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pdfCenters for Medicare & Medicaid Services
Center for Medicare Management (CM)
7500 Security Blvd
Baltimore, MD 21244-1850
Center for Medicare Management (CM)
Part B Drug Average Sale Price (ASP)
User Manual for Drug Manufacturers
Version: 2.0
Last Modified: July 21, 2014
Document Number: ASP-V1.0 UMX-2.00
Contract Number: HHSM-500-2009-00087G
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Table of Contents
APPROVALS
Submitting Organization’s Approving Authority:
Signature
Ray Lee
Printed Name
Date
410-992-3760
Phone Number
Date
410-786-0260
Phone Number
Date
410-786-4001
Phone Number
DCCA
CMS’ Approving Authority:
Signature
Dona Coffman
Printed Name
Project Officer
CMS Business Owner:
Signature
Sarah Harding
Printed Name
Government Task Leader
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REVISION HISTORY
Version
Date
Point of Contact/Organization
1.0
12/5/2013
Richard E. McCarthy/DCCA
1.5
5/30/2014
Richard E. McCarthy/DCCA
2.0
7/21/2014
Richard E. McCarthy/DCCA
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Description of Changes
Initial Issue
Revised screen captures throughout
the document
Revised screen captures throughout
the document
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Table of Contents
1
2
Introduction ............................................................................................................................. 1
1.1
What is the Medicaid Part B Average Sales Price (ASP) Application?........................... 1
1.2
Purpose of the ASP Application....................................................................................... 1
1.3
ASP User Roles ................................................................................................................ 3
ASP Application Access ......................................................................................................... 5
2.1
ASP Application Access Process ..................................................................................... 5
2.1.1
Obtaining a CMS Portal Username and Password ................................................... 5
2.1.2
Requesting ASP Application Access ...................................................................... 10
3
ASP Application Home Page ................................................................................................ 18
4
Data Submission ................................................................................................................... 19
5
4.1
Online Product Data ....................................................................................................... 19
4.2
Upload Product Data – File Transfer ............................................................................. 22
4.3
Add Financial Data – Online Data Entry ....................................................................... 27
4.4
Upload Financial Data – File Transfer ........................................................................... 29
4.5
View Submitted Drug Data ............................................................................................ 34
Certifications ......................................................................................................................... 36
5.1
Certify Drug Data Online ............................................................................................... 36
5.2
View Drug Data ............................................................................................................. 40
5.2.1
View Drug Data Certified in the Reporting Period ................................................ 40
5.2.2
View All Drug Data in the Reporting Period.......................................................... 42
5.3
6
7
Certification Assumptions .............................................................................................. 43
Re-statements ........................................................................................................................ 45
6.1
Restate Drug Financial Data – Online............................................................................ 45
6.2
Restate Drug Product Data – Online .............................................................................. 50
6.3
Add New Product – Re-statement Tab ........................................................................... 56
6.4
Restate Financial Data – File Upload ............................................................................. 57
6.5
Restate Drug Product Data – File Upload ...................................................................... 62
Compliance ........................................................................................................................... 66
7.1
Compliance Summary Overview ................................................................................... 66
7.2
Compliance Overview .................................................................................................... 67
7.2.1
Missing Drugs ......................................................................................................... 68
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7.2.2
Pending Certifications............................................................................................. 68
7.2.3
Pending Restatement Certifications ........................................................................ 70
7.2.4
Total Certified ......................................................................................................... 71
7.2.5
Total Restatement Certified .................................................................................... 72
7.2.6
Total New Drugs ..................................................................................................... 72
7.3
Export Options ............................................................................................................... 73
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Table of Figures
Figure 2-1: CMS Portal Home Page ............................................................................................... 6
Figure 2-2: CMS Secure Portal Section .......................................................................................... 7
Figure 2-3: CMS Portal Terms and Conditions Page ..................................................................... 7
Figure 2-4: CMS Portal Registration Page ..................................................................................... 8
Figure 2-5: CMS Portal User ID and Password Selection .............................................................. 9
Figure 2-6: CMS Portal Registration Complete............................................................................ 10
Figure 2-7: CMS Portal Home Page ............................................................................................. 11
Figure 2-8: CMS Secure Portal Section ........................................................................................ 12
Figure 2-9: CMS Portal Terms and Conditions Page ................................................................... 12
Figure 2-10: CMS Portal Log In Page .......................................................................................... 13
Figure 2-11: Request Application Access Button......................................................................... 13
Figure 2-12: View and Manage My Access Page ......................................................................... 14
Figure 2-13: Request New Application Access Page ................................................................... 14
Figure 2-14: Request New Application Access Page – Select Role ............................................. 15
Figure 2-15: Identity Verification Page ........................................................................................ 15
Figure 2-16: Terms and Conditions .............................................................................................. 16
Figure 2-17: Your Information Page............................................................................................. 17
Figure 3-1: ASP Application Home Page ..................................................................................... 18
Figure 4-1: Add Product Data Selection ....................................................................................... 19
Figure 4-2: Add Product Data ....................................................................................................... 20
Figure 4-3: Add Product Data – Alternate ID ............................................................................... 20
Figure 4-4: Product Data Upload Selection .................................................................................. 23
Figure 4-5: Product Data Upload .................................................................................................. 23
Figure 4-6: Attachment Upload -- .zip File .................................................................................. 24
Figure 4-7: Acceptable File Format Templates ............................................................................ 24
Figure 4-8: Sample Product Data Template.................................................................................. 25
Figure 4-9: Upload Product Data – File to be Uploaded .............................................................. 25
Figure 4-10: Product Data Upload Result..................................................................................... 26
Figure 4-11: Product Data Upload – Error ................................................................................... 26
Figure 4-12: Add/Edit Financial Data Selection ........................................................................... 27
Figure 4-13: Add or Edit Financial Data Home Page ................................................................... 28
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Figure 4-14: Add or Edit Financial Data – Financial Data Saved ................................................ 29
Figure 4-15: Financial Data Upload Selection.............................................................................. 30
Figure 4-16: Financial Data Upload Page ..................................................................................... 30
Figure 4-17: Attachment Upload -- .zip File ................................................................................ 31
Figure 4-18: Acceptable File Format Templates .......................................................................... 31
Figure 4-19: Sample Financial Data Template ............................................................................. 32
Figure 4-20: Financial Data Upload – File to be Uploaded .......................................................... 32
Figure 4-21: Financial Data Upload -- Result............................................................................... 33
Figure 4-22: Financial Data Upload – Error ................................................................................. 33
Figure 4-23: View Submitted Drugs Selection ............................................................................. 34
Figure 4-24: View Submitted Drugs ............................................................................................. 35
Figure 5-1: Drug Certification Selection ...................................................................................... 36
Figure 5-2: Drug Certification Home Page ................................................................................... 37
Figure 5-3: Drug Certification Page – Pending ............................................................................ 38
Figure 5-4: Product Details ........................................................................................................... 38
Figure 5-5: Financial Details ........................................................................................................ 39
Figure 5-6: Data Certification Statement ...................................................................................... 39
Figure 5-7: Proceed to Certify Data Button .................................................................................. 40
Figure 5-8: Certification Confirmation Message .......................................................................... 40
Figure 5-9: Drug Data Certified This Period Option .................................................................... 41
Figure 5-10: Drug Data Certified This Period Results ................................................................. 41
Figure 5-11: View All Drugs in Period Option ............................................................................ 42
Figure 5-12: View All Drugs in Period Results ............................................................................ 42
Figure 5-13: Certification Assumptions Selection........................................................................ 43
Figure 5-14: Certification Assumptions Page ............................................................................... 43
Figure 5-15: Certification Assumptions Page -- Upload .............................................................. 44
Figure 5-16: Certification Assumptions Saved ............................................................................. 44
Figure 5-17: Uploaded Certification Assumptions ....................................................................... 44
Figure 6-1: Restate Online Selection Screen ................................................................................ 45
Figure 6-2: Restate Online Screen – Main .................................................................................... 46
Figure 6-3: Restate Online Selection Screen ................................................................................ 46
Figure 6-4: Restate Online – Drugs Available for Re-Statement Selections ................................ 48
Figure 6-5: Restate Online -- Drugs Selected for Re-Statement................................................... 48
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Figure 6-6: Restate Online -- Review Re-Statement List ............................................................. 48
Figure 6-7: Re-State Product Data – Financial Data Saved .......................................................... 50
Figure 6-8: Restate Online Selection Screen ................................................................................ 51
Figure 6-9: Restate Online – Update Product Data Tab ............................................................... 51
Figure 6-10: Restate Online – Product Data ................................................................................. 52
Figure 6-11: Restate Online -- Selections ..................................................................................... 53
Figure 6-12: Restate Online --Drug Products Selected for Re-Statement .................................... 53
Figure 6-13: Restate Online -- Re-Statement Product List ........................................................... 54
Figure 6-14: Update Product Data Re-Statement Page................................................................. 54
Figure 6-15: Re-stated Product Data Saved .................................................................................. 56
Figure 6-16: Restate Online – Add New Product ......................................................................... 57
Figure 6-17: Restate Financial Data Upload Selection ................................................................. 58
Figure 6-18: Restate Financial Data Upload ................................................................................. 58
Figure 6-19: Attachment Upload -- .zip File ................................................................................ 59
Figure 6-20: Acceptable File Format Templates .......................................................................... 59
Figure 6-21: Sample Financial Data Template ............................................................................. 60
Figure 6-22: Restate Financial Data Upload – File to be Uploaded ............................................. 60
Figure 6-23: Restate Financial Data Upload -- Result .................................................................. 61
Figure 6-24: Upload Restate Financial Data Result -- Error ........................................................ 61
Figure 6-25: Restate Product Data Upload Selection ................................................................... 62
Figure 6-26: Restate Product Data Upload ................................................................................... 62
Figure 6-27: Attachment Upload -- .zip File ................................................................................ 63
Figure 6-28: Acceptable File Format Templates .......................................................................... 63
Figure 6-29: Sample Product Data Template................................................................................ 64
Figure 6-30: Restate Product Data Upload – File to be Uploaded ............................................... 64
Figure 6-31: Restate Product Data Upload -- Result .................................................................... 65
Figure 6-32: Restate Product Data Upload Result -- Error ........................................................... 65
Figure 7-1: Compliance Summary Overview ............................................................................... 66
Figure 7-2: Manufacturer’s Compliance Summary Report .......................................................... 67
Figure 7-3: Compliance Summary Overview—Missing Drugs ................................................... 68
Figure 7-4: Compliance Summary Overview—Resolve .............................................................. 68
Figure 7-5: Compliance Summary Overview—Pending Certifications ....................................... 69
Figure 7-6: Compliance Summary Overview—Resolve Pending Certifications ......................... 69
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Figure 7-7: Compliance Summary Overview—Pending Restatement Certification .................... 70
Figure 7-8: Compliance Summary Overview—Resolve Pending Restatement Certification ...... 71
Figure 7-9: Compliance Summary Overview—Total Certified ................................................... 71
Figure 7-10: Compliance Summary Overview—Total Restatement Certified............................. 72
Figure 7-11: Compliance Summary Overview—Total New Drugs ............................................. 73
Figure 7-12: Export Options ......................................................................................................... 74
Figure 7-13: Export Options Dialog Box...................................................................................... 74
Figure 7-14: CSV Export Option .................................................................................................. 75
Figure 7-15: PDF Export Option .................................................................................................. 75
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1
Introduction
1.1
What is the Medicaid Part B Average Sales Price (ASP) Application?
Introduction
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, beginning in
2006, the ASP methodology is used to determine the payment limit for all End Stage Renal
Disease (ESRD) drugs furnished by both independent and hospital-based ESRD facilities, as
well as specified covered outpatient drugs, and drugs and biologicals with pass-through status
under the Outpatient Prospective Payment System (OPPS). 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 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.
The business purpose of the project is to comply with the Sections 303(b) and (c) of the
Medicare Modernization Act (MMA) of 2003. Section 303 (b) and (c) of the MMA amended
Title XVIII of the Act by revising section 1842(o), the pricing methodology for Part B drugs and
biologicals, and adding section 1847A, the new average sale price drug payment methodology.
1.2
Purpose of the ASP Application
The purpose of the ASP Application is to:
Provide CMS 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 currently used,
Establish a relationship between the manufacturers’ reported data and the billing codes
used by Medicare providers to calculate a weighted average price for each billing code.
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Prices established for billing codes are used for payment of Part B drugs on certain
Medicare claims,
Accept, store, validate and calculate drug pricing on Medicare Part B drug data received
for the Center for Medicare Management (CM) stakeholders.
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 is 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, CMS will communicate the days remaining in the
submission period to each manufacturer and whether or not the manufacturer is in compliance
with the data submission requirements.
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 system, they need to choose either to submit their data on line 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
system. Validations and error messages will ensure that the drug manufacturer is entering data in
adherence to the system 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 ADP drug data is 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. CM
reviews the assumptions and may respond to the user if necessary. The user is able to 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 will be 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 has been submitted, the drug manufacturer can view all drug
data certified in the current reporting period and view whether or not current and previous drug
submissions is 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 2004) to CM at any time.
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Introduction
CM will assign each drug to one or more billing codes and determine the billing units per billing
code. The ASP for each billing code will be calculated based on the weighted average of all
ASPs within a billing code. Where a billing code does not exist, CMS will submit a request for
one to be established.
Updated ASP data is shared with each drug manufacturer. Either CMS through quality review or
drug manufacturers may identify errors in the data. The drug manufacturer submits any corrected
data so that CMS 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/DAS, 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/DAS runs drug submission reports. These reports include Impact Analysis
Report, Management Reports and Manufacturer Reports. A Drug Manufacturer also has the
option to mail Medicare Part B drug data and restated drug data to CM. CM Personnel may key
the data online or upload the data on behalf of the manufacturer. Along with the file sent by the
manufacturer a letter of certification is sent to CMS. In this case, CMS will confirm the written
certification received with the file.
CMS creates an output file to share with OIG so they can complete ASP comparison studies.
Updates with the AMP provided by OIG are added to the drug pricing file to replace the ASP for
some billing codes. After pricing updates are completed, the system creates the following
output:
An impact analysis comparing price changes in support of briefing documents for the
clearance process,
Crosswalk of NDCs to billing codes,
Part B pricing files for mainframe application for the fee for service contractors,
Part B pricing files for the internet for CMS website,
File of ASPs for not otherwise classified billing codes,
File of Competitive Acquisition Pricing (CAP) data, and
File of Outpatient and ASC Drug Pricing Data.
1.3
ASP User Roles
The ASP Application is a role-based system. This means that certain system functions have been
linked to specific “user role profiles.” When a new user is given access to the ASP Application,
system administrators link the user’s ID to the profile that provides access to the specific
functions they need. The ASP Application user roles are as follows:
Drug Manufacturers: Responsible for the calculation and quality of the Part B drug
prices. Drug manufacturers can be both Submitters and Certifiers.
CM Personnel: Responsible for the calculation and quality of the Part B drug prices.
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Introduction
Drug Compendium Contractors: Responsible for submitting drug pricing compendia data
for new drugs.
Fee For Service Contractors: Responsible for submitting new drug data to CM for
pricing calculations and billing code assignment
CMCS: Future participant to provide AMP data for comparative analyses of the ASP to
the AMP.
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ASP Application Access
A CMS User ID is required to access the ASP Application. To obtain a CMS User ID, you must
complete the Application for Access to the Centers for Medicare & Medicaid Services (CMS)
Computer Systems (Form CMS-20037). If you already have a CMS User ID, then you must
submit a request to access the ASP Application. The Application for Access to the Centers for
Medicare & Medicaid Services (CMS) Computer Systems (Form CMS-20037) can be
downloaded from the CMS Website at: http://www.cms.gov/Research-Statistics-Data-andSystems/CMS-Information-Technology/InformationSecurity/Downloads/EUAaccessform.pdf
Users that have been approved for access to the ASP application are assigned a CMS user ID and
a password. Users are required to access the CMS Portal to begin the authentication and role
assignment process. Users enter their assigned user ID in the User ID field and enter ASP User
in the Request field in the CMS portal. Users are then directed to the EIdM Authentication
System. The EIdM Authentication System performs identity proofing on the user. The EIdM
Authentication System will prompt 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 and
password. After the user successfully creates a username and password, the EIdM
Authentication System will begin the identity proofing process. After the user’s identity is
verified, the CMS Portal will push the user’s data to the ASP application. Users are assigned a
role, assigned organization codes, and the NDCI contact is applied to the user.
2.1
ASP 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.
2.1.1
Obtaining a CMS Portal Username and Password
A CMS Portal 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 URL in your browser:
https:\\portal.cms.gov. The CMS Portal Home Page is shown in Figure 2-1.
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Figure 2-1: CMS Portal Home Page
2. Click the New User Registration link in the CMS Secure Portal section located in the
top-right section of the CMS Portal home page. The CMS Secure Portal section of the
page is shown in Figure 2-2.
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Figure 2-2: CMS Secure Portal Section
3. The Terms and Conditions Page will open, as shown in Figure 2-3.
Figure 2-3: CMS Portal Terms and Conditions Page
4. Read through the Terms and Conditions on the page. The page states that you content to
monitoring while accessing and using this website. The page also details the reasons for
collecting Personal Identifiable Information (PII), which are that it will only be used to
uniquely identify the new user who is registering with the system. The page provides
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links to the HHS Rules of Behavior and the CMS Privacy Act Statement. If you agree to
the terms and conditions, click the corresponding check box and click the Next button.
Users must agree to the terms and conditions to continue the registration process. The
CMS Portal Registration page opens, as shown in Figure 2-4.
Figure 2-4: CMS Portal Registration 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.
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6. Click Next when completed. The screen shown in Figure 2-5will be displayed.
Figure 2-5: CMS Portal User ID and Password Selection
7. 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 (.).
8. Enter your desired password in the Password field. The CMS Portal password must
conform to the following CMS 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 a day;
d. Contain at least one (1) letter and one (1) number;
e. Contain at least one (1) uppercase and one (1) lowercase letter;
f. Not contain your User ID; and
g. Be different from your previous six (6) passwords.
9. Re-enter your desired password in the Confirm Password field.
10. Select a Challenge Question from each of the three (3) drop-down lists for which the
answer is known.
11. Enter the answers to the Challenge Questions in the corresponding Answer fields. The
special characters that are allowed are apostrophes (‘), hyphens (-), and spaces followed
by alphanumeric characters.
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12. Click the Next button to complete the registration process. The Registration Complete
screen is displayed as shown in Figure 2-6.
Figure 2-6: CMS Portal Registration Complete
13. Click OK to return to the CMS Portal Landing page. Please wait at least five (5) minutes
before logging on to the CMS Portal with your new 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) into your web browser and
press Enter. The CMS Portal Home Page will open as shown in Figure 2-7.
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Figure 2-7: CMS Portal Home Page
2. Click the Login to CMS Secure Portal button in the CMS Secure Portal section located
in the top-right section of the CMS Portal home page. The CMS Secure Portal section of
the page is shown in Figure 2-2.
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Figure 2-8: CMS Secure Portal Section
3. The Terms and Conditions Page will open, as shown in Figure 2-3.
Figure 2-9: CMS Portal Terms and Conditions Page
4. Read through the Terms and Conditions on the page. The page states that you content to
monitoring while accessing and using this website. The page also details the reasons for
collecting Personal Identifiable Information (PII), which are that it will only be used to
uniquely identify the new user who is registering with the system. The page provides
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links to the HHS Rules of Behavior and the CMS Privacy Act Statement. If you agree to
the terms and conditions, click the corresponding check box and click the Next button.
Users must agree to the terms and conditions to continue the log-in process.
5. The CMS Portal Log In page opens as shown in Figure 2-10.
Figure 2-10: CMS Portal Log In Page
6. Enter your user ID and password and click Log In. The CMS Portal Home Page will
open. Click the Request Access Now button on the on the CMS Portal home page, as
shown in Figure 2-11.
Figure 2-11: Request Application Access Button
7. The View and Manage My Access page opens after clicking the Request Access Now
button, as shown in Figure 2-12.
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Figure 2-12: View and Manage My Access Page
8. Click the Request New Application Access link in the My Access section. The request
New Application Access Page opens as shown in Figure 2-13.
Figure 2-13: Request New Application Access Page
9. Click the Application Description drop-down box and select ASP Application.
10. A Role drop-down box will appear as shown in Figure 2-14.
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Figure 2-14: Request New Application Access Page – Select Role
11. Select the appropriate role for the Role drop-down box and click Submit. The Identity
Verification page opens, as shown in Figure 2-15.
Figure 2-15: Identity Verification Page
12. The Identity Verification page describes how your personal information will be used to
verify your identity before being assigned to the selected role. CMS uses Experian as an
external identity provider. Experian uses information from your credit report to assist
with confirming your identity. The Experian application will pose questions to you based
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on the data in your report. Read the Identity Verification page carefully, and click the
Next button to proceed. The Terms and Conditions page opens, as shown in Figure 2-16.
Figure 2-16: Terms and Conditions
13. Read through the Terms and Conditions on the page. The page states that you content to
monitoring while accessing and using this website. The page also details the reasons for
collecting Personal Identifiable Information (PII), which are that it will only be used to
uniquely identify the new user who is registering with the system. The page provides
links to the HHS Rules of Behavior and the CMS Privacy Act Statement. If you agree to
the terms and conditions, click the corresponding check box and click the Next button.
The Your Information page opens, as shown in Figure 2-17.
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Figure 2-17: Your Information Page
14. Much of the information on this page will be pre-populated in the corresponding fields.
Enter any missing information in the fields and click the Next button. A page will open
that will ask you a series of questions to verify your identity. These questions are
generated from the information in your credit report. Answer the questions and click the
Next button. Your identity will be verified based on your answers, and access to your
requested role will be granted.
15. You will now be able to access the ASP Application using the CMS Portal. The ASP
Application is accessed using a link that is displayed on you My Access page.
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3
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 compliances). 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 is displayed with a gray background.
The ASP Application Home Page displays content based on your user role and the privileges
assigned to the user role. The user roles in the ASP Application are dynamic and are maintained
by the central system administrator. The ASP Application Home Page is shown in Figure 3-1.
Figure 3-1: ASP Application Home Page
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4
Data Submission
Drug manufacturers are required to submit quarterly drug data to the ASP application database
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 and product data using online data entry and through approved file uploads.
4.1
Online Product Data
The ASP database provides drug manufacturers the ability submit Medicaid Part B drug product
data to CMS. Perform the following steps to enter drug product data using the online data entry
process:
1. Click the Product Data button on the left side menu on the ASP Application Home Page
and select Add Product Data from the drop-down list. The Add Product Data Selection
on the ASP Application home page is shown in Figure 4-1.
Figure 4-1: Add Product Data Selection
2. Click Add Product Data. The Add Product Data page opens, as shown in Figure 4-2.
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Figure 4-2: Add Product Data
3. The Add Product Data pages defaults to the Add by NDC tab. Click the Add by
Alternate ID tab to open the Add Product Data page with the Add by Alternate ID view
which is displayed in Figure 4-3.
Figure 4-3: Add Product Data – Alternate ID
The following table describes the fields and the user actions on the Add Product Data screens.
Table 4-1
Name
NDC1
Add Product Data Page Information
User Action
Click the arrow on dropdown box and select the
desired National Drug Code
(NDC).
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Comments
NDC1 is a required field if Alternate ID is missing.
NDC1 is a 5-digit numeric entry.
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Name
User Action
Comments
Add new
NDC1 (link)
Click the link to add a New
NDC1.
Link displayed when the “Add by NDC” tab is
selected.
Add by
Existing NDC1
Click the link to enter an
existing NDC1.
Link is displayed when Add new NDC1 link is
selected.
NDC2
Enter the NDC2 in the field.
NDC2 is a required field if Alternate ID is missing.
NDC2 is a 4-digit numeric entry.
NDC3 is a required field if Alternate ID is missing.
NDC3 is a 2-digit numeric entry.
NDC3
Enter the NDC3 in the field.
Alternate ID
Enter the Alternate Product
ID
Alt ID is required if NDC is missing.
Manufacturer
Name
Enter the name of the drug’s
manufacturer.
If a new manufacturer is entered, the ASP
Application, the manufacturer’s name will be
marked ‘Pending.’
Brand Name
Enter the brand name of the
drug in the field.
The Brand Name field is only displayed when the
Has Brand Name? box is checked.
Brand Name is required if the Has Brand Name?
box is checked.
The Brand Name is limited to 250 characters.
The Brand Name field is optional.
Generic Name
Select the Generic Name
from the drop-down list.
The Generic Name is required.
Date of First
Sale
Enter the date when the
drug was first available for
sale.
The Date of First Sale is required.
The date format is MM/DD/YYYY.
Date of First Sale cannot occur before the FDA
Final Pre-Marketing/Approval Date.
Date of First Sale must occur prior to the reporting
period start date.
Expiration
Date of Final
Lot Sold
Enter the expiration date of
the final lot that was sold.
Scroll through the pop-up
calendar for the desired
date, or enter the date
directly into the field.
The date format is MM/DD/YYYY.
The Expiration Date of Final Lot Sold field is
optional.
Strength of
Product
Enter the Strength of
product in the field.
The Strength of Product is required.
The Strength of Product has a limit of 250
characters.
Volume Per
Item
Enter the Volume per Item in
the field.
The Volume per Item is required.
The Volume per Item has a limit of 250 characters.
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Name
User Action
Comments
Number of
Items per NDC
Enter the Number of Items
per NDC in the field.
The Number of Items per NDC is required.
FDA
Application
Number
Enter the FDA Application
Number in the field.
The FDA Application Number is required.
The FDA Application Number format is
alphanumeric.
FDA Final PreMarketing
Approval Date
Enter the FDA Final PreMarketing Approval Date.
Scroll through the pop-up
calendar for the desired
date, or enter the date
directly into the field.
The FDA Final Pre-Marketing Approval Date is
required.
The date format is MM/DD/YYYY.
The FDA Final Pre-marketing Approval Date
cannot be after the entered date of the data.
FDA
Supplemental
Number
Enter the FDA Supplemental
Number in the field.
The FDA Supplemental Number format must be
alphanumeric.
The FDA Supplemental Number field is optional
FDA Approval
Type
Select the FDA Approval
Type from the drop-down
list.
The FDA Approval Type is required.
4.2
Upload Product Data – File Transfer
The ASP database provides drug manufacturers the ability submit Medicaid Part B drug data to
CMS. Perform the following steps to upload drug product data using the file transfer process:
1. Click the Product Data button on the left side menu on the ASP Application Home Page
and select Product Data Upload from the drop-down list. The Product Data Upload
Selection on the ASP Application home page is shown in Figure 4-4.
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Figure 4-4: Product Data Upload Selection
2. Click Product Data Upload. The Product Data Upload page opens, as shown in Figure
4-5.
Figure 4-5: Product Data Upload
3. If the drug product data has been entered and saved to a file of an acceptable file format,
click Browse to locate the file path and name of the file to be uploaded.
4. If the drug product data has not been entered and saved to a file of an acceptable file
format, click the Click here of acceptable file formats link. A pop-up window opens
asking for authorization to upload a .zip file containing the file formats, as shown in
Figure 4-6.
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Figure 4-6: Attachment Upload -- .zip File
5. Click OK to upload the .zip file. The .zip file opens displaying the acceptable file format
templates, as shown in Figure 4-7.
Figure 4-7: Acceptable File Format Templates
6. Click any one of the Product Template files to open a product data template. There are
three options: productTemplate.csv, productTemplate.xlsx and productTemplate.xls. A
sample template is shown in Figure 4-8.
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Figure 4-8: Sample Product Data Template
* Please note that not all rows of the template are displayed in Figure 4-8.
7. Enter the drug product information on the template. The entries on the template consist of
the same fields that are described in Section 2.2, Upload Product Data – Online Data
Entry. Refer to Table 2-1 for a description of the fields and which fields are required.
Save the file using a different name and to an easily accessible location on your
computer. Close the file and return to the Upload Product Data page.
8. Click Browse to locate the file path and name of the file to be uploaded. A file upload
window will open.
9. Locate the file and click Open. The File Upload window will close, and the file to be
uploaded will be displayed on the Upload Product Data page, as shown in Figure 4-9.
Figure 4-9: Upload Product Data – File to be Uploaded
10. Click Upload. The Product Data Upload result screen will be displayed, along with a
message that the product data has been successfully saved, as shown in Figure 4-10.
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Figure 4-10: Product Data Upload Result
11. The Product Data Upload result screen will display a report of the drug product data that
was just uploaded using the file transfer process. Review the data on the screen. Data that
may be missing will be shown in the Status column. A sample upload with missing data
is shown in Figure 4-11.
Figure 4-11: Product Data Upload – Error
12. Reopen the file that was uploaded and make the necessary corrections. Save the file, and
repeat Step 8 through Step 10.
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4.3
Add Financial Data – Online Data Entry
The ASP database provides drug manufacturers the ability submit Medicaid Part B drug financial
data to CMS. Perform the following steps to add drug financial data using the online data entry
process:
1. Click the Financial Data button on the left side menu on the ASP Application Home
Page and select Add/Edit Financial Data from the drop-down list. The Add/Edit
Financial Data Selection on the ASP Application home page is shown in Figure 4-12.
Figure 4-12: Add/Edit Financial Data Selection
2. Click Add/Edit Financial Data. The Add or Edit Financial Data page opens, as shown
in Figure 4-13.
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Figure 4-13: Add or Edit Financial Data Home Page
The following table describes the fields and the user actions on the Add or Edit Financial Data
screen.
Table 4-2
Name
Manufacturer’s
ASP
Number of
ASP Units
Add or Edit Financial Data Home Page Information
User Action
Enter or update the
Manufacturer’s Average
Sale Price (ASP) in the field.
Enter the drug’s ASP Units
in the field.
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Comments
The Manufacturer’s ASP is a required field.
The Manufacturer’s ASP must be in a numeric
format.
The Manufacturer’s ASP must have three decimal
places (i.e., XXXXX.XXX).
The Manufacturer’s ASP can be a positive number,
a negative number, or be equal to 0.
The Number of ASP Units is a required field.
The Number of ASP Units must be in a numeric
format.
The Number of ASP Units must have three decimal
places (i.e., XXXXXXXXX.XXX).
The Number of ASP Units can be a positive
number, a negative number, or equal to zero (0).
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Name
Wholesale
Acquisition
Cost
Number of
CAP Units
Excluded
User Action
Enter the Wholesale
Acquisition Cost (WAC) in
the field.
Enter the Number of CAP
Unites Excluded
Comments
The WAC is a required field.
The WAC must be in a numeric format.
The WAC must have three decimal places (i.e.,
XXXXX.XX).
The WAC can be a positive number, a negative
number, or equal to zero (0).
The Number of CAP Units Excluded is a required
field.
The Number of CAP Units Excluded must have
three decimal places (i.e., XXXXXXXXX.XXX).
The Number of CAP Units Excluded can be a
positive number, a negative number, or equal to
zero (0).
3. The Add or Edit Financial Data home page lists all of the drugs that have been submitted
during the current reporting period. Scroll through the list of drugs displayed on the Add
or Edit Financial Data home 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
Search to filter the results.
4. Enter the Manufacturer’s ASP, Number of ASP Units, Wholesale Acquisition Cost,
and Number of CAP Units Excluded in the respective fields.
5. Click the Save Financial Data button to add the drug financial data. Figure 4-14 will be
displayed, which indicates that the drug financial data has been successfully saved to the
ASP application database.
Figure 4-14: Add or Edit Financial Data – Financial Data Saved
4.4
Upload Financial Data – File Transfer
The ASP database provides drug manufacturers the ability submit Medicaid Part B financial data
to CMS. Perform the following steps to upload drug financial data using the file transfer
process:
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1. Click the Financial Data button on the left side menu on the ASP Application Home
Page and select Financial Data Upload from the drop-down list. The Financial Data
Upload selection on the ASP Application home page is shown in Figure 4-15.
Figure 4-15: Financial Data Upload Selection
2. Click Financial Data Upload. The Financial Data Upload page opens, as shown in
Figure 4-16.
Figure 4-16: Financial Data Upload Page
3. If the drug financial data has been entered and saves to a file of an acceptable file format,
click Browse to locate the file path and name of the file to be uploaded.
4. If the drug financial data has not been entered and saves to a file of an acceptable file
format, click the Click here of acceptable file formats link. A pop-up window opens
asking for authorization to upload a .zip file containing the file formats, as shown in
Figure 4-17.
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Figure 4-17: Attachment Upload -- .zip File
5. Click OK to upload the .zip file. The .zip file opens displaying the acceptable file form
templates, as shown in Figure 4-18.
Figure 4-18: Acceptable File Format Templates
6. Click any one of Finance Template files to open a finance data template. There are three
finance upload template options: financeTemplate.csv, financeTemplate.xlsx and
financeTemplate.xls. A sample template is shown in Figure 4-19.
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Figure 4-19: Sample Financial Data Template
7. Enter the drug financial information on the template. The entries on the template consist of
the same fields that are described in Section 2.3, Add Financial Data – Online Entry. Refer
to Table 2-2 for a description of the fields and which fields are required. Save the file using
a different name and to an easily accessible location on your computer. Close the file and
return to the Upload Financial Data page.
8. Click Browse to locate the file path and name of the file to be uploaded. A file upload
window will open.
9. Locate the file and click Open. The File Upload window will close, and the file to be
uploaded will be displayed on the Upload Product Data page, as shown in Figure 4-20.
Figure 4-20: Financial Data Upload – File to be Uploaded
10. Click Upload. The Upload Financial Data Result screen will open, as shown in Figure 4-
21.
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Figure 4-21: Financial Data Upload -- Result
11. The Upload Financial Data Result screen displays a report of the drug financial data that
was just uploaded using the file transfer process. Review the data on the screen. Data that
may be missing will be shown in the Status column. A sample upload with missing data is
shown in Figure 4-22.
Figure 4-22: Financial Data Upload – Error
12. Reopen the file that was uploaded and make the necessary corrections. Save the file, and
repeat Step 8 through Step 10.
13. Click Home on the main menu bar to return to the Medicare Part B ASP Application home
page.
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4.5
View Submitted Drug Data
Drug manufacturers have the ability to view drug data that has been submitted and certified
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 the Product Data button on the left side menu on the ASP Application Home Page
and select View Submitted Drugs from the drop-down list. The View Submitted Drugs
Selection on the ASP Application home page is shown in Figure 4-23.
Figure 4-23: View Submitted Drugs Selection
2. Click View Submitted Drugs. The View Submitted Drugs page opens, as shown in
Figure 4-24.
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Figure 4-24: View Submitted Drugs
3. Drug financial data and drug product data are displayed on this screen. This screen can be
used to verify drug data for accuracy. Scroll through the list of drugs displayed on the
View Submitted Drugs 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 Search to filter
the results Click Home on the main menu bar to return to the Medicare Part B ASP
Application home page.
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5
Certifications
Certifications
Data 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 CM for ASP pricing. The Drug Manufacturer certifies that the data reported are
correct.
5.1
Certify Drug Data Online
If you have the appropriate user access, the ASP Application provides drug manufacturers the
ability to certify the accuracy of drug data that has been previously submitted. Perform the
following steps to certify drug data online:
1. Begin certifying drug data by clicking the Certification button on the left side menu on the
ASP Application Home Page and select Drug Certification from the drop-down list, as
shown in Figure 5-1.
Figure 5-1: Drug Certification Selection
2. Click Drug Certification. The Drug Certification page opens, as shown in Figure 5-2.
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Figure 5-2: Drug Certification Home Page
The following table describes the fields and the user actions on the Drug Certification Screen..
Table 5-1
Name
Select Certification Status Page Information
User Action
Comments
Reporting
Period
Click the arrow on dropdown box and select the
desired quarterly
reporting period.
Defaults to the current quarterly reporting period.
Selection
Option
Click the arrow on the
drop-down box and
scroll through the list of
values. Click the
desired value.
Results will be displayed depending on the
selection of one of the following values: Drug Data
Pending Certification; Drug Data Certified this
Period; and View All Drugs in Period.
Manufactu
rer Name
Click the arrow on the
drop-down box to
display the list of
manufacturer names
Defaults to the View All value, which will display all
of the manufacturers’ names for the selected
quarterly reporting period.
Drug
Identifier
Enter all or part of the
drug identifier in the
Drug Identifier field.
This field is optional.
3. Select the desired quarterly reporting period from the Reporting Period drop-down list.
4. Select Drug Data Pending Certification from the Selection Option drop-down list (Drug
Data Pending Certification is the default value).
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5. Select the desired drug identifier from the Manufacturer Name drop-down list. The View
All value is the default value and will display all of the drugs for the selected quarterly
reporting period in the results,
OR
Enter all of part of the drug identifier in the Drug Identifier field.
6. Click the Submit button. The Drug Certification page shown in Figure 5-3 is displayed.
This page lists the drug data that are pending certification for the selected quarterly
reporting period. Each drug that is listed displays the following data: Drug Identifier;
Generic (Brand Name); Manufacturer’s ASP; Number of ASP Units; Wholesale
Acquisition Cost; Number of CAP Units Excluded; Status and Drug Details links.
Figure 5-3: Drug Certification Page – Pending
7. Click the Product link on any of the listed drugs to review the drug’s product details. The
drug product details are displayed in Figure 5-4.
Figure 5-4: Product Details
8. The drug’s product details that are displayed are the following: Manufacturer’s Name;
Generic (Brand Name); Strength of Product; Volume Per Item; Number of Items per
NDC/AltID; Date of First Sale; Expiration Date of Final Lot Sold; FDA Approval Date;
FDA Approval Type/App #/Supp #; and Status. Click the Close link to hide the drug
product data details.
9. Click the Financial link on any of the listed drugs to review the drug’s financial details.
The drug financial details are displayed in Figure 5-5.
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Figure 5-5: Financial Details
10. The drug’s financial details that are displayed are the following: Reporting Period;
Manufacturer’s ASP; Number of ASP Units; Wholesale Acquisition Cost; Number of CAP
Units Excluded; Status; and Drug Details links. Click the Close link to hide the drug
financial data.
11. Select the drugs to be certified. This can be done by clicking the Certify check box of the
individual drugs or by clicking the Certify All Data button at the bottom of the page. If a
drug is checked inadvertently, click the Reset All Checked Drugs button to clear the drug
check boxes.
12. Click the Certify Selected Data button or the Certify All Data button to begin the
certification process. The Data Certification Statement opens in a pop-up window as shown
in Figure 5-6.
Figure 5-6: Data Certification Statement
13. Review the certification statement that pertains to product certifications.
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14. Check the box next to I agree to the above certification statement to continue the
certification process.
15. Click the Proceed to Certify Data button located beneath the certification statement
checkbox. The Proceed to Certify Data button is shown in Figure 5-7.
Figure 5-7: Proceed to Certify Data Button
16. The ASP Application certifies the drug(s) and displays the confirmation message displayed
in Figure 5-8.
Figure 5-8: Certification Confirmation Message
5.2
View Drug Data
Drug Manufacturers have the ability to view all drug data that were certified during a selected
reporting period. In addition, Drug Manufacturers also have the ability to view all drug data, with
the statuses of Certified, Saved, or Pending, in a selected reporting period. These functions allow
drug manufacturers to view the drug data certification history for each submission.
5.2.1
View Drug Data Certified in the Reporting Period
Perform the following steps to view drug data that were certified during a selected reporting
period:
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1. Click the Certification button on the left side menu on the ASP Application Home Page
and select Drug Certification from the drop-down list. The Drug Certification page opens
(See Figure 5-2).
2. Select the desired reporting period from the Reporting Period drop-down list.
3. Select the Drug Data Certified this Period option from the Select Option drop-down list,
as shown in Figure 5-9.
Figure 5-9: Drug Data Certified This Period Option
4. Select the desired manufacturer from the Manufacturer Name drop-down list. The View
All value is the default value and will display all of the drugs for the selected quarterly
reporting period in the results,
OR
Enter all of part of the drug identifier in the Drug Identifier field.
5. Click the Submit button. The search results will be displayed, as shown in Figure 5-10.
Figure 5-10: Drug Data Certified This Period Results
6. Each record of drug data that has been certified displays the following: Drug Identifier;
Generic (Brand Name); Manufacturer’s ASP; Number of ASP Units; Wholesale
Acquisition Cost; Number of CAP Units Excluded; Status and Drug Details links. Click the
Product or Financial links under View Details to review the product or financial data for
a selected drug (See Figure 5-4 and Figure 5-5). Click the Close link to hide the drug
product data and drug financial data.
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5.2.2
Certifications
View All Drug Data in the Reporting Period
Perform the following steps to view all drug data with statuses of Certified, Saved, or Pending
during a selected reporting period:
1. Click the Certification button on the left side menu on the ASP Application Home Page
and select Drug Certification from the drop-down list. The Drug Certification page opens
(See Figure 5-2).
2. Select the desired reporting period from the Reporting Period drop-down list.
3. Select the View All Drugs in Period option from the Select Option drop-down list, as
shown in Figure 5-11.
Figure 5-11: View All Drugs in Period Option
4. Select the desired manufacturer from the Manufacturer Name drop-down list. The View
All value is the default value and will display all of the drugs for the selected quarterly
reporting period in the results,
OR
Enter all of part of the drug identifier in the Drug Identifier field.
5. Click the Submit button or press Enter. The search results will be displayed, as shown in
Figure 5-12.
Figure 5-12: View All Drugs in Period Results
6. Each record of the View All Drugs in Period Results displays the following: Drug
Identifier; Generic (Brand name): Manufacturer’s ASP; Number of ASP Units; Wholesale
Acquisition Cost; Number of CAP Units Excluded; Status and View Details links. Click
the Product or Financial links under View Details to review the product or financial data
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Certifications
for a selected drug (See Figure 5-4 and Figure 5-5). Click the Close link to hide the drug
product data and drug financial data.
5.3
Certification Assumptions
Drug Manufacturers can submit comments regarding their certifications to CMS. These
comments may be submitted during both the current and prior reporting periods. Perform the
following steps to submit certification assumptions to CMS:
1. Begin certifying drug data by clicking the Certification button on the left side menu on the
ASP Application Home Page and select Assumptions from the drop-down list. The
Assumptions selection is shown in Figure 5-13.
Figure 5-13: Certification Assumptions Selection
2. The Certification Assumptions pages opens, as shown in Figure 5-14.
Figure 5-14: Certification Assumptions Page
3. Select the desired reporting period from the Reporting Period drop-down list.
4. Select the desired manufacturer name from the Manufacturer Name drop-down list.
5. The ASP Application allows assumptions to be submitted by entering them directly in the
text box shown in Figure 5-14, or by uploading an attachment. Click the Upload your
assumptions document (.doc, .docx, .txt, .pdf/A) tab to open the Certification
Assumptions Page – Upload.
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6.
Certifications
The Certification Assumptions Page – Upload is shown in Figure 5-15.
Figure 5-15: Certification Assumptions Page -- Upload
7. Enter the assumptions and comments about a submission in the text box and click the
Submit button, or
8. Click the Browse button on the Upload your assumptions document (.doc, .docx, .txt,
or.pdf/A) tab, select the document to upload, and click the Submit button. The document
file must have one of the following extensions: .doc., .docx, or .txt, or .pdf/A.
9. The ASP Application will save the Certification Assumption and display a message as
shown in Figure 5-16.
Figure 5-16: Certification Assumptions Saved
10. Certification Assumptions that have been uploaded can be viewed by clicking the
Assumptions tab. The screen shown Figure 5-17 shows an example of a certification
assumption that has been uploaded.
Figure 5-17: Uploaded Certification Assumptions
11. The Certification Assumptions can be viewed and opened by clicking the file link in the
File Name column.
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6
Re-statements
Re-statements
Drug Manufacturers have the ability to resubmit drug data from prior quarters using the ASP
application. Drug data that can be restated includes both drug product data and drug financial
data. The drug data must have been certified in order for it to be restated. Restated data can be
submitted for any reporting period, including the current reporting period; however, the data
must have been certified. The ASP Application will then validate the drug product data or drug
financial data. The following subsections describe the steps to follow to restate both drug product
data and drug financial data.
6.1
Restate Drug Financial Data – Online
The ASP Application provides drug manufacturers the ability to restate drug financial data that
has been previously submitted and certified. Perform the following to re-state drug financial
data:
1. Begin re-stating drug data by clicking the Re-statements button on the left side menu on
the ASP Application Home Page. Select Restate Online from the drop-down list. The
Restate Online Selection on the ASP Application home page is shown in Figure 6-1.
Figure 6-1: Restate Online Selection Screen
2. Click Restate Online. The Restate Online page opens, as shown in Figure 6-2. The Restate
Online screen defaults to the Update Financial Data tab.
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Figure 6-2: Restate Online Screen – Main
3. Select the desired reporting period from the Select Re-Statement Period drop-down list.
The Drugs Available for Re-Statement field will be populated with all of the drugs that
are available for restatement in the reporting period that was selected (in the box on the
left). The Restate Online Selection screen opens as shown in Figure 6-3.
Figure 6-3: Restate Online Selection Screen
The following table describes the fields and the user actions on the Restate Online Selection
Screen on the Update Finance tab.
Table 6-1
Name
Restate Online Page Information – Update Financial Data Tab
User Action
Comments
Select ReStatement
Period
Click the arrow on dropdown box and select the
desired quarterly reporting
period.
The available Drug Identifiers will be listed after the
Re-Statement Period is selected.
Drugs
Available for
Re-Statement
Click the arrow on the dropdown box and scroll through
the list of values. Click the
desired value.
This box is on the left side of the screen.
Multiple Drug Identifiers can be selected.
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Name
Re-statements
User Action
Comments
Search/
Filter
Enter a few letters of the
drug’s generic name or the
numbers of the Drug
Identifier to filter the
selections in the field.
This field is optional.
Drugs Selected
for ReStatement
Click the arrow on the dropdown box to display the list
of drug identifiers.
The box will be populated with drugs available for
re-statement after a re-statement period is
selected.
Add>>
Click Add>> to move the
selected drugs available for
re-statement (in the box on
the left) to the Drugs
Selected for Re-Statement
field.
Once the drug identifiers are in the Drugs Selected
for Re-Statement box, they can be submitted for
restatement.
Add All>>
Click Add All>> to move all
available for re-statement (in
the box on the left) to the
Drugs Selected for ReStatement field.
Once the drug identifiers are in the Drugs Selected
for Re-Statement box, they can be submitted for
restatement.
<> or click Add All>> to select all
available drugs for re-statement. The selections have been moved and are to be populated
in the Drugs Selected for Re-Statement field as shown in Figure 6-5.
Figure 6-5: Restate Online -- Drugs Selected for Re-Statement
6. Click the Submit Re-Statement List button. The Review Re-Statement List opens as
shown in Figure 6-6.
Figure 6-6: Restate Online -- Review Re-Statement List
The drug’s financial details that can be modified are the following: ASP; ASP Units; WAC; and
CAP Units. The following table describes the fields and the user actions on the Add or Edit
Financial Data screen.
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Table 6-2
Name
Manufacturer’s
ASP
Number of
ASP Units
Wholesale
Acquisition
Cost
Number of
CAP Units
Excluded
Add or Edit Financial Data on the Re-Statement List Page
User Action
Enter or update the
Manufacturer’s ASP in the
field.
Enter the number of ASP
Units in the field.
Enter the Wholesale
Acquisition Cost (WAC) in
the field.
Enter the number of CAP
unites excluded
Comments
The Manufacturer’s ASP is a required field.
The Manufacturer’s ASP must be in a numeric
format.
The Manufacturer’s ASP must have three decimal
places.
The Manufacturer’s ASP can be a positive number,
a negative number, or be equal to 0.
The Number of ASP Units is a required field.
The Number of ASP Units must be in a numeric
format.
The Number of ASP Units must have three decimal
places.
The number of Number of ASP Units must be
greater than zero (0).
The WAC is a required field.
The WAC must be in a numeric format.
The WAC must have three decimal places.
The WAC cannot be equal to zero (0).
The Number of CAP Units Excluded is an optional
field.
The Number of CAP Units Excluded must be in a
numeric format.
The Number of CAP Units Excluded must have
three decimal places.
The Number of CAP Units Excluded must be
greater than zero (0).
7. Enter the necessary re-statement amounts for the Manufacturer’s Number of ASP Units;
Wholesale Acquisition Cost; and the Number of CAP Units Excluded values in the
respective fields.
8. Click the Re-State button located at the bottom of the screen. The re-stated financial data
will be saved and the screen shown in Figure 6-7 will be displayed.
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Figure 6-7: Re-State Product Data – Financial Data Saved
9. Click Home on the main menu bar to return to the Medicare Part B ASP Application home
page.
6.2
Restate Drug Product Data – Online
The ASP Application provides drug manufacturers the ability to restate drug product data that
has been previously submitted and certified. Perform the following to re-state drug product data:
1. Begin re-stating drug data by clicking the Re-statements button on the left side menu on
the ASP Application Home Page. Select Restate Online from the drop-down list. The
Restate Online Selection on the ASP Application home page is shown in Figure 6-8.
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Figure 6-8: Restate Online Selection Screen
2. Click Restate Online. The Restate Online page opens, as shown in Figure 6-2. The Restate
Online screen defaults to the Update Finance tab. Click the Update Product tab and select
the Re-Statement Period from the Select Re-Statement Period drop-down list as shown in
Figure 6-9.
Figure 6-9: Restate Online – Update Product Data Tab
3. The Restate Online -- Product Data screen opens, as shown in Figure 6-10.
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Figure 6-10: Restate Online – Product Data
The following table describes the fields and the user actions on the Restate Online Product Data
screen on the Update Product Data tab.
Table 6-3
Name
Restate Online -- Product Data Page Information
User Action
Comments
Select ReStatement
Period
Click the arrow on dropdown box and select the
desired quarterly reporting
period.
The available Drug Identifiers will be listed after the
Re-Statement Period is selected.
Drugs
Available for
Re-Statement
Click the arrow on the dropdown box and scroll through
the list of values. Click the
desired value.
This box is on the left side of the screen.
Multiple Drug Identifiers can be selected.
Search/
Filter
Enter a few letters of the
drug’s generic name or the
numbers of the Drug
Identifier to filter the
selections in the field.
This field is optional.
Drugs Selected
for ReStatement
Click the arrow on the dropdown box to display the list
of drug identifiers.
The box will be populated with drugs available for
re-statement after a re-statement period is
selected.
Add>>
Click Add>> to move the
selected drugs available for
re-statement (in the box on
the left) to the Drugs
Selected for Re-Statement
field.
Once the drug identifiers are in the Drugs Selected
for Re-Statement box, they can be submitted for
restatement.
Add All>>
Click Add All>> to move all
available for re-statement (in
the box on the left) to the
Drugs Selected for ReStatement field.
Once the drug identifiers are in the Drugs Selected
for Re-Statement box, they can be submitted for
restatement.
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Name
User Action
Comments
<> or click Add All>> to select all
available drugs for re-statement. The selections have been moved and are be populated in
the Drugs Selected for Re-Statement field as shown in Figure 6-12.
Figure 6-12: Restate Online --Drug Products Selected for Re-Statement
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7. Click the Submit Re-Statement List button. The Restate Online -- Re-Statement Product
List opens as shown in Figure 6-13.
Figure 6-13: Restate Online -- Re-Statement Product List
8. Click on any of the drugs’ links to begin the re-statement process. A sample Update
Product Data Re-Statement page is shown in Figure 6-14.
Figure 6-14: Update Product Data Re-Statement Page
The following table describes the fields and the user actions on the Update Product Data ReStatement page.
Table 6-4
Name
Drug Identifier
Update Product Data Re-Statement Page Information
User Action
Enter the Drug Identifier in
the field.
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Select Drug Identifier is for display only.
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Name
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User Action
Comments
Manufacturer
Name
Enter the name of the drug’s
manufacturer.
If a new manufacturer is entered into the ASP
Application, the manufacturer’s name will be
marked ‘Pending.’
Brand Name
Enter the brand name of the
drug in the field.
The Brand Name field is only displayed when the
Has Brand Name? box is checked.
Brand Name is required if the Has Brand Name?
box is checked.
The Brand Name is limited to 250 characters.
Generic Name
Select the Generic Name
from the drop-down list.
The Generic Name is required.
Date of First
Sale
Enter the date when the
drug was first available for
sale.
The Date of First Sale is required.
The date format is MM/DD/YYYY.
Expiration
Date of Final
Lot Sold
Enter the expiration date of
the final lot that was sold.
Scroll through the pop-up
calendar for the desired
date, or enter the date
directly into the field.
The date format is MM/DD/YYYY.
Strength of
Product
Enter the Strength of
product in the field.
The Strength of Product is required.
The Strength of Product has a limit of 250
characters.
The Strength of Product includes both the amount
and units (i.e., 6 ml).
The Volume per Item is required.
The Volume per Item has a limit of 250 characters.
The Strength of Product includes both the amount
and units (i.e., 6 ml).
Volume per
Item
Enter the Volume per Item in
the field.
Number of
Items per NDC
Enter the Number of Items
per NDC in the field.
The entry must be in a numeric format.
FDA
Application
Number
Enter the FDA Application
Number in the field.
The FDA Application Number is required.
The FDA Application Number format must be
alphanumeric.
FDA Final Premarketing
Approval Date
Enter the FDA Final Premarketing approval date.
Scroll through the pop-up
calendar for the desired
date, or enter the date
directly into the field.
The FDA Final Pre-marketing Approval Date is
required.
The date format is MM/DD/YYYY.
The FDA Final Pre-marketing Approval Date
cannot be after the upload date.
Enter the FDA Supplemental
Number in the field.
The FDA Supplemental Number format must be
alphanumeric.
This field is optional
FDA
Supplemental
Number
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Name
FDA Approval
Type
Re-statements
User Action
Select the FDA Approval
Type from the drop-down
list.
Comments
The FDA Approval Type is required.
9. Enter the necessary re-statement amounts for the desired fields.
10. Click the Update button located at the bottom of the screen. The re-stated product data will
be saved and the screen shown in Figure 6-15 will be displayed.
Figure 6-15: Re-stated Product Data Saved
11. Click Home on the main menu bar to return to the Medicare Part B ASP Application home
page.
6.3
Add New Product – Re-statement Tab
The Re-Statement Online functions allow drug manufacturers to add new drug product data for
previous reporting periods. Perform the following steps to add new product data using the ReStatement feature:
1. Click the Re-statements button on the left side menu on the ASP Application Home Page.
Select Restate Online from the drop-down list, and click the Add New Product tab.
2. Select a previous re-statement period from the Select Re-Statement Period drop-down
list. The screen shown in Figure 6-16 will be displayed.
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Figure 6-16: Restate Online – Add New Product
4. Refer to Section 4, Data Submission, for the steps needed to add new Product Data, and
click Save when complete.
6.4
Restate Financial Data – File Upload
The ASP database provides drug manufacturers the ability re-state Medicaid Part B financial
data to CMS. The ASP Application provides drug manufacturers the ability to restate drug
product data and drug financial data that has been previously submitted and certified. Also, the
ASP Application allows entry of prior quarters’ financial data through the use of the re-statement
function. This covers data that did not exist before the particular quarter. Perform the following
steps to re-state drug financial data using the file transfer process:
1. Click the Re-Statements button on the left side menu on the ASP Application Home
Page and select Restate Financial Data Upload from the drop-down list. The Restate
Financial Data Upload selection on the ASP Application home page is shown in Figure 617.
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Figure 6-17: Restate Financial Data Upload Selection
2. Click Restate Financial Data Upload. The Restate Upload Financial Data Upload
screen opens, as shown in Figure 6-18.
Figure 6-18: Restate Financial Data Upload
3. Select the desired re-statement period from the Select Re-Statement Period drop-down
list.
4. If the re-stated drug financial data has been entered and saved to a file of an acceptable
file format (.xls, .xlsx, or .csv), click Browse to locate the file path and the name of the
file to be uploaded.
5. If the re-stated drug financial data has not been entered and saved to a file of an
acceptable file format click the Click here of acceptable file formats link. A pop-up
window opens asking for authorization to upload a .zip file containing the file formats, as
shown in Figure 6-19.
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Figure 6-19: Attachment Upload -- .zip File
6. Click OK to upload the .zip file. The .zip file opens displaying the acceptable file form
templates, as shown in Figure 6-20.
Figure 6-20: Acceptable File Format Templates
7. Click any one of Finance Template files to open a product data template. A sample
template is shown in Figure 6-21.
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Figure 6-21: Sample Financial Data Template
8. Enter the re-stated drug financial information on the template. The entries on the template
consist of the same fields that are described in Section 6.1, Re-State Drug Financial Data
– Online Entry. Refer to Table 6-2 for a description of the fields and which fields are
required. Save the file using a different name and to an easily accessible location on your
computer. Close the file and return to the Restate Upload Financial Data page.
9. Click Browse to locate the file path and name of the file to be uploaded. A file upload
window will open.
10. Locate the file, click on the file, and click Open. The File Upload window will close, and
the file to be uploaded will be displayed on the Restate Financial Data Upload page, as
shown in Figure 6-22.
Figure 6-22: Restate Financial Data Upload – File to be Uploaded
11. Click Upload. The Restate Financial Data upload -- Result screen will open, as shown in
Figure 6-23.
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Figure 6-23: Restate Financial Data Upload -- Result
12. The Restate Financial Data Upload -- Result screen displays a report of the restated drug
financial data that was just uploaded using the file transfer process. Review the data on
the screen. Data with no errors is saved, and the upload status will display a message
stating that the data has been successfully saved. Data that contains errors will display the
errors in the Status column. A sample upload with erroneous data is shown in Figure 624.
Figure 6-24: Upload Restate Financial Data Result -- Error
13. Reopen the file that was uploaded and make the necessary corrections. Save the file, and
repeat Step 8 through Step 10.
14. Click Home on the main menu bar to return to the Medicare Part B ASP Application
home page.
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6.5
Re-statements
Restate Drug Product Data – File Upload
The ASP database provides drug manufacturers the ability re-state Medicaid Part B drug data to
CMS. Perform the following steps to re-state drug product data using the file transfer process:
1. Click the Re-Statements button on the left side menu on the ASP Application Home
Page and select Restate Product Data Upload from the drop-down list. The Restate
Product Data Upload Selection on the ASP Application home page is shown in Figure 625.
Figure 6-25: Restate Product Data Upload Selection
2. Click Restate Product Data Upload. The Upload Product Data page opens, as shown in
Figure 6-26.
Figure 6-26: Restate Product Data Upload
3. If the drug product data has been entered and saved to a file of an acceptable file format
(.xls, .xlsx, or .csv), click Browse to locate the file path and the name of the file to be
uploaded.
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4. If the drug data has not been entered and saved to a file of an acceptable file format click
the Click here of acceptable file formats link. A pop-up window opens asking for
authorization to upload a .zip file containing the file formats, as shown in Figure 6-27.
Figure 6-27: Attachment Upload -- .zip File
5. Click OK to upload the .zip file. The .zip file opens displaying the acceptable file form
templates, as shown in Figure 6-28.
Figure 6-28: Acceptable File Format Templates
6. Click any one of Product Template files to open a product data template. A sample
template is shown in Figure 6-29.
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Figure 6-29: Sample Product Data Template
* Please note that not all rows of the template are displayed in Figure 6-29.
7. Enter the drug product information on the template. The entries on the template consist of
the same fields that are described in Section 2.2, Upload Product Data – Online Data Entry.
Refer to Table 2-1 for a description of the fields and which fields are required. Save the file
using a different name and to an easily accessible location on your computer. Close the file
and return to the Upload Product Data page.
8. Click Browse to locate the file path and name of the file to be uploaded. A file upload
window will open.
9. Locate the file, click on the file, and click Open. The File Upload window will close, and
the file to be uploaded will be displayed on the Upload Product Data page, as shown in
Figure 6-30.
Figure 6-30: Restate Product Data Upload – File to be Uploaded
10. Click Upload. The Upload Product Data Result screen will open, as shown in Figure 6-31.
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Figure 6-31: Restate Product Data Upload -- Result
11. The Upload Product Data Result screen display a report of the drug product data that was
just uploaded using the file transfer process. Review the data on the screen. Data with no
errors is saved, and the upload status will display a message stating that the data has been
successfully saved. Data that contains errors will display the errors in the Status column. A
sample upload with erroneous data is shown in Figure 6-32.
Figure 6-32: Restate Product Data Upload Result -- Error
12. Reopen the file that was uploaded and make the necessary corrections. Save the file, and
repeat Step 8 through Step 10.
13. Click Home on the main menu bar to return to the Medicare Part B ASP Application home
page.
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Compliance
Compliance
The Compliance features allow Drug Manufacturers to view whether a drug is in compliance
with the drug submission reporting requirements. Drug Manufacturers can view compliance
statuses in one of two ways: CMS may send the Drug Manufacturer a compliance report
notification on their home page informing them that some data is out of compliance. Or Drug
Manufacturers can access a compliance summary for all drugs using the Compliance Summary
menu button on the ASP Application Home Page. The following subsections describe the steps
to view compliance reports using each method.
7.1
Compliance Summary Overview
In this scenario, CMS must have previously sent a bulletin to the Drug Manufacturer notifying
them of the compliance status. Perform the following steps to view compliance data using this
method:
1. Click the Compliance Summary selection on the ASP Application home page. The
Compliance Summary Overview page opens as shown in Figure 7-1.
Figure 7-1: Compliance Summary Overview
The following table describes the fields and the user actions on the Compliance Summary
Overview screen.
Table 7-1
Name
Reporting
Period
Select Certification Status Page Information
User Action
Click the arrow on dropdown box and select the
desired quarterly reporting
period.
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Comments
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Name
Manufacturer
(NDC1 Code)
Compliance
User Action
Click the arrow on the dropdown box and scroll through
the list of Manufacturers.
Click the desired
Manufacturer (and NCD1
Code).
Comments
Results will be displayed depending on the
selection of the Manufacturer.
2. The Compliance Summary Overview screen lists the compliance summary for all
manufacturers as a default. Select the desired reporting period from the Reporting
Period drop-down list and the desired manufacturer from the Manufacturer drop-down
list to view a compliance summary for a specific manufacturer. Click the View
Compliance Overview Detail button to display the summary report. A sample
manufacturer compliance summary report is shown in Figure 7-2.
Figure 7-2: Manufacturer’s Compliance Summary Report
3. The Compliance Summary Overview screen will display statements whether the Drug
Manufacturer is within compliance for all drug data within the reporting period. Drugs
that are listed in the columns as Missing; containing Saved Finance Data and Pending
Certification; or containing Restated Saved Finance Data and Pending Certification are
the drugs that are not compliant with the data reporting requirements. The additional
columns on the Compliance Overview page and their contents are reviewed in further
detail in the subsequent sections.
7.2
Compliance Overview
The Compliance Overview page displays all aspects of the reporting compliance for the selected
reporting period. The Compliance Overview page displays a notice to drug manufacturers
whether they are compliant with the data reporting requirements and the percentage of drugs that
have been certified out of the total number of drugs that have been submitted. Each tab on the
Compliance Overview page is further detailed in the following sub-sections.
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7.2.1
Compliance
Missing Drugs
Drug Manufacturers can view and update drugs that are not compliant because the information
about the drug is incomplete or insufficient by clicking on the Missing Drugs tab. The screen
shown in Figure 7-3 will be displayed.
Figure 7-3: Compliance Summary Overview—Missing Drugs
Drug Manufacturers have the ability to correct the deficiencies in the drug data by clicking
the Resolve link in the drug data’s summary or information. Click the Resolve link, and the
screen shown in Figure 7-4 opens displaying a warning banner that describes what needs to
be resolved in order for the drug data to be in compliance.
Figure 7-4: Compliance Summary Overview—Resolve
Refer to Section 4, Data Submission, for the steps needed to add and/or edit financial or drug
data in order to resolve the deficiencies.
7.2.2
Pending Certifications
Drug Manufacturers can view and update drugs that have saved financial data but whose
certifications are pending. Click the Pending Certification tab to view the drugs that require
certification resolution. The screen shown in Figure 7-5 is displayed.
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Figure 7-5: Compliance Summary Overview—Pending Certifications
Click the Resolve link on any drug listed to begin the resolution process. The screen shown in
Figure 7-6 is displayed.
Figure 7-6: Compliance Summary Overview—Resolve Pending Certifications
Refer to Section 5, Certifications, for the steps needed to certify drug data.
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7.2.3
Compliance
Pending Restatement Certifications
Drug Manufacturers can view and update drugs that have saved financial data that need to be
restated but whose certifications are pending. Click the Pending Restatement Certification tab
to view the drugs that require certification resolution. The screen shown in Figure 7-7 is
displayed.
Figure 7-7: Compliance Summary Overview—Pending Restatement Certification
Click the Resolve link on any drug listed to begin the resolution process. The screen shown in
Figure 7-8 is displayed.
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Figure 7-8: Compliance Summary Overview—Resolve Pending Restatement Certification
Refer to Section 5, Certifications, for the steps needed to certify drug data.
7.2.4
Total Certified
Drug Manufacturers can view and update drugs that have been certified during the selected
reporting period. Drug manufacturers are only permitted to view this information; changes
cannot be made on this tab. Click the Total Certified tab to view the drugs that have been
certified during the selected reporting period. The screen shown in Figure 7-9 is displayed.
Figure 7-9: Compliance Summary Overview—Total Certified
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Click the Total Certified tab to hide the new certified drug information.
7.2.5
Total Restatement Certified
The Total Restatement Certified tab allows drug manufacturers to view the product and financial
information for drugs that have been restated and certified. Drug manufacturers are only
permitted to view this information; changes cannot be made on this tab. Click the Total
Restatement Certified tab to view the restated drugs that have been certified. The screen shown
in Figure 7-10 is displayed.
Figure 7-10: Compliance Summary Overview—Total Restatement Certified
Click the Total Restatement Certified tab to hide the new certified drug information.
7.2.6
Total New Drugs
The Total New Drugs tab allows drug manufacturers to view the product and financial
information for new drugs that have been certified or saved. Drug manufacturers are only
permitted to view this information; changes cannot be made on this tab. Click the Total New
Drugs tab to view the new drugs that have been certified or saved. The screen shown in Figure
7-11 is displayed.
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Figure 7-11: Compliance Summary Overview—Total New Drugs
Click the Total New Drugs tab to hide the new certified drug information.
7.3
Export Options
Drug Manufacturers have the ability to export any of the Compliance data into three different file
formats: CSV, EXCEL, or PDF formats. The export options are listed at the bottom of a tab that
has been opened to display the selected compliance data. An example of the export options are
highlighted in Figure 7-12.
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Figure 7-12: Export Options
Click the desired export option to view the results. A dialog box will open similar to what is
shown in Figure 7-13
Figure 7-13: Export Options Dialog Box
Drug Manufacturers have the option to immediately open the file or save it to a selected location.
A sample file export in the CSV format is shown in Figure 7-14.
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Figure 7-14: CSV Export Option
The Excel export option is similar in format to the CSV Export option. A sample file export in
the PDF format is shown Figure 7-15
Figure 7-15: PDF Export Option
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| File Type | application/pdf |
| Author | rmccarthy |
| File Modified | 2018-02-13 |
| File Created | 2015-10-09 |