, and click on the Search button to filter the results.
3. Enter the Manufacturer’s ASP, Number of ASP Units, Wholesale Acquisition Cost, and
Number of CAP Units Excluded in the respective fields, using the following criteria:
Manufacturer’s ASP: numeric
Must have three decimal places (i.e., XXXXXXXXXX.XXX).
can be a positive number, a negative number, or be equal to
0.000
Number of ASP units:

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must have three decimal places (i.e., XXXXXXXXX.XXX).
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Financial Data

Wholesale Acquisition Cost: numeric
must have three decimal places (i.e.,
XXXXXXXXXX.XXX).
can be a positive number, a negative number, or be
equal to 0.000
Number of Cap Units Excluded: optional
numeric
must have three decimal places (i.e.,
XXXXXXXXX.XXX).
can be a positive number or be equal to 0.000
The fields populate, as shown in Figure 7-2.

Figure 7-2: Add/Edit Financial Data Screen – Fields Populated

4. Click on the Save Financial Data button to add/update the Drug Identifier financial data.
A message displays indicating that the Drug Identifier financial data have been saved to
the ASP application and the status of the drug changes from “PENDING” to “SAVED,” as
shown in Figure 7-3.

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Figure 7-3: Add/Edit Financial Data Screen – Financial Data Saved

5. To view the product data for the Drug Identifier, click on the “Product” link in the “View
Details” tab.
The product data for the selected financial data display, as shown in Figure 7-4.

Figure 7-4: Add/Edit Financial Data Screen – Selected Financial Data

7.2

Upload Financial Data

ASP provides the drug manufacturer the ability to submit Medicare Part B financial data to CMS.
Perform the following steps to upload drug financial data using the file transfer process.
1. Click on Financial Data from the menu on the left side of the screen, and then click on
Upload Financial Data.

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Financial Data

The “Upload Financial Data” screen displays, as shown in Figure 7-5.

Figure 7-5: Upload Financial Data Screen

2. To upload data, click on the Browse… button.
The file directory opens, as shown in Figure 7-6.

Figure 7-6: File Directory Window

3. Select a file and double-click on it.
The “Browse…” field is populated, as shown in Figure 7-7.

Figure 7-7: Upload Financial Data Browse Field Populated

4. Click on the Upload button.
A message displays confirming that the financial data were uploaded successfully, and
the drug financial data are listed, as shown in Figure 7-8.
Note: ASP offers a “Refresh” button for times when an upload takes longer to process;
the system will notify you to come back later while the status for the upload will say
“Processing.” If you want to know if the upload finished processing, you would click on
the Refresh button and the system will give the current status of the upload. When the
upload is finished, the status will say “Completed.”

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Financial Data

Figure 7-8: Upload Financial Data Saved Successfully

Note: Errors will be displayed in the “Status” column detailing what you will have to
change in the Upload File.
Note: If there are errors in uploading the document where leading zeros are removed
from the NDC and date field values, the file will need to be edited and certain columns
reformatted. To do this, open your file and continue with Step 5. To be certain of file
column formatting, click on the “Click here for acceptable file formats” link, or follow the
criteria below.
5. Open the “Upload Financial” file, as shown in Figure 7-9.

Figure 7-9: Upload Financial Data File

6. To reformat a column, right-click on a column header.
The “Column Editing” dropdown displays, as shown in Figure 7-10.

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Figure 7-10: Upload Financial Data Column Editing Dropdown

7. Select “Format Cells.”
The “Format Cells” window displays, as shown in Figure 7-11.

Figure 7-11: Upload Financial Data Format Cells Number Editing

8. Make the following changes in the “Type” field according to the below criteria:
Note: For NDC1, NDC2, and NDC3 columns, select “Number” and then “Custom.”
•

NDC1: Type 5 0s (00000), click on the OK button, and repeat from Step 7 for any
other column changes

•

NDC2: Type 4 0s (0000), click on the OK button, and repeat from Step 7 for any
other column changes

•

NDC3: Type 2 0s (00), click on the OK button, and repeat from Step 7 for any
other column changes

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Figure 7-12: Upload Financial Data Format Cells Number Custom Editing Example

Note: For Manufacturer’s Average Sales Price, Number of ASP Units, Wholesale
Acquisition Cost, and Number of CAP Units Excluded, select “Number.”
•

Manufacturer’s Average Sales Price: Change the number of decimal places to
“3,” click on the OK button, and repeat from Step 7 for any other column changes

•

Number of ASP Units: Change the number of decimal places to “3,” click on the
OK button, and repeat from Step 7 for any other column changes

•

Wholesale Acquisition Cost: Change the number of decimal places to “3,” click
on the OK button, and repeat from Step 7 for any other column changes

•

Number of CAP Units Excluded: Change the number of decimal places to “3,”
click on the OK button, and repeat from Step 7 for any other column changes

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Financial Data

Figure 7-13: Upload Financial Data Format Cells Number Editing Example

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Generate One Time Password (OTP) - Submitter

Once the ASP Submitter successfully enters all the Product and Financial Data for the first time
into the ASP application, the ASP Submitter can generate a One Time Password (OTP) for
each Manufacturer Name. Once the OTP is generated, the ASP Submitter can provide the OTP
to the Certifier. The OTP expires after 7 days of being generated. If the OTP expires, the ASP
Submitter can generate another OTP and once again provide the OTP to the ASP Certifier.
There can only be one active Certifier for a manufacturer. If the Certifier changes, the Submitter
has to share a new OTP with the new Certifier.
1. Click on Generate One Time Password (OTP) from the menu on the left side of the
screen.
The “Generate One Time Password (OTP)” screen displays, as shown in Figure 8-1.

Figure 8-1: Generate One Time Password (OTP) Screen

2. Select a Manufacturer name from the “Please select the Manufacturer Name*:”
dropdown list.
The selected Manufacturer populates in the field, as shown in Figure 8-2.

Figure 8-2: Generate OTP – Please select the Manufacturer name*: Field Populated

3. Click on the Generate One Time Password (OTP) button.
The OTP displays and is available for 7 days, as shown in Figure 8-3.

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Generate One Time Password (OTP) - Submitter

Figure 8-3: OTP Generated Successfully

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Verify OTP - Certifier

Once the ASP Submitter generates and provides an OTP for each Manufacturer Name to the
Certifier, the Certifier must verify the OTP. The one-time password expires after 7 days of being
generated. If the OTP expires, the ASP Submitter can generate another OTP and once again
provide the OTP to the ASP Certifier.
1. Click on Verify One Time Password (OTP) from the menu on the left side of the
screen.
The “Verify One Time Password (OTP)” screen displays, as shown in Figure 9-1.

Figure 9-1: Verify One Time Password (OTP) Screen

2. Enter the OTP in the “Enter OTP provided by your data submitter*” field.
The “Enter OTP provided by your data submitter*” field populates, as shown in Figure 92.

Figure 9-2: Verify OTP – Enter OTP provided by your data submitter*: Field Populated

3. Click on the Verify button.
A message displays that the OTP has been verified and the data for that manufacturer
are ready for certification, as shown in Figure 9-3.

Figure 9-3: Verify OTP – OTP Verified Message

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Assumptions

10. Assumptions
10.1 Assumptions - Submitter
Drug Manufacturers can submit comments regarding their certifications to CMS. These
comments may be submitted for either the current or prior reporting periods. Perform the
following steps to submit certification assumptions to CMS.
1. Begin by clicking on Assumptions button from the menu on the left side of the screen.
The “Assumptions” page displays showing the current report period, as shown in Figure
10-1.

Figure 10-1: Assumptions Screen - Submitter

2. Select the desired reporting period from the “For Reporting Period” dropdown list and
select the desired manufacturer name from the “Manufacturer Name” dropdown list.
The “Assumptions” page is shown with the Manufacturer name populated, as shown in
Figure 10-2.

Figure 10-2: Assumptions – For Reporting Period Field Populated

3. Select the “Enter your assumptions / comments about a submission below” tab and
enter your comment in the text field.
The text field is populated, as shown in Figure 10-3.

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Figure 10-3: Assumptions – Comments Field Populated

4. Click on the Submit button.
A message displays that the assumption has been successfully saved, as shown in
Figure 10-4.

Figure 10-4: Assumptions Saved Successfully

5. To upload an assumption, select a Manufacturer Name, select the “Upload your
assumptions document (.doc,.docx,.txt,.pdf)” tab, and click on the Browse button.
The file directory window opens, as shown in Figure 10-5.

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Figure 10-5: File Directory Window

6. Select the document to upload, and click on the Submit button.
A message displays that the assumption has been successfully saved, as shown in
Figure 10-6.

Figure 10-6: Assumptions Saved Successfully

7. To view assumptions that have been added, select a Manufacturer Name and click on
the “Assumptions” tab.
The added assumptions are listed, as shown in Figure 10-7.

Figure 10-7: Assumptions Listed

The Assumptions can be viewed and opened by clicking the file link in the “File Name”
column.

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Assumptions

10.2 Assumptions – Certifier
Drug Manufacturers can submit comments regarding their certifications to CMS. These
comments may be submitted for either the current or prior reporting periods. Perform the
following steps to submit certification assumptions to CMS.
1. Begin by clicking on Certification from the menu on the left side of the screen, and then
click on Assumptions.
The “Assumptions” page displays showing the current report period, as shown in Figure
10-8.

Figure 10-8: Assumptions Screen - Certifier

Figure 10-9: Assumptions – For Reporting Period Field Populated

3. Select the “Enter your assumptions / comments about a submission below” tab and
enter your comment in the text field.
The text field is populated, as shown in Figure 10-10.

Figure 10-10: Assumptions – Comments Field Populated

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4. Click on the Submit button.
A message displays that the assumption has been successfully saved, as shown in
Figure 10-11.

Figure 10-11: Assumptions Saved Successfully

Figure 10-12: File Directory Window

6. Select the document to upload, and click on the Submit button.
A message displays that the assumption has been successfully saved, as shown in
Figure 10-13.

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Assumptions

Figure 10-13: Assumptions Saved Successfully

7. To view assumptions that have been added select a Manufacturer Name and select the
“Assumptions” tab.
The added assumptions are listed, as shown in Figure 10-14.

Figure 10-14: Assumptions Listed

The Assumptions can be viewed and opened by clicking the file link in the “File Name”
column.

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Re-Statements

11. Re-Statements
11.1 Add/Edit Restate Financial Data
The ASP application provides the drug manufacturers the ability to restate Medicare Part B drug
financial data to CMS. Perform the following steps to restate the drug financial data manually
using the online data entry process.
1. Click on Re-Statements from the menu on the left side of the screen, and then click on
Add/Edit Restate Financial Data.
The “Add/Edit Restate Financial Data” screen displays, as shown in Figure 11-1.

Figure 11-1: Add/Edit Restate Financial Data Screen

2. To add or edit data, select a reporting period from the dropdown menu in the “Select ReStatement Period:” field and select a drug identifier.
The “Select Re-Statement Period:” and “Please select the Drug Identifier*:” fields
populate, as shown in Figure 11-2.

Figure 11-2: Add/Edit Restate Financial Data – Select Re-Statement Period and Drug
Identifier

3. Add or edit the Manufacturer’s ASP, Number of ASP Units, Wholesale Acquisition Cost,
and Number of CAP Units Excluded in the respective fields, using the following criteria:

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Re-Statements

Manufacturer’s ASP: numeric
must have three decimal places (i.e., XXXXXXXXXX.XXX).
can be a positive number, a negative number, or be equal to
0.000
Number of ASP units: numeric
must have three decimal places (i.e., XXXXXXXXX.XXX).
can be a positive number, a negative number, or be equal to
0.000
Wholesale Acquisition Cost: numeric
must have three decimal places (i.e.,
XXXXXXXXXX.XXX).
can be a positive number, a negative number, or be
equal to 0.000
Number of Cap Units Excluded: optional
numeric
must have three decimal places (i.e.,
XXXXXXXXX.XXX).
can be a positive number or be equal to 0.000
The fields populate, as shown in Figure 11-3.

Figure 11-3: Add/Edit Restate Financial Data – Add/Edit Data

4. Click on the Re-State button.
A message displays stating that the financial data have been saved, as shown in Figure
11-4.

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Re-Statements

Figure 11-4: Add/Edit Restate Financial Data – Data Saved Successfully

11.2 Upload Re-State Financial Data
ASP provides drug manufacturers the ability to restate Medicare Part B financial data to CMS.
Perform the following steps to upload financial data using the file transfer process.
1. Click on Re-statements from the menu on the left side of the screen, and then click on
Upload Restate Financial Data.
The “Upload Restate Financial Data” screen displays, as shown in Figure 11-5.

Figure 11-5: Upload Restate Financial Data Screen

2. To upload data, select a reporting period from the dropdown menu in the “Select ReStatement Period:” field.
The “Select Re-Statement Period:” field populates, as shown in Figure 11-6.

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Figure 11-6: Upload Restate Financial Data Screen – Select Re-Statement Field Populated

3. Click on the Browse button.
The file directory opens, as shown in Figure 11-7.

Figure 11-7: File Directory Window

4. Select a file in the appropriate format and double-click on it.
The “Browse” field is populated, as shown in Figure 11-8.

Figure 11-8: Upload Restate Financial Data Screen – Browse Field Populated

5. Click on the Upload button.
A message displays confirming that the financial data were saved successfully, and the
financial data are listed, as shown in Figure 11-9.
Note: ASP offers a “Refresh” button for times when an upload takes longer to process;
the system will notify you to come back later while the status for the upload will say
“Processing.” If you want to know if the upload finished processing, you would click on
the Refresh button and the system will give the current status of the upload. When the
upload is finished, the status will say “Completed.”

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Re-Statements

Figure 11-9: Upload Restate Financial Data Screen – Re-Stated Financial Data Successfully

Note: Errors will be displayed in the “Status” column detailing what you will have to
change in the Upload File.
Note: If there are errors in uploading the document where leading zeros are removed
from the NDC and date field values, the file will need to be edited and certain columns
reformatted. To do this, open your file and continue with Step 6. To be certain of file
column formatting, click on the “Click here for acceptable file formats” link, or follow the
criteria below.
6. Open the “Upload Financial” file, as shown in Figure 11-10.

Figure 11-10: Upload Restate Financial Data File

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Re-Statements

7. To reformat a column, right-click on a column header.
The “Column Editing” dropdown displays, as shown in Figure 11-11.

Figure 11-11: Upload Restate Financial Data Column Editing Dropdown

8. Select “Format Cells.”
The “Format Cells” window displays, as shown in Figure 11-12.

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Figure 11-12: Upload Restate Financial Data Format Cells Number Editing

9. Make the following changes as shown in Figure 11-13 and Figure 11-14, in the “Type”
field according to the below criteria:
Note: For NDC1, NDC2, and NDC3 columns, select “Number” and then “Custom.”
•

NDC1: Type 5 0s (00000), click on the OK button, and repeat from Step 7 for any
other column changes

•

NDC2: Type 4 0s (0000), click on the OK button, and repeat from Step 6 for any
other column changes

•

NDC3: Type 2 0s (00), click on the OK button, and repeat from Step 6 for any
other column changes
Example:

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Re-Statements

Figure 11-13: Upload Restate Financial Data Format Cells Number Custom Editing Example

Note: For Manufacturer’s Average Sales Price, Number of ASP Units, Wholesale
Acquisition Cost, and Number of CAP Units Excluded, select “Number.”
•

Manufacturer’s Average Sales Price: Change the number of decimal places to
“3,” click on the OK button, and repeat from Step 6 for any other column changes

•

Number of ASP Units: Change the number of decimal places to “3,” click on the
OK button, and repeat from Step 6 for any other column changes

•

Wholesale Acquisition Cost: Change the number of decimal places to “3,” click
on the OK button, and repeat from Step 7 for any other column changes

•

Number of CAP Units Excluded: Change the number of decimal places to “3,”
click on the OK button, and repeat from Step 7 for any other column changes

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Re-Statements

Figure 11-14: Upload Restate Financial Data Screen – Re-Stated Financial Data Successfully

10. Save the file and go back to Step 2.
Note: Be sure that you do NOT change any of the column headers, as that will invalidate
the upload.
Note: Any time that you have to retrieve a file to edit, you will have to perform Steps 6
through 8 again, before you resave the file.

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Drug Certification

12. Drug Certification
Drug certification is a process where a drug manufacturer certifies the accuracy of the drug
data. In this section, data are selected and marked for immediate certification or later
certification. Selection may be one drug product item, a list of drug items or all drug items
pending certification for a manufacturer. The Drug Manufacturer gathers required quarterly drug
data and submits it to the ASP application for ASP pricing. The Drug Manufacturer certifies that
the data reported are correct.
With the appropriate user access, the ASP Application provides drug manufacturers the ability
to certify the accuracy of drug data that have been previously submitted. This is for the Certifier
to perform the following steps to certify drug data online.
1. Log into the application, click on Certification from the menu on the left side of the
screen, and then click on Drug Certification.
The “Drug Certification” screen displays, as shown in Figure 12-1.

Figure 12-1: Drug Certification Screen

2. Select a Reporting Period from the dropdown list, a certification status, the manufacturer
name (optional), and the drug identifier (optional), and click on the Submit button.
The status for the drug information displays as “SAVED,” as shown in Figure 12-2.

Figure 12-2: Selected Drugs to be Certified

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Drug Certification

3. Select the drugs to be certified by clicking the “Certify” check box of the individual drugs
and clicking on the Certify Selected Data button, or by clicking on the Certify All Data
button at the bottom of the page. If a drug is checked inadvertently, click on the Reset
All Checked Drugs button to clear the “Certify” check boxes.
A “Data Certification Statement” window displays, as shown in Figure 12-3.

Figure 12-3: Data Certification Statement

4. Review the statement, click on the checkbox next to “I agree to the above certification
statement,” and click on the Proceed to Certify Data button.
A message displays stating that the data have been successfully certified, as shown in
Figure 12-4.

Figure 12-4: Drug Information Successfully Certified

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Record of Changes

Appendix A: Record of Changes
Table A-1: Record of Changes
Version
Number

Date

Author/Owner

Description of Change

1.0

03/23/2018

Maureen Campbell

Initial Release

1.1

04/26/2018

Maureen Campbell

Section 4.1: Add Product Data - Increased the
requirements for “Strength of the Product” from 250
characters to 500 characters; made changes for
requirements for “FDA Application Number,” “FDA
Approval Type,” “FDA Approval Date,” and “Alternate
ID.”

1.1

04/26/2018

Maureen Campbell

Section 4.3: Update Product Data - Increased the
requirements for “Strength of the Product” from 250
characters to 500 characters; made changes for
requirements for “FDA Application Number,” “FDA
Approval Type,” “FDA Approval Date,” and “Alternate
ID.”

1.1

04/26/2018

Maureen Campbell

Section 7.1: Restate Online - Increased the
requirements for “Strength of the Product” from 250
characters to 500 characters; made changes for
requirements for “FDA Application Number,” “FDA
Approval Type,” and “FDA Approval Date.”

2.0

3/28/2019

Maureen Campbell

Globally: Changes to reflect changes in the
application for Release 9

2.1

5/29/2019

Maureen Campbell

Section 5: Compliance Summary – Submitter –
replaced section; Globally: changed FDA Application
Number requirements from 9 digits to 10 digits;
replaced most screenshots to reflect the absence of
reporting period on the screens. Added Note about
the Refresh button when uploading files. Increase
Manufacture ASP and WAC digits increased from 6
to 10. Added Compliance Summary – Certifier and
Assumptions – Certifier sections.

2.2

01/10/2023

Felicia Brown

Section 1 and 2.1: revised language

2.3

01/12/2023

Jenn Palmer

Added Appendix C, updated formatting, Added
Figure 3-1 and corresponding instructions.

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Acronyms

Appendix B: Acronyms
Table B-1: Acronyms
Acronym

Definition

ALT ID

Alternate Identification

AMP

Average Manufacturer Price

ARS

Acceptable Risk Safeguards

ASP

Average Sales Price

AWP

Average Wholesale Price

CAP

Competitive Acquisition Pricing

CHIP

Children’s Health Insurance Program

CLFS

Clinical Laboratory Fee Schedule

Center for Medicare

CMCS

Center for Medicaid and CHIP Services

CMS

Centers for Medicare & Medicaid Services

CSV

Comma-Separated Values

DAS

Division of Ambulatory Services

DCCA

Data Computer Corporation of America

EIDM

Enterprise Identity Management

ESRD

End Stage Renal Disease

EUA

Enterprise User Administration

FDA

Food and Drug Administration

FFS

Fee-for-Service

FFSDCS

Fee-for-Service Data Collection System

HHS

Health and Human Services

IVR

Interactive Voice Response

MFA

Multi-Factor Authentication

MMA

Medicare Modernization Act

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Acronyms

Acronym

Definition

NDC

National Drug Code

OIG

Office of the Inspector General

OPPS

Outpatient Prospective Payment System

OTP

One Time Password

PII

Personally Identifiable Information

RIPD

Remote Identity Proofing

SMS

Short Message Service

SNOW

Service Now

URL

Uniform Resource Locator

WAC

Wholesale Acquisition Cost

XLC

eXpedited Life Cycle

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Field Definitions

Appendix C: Field Definitions
1. Table 1 contains the field definitions for drugs and biologicals reported on
the NDC or CMS-specified unit level.
Most ASP reporting is done at the NDC level where the ASP corresponds to the amount
of drug represented by that NDC. However, for a limited number of products, reporting at
the NDC unit level is not appropriate and must be done at a CMS-specified unit level. A
list of such drug products is maintained on the CMS website at:
http://www.cms.gov/McrPartBDrugAvgSalesPrice/. For these drugs and biologicals,
manufacturers will still submit ASP sales data for an NDC, but will do so on an ASP unit
level specified in this list.

Table C-1: Field Definitions for Drugs and Biologicals
Field Name

Field Definition

Manufacturer's
Name

The reporting manufacturer’s name.

11-Digit National
Drug Code (NDC1)

11-Digit National
Drug Code (NDC2)

The NDC1 is the first 5 digits of the 11 digit National Drug Code that identifies the labeler.
The 11 digit NDC consists of the NDC1, NDC2, and NDC3, which identifies the labeler,
product, and package size.
The NDC2 is the sixth through the ninth digits of the 11 digit National Drug Code that
identifies the product.
The 11 digit NDC consists of the NDC1, NDC2, and NDC3, which identifies the labeler,
product, and package size.
The NDC3 is the last 2 digits of the 11 digit National Drug Code that identifies the package

11-Digit National
Drug Code (NDC3)

size.
The 11 digit NDC consists of the NDC1, NDC2, and NDC3, which identifies the labeler,
product, and package size.

Alternate ID

Numeric or alphanumeric alternate identifier (ex: an NHRIC or UPC number) used when an
11 digit NDC is not available.

Manufacturer's
Average Sales Price

ASP for a corresponding ASP unit rounded to 3 or more decimal places.

Number of ASP
Units

The number of ASP units sold.
The WAC for a corresponding ASP unit in effect on the last day of the reporting period.

Wholesale
Acquisition Cost
(WAC)

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WAC is defined in Section 1847A(c)(6)(B) as “the manufacturer’s list price for the drug or
biological to wholesalers or direct purchasers in the United States, not including prompt
pay or other discounts, rebates or reductions in price, for the most recent month for which
the information is available, as reported in wholesale price guides or other publications of
drug or biological pricing data.” CMS further clarified, in 70 FR 70221, that manufacturers
must report WAC for all single source drugs and biologicals (including new drugs) each
reporting period. Manufacturers must report the WAC in effect on the last day of the
reporting period.

Medicare Part B Drug Average Sales Price (ASP)

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Field Definitions

Field Name

Field Definition

Name of Drug or
Biological

The trade or brand name of the product or the active ingredient name.

Strength of the
Product

The dosage strength of one item (e.g.: 250 mg tablet, 20 mg/ml solution, 1 IU).

Volume Per Item

The amount in one item (ex: 10 ml in one vial, or 500 tablets in one bottle).

Number of Items Per
NDC

The number of items in the 11-digit NDC (ex: if an NDC packaged as a box contains 4
vials, the number of items per NDC is 4).

Expiration Date of
Final Lot Sold

The expiration date of the final lot sold must be reported to CMS once at the end of
utilization of the NDC or when there are no sales for three consecutive quarters. For ASP
purposes, “at the end of utilization” means the manufacturer will not make sales of that
NDC to any purchaser.

Date of First Sale

Report for NDCs first sold on or after 04/01/2006. Report at least once and no later than
with the first ASP report.

Number of CAP
Units Excluded

Beginning with the 3Q2006 reporting period, report the number of whole or fractional units
administered to a beneficiary by a Part B Drug Competitive Acquisition Program
participating physician excluded from the ASP calculation.

FDA Application
Number

The application number assigned by the Food and Drug Administration (FDA).

FDA Application
Supplement Number

The application number assigned by the Food and Drug Administration (FDA).

Additional FDA
Application
Supplement Number
#1
Additional FDA
Application

The application supplement number assigned by the Food and Drug Administration (FDA).

The application number assigned by the Food and Drug Administration (FDA).

Number #2
Additional FDA
Application
Supplement Number
#2

The application supplement number assigned by the Food and Drug Administration (FDA).

FDA Final PreMarketing Approval
Date

This is the original date that the FDA granted approval for the drug (NDA), biological (BLA),
or pre-marketing application (PMA).

FDA Approval Type

The type of FDA approval for the product.

Description of FDA
Approval Type

If Other was specified in the column ‘FDA Approval Type,’ please specify the type.

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Field Definitions

2. Table 2 contains the field definitions for dermal grafting products.
Some dermal grafting products are not assigned an NDC. Instead, manufacturers identify them
using product codes, which can be catalog numbers, Universal Product Codes (UPCs), or other
unique identifiers. If an NDC is not available, the UPC or other unique identifier must be entered
in the field “Alternate ID”. Manufacturers may not convert a UPC or other alternative identifier to
an NDC format by adding zeros or removing numbers. Additionally, where the strength of a
dermal grafting product must be described in units of area, manufacturers must report in units of
square centimeters. Dermal grafting products that are sold in customized or irregularly shaped
sheets must be quantified and reported using square centimeters. Other units of measure such
as “square inches”, “each”, ”sheet”, etc are not acceptable. Dermal grafting products that are
sold in powder, foam, or liquid form must be quantified and reported in metric measures such as
grams, milligrams, or milliliters.

Table C-2: Field Definitions for Dermal Grafting Products
Field Name

Field Definition

Manufacturer's
Name

The reporting manufacturer’s name.

11-Digit National
Drug Code (NDC1)

11-Digit National
Drug Code (NDC2)

11-Digit National
Drug Code (NDC3)

Alternate ID

size.
The 11 digit NDC consists of the NDC1, NDC2, and NDC3, which identifies the labeler,
product, and package size.
Numeric or alphanumeric alternate identifier (ex: an NHRIC number or UPC) used when an
11 digit NDC is not available.
ASP rounded to 3 or more decimal places.

Manufacturer's
Average Sales Price

Report the ASP per package, as identified by the NDC or alternate ID (ex: for an NDC or
Alternate ID that represents a box of five 2 cm x 3cm grafts, report the ASP per box of
five).

Number of ASP
Units

Report the number of packages sold (ex: for an NDC or Alternate ID that represents a box
of five 2 cm x 3cm grafts, report the number of boxes sold).

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Field Name

Field Definitions

Field Definition
The WAC in effect on the last day of the reporting period. Report the WAC per package.

Wholesale
Acquisition Cost
(WAC)

Name of Drug or
Biological

The trade or brand name of the product or the active ingredient name.

Strength of the
Product

For products sold in sheets: the total square centimeters in one item (ex: a 6cm x 8cm item
is 48 sq cm).

Volume Per Item

Use this field for dermal grafting products that are reported in units of volume, for example
liquids. Report the volume amount in one item, include the metric unit of measurement,
such as cc or ml. Enter “1” for powders and sheets.

Number of Items Per
NDC

The number of items in the 11-digit NDC or Alternative ID (ex: for an NDC or Alternate ID
that has 5 grafts in a package, the number of items per NDC is 5).

Expiration Date of
Final Lot Sold

The expiration date of the final lot sold must be reported to CMS once at the end of
utilization of the NDC or Alternate ID when there are no sales for three consecutive
quarters. For ASP purposes, “at the end of utilization” means the manufacturer will not
make sales of that NDC or Alternate ID to any purchaser.

Date of First Sale

Report for NDCs/Alternate IDs first sold on or after 04/01/2006. Report at least once and
no later than with the first ASP report.

Number of CAP
Units Excluded

FDA Application
Number

The application number assigned by the Food and Drug Administration (FDA).

FDA Application
Supplement Number

Additional FDA
Application Number
#1
Additional FDA
Application
Supplement Number
#1

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The application supplement number assigned by the Food and Drug Administration (FDA).

The application number assigned by the Food and Drug Administration (FDA).

The application supplement number assigned by the Food and Drug Administration (FDA).

Medicare Part B Drug Average Sales Price (ASP)

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Field Definitions

Field Name

Field Definition

Additional FDA
Application Number
#2

The application number assigned by the Food and Drug Administration (FDA).

Additional FDA
Application
Supplement Number
#2

The application supplement number assigned by the Food and Drug Administration (FDA).

FDA Final PreMarketing Approval
Date

This is the original date the FDA granted approval for the drug (NDA), biological (BLA), or
pre-marketing application (PMA).

FDA Approval Type

The type of FDA approval for the product.

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