New Registration and Recertification Requirements and Enhancements to the 340B Office of Pharmacy Affairs Information System (340B OPAIS)

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).

These new requirements and enhancements will become effective in the registration component of 340B OPAIS beginning August 1, 2020. Some of the requirements/enhancements will only impact certain entity types as indicated in more detail below.

New Registration and Recertification Requirements

Impacted Covered Entities	Overview of New Requirement	Why is HRSA Making this Change?
All Hospital Types	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. For more information on each classification, please review HRSA’s 340B Program Hospital Registration Instructions (DF - 94 KB). If a hospital is changing classifications during recertification, they will also be required to upload supporting documents.	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. HRSA is now requesting documentation to support the hospital classification selected at the time of registration to further verify eligibility of hospital registrations.
Sexually Transmitted Disease (STD) Clinics/Tuberculosis (TB) Clinics and Ryan White HIV/AIDS Clinics (RW)	STD/TB/RW entities will be required to enter the following in 340B OPAIS at the time of registration: the Notice of Funding Opportunity (NOFO) number at the time of registration; the date range of their NOFO funding; the type of in-kind support they are receiving (if applicable). Any currently active STD/TB/RW entity will be required to update this information during their next recertification submission.	This change was made to assist HRSA in accurately determining the eligibility of the STD/TB/RW registration. The NOFO number correlates to the Federal Grant Number, which is already required during registration. Providing the NOFO number and the other elements is an additional check on eligibility of an STD/TB/RW entity.
All	The Medicaid billing question is modified as follows: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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. Billing number(s) may include the billing provider’s national provider identifier (NPI) only, state assigned Medicaid number only, or both NPI and state assigned Medicaid number. 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 MEF only applies to fee-for-service Medicaid. HRSA encourages covered entities to work with states and their respective MCOs to develop strategies to prevent duplicate discounts. If a covered entity site does not intend to bill any state’s Medicaid fee-for-service program for 340B drugs, the covered entity site should answer “no” to the Medicaid billing question. 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?) in the 340B OPAIS by the end of their next annual recertification period.	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.

Impacted Covered Entities

Overview of New Requirement

Why is HRSA Making this Change?

All Hospital Types

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.

For more information on each classification, please review HRSA’s 340B Program Hospital Registration Instructions (DF - 94 KB).

If a hospital is changing classifications during recertification, they will also be required to upload supporting documents.

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.

HRSA is now requesting documentation to support the hospital classification selected at the time of registration to further verify eligibility of hospital registrations.

Sexually Transmitted Disease (STD) Clinics/Tuberculosis (TB) Clinics and Ryan White HIV/AIDS Clinics (RW)

STD/TB/RW entities will be required to enter the following in 340B OPAIS at the time of registration:

the Notice of Funding Opportunity (NOFO) number at the time of registration;
the date range of their NOFO funding;
the type of in-kind support they are receiving (if applicable).

Any currently active STD/TB/RW entity will be required to update this information during their next recertification submission.

This change was made to assist HRSA in accurately determining the eligibility of the STD/TB/RW registration. The NOFO number correlates to the Federal Grant Number, which is already required during registration. Providing the NOFO number and the other elements is an additional check on eligibility of an STD/TB/RW entity.

All

The Medicaid billing question is modified as follows: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?”

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.

Billing number(s) may include the billing provider’s national provider identifier (NPI) only, state assigned Medicaid number only, or both NPI and state assigned Medicaid number.

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 MEF only applies to fee-for-service Medicaid. HRSA encourages covered entities to work with states and their respective MCOs to develop strategies to prevent duplicate discounts.

If a covered entity site does not intend to bill any state’s Medicaid fee-for-service program for 340B drugs, the covered entity site should answer “no” to the Medicaid billing question.

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?) in the 340B OPAIS by the end of their next annual recertification period.

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.

New 340B OPAIS Enhancements

New 340B OPAIS Enhancement	Description of Change
Contract Pharmacy Terminations	The 340B OPAIS will now feature the ability for AOs to better locate and select contract pharmacies (CPs) for termination. 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. Please note, that PCs will still be able to submit the CP termination request, and AOs will still have to attest.
“My Tasks” and “My Entities” Pages	The “My Entities” page is renamed to “Participant Dashboard,” which will include two distinct tabs: “My Tasks” and “My Entities”. 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. AO/PC users will have the flexibility to add more columns and filter to locate the tasks efficiently. For example, the field 340B ID will be added to the tasks list to enable participant users to identify tasks easily. The “My entities” tab will include three different tabs, including: “Active/Approved”- which will only contain entities that are currently active or have recently been approved. “Pending”- which will contain pending registrations or change requests. “Terminated”- which will contain terminated or rejected entities.
Hospital Reinstatement Process	340B OPAIS will now allow hospitals to efficiently reinstate previously terminated sites. 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. This process will allow the hospital to also reinstate their child sites. Contract Pharmacies must also be registered again.
Parent Hospital Recertification Process	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. 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. Please note that this message is just a warning and will not stop the AO/PC from submitting the recertification.
Recertification Completion Notifications	During the annual recertification period, all covered entity AOs/PCs will receive a daily email that summarizes the status of their recertification activities. These include: "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 AOs/PCs will stop receiving this daily email once all recertifications have been completed.