Purpose: This document provides information on what to report to the Health Resources and Services Administration (hrsa) when a 340B price is unavailable for a covered outpatient drug. Instructions



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340B Price Unavailable

HRSA Notification Template







Purpose: This document provides information on what to report to the Health Resources and Services Administration (HRSA) when a 340B price is unavailable for a covered outpatient drug.
Instructions: Enter data in each field that describe the entity’s experience with the unavailable 340B price(s). Prior to the completion and submission of the form, covered entities are encouraged to directly contact the wholesaler and manufacturer to determine the reason for the unavailability and to better equip HRSA in understanding the circumstance. HRSA follows up on all allegations of non-compliance brought to our attention and will follow-up with all parties once the issue is reviewed.
The completed form should be emailed to HRSA at: 340Bpricing@hrsa.gov

Disclosure options:




  1. My signature below serves as consent for HRSA to disclose contact information to the manufacturer(s) in question, if necessary, so the covered entity can be contacted to help resolve the issue in question.




Contact’s Name:




Phone Number:




Email Address:




Printed Name of Submitter:




Date:




Submitter’s Signature:







  1. Check this box if the covered entity does not want to be disclosed to the manufacturer(s).




Field

Description

Enter Data Here

340B entity name, 340B ID, address of entity making report and contact name

Enter the covered entity name, 340B ID, address of the entity making this report, contact information for the person submitting the request, and date of submission

Entity Name:




340B ID:




Address:




Contact Name:




Contact Phone #:




Contact Email:




Notification Submission Date:




NDC

Drug Name and Strength Manufacturer



Enter the NDC, drug name and strength, and the manufacturer associated with the product.

NDC

Drug Name & Strength

Manufacturer










Date lack of 340B price was first observed

Enter the calendar date (MM-DD- YYYY) or approximate date when the lack of a 340B price was first observed. Enter NEVER if the 340B price has never been available.

MM

DD

YYYY










Date of last 340B purchase for this NDC

Enter calendar date (MM-DD-YYYY) or approximate date when the product was last available at a 340B price. Enter NEVER if the 340B price has never been available.

MM

DD

YYYY














Field

Description

Enter Data Here

340B entity’s method to purchase product during period of unavailable 340B price

Describe the mechanism through which the 340B entity makes purchases of this product during the time of the unavailable 340B price (e.g., GPO account,

Non-GPO/WAC account).



Period of unavailability:




to




Procurement method during this time:




Other/special description

This might include a product that has a 340B price available, but the entity is unable to actually purchase the product at a 340B price because of special limitation on purchasing. Example: the product is available only via a specialty pharmacy.

Other/Special Description:




Communications with manufacturer and/or wholesaler and response/reason for lack of price availability

This might include reasons such as a drug shortage or that the drug is not a covered outpatient drug or the distribution network is limited.

Name of wholesaler or distributor:




Reason given for lack of 340B availability and how this was communicated to the entity:




Please also submit to HRSA a copy of any written documentation of the communication.


Additional comments:


This tool is written to align with Health Resources and Services Administration (HRSA) policy, and is provided only as an example for the purpose of encouraging 340B program integrity. This information has not been endorsed by HRSA and is not dispositive in determining compliance with or participatory status in the 340B Drug Pricing Program. 340B stakeholders are ultimately responsible for 340B program compliance and compliance with all other applicable laws and regulations. Apexus encourages all stakeholders to include legal counsel as part of their program integrity efforts.
© 2016 Apexus. Permission is granted to use, copy, and distribute this work solely for 340B covered entities and Medicaid agencies.



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