340B OPAIS Pricing Application

Covered Entity User Guide

Table of Contents Introduction .............................................................................................................................. 1

Create an Authorizing Official (AO) Account ......................................................................... 2

HRSA Notification Email and Create AO User Account .......................................................... 2

Create a Primary Contact (PC) Account ................................................................................. 7

HRSA Notification Email and Create PC User Account........................................................... 7

Login and Authentication .......................................................................................................11

Login and Attestation .............................................................................................................11 Change Password/Forgot Password ......................................................................................17

Menu Bar Navigation ..............................................................................................................20

Menu Bar ...............................................................................................................................20

Ceiling Price Search ...............................................................................................................21

Ceiling Price Search ..............................................................................................................21

1

Introduction

The 340B OPAIS Pricing Application allows Covered Entities (CEs) the ability to establish a User Account to view verified 340B Ceiling Prices for covered discounted drugs. The Authorizing Official (AO) of the Covered Entity is required to self-attest their identity as well as approve access to the application for a Primary Contact Person (PCP) listed in the 340B Drug Pricing Program Database.

This guide describes how to:

Establish your user account

Login and Authenticate

Agree to the Health Resources and Services Administration (HRSA) Rules of Behavior

Sign the Attestation Form to attest to your identity

Look up Ceiling Prices

Covered Entity User Guide

Create an Authorizing Official (AO) Account

2

Create an Authorizing Official (AO) Account

HRSA Notification Email and Create AO User Account

1) HRSA will send an “ACTION REQUESTED: HRSA 340B OPAIS Pricing Application New Account Activation” email to the registered email address on file of the Authorizing Official of your organization with instructions on how to create an account. Click on the link in the email.

Figure 1: New Account Activation email

Covered Entity User Guide

Create an Authorizing Official (AO) Account

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2) When you click on the link in the email, the HRSA Rules of Behavior page is displayed.

Figure 2: Top portion of Rules of Behavior page

Figure 3: Bottom portion of Rules of Behavior page

The purpose of each of the form elements in the above screenshot are elaborated below:

3) Checkbox – “I Acknowledge and understand my responsibilities and agree to comply with the Rules of Behavior for the system.” – Acknowledge that you have read the HRSA Rules of Behavior by checking the box.

Covered Entity User Guide

Create an Authorizing Official (AO) Account

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4) User’s Name text box – Enter your first and last name.

5) Agree button – Click the button to indicate that you agree to the Rules of Behavior.

6) The Covered Entity Authorizing Official Attestation page is displayed. After reviewing your Primary Contacts’ and your contact information and associated 340B IDs, acknowledge by clicking on the check box. Then click ‘Submit’.

Note: If any of the information listed on this form is incorrect, please click on the “Click Here” link at the bottom of the page, to submit a Covered Entity Change Request.

Figure 4: Covered Official Attestation Form showing acknowledgement checkbox

7) After reviewing the Attestation Form, acknowledge the terms by clicking the checkbox.

The attestation text reads as follows:

“By selecting this checkbox, I confirm that I am the Authorizing Official and I have permission to access the 340B OPAIS Pricing Application. I also confirm that the above list of Primary Contacts associated with the Labeler Codes is correct and the Primary Contacts have permission to access the 340B OPAIS Pricing Application.”

8) Click one of the following buttons:

Submit: Click this button to submit the Attestation Form.

Cancel: Click this button to close the Attestation Form and cancel creation of your user account. The User Verification Cancelled page is displayed.

Covered Entity User Guide

Create an Authorizing Official (AO) Account

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9) HRSA will process your submitted account information and send a confirmation e-mail containing your user name and a link to the 340B OPAIS Pricing Application.

Figure 5: Confirmation e-mail containing user name and link to 340B OPAIS Pricing Application

10) Your submission of information to HRSA will also trigger an e-mail to your organization’s Primary Contact(s) containing a link to the HRSA Rules of Behavior page.

Figure 6: Confirmation e-mail containing user name and link to Rules of Behavior page

Covered Entity User Guide

Create an Authorizing Official (AO) Account

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11) Once the 340B OPAIS Pricing Application completes the approval process, the Set Password page is displayed.

Figure 7: Enter New Password page

12) Use the “Password” and “Confirm Password” spaces provided to enter your password and confirm it.

13) Click the “Set Password” button to set your password and create your user account.

14) When you click the “Set Password” button your password is set and your User Account is created and User Account Successfully Created page is displayed.

Figure 8: Account Successfully Created page

15) Click on the link in the Account Created page to display the 340B OPAIS Pricing Application Login page. See Login and Authentication Section for Login instructions.

Covered Entity User Guide

Create a Primary Contact (PC) Account

7

Create a Primary Contact (PC) Account

HRSA Notification Email and Create PC User Account

1) HRSA will send an “ACTION REQUESTED: HRSA 340B OPAIS Pricing Application New Account Activation” email to the registered email address on file of the Primary Contact of your organization with instructions on how to create an account. Click on the link in the email.

Figure 9: New Account Activation email

Covered Entity User Guide

Create a Primary Contact (PC) Account

8

2) When you click on the link in the email, the HRSA Rules of Behavior page is displayed.

Figure 10: Top portion of Rules of Behavior page

Figure 11: Bottom portion of Rules of Behavior page

The purpose of each of the form elements in the above screenshot are elaborated below:

3) Checkbox – “I Acknowledge and understand my responsibilities and agree to comply with the Rules of Behavior for the system.” – Acknowledge that you have read the HRSA Rules of Behavior by checking the box.

4) User’s Name text box – Enter your first and last name.

Covered Entity User Guide

Create a Primary Contact (PC) Account

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5) Agree button – Click the button to indicate that you agree to the Rules of Behavior.

6) The Covered Entity Primary Contact Attestation page is displayed. After reviewing your contact information and associated 340B ID, acknowledge by clicking the check box and then click the “Submit” button.

Figure 12: Covered entity Point of Contact Attestation Form showing acknowledgement checkbox

7) HRSA will process your submitted account information and send a confirmation e-mail containing your user name and a link to the 340B OPAIS Pricing Application.

Figure 13: Confirmation e-mail containing user name and link to 340B OPAIS Pricing Application

Covered Entity User Guide

Create a Primary Contact (PC) Account

10

8) Once the 340B OPAIS Pricing Application completes the approval process, the Set Password page is displayed.

Figure 14: 340B OPAIS Pricing Application Set Password page

340B OPAIS Pricing Application Set Password page provides spaces to enter your password and password confirmation, as well as instructions for password creation. (Your login name is automatically populated by the system.) The password instructions read as follows:

Note: Passwords must consist of at least eight (8) characters that cannot be easily guessed and must adhere to the following guidelines:

Passwords must contain at least one character from each of the following four categories: 1. English uppercase characters (A-Z)

2. English lowercase characters (a-z)

3. Numerical digits (0-9)

4. Special characters (e.g. @, !, $, %)

Characters may not be repeated more than once within a succession.

Passwords shall not contain all or part of the user’s account name.

9) Use the “Password” and “Confirm Password” spaces provided to enter your password and confirm it.

10) Click the “Set Password” button to set your password and create your user account. The User Account Successfully Created page is displayed.

Covered Entity User Guide

Login and Authentication

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Figure 15: Account Successfully Created page

11) Click the “Click Here” link in the Account Created page to display the 340B OPAIS Pricing Application Login page. See Login and Authentication Section for Login instructions.

Login and Authentication

Login and Attestation

1) Navigate to the HRSA website at https://opanet.hrsa.gov/340B/ and click the “CE Only” icon to reach the 340B Drug Pricing Program Database login page.

Figure 16: 340B Drug Pricing Program Database login page

Covered Entity User Guide

Login and Authentication

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2) Alternatively you can enter the URL https://340bpricing.hrsa.gov/ your browser’s address field to launch the 340B OPAIS Pricing Application Login page.

Figure 17: 340B OPAIS Pricing Application Login page

3) On the Login page, enter your Login Name and Password and click “Sign in.”

Note: You can only login after your User Account is created. For creating User Account see Create an Authorizing Official (AO) Account Section or Create a Primary Contact (PC) Account Section in this User Guide.

4) An Authentication Code email is sent to your email address on file. The Authentication Code email will include an authentication code to be entered on the Authentication Code page displayed after submitting your login credentials.

Note: If you do not see the Authentication Code email in your inbox, please check your junk mail folder.

Figure 18: Sample of Authentication Code Email

Covered Entity User Guide

Login and Authentication

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5) The Authentication Code page is displayed after submitting your login credentials. Enter your Authentication Code and click “Submit.”

Figure 19: Enter Authentication Code page

6) The HRSA Rules of Behavior page is displayed. After reading the Rules of Behavior, acknowledge by clicking on the check box and entering your full name in the User’s Name field and then click “Agree.”

Figure 20: Enter Authentication Code page

Covered Entity User Guide

Login and Authentication

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7) If you are an Authorizing Official, the Covered Entity Authorizing Official Attestation Form is displayed, containing the contact information for the Authorizing Official and provides data fields to edit it, as well as associated labeler codes and primary contacts. There is an attestation message, a “Click Here” link to enter changes via the 340B Manufacturer Change form, and “Submit” and “Cancel” buttons.

Note: If any of the information listed on this form is incorrect, please click on the “Click Here” link at the bottom of the page, to submit a Covered Entity Change Request.

Figure 21: Covered Entity Authorizing Official Attestation Form

8) After reviewing the Attestation Form, acknowledge the terms by clicking the checkbox.

The attestation text reads as follows:

“By selecting this checkbox, I confirm that I am the Authorizing Official and I have permission to access the 340B OPAIS Pricing Application. I also confirm that the above list of Primary Contacts associated with the Labeler Codes is correct and the Primary Contacts have permission to access the 340B OPAIS Pricing Application.”

9) Click one of the following buttons:

Submit: Click this button to submit the Attestation Form.

Cancel: Click this button to close the Attestation Form and cancel creation of your user account. The User Verification Cancelled page is displayed.

Covered Entity User Guide

Login and Authentication

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10) If you are a Primary Contact the Covered Entity Primary Contact Attestation Form is displayed, showing the name and contact information for the current PC and provides spaces to change it, as well as the associated labeler codes, a checkbox for accepting the attestation text, and “Submit” and “Cancel” buttons.

Figure 22: Covered Entity Primary Contact Attestation Form

11) After reviewing the Attestation Form, acknowledge the terms by clicking the checkbox.

The attestation text reads as follows:

“By selecting this checkbox, I confirm that I am the Primary Contacts and I have permission to access the 340B OPAIS Pricing Application.”

12) Click one of the following buttons:

Submit: Click this button to submit the Attestation Form.

Cancel: Click this button to close the Attestation Form and cancel creation of your user account. The User Verification Cancelled page is displayed.

Covered Entity User Guide

Login and Authentication

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13) The Ceiling Price Search page is displayed (for instructions, refer to the Ceiling Price Search section).

Figure 23: Ceiling Price Search page

Figure 24: Product Detail page

Covered Entity User Guide

Login and Authentication

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Change Password/Forgot Password

1) To change your password or if you have forgotten your password, click on the “Click here to recover your account” link on the Login page.

Figure 25: 340B OPAIS Pricing Application Login page

2) The “Forgot your password?” page is displayed. Enter your Login Name and click “Email Link.”

Figure 26: “Forgot your password?” page

Covered Entity User Guide

Login and Authentication

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3) Email confirmation page is displayed.

Figure 27: Password Reset Confirmation page

4) An email with a link to the ‘Reset Password’ page is sent to your email address on file.

Note: If you do not see the email in your inbox, please check your junk mail folder.

Figure 28: Snipped of “Forgot Password” email with reset password link

Covered Entity User Guide

Login and Authentication

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5) When you click on the link in the email the ‘Reset Password’ page is displayed.

Figure 29: Enter Your New Password page

6) In the spaces provided, enter your Login Name, enter your new password, and re-enter your new password to confirm it.

7) Click the “Reset button.” Your password is reset and a password reset confirmation is displayed.

Covered Entity User Guide

Menu Bar Navigation

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Menu Bar Navigation

Menu Bar

1) The Covered Entity Menu Bar displays the following Menu options:

Ceiling Price Search

Log Out

Figure 30: Covered Entity Menu Bar

Ceiling Price Search: When you click on the Ceiling Price Search menu option the Ceiling Price Search page is displayed.

Log Out: When you click on the Log Out menu option the 340B OPAIS Pricing Application logs you out.

Covered Entity User Guide

Ceiling Price Search

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Ceiling Price Search

Ceiling Price Search

1) When you select the “Ceiling Price Search” menu option, the Ceiling Price Search page is displayed.

Figure 31: Ceiling Price Search page

Edit Favorites: When you click on ‘Edit Favorites’, a pop up window is displayed. User can enter the favorite list of NDCs to be searched and displayed

Only Favorites: When you check the box ‘only favorites’ the previously saved favorite list of NDCs are displayed on the grid. When you uncheck the Covered Entities dashboard with the default ceiling price search results are displayed.

Column Heading: When you click on any of the column headings, such as National Drug Code, the report is sorted in ascending or descending order.

Expand Row: When you click on a National Drug Code link, the Product Detail page is displayed.

Column Filter: When you click on any of the column filter icons , the column filter

menu is displayed.

Covered Entity User Guide

Ceiling Price Search

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Column Filter Menu: The column filter menu options will vary based on the data displayed in the columns

No Filter: When you select “No Filter” from the Column Filter Menu, the No Filter options are displayed.

Page Scroll Options: To scroll through the report, page scroll options are displayed at the bottom of the last row.

2) When you click on ‘Edit Favorites’ button, a pop up window with header ‘Enter NDCs to Perform Search’ is displayed.

Figure 32: Ceiling Price Search page

Search: On the pop up window, enter the list of favorite NDCs to be displayed and click on button ‘search’.

Close: Click on close button to close the pop up window.

Covered Entity User Guide

Ceiling Price Search

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Figure 33: Product Detail page