HRSA - 340B Drug Pricing Program/Pharmacy Affairs

HRSA - U.S Department of Health and Human Services, Health Resources and Service Administration

Pharmacy Affairs & 340B Drug Pricing Program

340B Drug Pricing Program Update

340B Drug Pricing Program Registration Period Changes
The Office of Pharmacy Affairs (OPA) hosted a webinar on August 23, 2012 at 2pm, ET to inform stakeholders of the revised deadlines for registration of new covered entities and for adding outpatient facilities and contract pharmacy arrangements to the 340B Drug Pricing Program (340B Program). Please click here to review the 340B Drug Pricing Program Registration Period Changes webinar from August 23, 2012.

Online Covered Entity Change Requests
The Office of Pharmacy Affairs’ 340B registration database is now accepting online covered entity change requests. Entities should follow the ‘Submit Change Request’ link on the database home page to submit updated names, addresses, contact information and/or Medicaid billing details; all changes will be forwarded to the entity’s Authorizing Official for acceptance prior to being reviewed by OPA staff.

Please note that paper change request forms are still required for entity termination requests, changes to Authorizing Officials and/or changes to contract pharmacy relationships or manufacturer information. Paper requests for changes that can be made online are no longer being accepted; entities do not need to resubmit previously submitted paper requests online.

Health Resources and Services Administration Notice Regarding Section 340B of the Public Health Service Act Registration Period

July 24, the Health Resources and Services Administration (HRSA) issued a Federal Register notice to inform stakeholders of revised deadlines for registration of new covered entities and for adding outpatient facilities and contract pharmacy arrangements to the 340B Drug Pricing Program (340B Program). This revised registration process is effective October 1, 2012. The new deadlines are as follows:

Deadlines *

Registration Period

Start Date

October 1-October 15

January 1

January 1-January 15

April 1

April 1-April 15

July 1

July 1-July 15

October 1

* If the last date falls on a Saturday, Sunday, or Holiday, the following Monday will be the deadline.

This notice replaces all previous 340B Program guidance documents addressing the deadline and enrollment period for the 340B Program registration of new covered entities, addition of outpatient facilities and contract pharmacies, including any individual correspondence issued by HRSA on the subject.

Please note that for the quarter beginning October 1, 2012, the deadline remains September 1.

Program Integrity

New fact about HRSA 340B Program Audits have been posted.

Policy Release Update

2011-1.1 May 23, 2012 Clarification of Non-Discrimination Policy (PDF - 32 KB)

2012-1 May 23, 2012 Accountable Care Organizations (ACO) Policy Release (PDF - 32 KB)

Updated Frequently Asked Questions

New FAQs have been posted, including clarifications on hospital registration/recertification requirements.

340B Hospital Recertification Webinar for Manufacturers and Wholesalers

The Office of Pharmacy Affairs (OPA) hosted a webinar for manufacturers and wholesalers on April 26, 2012 at 3pm, ET to describe the upcoming annual recertification process for all participating 340B hospitals. As part of its overall program integrity strategy, OPA is conducting annual recertification of all 340B covered entities in Fiscal Year 2012. OPA wants to ensure that manufacturers and wholesalers understand the process and impact of this recertification process. All hospitals that entered the program prior to June 1st, 2011 must recertify their entity information. Please click here to review the 340B Hospital Recertification Webinar for Manufacturers and Wholesalers on April 26, 2012.

340B Peer-to-Peer Community

The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) and Pharmacy Services Support Center (PSSC) announce the launch of the Peer-to-Peer Community on healthcarecommunities.org. This 340B community will connect enrolled and eligible 340B entities with high performing sites that have exemplary pharmacy service offerings. This online resource contains various resources on 340B. Peer-to-Peer assistance will be provided through the 340B Network Webinar series where entities will have the opportunity to interact with the mentor sites for guidance, as well as access to a listserv to ask questions to the community as a whole. For more information, register as a member of the new 340B Peer-to-Peer Community . Once registered, select 340B Peer-to-Peer Community under the "My Communities" page.

340B Program Information

Register for the 340B Program on-line

Affordable Care Act Entities

Affordable Care Act Entities enrolled in the 340B Program as of 01/01/12 (XLSX - 153 KB)

A component of the Health Resources and Services Administration Healthcare Systems Bureau, the Office of Pharmacy Affairs has three primary functions:

Administration of the 340B Drug Pricing Program, through which certain federally funded grantees and other safety net health care providers may purchase prescription medication at significantly reduced prices.
Development of innovative pharmacy services models and technical assistance.
Service as a federal resource about pharmacy.

In all of its activities, OPA emphasizes the importance of comprehensive pharmacy services being an integral part of primary health care. Comprehensive pharmacy services include patient access to affordable pharmaceuticals, application of "best practices" and efficient pharmacy management and the application of systems that improve patient outcomes through safe and effective medication use.