STD/TB CHANGE REQUESTS (11/19/2013)
Access to online change requests for STD or TB grantees has been restored, although entities still need to update their authorizing official first via paper change request if the official listed on their database record is no longer correct.
OFFICE OF PHARMACY AFFAIRS / 340B DATABASE STATUS (10/17/2013)
The 340B Drug Pricing Program received registrations during the lapse in appropriations. We will not extend the registration period at this time. We will assume normal review processes beginning October 17, 2013. The 340B Program will contact registrants if there is an issue with the registration. If you have questions regarding a registration, please contact the 340B Prime Vendor Program at 888-340-2787 or ApexusAnswers@340Bpvp.com.
UPDATE FOR COVERED ENTITY/CONTRACT PHARMACY REGISTRATIONS (10/17/2013)
Covered entity and contract pharmacy registrations were accepted from 10/1/2013 through 10/15/2013 for a program start date of 1/1/2014; the next opportunity to register will be from 1/1/2014 through 1/15/2014 for a start date of 4/1/2014. There are no declared public health emergencies at this time.
OPA encourages registration early in the period so that any problems may be addressed and registrations resubmitted, if necessary. OPA cannot grant exceptions for incomplete registrations submitted at end of the period and not identified until after the deadline. For assistance with registrations, contact the 340B Prime Vendor Program at email@example.com call or 1-888-340-2787.
For hospitals: OPA requires copies of several documents to verify eligibility. Please review the supplemental hospital registration instructions carefully and submit the applicable documents on the same day that online registration is completed; registrations not accompanied by complete and correct documentation will be deleted and will not be reviewed (entities whose registrations have been deleted will be notified and can re-register until the last day of the registration period).
Please e-mail or fax materials to the appropriate address for your organization type; your Medicare provider number should be in the subject of the e-mail or prominently on the fax cover sheet:
|Disproportionate Share Hospitals
|Critical Access Hospitals
|Sole Community Hospitals
|Rural Referral Centers
|Freestanding Cancer Hospitals
Materials may also be sent via overnight courier at the entity’s discretion, although originals may be retained by the entity if e-mailed or faxed.
Health Resources and Services Administration
Attn: Office of Pharmacy Affairs
5600 Fishers Lane, 10C-03
Rockville, MD 20857
For Consolidated Health Center (CHC) and FQHC Lookalike program entities: The 340B database relies on HRSA's Electronic Handbooks (EHB) system to pre-validate site information and increase the efficiency of the registration process. You will need to know your HRSA grant or lookalike designation number, and you will not be able to register unless the proposed site is active and the site's EHB record is complete and accurate. (Sites that are still pending verification are NOT eligible to register for the 340B program.) If you need help locating your grant/designation number, contact the HRSA Bureau of Primary Health Care (BPHC) Help Line at firstname.lastname@example.org or 1-877-974-BPHC. If your EHB record is inaccurate, contact your HRSA project officer for assistance.
For other non-hospital covered entities: No additional documents are required at registration, although OPA may request additional information during our review of your registration material.
For contract pharmacy registrations: 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. Signed contract certification forms are no longer required; covered entity authorizing officials will receive e-mailed requests to certify registrations (or terminations) online and will have 15 calendar days to respond. Requests will expire if not certified within 15 calendar days; terminations may be re-entered at any time but new contract pharmacy arrangements will not be accepted until the next open registration period.
ORPHAN DRUG EXCLUSION (9/17/2013)
NOTE: Opt-in/out decisions were not reported for 102 covered entity sites in the original orphan drug exclusion file posted on 9/15/2013. The file was updated on 9/16/2013 and may be redownloaded by manufacturers, wholesalers and other stakeholders immediately. The replacement file name is "OrphanDrugRpt20130916.xlsx".
The 340B program database allows drug manufacturers and wholesalers to identify affected hospitals that will purchase orphan drugs under the 340B Program and will maintain auditable records to demonstrate compliance with the orphan drug exclusion, or that cannot or do not wish to maintain auditable records regarding compliance with the orphan drug exclusion and will purchase all orphan drugs outside of the 340B Program regardless of the indication for which the drug is used.
Covered entities may request changes to their orphan drug selection at any time, but changes are effective quarterly and only then if approved by OPA before the time of the snapshot (12:01am ET on the 15th day of the month prior to the start of each calendar quarter, irrespective of weekends or holidays). To access current or past quarters' selection files, follow the 'Download Orphan Drug Selection File' link above.
For more information about the orphan drug exclusion, view the archived version of HRSA's educational webinar. Please note that HRSA is revising the example and will provide updated slides as soon as possible; the current version may also be downloaded here.
ONLINE COVERED ENTITY CHANGE REQUESTS (6/27/2013)
Entities may now follow the ‘Submit Change Request’ link on the 340B database home page to submit online authorizing official updates if the existing authorizing official is available to certify the request. If the existing authorizing official has left the organization or is otherwise no longer available, paper change request forms are still required.
Paper change request forms are also required for entity termination requests; OPA continues to accept online requests for updates to site names, addresses, contact information and/or Medicaid billing details. For additional guidance, refer to the change request user guide located under the "Useful Links" section above.