Office of

Pharmacy Affairs Website

STD, TB, FP,

RWI & RWII Recertification & Revalidation<= /o:p>

Manual

HTML Version

Updated 10.5.2007<= /o:p>

Important Notice:

The information contained in this manual ONLY pertains to= the recertification and revalidation of the following entity types:

STD, TB, FP, Ryan White I and Ryan Whit= e II.

Entity Recertification/Revalidation Instructi= ons

Introduction

These instructions are provided for Grantees to comple= te the annual recertification/revalidation process for their funded 340B Covered Entities.

In an effort to maintain current and accurate informat= ion, the recertification/revalidation process allows Grantees to update their 34= 0B Covered Entities using the HRSA OPA website at https://opan= et.hrsa.gov/opa/certification/Login.aspx with the logins provided.

Grantees or Covered Entities may request special inter= im updates and recertification/revalidation as needed from HRSA OPA and PSSC Staff.

Introduction. 2

Beginning the Recertification Process. 3

Certifying and Revalidating Information. 4

Frequently Asked Questions. 6

Beginning the Recertification Process

Receive Email notification <= o:p>

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St= ep 1. Receive E-mail notification

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· Open E-mail

· Click on Link to the login screen https://opane= t.hrsa.gov/opa/Certification/Login.aspx

Login to OPA Website

Step 2. Login using temporary password provided = in e-mail

· Enter Username from E-mail into the User Name box

· Copy and paste the temporary Password from E-mail into the Password box

· Click the Login button to go to the screen to change your password

Change Password

Step 3. Change temporary password

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· Enter a new password

· Enter new password again to confirm it

· New password must:

oContain 6-12 characters

oInclude alpha-numeric characters: a b c… 1 2 3…=

o= Include a special character from= this list: = @ # $ % ^ & * /

· Click the Change Password button=

· A notification message will disp= lay regarding an activation E-mail that will be sent=

Do not enable the “remember password” feature as we require freque= nt password changes.

Certifying and Revalidating Information
Receive Activation Email

Step 1. Receive Account Activation E-mail <= /o:p>

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·     Open E-mail

·     Click on Link to the login screen or copy and paste the address into your internet browser=

Login to Recertification Too= l

Step 2. Password Verification screen leads to the Login Page

·     Click the Login Page button

·     Enter your Username in the User Name box

·     Enter the new password you created into the Password box=

·     Click the Login button to view records awaiting recertification=

<= span style=3D'font-size:11.0pt'>

View Records to be Recertifi= ed

Step 3. View Records to be Recertified

·     To sort columns, click on the column title (to sort the information by that column in ascending order)<= span style=3D'font-size:11.0pt'> <= /o:p>

·     Click on a 340B ID number to ope= n the Entity record and view the detailed information to be updated and recertifi= ed (see next page)

View Details, Update, Recert= ify or Decertify Records

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Detailed record in= formation reflects contents of the 340B OPA database at the time the recertification batch was created.

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Step 4. Review and update Entity information

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·     Review all editable fields

·     Make updates as needed

·     If an Entity is still receiving funding and is continuing to participate, click t= he Certify (Revalidate) button when you are finished<= /p>
·     Confirm or cancel your selection when the message appears

·     If an Entity is no longer funded or chooses not to participate, click the Decertify (Terminate) button and fill in a reason for termination*.

·     Reset will return the original page data

·     Cancel will return you to the list without making changes to a record (this is good for viewing or printing)

·     Confirm or cancel your selection when the message appears

·     When selection is confirmed, the changes are saved and the list of records shows ONLY remaining the records to be completed

·     When all records have been updated, a notification message will indicate that the recertification process is complete.

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View Completion Message=

·     When selection is confirmed, the= changes are saved and shows ONLY the remaining records to be completed.<= /span>

·     When all records have been updat= ed, a notification message appears indicating that the recertification process is complete.

Completing the Certification Documents
Receive Certification Document Email =

Once the batch of Entities has been electronical= ly completed, HRSA will send an email containing Certification Documents and a batch summary.

Upon receipt of the Certification Documents:

STD, TB, RW I and RW II Entities=

= Complete the estimated dollar amount expended for covered outpatient drugs for = the preceding year

= Sign and date the document

= Fax completed document to 202-449-9473 or mail the signed original to:

  &nbs= p;   Office of Pharmacy Affairs

  &nbs= p;   HRSA 340B Recertification

  &nbs= p;   5600 Fishers Lane, Room 10C-03

  &nbs= p;   Rockville, MD 20857<= /span>

FP Entities

= Sign and date the document

= Fax completed document to 202-449-9473 or mail the signed original to:

  &nbs= p;   Office of Pharmacy Affairs

  &nbs= p;   HRSA 340B Recertification

  &nbs= p;   5600 Fishers Lane, Room 10C-03

  &nbs= p;   Rockville, MD 20857<= /span>

When this signed document is received by HRSA, t= he annual recertification process is complete. The updated Entities will be reflected in the database on the first day of the next calendar quarter.

Frequently Asked Questions

How do I use the 340B Recertification application?

Please use Internet Explorer as your internet br= owser. T= he application use is explained in this Recertification/Revalidation Manual.

How do I log in?<= /span>

This Recertification/Revalidation Manual will take you through the log in process step by step. It’s available online at http://opanet.hrsa.= gov/opa/Login/MainMenu.aspx. Click on the Need Help (?) icon and download the manual there.

I clicked the link in the activation email but nothing happens?

You may have received the email in plain text instead of HTML. Copy the address from the email and paste it into your internet browser address field, or ty= pe in the address: https://opanet.hrsa.gov/opa/Certification/Login.aspx

I entered the wrong password several times and it says I am locked out, contact the Administrator. What should I do?

Please notify us at 340B.recertification@hrsa.gov= or by calling 202-429-4110. We can “unlock” the account = so you can log in.

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I can’t log in. What should I do?

Accessing the internet through other applications (Lotus Notes) can cause problems with log in. Al= so, your individual computer or network settings may interfere with log in.

If you cannot log = in, please call 202-429-4110 or = email 340B.recertification@hrsa.gov= for assistance.

I want to delegate this proj= ect to someone on my staff. Will the= y be able to log in?

Yes, please email the person’s name, email address, 340B ID a= nd your organization name to us at 340B.recertification@hrsa.gov and we will resend a link to them.

Don’t simply forward the email to your designee. If you do, w= hen they log in, the automatic activation email will still be sent back to your email address. We need to upd= ate the 340B Database with your designee’s information so they receive the activation email, which is essential to complete the log-in process.

How do I look at a record wi= thout making changes?

Log in to the recertification/revalidation batch and Click on the 340B ID number. Click C= ancel to exit the record without making changes.

When I look at an entity rec= ord, why are most of the fields completed?

The entity record sho= ws the existing information in the 340B Database when we sent out the recertificat= ion batch.

I need a worksheet of each record. How can I print them?=

· Click on the 340B ID number

· Select File at the top menu, Select Page Setup, Select Landscape Orientation and O= K

· Click on File again, Select Print, and OK

· To exit the detail record click Cancel

How do I get out of the reco= rd if I’m not ready to Certify or Decertify?

Click Cancel at the b= ottom of the page. This returns you to= the main list and keeps the record in your list to be completed.

How do I make changes to the information?

Tab or click on the f= ield you want to change, then type in changes. You must then click Certify at the bottom of the page to save changes. There is no need to = make changes to records you will be decertifying.

Can I make changes and not Certify?

No, the only way to s= ave changes is to click Certify.

When I click Certify or Dece= rtify, why is the record removed from my main list?

When you click Certif= y or Decertify, you have completed the record so it is removed visually from your list. The only records on you= r main list are the ones you need to complete. When you decertify a record, be sur= e to enter the reason for termination in the pop up window that appears.

How do I get back into the application after I log off?

Add this link to your Favorites in your Internet Browser: htt= ps://opanet.hrsa.gov/OPA/Certification/Login.aspx

To log in the next ti= me, click this favorite and log in with the user name and password you created.=

I have two records for the s= ame program. How can I correct th= is?

Decide which one you = want to keep, make updates, and click Certify.&nbs= p; On the duplicate you do not want to keep, click Decertify and enter “Duplicate record” along with the 340B ID of the active record,= in the pop up window that appears.

I have a record that shows a shipping address. Do I need to click Add Shipping Address button?

No, if a shipping add= ress shows, it is already in the record. You may modify shipping address if you = need to by clicking in the fields and updating the information there. Click Cert= ify to save the updates, when you are finished.

Where do I send my completed Certification Documents?

Completed Certificati= on Documents can be:

Faxed to: <= /b>202-449-9473 or=

Mailed to:<= /b> Office of Pharmacy Affairs, HRSA 340B Recertification, 5600 Fish= ers Lane, Room 10C-03, Rockville, MD 20857

When do I add a Medicaid Pro= vider Number?

If your= entity is billing a states' Medicaid program directly (by NDC) for drugs purchased at 340B prices, the Office of Pharmacy Affairs is responsible for posting an entity's Medicaid Provider Number in the 340B Covered Entity Database, so you should include it.

State M= edicaid Programs use the 340B Medicaid Provider Numbers to create an exclusion file. The exclusion file is used to exclude Medicaid payment data for 340B priced drugs from states' Medicaid Rebate Claims to drug manufacturers. Legally, the manufacturers do not have to pay a Medicaid Rebate on drugs that were purchased at 340B discount. The state Medicaid programs only have to reimburse 340B drugs at acquisition cost plus dispensing.

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If you = do not directly bill states' Medicaid programs for 340B drugs or if you purch= ase drugs from non-340B sources for your Medicaid patients, then there is no possibility for a double discount and rebate and those rules do not apply. A non-340B drug may be billed at your standard Medicaid rate. In this situation you would enter "N/A" in the 340B Covered Entity database in the Medicaid Provider Number field because you do not bi= ll Medicaid for 340B drugs. If y= ou include your Medicaid Provider Number for drugs not billed to Medicaid, you will ca= use your state to erroneously exclude legitimate claims from their unit rebates= .

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When do the changes actually appear in the 340B Database?

Once approval is rece= ived from the Approving Manager, updated records will be activated in the 340B Database. All approved update= s will appear at the beginning of the next calendar quarter.

If I have additional questio= ns, who do I contact?

General 340B Questions:

HRSA Pharmacy Services Support Center
Phone: 202-429-4110 (local)
Email: pssc@a= phanet.org

Recertification Process Questions:

HRSA 340B Recertifica= tion Help Line

Phone: 202-449-9473

Email: 340B.recertification@hrsa.gov=

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Entity Recertification/Revalidation Instructi= ons

Introduction

Table of Contents

Frequently Asked Questions