August 13, 2020. We will review steps, as well as discuss important details, that will help guide Covered Entities through the process. These new requirements and enhancements will become effective in the registration component of 340B OPAIS beginning August 1, 2020. Authorized users of 340B OPAIS must have a user account with appropriate roles and permissions granted by HRSA. 5. From the close of the two-week standard registration period through the end of the extended quarterly registration period, once a site is “active” in EHBs, the health center will need to contact the 340B call center to request a “one-time registration link.” The “My Entities” page is renamed to “Participant Dashboard,” which will include two distinct tabs: “My Tasks” and “My Entities”. Incorrect or outdated information in OPAIS can disrupt a health center’s eligibility for 340B pricing — leading to adverse find-ings during an audit, and required repayments to manufacturers. Please change or update your browser as needed. The 340B registration and pricing databases are collectively known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Please note that the registration function is only available during an open registration period. If the 340B covered entity site (340B ID) answers “yes” to this question, the site must also provide each Medicaid state it plans to bill and the billing number(s) it will list on the bill to the state. Welcome to 340B OPAIS. Recent changes to process for updating OPAIS With the launch of OPAIS in 2017, there were several changes to how “change requests” are handled. Make sure address on OPAIS matches address on your Contract Pharmacy Agreements; Accurately answer the Medicaid Carve-in/out question accurately for each site; If you process Medicaid claims for more than one state, make sure the Medicaid number from each state is listed on OPAIS “Active/Approved”- which will only contain entities that are currently active or have recently been approved. Purpose: The purpose of this tool is to provide an example of a 340B policy and procedure manual (P&P manual) that exhibits high program integrity, to assist participating family planning entity leaders in the preparation of a unique site-specific P&P manual that supports compliant 340B practices. However, because the new facility is not a reimbursable clinic with outpatient costs/charges on the hospital’s currently filed Medicare cost report (MCR), the hospital was not able to register this new clinic on the OPAIS database until it meets 340B clinic eligibility requirements. If the warning message is displayed, 340B OPAIS will prompt the AO/PC to attach a signed/dated Worksheet S from their most recently filed MCR. In addition to adopting new Covered Entity registration and recertification requirements, the Program Update outlines enhancements to the 340B Office of Pharmacy Affairs Information System (OPAIS). Office of Pharmacy Affairs Main Menu. UTMB begins using the contract pharmacy services arrangement only on, or after, the effective date shown on the HRSA 340B OPAIS. This information listed for each covered entity site (340B ID) in OPAIS is used to generate a quarterly Medicaid Exclusion File (MEF), which is the official data source used by stakeholders to determine which covered entity sites bill Medicaid fee-for-service for 340B drugs. The 340B Oversight Committee validates that each new associated site participating in the 340B Program is registered as associated sites on OPAIS during the OPA registration window which follows the site becoming active on the EHB. For more information on each classification, please review HRSA’s 340B Program Hospital Registration Instructions (DF - 94 KB). The registration has a separate User Guide to help users register. registration windows. HRSA also recently released new registration and recertification requirements. The audience for this 340B OPAIS User Guide is the Office of Pharmacy Affairs (OPA) Pricing Component for Covered Entity Authorizing Officials and Primary Contacts. in the 340B OPAIS by the end of their next annual recertification period. Browse Topics. Simplified® SUNRx was founded in 2006 with a single mission: to transform our client’s experiences and financial outcomes through relentless pursuit of knowledge and innovative healthcare services to help our clients focus on what matters most to you — improving care and medication access for low-income, rural, and vulnerable patients. Specific recertification window dates vary from year to year, but each year HRSA will send a notification to both the authorizing official and primary contact with details. The “My Tasks” tab will be displayed by default when participant users access the “Participant Dashboard” page and the tasks listed will span the entire page. 5. New registrations are accepted October 1-15, January 1-15, April 1-15 and July 1-15. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system. •The next quarterly window to register new delivery sites and contract pharmacy arrangements with HRSA will be Jan 1-15, 2019. Providing the NOFO number and the other elements is an additional check on eligibility of an STD/TB/RW entity. resources. A similar quarterly registration timeframe will be employed each quarter. Filter: All Files; Submit Search. If approved by OPA, the contract pharmacy may begin participating on the first day of the upcoming quarter. See registration dates above. HRSA encourages covered entities to work with states and their respective MCOs to develop strategies to prevent duplicate discounts. During the annual recertification period, all covered entity AOs/PCs will receive a daily email that summarizes the status of their recertification activities. We require registration and approval for covered entities to participate in the 340B Program. Visit the HRSA OPA website for information on registration and recertification. Any currently active covered entity site is responsible for updating their response to the modified Medicaid billing question (at this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?) For example, when a hospital was previously registered as an RRC, is currently active as a DSH, and wants to change its entity type back to an RRC. Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 U.S.C. the Office of Pharmacy Affairs Information System (OPAIS). Access the 340B Office of Pharmacy Affairs Information System. Links. 4. Get Started Search. 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. Reports / Files. In addition to adopting new Covered Entity registration and recertification requirements, the Program Update outlines enhancements to the 340B Office of Pharmacy Affairs Information System (OPAIS). This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network. This process will allow the hospital to also reinstate their child sites. ET) The links marked (PDF) are for PDF manuals suitable for printing. Find Information. 2. Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring. AO/PC users will have the flexibility to add more columns and filter to locate the tasks efficiently. Contract Pharmacies must also be registered again. OPAIS Registration happens quarterly, and with the summer registration period approaching this July, it is important for organizations to have all of their ducks in a row and feel confident, prepared, and organized. “Pending”- which will contain pending registrations or change requests. Subscribe to receive RSS notifications when new 340B recertification FAQs are added or updated. The signed forms “are due to OPA [the Office of Pharmacy Affairs] within 15 days from the time online registration was completed” and “incomplete packages will not be considered.” If you have any questions, please contact 340B Health General Counsel Maureen Testoni at … Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose. Post Navigation. The Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) is providing an update on new covered entity registration and recertification requirements and enhancements to the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Contact the 340B Prime Vendor. •Registrations made during this window will become effective starting April 1, 2019 OPAIS Registration Window Coming Soon Whenever possible, please register your sites with HRSA during the regular two- SUNRx 340B. If the PC creates the registration, the AO will receive email task notifications indicating there are contract pharmacy registrations … The pricing component of the 340B OPAIS will send an email alert to the registered authorizing official and primary contact of the manufacturer when the two-week window for reporting is open, as well as daily reminders that tasks are pending within the pricing component of the 340B OPAIS. Some of the requirements/enhancements will only impact certain entity types as indicated in more detail below. Registration is the process of adding a new covered entity, outpatient facility, or contract pharmacy to the 340B Drug Pricing Program. The NOFO number correlates to the Federal Grant Number, which is already required during registration. A progress window is displayed while the export is being prepared. See the complete list of eligible entities. The new information system focuses on three key priorities: Security; User accessibility; Accuracy; On September 18, 2017, the Health Resources and Services Administration (HRSA) replaced the 340B Database with the much-anticipated 340B Office of Pharmacy Affairs Information System (OPAIS). 3. 8AM-5PM CT Mon-Fri. ApexusAnswers@340Bpvp.com. Coordinate registration of your contract pharmacy. If this is your first time registering, or you need a refresher, sign up for our educational webinar. The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Office of Sexually Transmitted Disease (STD) Clinics/Tuberculosis (TB) Clinics and Ryan White HIV/AIDS Clinics (RW). HRSA is now requesting documentation to support the hospital classification selected at the time of registration to further verify eligibility of hospital registrations. The Free Dictionary 256b) lists the various types of organizations eligible to participate in and purchase discounted drugs under the 340B Program. Search. Ways To Manage Cash Flow Healthy Food Ideas Recent Posts 340B OPAIS will prompt Authorizing Officials and Primary Contacts (AOs and PCs) to upload supporting documentation for the “Hospital Classification” selected at the time of registration of a parent hospital. Click the Cancel button if you want to cancel the export before it finishes. A message window displays when the export is completed and a dialog box will prompt you to open the file or save it for later. Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties. Types of entities eligible to participate in the 340B Drug Pricing Program are listed in section 340B(a)(4) of the Public Health Service Act (PHSA). Registration. OMB Number: 0915-0327, Expiration: 11/30/2022, U.S. Department of Health and Human Services. On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. Office of Pharmacy Affairs Frequently Asked Questions, 340B University with slides, notes and other tools, 340B Prime Vendor Program website The Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) is providing an update on new covered entity registration and recertification requirements and enhancements to the 340B Office of Pharmacy Affairs Information System (340B OPAIS). OPAIS Registration is right around the corner, July 1st – 15th! The registration process must be completed during the open enrollment window between October 1 through 15, 2019 as required by Health Resource and Services Administrations's (HRSA), Office of Pharmacy Affairs (OPA). Welcome to 340B OPAIS Online Help for Public Users. Purpose: The purpose of this tool is to provide an example 340B Program policy and procedure (P&P) manual that exhibits high program integrity to assist participating rural referral center (RRC) leaders in the preparation of their own unique, site-specific P&P manual that supports placing guidance and/or policy into compliant practice. These include: the Notice of Funding Opportunity (NOFO) number at the time of registration; the type of in-kind support they are receiving (if applicable). Within 15 days from the date of the online registration, the Authorizing Official attests online that the contract pharmacy registration request was completed. Eligible Organizations Section 340B(a)(4) of the Public Health Service Act specifies which covered entities are eligible to participate in the 340B Drug Program. Get reimbursed for COVID-19 testing and treatment of uninsured individuals. Disclaimer: This application is only supported by Chrome or Internet Explorer version 9, and 11 or later. Review OPAIS Database every Quarter during the registration window. April 26, 2020. Please note, that PCs will still be able to submit the CP termination request, and AOs will still have to attest. The 340B OPAIS will now display a warning message to Parent hospitals if their Medicare Cost Report (MCR) Filing Date is more than 5 months and 5 days after the Cost Report End Date in the Qualification Information section. Health Care Alert. In addition, the 340B OPAIS has been enhanced based on HRSA’s July 2020 update. apexusanswers@340bpvp.com. These include qualifying hospitals, Federal grantees from HRSA, the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services’ Office of Population Affairs, and the Indian Health This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network. 340B Program . registration windows. This system is provided for Government-authorized use only. STD/TB/RW entities will be required to enter the following in 340B OPAIS at the time of registration: This change was made to assist HRSA in accurately determining the eligibility of the STD/TB/RW registration. We limit the registration period for The 340B OPAIS will now feature the ability for AOs to better locate and select contract pharmacies (CPs) for termination. The 340B Oversight Committee validates that each new associated site participating in the 340B Program is registered as associated sites on OPAIS during the OPA registration window which follows the site becoming active on the EHB. The MEF only applies to fee-for-service Medicaid. For security reasons inactive sessions are automatically closed. AOs will be able to view a summary page that lists all of the CPs the AO has selected for termination and this should help eliminate any confusion on what CPs are being terminated. What would you like to do? Message You are entering an official US Government computer network! Recertification is performed via the HRSA 340B Office of Pharmacy Affairs Information System (340B OPAIS) during quarterly open registration windows. OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification Requirements. AOs/PCs will stop receiving this daily email once all recertifications have been completed. Office of Pharmacy Affairs 340B OPAIS The hospital contacted Apexus Answers to determine what account should be used to purchase the … 340B OPAIS will now allow hospitals to efficiently reinstate previously terminated sites. That is where 340Basics comes in to help! These new requirements and enhancements will become effective in the registration component of 340B OPAIS beginning August … Have questions? Covered entities began using 340B OPAIS in 2017 and at that time, HRSA removed the requirement of a Government Official to attest to the hospital classification of a parent hospital. "Pending AO/PC"- any recertification task that is still waiting on submission from the AO or PC, "Pending OPA Review"- any recertification submission that is being reviewed by OPA, "Completed"- any recertification that has been approved by OPA. Health Resources & Services Administration, Performance Measurement & Quality Improvement, 340B Program Hospital Registration Instructions, U.S. Department of Health and Human Services. “Terminated”- which will contain terminated or rejected entities. Previous Post opais. For example, the field 340B ID will be added to the tasks list to enable participant users to identify tasks easily. OPAIS is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms OPAIS - What does OPAIS stand for? CHCLC begins using the contract pharmacy services arrangement only on or after the effective date shown on the HRSA OPAIS 340B Database. Search Reports/Files I am a Participant. The Medicaid billing question is modified as follows: This change was made to clarify that the question is specific to Medicaid fee-for-service, to a covered entity site and to clearly delineate each Medicaid state that is billed for 340B drugs, and the billing number(s) listed on the bill to the Medicaid state. By using this system, you understand and consent to the following: The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. www.340bpvp.com 1-888-340-2787. Everything You Need to Know About OPAIS Registration. Reports / Files. Within 15 days from the online registration, the Authorizing Official certifies online completion of the contract pharmacy registration. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. The following links provide additional 340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA).