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What's New

RECERTIFICATION: FAMILY PLANNING (4/7/2014)

The Office of Pharmacy Affairs (OPA) is required to recertify all participating 340b covered entities annually to ensure 340B database accuracy and promote compliance with 340B program requirements. OPA held an informational recertification webinar for Title X Family Planning Grantees on 4/2/2014; a recording of the session is available for review.

Authorizing Officials for family planning grantees will receive user names and passwords on 4/21/2014; all sites must be certified/decertified and the final attestation step completed by 5/21/2014. Covered entities that fail to complete the process will be terminated from the program and will need to reapply during the next registration period (7/1/2014 - 7/15/2014, for a start date of 10/1/2014).

For more information about recertification, or if your Authorizing Official does not receive their user name and password on 4/21/2014, contact the 340B Prime Vendor Program at 1-888-340-2787 or apexusanswers@340bpvp.com.

DATABASE ENHANCEMENTS (3/31/2014)

The Office of Pharmacy Affairs has added the following features to the 340B database:

- Online requests for reinstatement of previously active sites
- Simultaneous online covered entity and contract pharmacy registrations
- Online covered entity termination requests

An updated user guide will be available shortly.

Important Notifications

340B CHANGE REQUESTS / PERFORMANCE (4/16/2014)

Covered entities may resume submission of change requests to add Medicaid provider numbers and/or NPIs to records where none previously existed, although the ability to add initial shipping addresses remains limited. (Additional shipping addresses may be added and existing addresses removed, but users still receive an error when attempting to add shipping addresses where none previously existed. We continue to investigate the problem and will post a notice here once a resolution has been identified.)

OPA is aware of broader performance concerns with the 340B database; our technical team is investigating and we ask for your patience as we attempt to implement both short- and long-term solutions. If possible, accessing the database in the early morning or in the evening may yield a more satisfying experience than attempting to do so in the middle of the day.



COVERED ENTITY/CONTRACT PHARMACY REGISTRATIONS (4/16/2014)

The April 2014 window for covered entity and contract pharmacy registrations has closed; registrations will next be accepted from 7/1/2014 through 7/15/2014 for a program start date of 10/1/2014. The following opportunity to register will be from 10/1/2014 through 10/15/2014 for a start date of 1/1/2015.

Due to the limited nature of the registration period, OPA encourages entities to register early so that any problems may be addressed and registrations resubmitted, if necessary. For registration assistance, contact the 340B Prime Vendor Program at apexusanswers@340bpvp.com or call 1-888-340-2787.

Hospitals should review the supplemental registration instructions carefully; Consolidated Health Center and FQHC Lookalike program entities should confirm that their sites are active in HRSA's Electronic Handbooks (EHB) system and that the information for those sites is complete and accurate. The 340B database utilizes information from the U.S. Drug Enforcement Administration (DEA) to ensure consistent and accurate contract pharmacy registrations. Registrants will identify proposed contract pharmacies by entering DEA numbers or searching by pharmacy name/location; covered entity authorizing officials will receive e-mailed requests to certify registrations (or terminations) online and will have 15 calendar days to respond.

Covered entities and manufacturers/wholesalers may verify individual approved/terminated covered entity and contract pharmacy registrations using the search functions above; industry stakeholders are encouraged to download the Covered Entity Daily Report under the 'Reports' tab (please also note that the report contains a separate row for each possible combination of shipping address and contract pharmacy -- a site with two shipping addresses and five contract pharmacies will be listed across ten rows).


You are entering an official US Government computer network! NEVER save your user-ID or password when accessing this system (especially on non-government computers). Please Note: You are entering an official United States government system, which may be used only for authorized purposes. This system may contain nonpublic HRSA information within the meaning of 12 CFR 4.32(b) that is subject to use and disclosure restrictions specified at 12 CFR 4.37. The unauthorized use or disclosure of nonpublic HRSA information or the unauthorized modification of any information stored on this system may result in criminal prosecution or administrative proceedings.

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0327. Public reporting burden for this collection of information is estimated to average one to two hours per response for registration and thirty minutes for recertification, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-29, Rockville, Maryland, 20857.


OMB Number: 0915-0327, Expiration: 10/31/2015
U.S. Department of Health and Human Services (HHS)
Health Resources and Services Administration (HRSA)
Office of Pharmacy Affairs (OPA) - 340B Program
April 20, 2014
6:46 AM ET
Questions, Comments, or Suggestions
Email Us: ApexusAnswers@340bpvp.com
Call Us: 1 - 888 - 340 - 2787

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