Hrsa 340B Contract Pharmacy Registration

In addition to the full online registration, you must submit all required documents on the same day you complete the online registration. We will not consider incomplete packages. The RFP or PM has five business days to confirm that the company is receiving an eligible grant. If they do not respond to the email within the allotted time, we will refuse the registration. We limit the registration period for the registration of the 340B program of new covered facilities and the addition of ambulatory care facilities to the following: The instructions for registering 340B program hospitals (PDF – 94 KB) describe the required documentation. Contract pharmacies should be listed with the correct names and addresses to avoid delays in implementation. Contract pharmacies cannot participate in the 340B program until they have been approved by the Bureau of Pharmaceutical Affairs and the contract pharmacy is not listed on the 340B OPAIS. Contract pharmacies must enroll in the 340B program and be enrolled in OPAIS 340B before dispensing 340B drugs on behalf of a covered company. The companies concerned are responsible for compliance with their pharmacy contract(s) with all the requirements of the 340B program. Contract pharmacies must outsource Medicaid (i.e., not use 340B drugs for Medicaid patients) unless the covered entity has an agreement with the state Medicaid agency to avoid double discounts. The covered company must notify hrsa of these agreements. The Covered Entity Acquisition Application Checklist contains information on how to determine the right to hatch.

Requests for pharmacies under a cutting contract should be sent to OPAexclusion@hrsa.gov. Answering all the points on the checklist makes it easy to sign up smoothly. Outbreak applications will be reviewed by HRSA and, once approved and registered as an authentication option on the OPAIS 340B, the Company may begin training in contract pharmacies early in the next quarter. Contact the 340B Prime Vendor Program (PVP) for more information on sculpture contract pharmacies. Failure to correctly register contract pharmacies in OPAIS 340B may be a reason for the withdrawal of contract pharmacies from the 340B program. HRSA reserves the right to request documents for clarification or to verify compliance at any time. To verify eligibility, we will email the appropriate Project Manager (RFP) or Program Manager (PM) to confirm that the Corporation will receive an eligible grant for all types of registrations (e.g. B Ryan White (RW), Family Planning (FP), Hemophilia Treatment Centres (HTC), STD/318 and TB/317). If you do not complete the registration process, registration will be closed and you will need to start at the beginning of the process. Applications must be approved and submitted by the AO before the end of the open registration period. We require registration and approval of covered companies to participate in the 340B program.

Have all the information ready to complete the registration process efficiently. We may request more information during the review process and ask clarification questions about eligibility. Affected companies may not submit records outside of the above data unless the Secretary declares a public health emergency. Quarterly registration periods take place from the first to the fifteenth of January, April, July and October. This is the only time you can submit a new registration. In order to comply with the ongoing obligation to comply, all covered entities are required to supervise the contract pharmacy, maintain verifiable records and conduct annual audits of their contract pharmacies by an independent accounting firm. Any compliance activity or audit performed by a registered entity that indicates a violation of the requirements of the 340B program must be disclosed to THE HRSA and include the company`s plan to remedy the violation. You can only register contract pharmacies after entering into a written contract with a contract pharmacy before the end of the registration period.

Note: During the registration process, determine the classification you want to select before you begin. Use the Help section of 340B OPAIS to access user guides. Or you can contact the PVP before and during the registration period for technical support. Affected companies that decide to use pharmacy contracts must register each contract pharmacy. The companies concerned must register online pharmacy contracts during a registration period opened after a written contract. 340B OPAIS will inform you to upload documents upon registration if we need additional information. If you do not upload the required documents, we will not review or reject the registration. You must complete the online registration in a single session. If you do not complete the registration process, it will be closed and you will have to start at the beginning of the process. Note: Please note all deadlines included in the comments of the registration we return.

If we have any questions about your registration, the AO will receive a task notification email. This indicates an action to be taken when registering or to answer questions. To ensure that the authoritative agent (AO) and primary contact (PC) 340B receive OPAIS email notifications, add noreply@hrsa.gov to your email program`s spam filter. Read the detailed hospital registration instructions in the 340B program (PDF – 94 KB), including converting from one type of hospital to another. You must complete the online registration in a single session. When registering, have the Drug Enforcement Agency (DEA) number and pharmacy address of your pharmacy ready. The AO must be someone who can bind the organization to a contract, such as a CEO, chief operating officer, .B s chief financial officer, clinic administrator, or program manager. Be prepared to register all contract pharmacies at the time of registration. Search for 340B OPAIS for registered websites. This prevents you from saving duplicates or identifying completed records that you may want in the 340B program. Notice regarding the Drug Pricing Program 340B — Contract Pharmacy Services (PDF – 72.6 KB) are the guidelines governing the operation and compliance of contract pharmacies for businesses covered by 340B.

Applications must be approved and submitted by the AO before the end of the open registration period. The PC must be an employee of the organization. They may not be the same as the AO and may not be a consultant or contractor. Companies covered by 340B may choose to provide 340B drugs to patients through contract pharmacy services, an agreement in which the company covered by 340B signs a written contract with a pharmacy to provide pharmacy services. The use of a single contract pharmacy or several contract pharmacies is voluntary and a covered entity should first determine its pharmacy service needs and the appropriate distribution mechanism for those services when deciding whether or not to use a contract pharmacy. The written contract should identify all pharmacy locations and all covered business locations that use 340B drugs. HRSA recommends that the written agreement include all essential elements of the Guidelines for ContractEd Pharmacies (75 Fed. Reg. 10272 (5 March 2010)). . Your hospital must meet one of these classifications:.

. . Use the Help section of 340B OPAIS to access user guides. You should also use this number to periodically check that your entity`s information covered in the 340B OPAIS is up to date. It is your responsibility to ensure that your information is accurate. Let us know immediately if there are any changes to your eligibility. To register, you need a user account at the 340B Pharmaceutical Affairs Office (340B OPAIS). Visit the 340B OPAIS website and select “Help” in the top right corner of the page… Section 340B(L)(i) of the Public Health Services Act (PDF – 40 KB) defines the classifications of hospitals eligible for program 340B. . You can also find the federal grant number at the organization receiving the Federal Grant Program grant.

If you plan to use 340B drugs for your Medicaid patients, you must provide your Medicaid bill number or national provider ID. . Note: Always have your 340B ID number ready when you contact PVP for technical support… The 340B identification number is the unique number of your covered business that manufacturers, wholesalers and others use to verify your participation in the 340B program. If you`re not sure if your sites are already registered, contact the 340B Prime Vendor Program (PVP) for assistance. Hospitals must first enroll in the 340B program so that we can verify that the hospital meets all legal requirements before participating. You can only be registered and participate as a single hospital. . Use the following table as a guide to determine the federal grant number. Contact the PVP for assistance.

Upon approval, we will send an email to the AO confirming successful enrollment in the 340B program. This email includes the date on which you can start buying 340B drugs and the 340B identification number of your insured company. .