DTS-ASP-Registration-UserGuide

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

DTS-ASP-Registration-UserGuide

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Average Sales Price (ASP)
Registration User Guide
Version 0.1
Date: January 22, 2024

ASP Registration User Guide

Table of Contents
1. Purpose.................................................................................................................................3
2. New User Registration ..........................................................................................................4
3. Logging in Using MFA .........................................................................................................11
4. Select User Role/Application Request .................................................................................16
5. Technical Support Contact Information................................................................................24
Appendix A: Revision History ....................................................................................................25
Appendix B: Glossary................................................................................................................26
Appendix C: Figures and Tables ...............................................................................................28

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1.

Purpose

The purpose of this user guide is to provide instructions for registering as a new user in the
Centers for Medicare & Medicaid Services (CMS) Identity Management (IDM) system to request
access to the Fee-for-Service Data Collection System (FFSDCS) Average Sales Price (ASP)
Module.
CMS requires an automated data collection system that can collect and synthesize large
amounts of data related to products falling under the Fee-for-Service (FFS) payment
mechanisms.
CMS supplies the Medicare FFS claims processing contractors with the drug pricing files for
Medicare Part B. CMS uses the FFSDCS to house various Fee-for-Schedule platforms,
including the ASP Module.
Before you can log in to any FFSDCS Module, you must create a new user account. All
FFSDCS Module users, regardless of their role, must complete the new user registration steps
in the following section.

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2.

New User Registration

You must have an IDM username and password to access the ASP Module. Follow these steps
to register with IDM and receive your credentials:
1.

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

Figure 1: CMS Enterprise Portal - Login Page

2.

Click the New User Registration button.
The Select Your Application page opens. Refer to Figure 2.

Figure 2: New User Registration - Select Your Application Drop-down

3.

Click the Select Your Application drop-down; select FFSDCS from the list of
applications.

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The Step #1: Terms and Conditions page opens. Refer to Figure 3.

Figure 3: New User Registration - Terms & Conditions

4.

Read the Terms & Conditions. If you agree, select the I agree to the Terms &
Conditions checkbox; click Next.
Note: By selecting this checkbox, you certify that you read and consent to monitoring
while accessing and using the portal. The terms and conditions describe why the
application collects personally identifiable information (PII), which is to identify the
unique, new user who is registering to use the application.
The terms and conditions link provides additional hyperlinks to the HHS Rules of
Behavior and the CMS Privacy Act Statement.

5.

The Step #2: Register Your Information page opens. Refer to Figure 4.

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Figure 4: New User Registration - Step #2 Register Your Information

6.

Enter your personal information in each of the required fields; click Next.
Note: The application requires you to complete all fields unless marked as optional.
The Step #3: Create User ID, Password & Security Question/Answer page opens.
Refer to Figure 5.

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Figure 5: New User Registration - Step #3 Create User ID & Password

7.

Type your desired user identification in the User ID field.
Note: Per the User ID Requirements, your user ID must:
a. Consist of a minimum of six (6) alphanumeric characters and cannot exceed

seventy-four (74) characters.

b. Contain at least one (1) uppercase or lowercase letter.
c. Contain one (1) special character. You may use hyphens (-), underscores (_),

apostrophes (‘), and periods (.).

d. Not have a special character as the first or last letter of your user ID.
e. Not contain eight (8) consecutive numbers.

8.

Type your desired password in the Password field; then re-type your password in the
Confirm Password field. Passwords must match before you move onto the next step.
Note: Your password must conform to the CMS Acceptable Risk Safeguards (ARS)
Password Policy. You may only change your password once every 24 hours. Per the
password policy, your password must:
a. Consist of a minimum of fifteen (15) alphanumeric characters and cannot exceed
b.
c.
d.
e.

sixty (60) characters.
Contain at least one (1) uppercase and one (1) lowercase letter.
Contain at least one (1) number.
Not contain part of your user ID, first name, last name, or common passwords.
Be different from your previous six (6) passwords.

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Note: Special characters are optional in your password. The system accepts the
following special characters: (‘), (“), (!), (#), ($), (%), (&), ((), ()), (*), (+), (,), (-), (.), (/), (:),
(;), (<), (>), (=), (?), (@), ([), (]), (^), (_), (`), (~).
9.

Select a security question from the Security Question drop-down; enter your answer in
the Security Answer field. Refer to Figure 6.
Note: The system requires your security answer to reset your password or unlock your
account. Per the security answer requirements, your security answers:
a.
b.
c.

Must contain at least four (4) alphanumeric characters.
Cannot contain part of your security question.
Can contain spaces.

Figure 6: New User Registration - Security Question/Answer Page

10. Click Next to complete the registration process.
The New User Registration Summary page opens. Refer to Figure 7.

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Figure 7: New User Registration - Summary

Note: You may click the Cancel button to exit out of the registration process; however,
the system does not save any of the changes you entered.
11. Review the New User Registration Summary page; make necessary changes.
12. Click the Submit User button to complete the registration process.

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A Confirmation message displays. Refer to

Figure 8.

Figure 8: New User Registration Confirmation

13. Click the login hyperlink to return to the main login page.
Note: Wait at least five minutes before logging in to the FFSDCS Module with your new
User ID and Password.

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3.

Logging in Using MFA

Following registration, use these steps to log in to the FFSDCS Module:
1.

Navigate to the CMS Enterprise Portal main page.
The FFSDCS Module Login Page opens. Refer to Figure 9.

Figure 9: Logging in Using MFA - FFSDCS Module Login Page

2.
3.
4.

Type your user ID and password in the User ID and Password fields.
Click the Terms & Conditions hyperlink and review the text in the pop-up window; close
the window.
Read the terms and conditions. If you agree, select the I agree to the Terms &
Conditions checkbox.
Note: By selecting this checkbox, you certify that you read and consent to monitoring
while accessing and using the portal. Additionally, the terms and conditions provide
hyperlinks to the HHS Rules of Behavior and the CMS Privacy Act Statement.

5.

Click Login.
Note: If you forget your user ID or password, click the appropriate hyperlinked text in
Forgot your User ID or your Password? under the Login button and follow the
provided instructions. If you are still not able to access your account and need to unlock
your account, click the hyperlinked unlock text under Need to unlock your account?

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To confirm the security of the FFSDCS Module, as well as your data, you must authenticate
your identity using a multifactor authentication (MFA) process. Users have various
authentication options, including Interactive Voice Response (IVR), Email, Text Message (Short
Message Service (SMS)), or Okta Verify.
6.

Click the Select MFA Device drop-down; select your preferred MFA device type from
the list. Whenever you log back into the ASP Module through this process, your
preferred method of MFA reloads automatically. Refer to Figure 10.

Figure 10: Logging in Using MFA - Select MFA Device Type Drop-Down

7.

Click the Send MFA Code green button to receive a one-time phone call, email, text
message, or other communication to confirm registration of your identity with the
FFSDCS Module. This user guide demonstrates email as the chosen MFA method.
Refer to Figure 11.

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Figure 11: Logging in Using MFA - MFA Code

The Module sends an email with a six-digit code to confirm your identity. Refer to Figure
12.

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Figure 12: Logging in Using MFA - Confirmation Code in Email

8.

Record and type the six-digit code into the Enter MFA Code field. Click the Add Device
button to confirm your identity and enter the FFSDCS Module.
The My Portal landing page opens, displaying a Welcome to CMS Enterprise Portal
message. Refer to Figure 13.

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Figure 13: Logging in Using MFA - My Portal Landing Page

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4.

Select User Role/Application Request

The Medicare ASP Data Collection System is a role-based system. This means that certain
system functions link to specific user role profiles. When a new user receives access, the
approved role provides access to the specific functions the user needs.
As noted above, the two roles are:
Submitter: This role is designated for the person who gathers the required Medicare Part B
drug data to enter and submit into the system. Once this person has completed and submitted
the data, they generate a one-time password (OTP) to send to the Certifier to establish a
relationship within the system. This step only happens once to initiate the relationship and only
needs to happen again if the person in either role changes. A Submitter can be any individual
the manufacturer chooses, including a third-party contractor.
Certifier: This role is designated for the person who reviews the information the Submitter
reports to ensure it is correct and complete. The Certifier then certifies the submission of the
reported data. If the Certifier requires changes to the originally submitted data reported in the
system, the Certifier must notify the Submitter to update and submit the revised data. As stated
in 42 CFR 414.804(a)(7), the Certifier must be the manufacturer’s Chief Executive Officer (CEO)
or Chief Financial Officer (CFO) or an individual who has delegated authority to sign for, and
who reports directly to, the manufacturer’s CEO or CFO.
It is at the discretion of each organization who to designate as Submitter and Certifier. These
individuals require access to financial data and must have a strong working knowledge of how
the organization operates. The Submitter and Certifier must be two different authorized
representatives from the Drug Manufacturer. The manufacturer’s CEO or CFO assumes
responsibility for the information entered into the system.
Follow these steps to request access to an application and establish your role in the application:
1.

Click the Add Application button.
The Request Application Access page opens. Refer to Figure 14.

Figure 14: Select User Role/Application Request - Request Application Access

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2.

Click the Select an Application drop-down; scroll or search for your application. Refer
to Figure 15.

Figure 15: Select User Role/Application Request - Select an Application Drop-down

3.

Select FFSDCS from the drop-down menu. To be a Submitter or Certifier, you must
register for the role on the FFSDCS Module.
The Request Application Access page opens. Refer to Figure 16.

Figure 16: Select User Role/Application Request - Select an Application

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4.

Click the Next button.
A checkmark displays next to FFSDCS; the application automatically moves you to the
Select a Role section. Refer to Figure 17.

Figure 17: Select User Role/Application Request - Select a Role

5.

Click the Select a Role drop-down; scroll or search for your application. Refer to Figure
18.

Figure 18: Select User Role/Application Request - Select a Role Drop-down

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6.

Select the correct role for the application. For example:
a. If you are an ASP Submitter, click the Role drop-down and select ASP End User as
your role. ASP Submitters can only submit data.
b. If you are an ASP Certifier, click the Role drop-down and select ASP Certifier. ASP
Certifiers can only certify data.
For example, the user has selected the ASP End User (Submitter) role in Figure 19.

Figure 19: Select User Role/Application Request - Selected Role as ASP End User

7.

Click the Next button to confirm your role.
A checkmark displays next to your selected role; the application automatically moves
you to the Complete Identity Verification section. Refer to Figure 20.

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Figure 20: Select User Role/Application Request - Complete Identity Verification

8.

Click the Launch button.
The Step #1: Identity Verification Overview page opens. Refer to Figure 21.

Figure 21: Select User Role/Application Request - Step #1: Identity Verification Overview

9.

Read the Identity Verification Overview to gain an understanding of your privacy as
well as the process Experian Credit Bureau uses to accurately confirm the identity of
users; click Next.
The Step #2: Accept Terms & Conditions page opens. Refer to Figure 22.

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Figure 22: Select User Role/Application Request - Step #2: Accept Terms & Conditions

10. Read the terms and conditions derived from the Paperwork Reduction Act of 1995,
consisting of three sections: Protecting Your Privacy, HHS Rules of Behavior, and
Identity Verification.
11. If you agree to the terms and conditions, select the I agree to the Terms & Conditions
checkbox; click Next.
The Step #3: Enter Your Information page opens. Refer to Figure 23.

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Figure 23: Select User Role/Application Request - Enter Your Information

12. Enter your information in all required fields.
Note: Once you complete all fields, ensure the checkmark is present at the bottom of the
page before moving on.
13. Click Next.
The Multi-Factor Authentication Information page opens. Refer to Figure 24.

Figure 24: Select User Role/Application Request - MFA Information

14. Read the message about MFA information; click Next to continue.
The Register Your Phone, Computer, or Email page opens. Refer to Figure 25.

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Figure 25: Select User Role/Application Request - Register Your Phone, Computer, or Email

15. Select a device from the MFA Device Type drop-down. Enter any required information
requested for the selected device; click Next.
A message opens indicating the system successfully registered your device. Refer to
Figure 26.

Figure 26: Select User Role/Application Request - Successfully Registered MFA Device

16. Click OK.
A Request Acknowledgement page opens. Refer to Figure 27.

Figure 27: Select User Role/Application Request - Request Acknowledgement

17. Read the Request Acknowledgement statement; click OK.
Note: Following submission, you may have to wait up to 72 hours (3 days) to receive an
email notification.

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5.

Technical Support Contact Information

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

Account unlock
Password reset
Registration process questions
System availability escalations

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

Phone
Number
1-844-8760765

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

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

Date

Author/Editor

01/22/2024

Index
Analytics

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

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

Acronym/Term

Definition

Average Sales
Price

ASP

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

Centers for
Medicare &
Medicaid Services

CMS

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

Chief Executive
Officer

CEO

A CEO is the highest-ranking officer or Administrator in charge
of management with a corporation.

Chief Financial
Officer

CFO

A CFO is the corporate executive having financial authority to
make appropriations and authorize expenditures for a firm.

Eastern Standard
Time

EST

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

Experian

NA

Experian is a global credit information group.

Fee-for-Service
Data Collection
System

FFSDCS

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

Identity
Management

IDM

IDM is the process of managing user access to data.

Interactive Voice
Response

IVR

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

Medicare

NA

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

Medicare
Modernization Act

MMA

The MMA, or Medicare Prescription Drug, Improvement, and
Modernization Act, is a federal law.

Medicare Part B

NA

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

Multifactor
Authentication

MFA

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

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Expanded Form

Acronym/Term

Definition

Okta

NA

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

One-Time
Password

OTP

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

Personally
Identifiable
Information

PII

PII is information that identifies or describes an individual,
including but not limited to name, address, telephone number,
Social Security Number, credit card number, and personal
characteristics that make individual identity easily
discoverable.

Short Message
Service

SMS

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

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Appendix C: Figures and Tables
List of Figures
Figure 1: CMS Enterprise Portal - Login Page.............................................................................4
Figure 2: New User Registration - Select Your Application Drop-down .......................................4
Figure 3: New User Registration - Terms & Conditions ...............................................................5
Figure 4: New User Registration - Step #2 Register Your Information .........................................6
Figure 5: New User Registration - Step #3 Create User ID & Password ......................................7
Figure 6: New User Registration - Security Question/Answer Page ............................................8
Figure 7: New User Registration - Summary ...............................................................................9
Figure 8: New User Registration Confirmation ..........................................................................10
Figure 9: Logging in Using MFA - FFSDCS Module Login Page ...............................................11
Figure 10: Logging in Using MFA - Select MFA Device Type Drop-Down ................................. 12
Figure 11: Logging in Using MFA - MFA Code ..........................................................................13
Figure 12: Logging in Using MFA - Confirmation Code in Email ................................................ 14
Figure 13: Logging in Using MFA - My Portal Landing Page .....................................................15
Figure 14: Select User Role/Application Request - Request Application Access ....................... 16
Figure 15: Select User Role/Application Request - Select an Application Drop-down ............... 17
Figure 16: Select User Role/Application Request - Select an Application .................................. 17
Figure 17: Select User Role/Application Request - Select a Role ..............................................18
Figure 18: Select User Role/Application Request - Select a Role Drop-down ........................... 18
Figure 19: Select User Role/Application Request - Selected Role as ASP End User ................ 19
Figure 20: Select User Role/Application Request - Complete Identity Verification ..................... 20
Figure 21: Select User Role/Application Request - Step #1: Identity Verification Overview ....... 20
Figure 22: Select User Role/Application Request - Step #2: Accept Terms & Conditions .......... 21
Figure 23: Select User Role/Application Request - Enter Your Information ............................... 22
Figure 24: Select User Role/Application Request - MFA Information......................................... 22
Figure 25: Select User Role/Application Request - Register Your Phone, Computer, or Email.. 23
Figure 26: Select User Role/Application Request - Successfully Registered MFA Device ......... 23
Figure 27: Select User Role/Application Request - Request Acknowledgement ........................ 23

List of Tables
Table 1: Technical Support Contacts ........................................................................................24
Table 2: Revision History ..........................................................................................................25
Table 3: Glossary ......................................................................................................................26

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File Typeapplication/pdf
File TitleMedicare Part B Average Sales Price (ASP) Module Registration User Guide
SubjectASP Module Registration User Guide for Medicare Part B
AuthorCMS
File Modified2024-01-24
File Created2024-01-24

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