#340B PROGRAM OVERVIEW REGISTRATION#

Visit the 340B OPAIS site and select вЂњhelpвЂќ in the upper right hand corner of the page. To register, you must have a 340B Office of Pharmacy Affairs (340B OPAIS) user account. What should you do before you register for the 340B Program?

You may register as more than one entity type-but, only if you meet the eligibility requirements for both. We will not consider incomplete packages.Д¬overed Entities must register for the 340B Program first so we can verify that you meet all statutory requirements prior to participation.

In addition to the complete online registration, you must submit any required supporting documentation on the same day you complete online registration. If the 15th falls on a Saturday, Sunday, or federal holiday, the deadline will be the next business day.Д¬overed entities will not be able to submit registrations outside of the dates we list above except when the Secretary declares a Public Health Emergency.

October 1-October 15 for an effective start date of January 1.

July 1-July 15 for an effective start date of October 1 and.

April 1-April 15 for an effective start date of July 1.

January 1-January 15 for an effective start date of April 1.

#340B PROGRAM OVERVIEW REGISTRATION#

We limit the registration period for 340B Program registration of new covered entities and the addition of outpatient facilities to the following: We require registration and approval for covered entities to participate in the 340B Program. See the complete list of eligible entities. 256b) lists the various types of organizations eligible to participate in and purchase discounted drugs under the 340B Program. A covered entity in an emergency situation should continue to ensure it has policies and procedures in place to address the situation and it must continue to keep auditable records.Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 U.S.C. This documentation should recognize the emergency nature of the situation, the name and address of the volunteer, and his/her relationship to the clinic, and should be kept on file by the covered entity. In the event of a declared emergency, where volunteer health professionals are providing health care, emergency documentation should be generated to make the relationship between the provider and the covered entity clear and to make clear the covered entityвЂ™s responsibility for providing care. In the event of a declared emergency, self-reporting of identity, condition and history are adequate for purposes of 340B recordkeeping requirements. For example, under these circumstances the patient may be without insurance cards or identity papers and providers may not have access to documented medical histories. It is the recorded information that creates a record. For purposes of 340B Program eligibility, the record may be a single form or note page. The record must identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed. In a declared emergency, an abbreviated health record may be adequate for purposes of the 340B Program. However, the context of the situation may be taken into account in determining whether an individual can qualify to receive 340B drugs during an emergency and meet the patient definition as outlined by HRSA.

An individual receiving 340B drugs must be a patient of the covered entity as defined by HRSA (PDF - 32 KB). HRSA recognizes that the circumstances surrounding disaster relief efforts warrant additional flexibility to affected 340B entities. Guidance to 340B providers participating in relief efforts during the Public Health Emergency Declaration by the Secretary If there is a change in a covered entity's eligibility status, the covered entity has a responsibility to immediately notify OPA and should stop purchasing drugs through the 340B Program.

Comprehensive Hemophilia Diagnostic Treatment CentersД¬overed entities must recertify their eligibility every year and notify the Office of Pharmacy Affairs whenever there is a change in their eligibility.

Federally Qualified Health Center Look-Alikes.

340b program overview