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340B Drug Pricing Program Update
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.
Public Health Emergency for State of New York
The public health emergency declaration for the State of New York has expired as of March 21; prospective 340B sites in New York will be enrolled under normal program timelines.
Public Health Emergency for State of Missouri
The public health emergency declaration for the State of Missouri has expired as of May 15; prospective 340B sites in Missouri will be enrolled under normal program timelines.
340B Program Information
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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.
Office
of Pharmacy Affairs
5600 Fishers Lane,
Parklawn Building, Mail Stop 10C-03
Rockville, MD 20857
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Current Issues / Highlights
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Zyprexa® Limited Distribution System (PDF - 38 KB) (March 28, 2012)
Stakeholders Letter: Program Integrity (PDF - 122 KB) (February 10, 2012)
Dava Pharmaceuticals Settlement (February 2012)
GAO Report Reveals 340B Program Benefits and Opportunities for Improvement (September 2011)
OIG Report on State Medicaid Policies and Oversight Activities Related to 340B Purchased Drugs (PDF - 728 KB) (June 2011)
New Technical Assistance Model (March 1, 2011)
Astra USA, Inc. v. Santa Clara County Supreme Court Opinion (PDF - 137 KB) (April 1, 2011)
Pulmicort Respules Allocation Management Program (PDF - 11 KB) (April 1, 2011)
Yaz® Limited Distribution System (PDF - 21 KB) (April 1, 2011)
Notice of Adjustment of 340B Ceiling Prices for Santarus, Inc (PDF - 14 KB) (March 11, 2011)
Notice of Re-Calculation of 340B Ceiling Prices for Biogen Idec (PDF - 19 KB) (March 11, 2011)
Medicare and Medicaid Extenders Act of 2010 (PDF - 130 KB) (February 28, 2011)
Notice Regarding Refunds of 340B Overchargers for Products Manufactured by Impax (PDF - 9 KB) (November 23, 2010)
HRSA Announces Director of OPA (PDF - 130 KB) (July 14, 2010)
More Current Issues |
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