Q: May covered entities list the Medicaid provider numbers of healthcare professionals on the HRSA Medicaid Exclusion File (MEF) if that is the only billing identifier submitted on the claim?
A: A covered entity site may list a health care professional’s Medicaid provider number on the Medicaid Exclusion File (MEF) if the health care professional’s Medicaid provider number is listed as the billing provider on the Medicaid billing form (for example, box 56 or box 57 on a CMS 1450 (UB-04) cla... A covered entity site may list a health care professional’s Medicaid provider number on the Medicaid Exclusion File (MEF) if the health care professional’s Medicaid provider number is listed as the billing provider on the Medicaid billing form (for example, box 56 or box 57 on a CMS 1450 (UB-04) claim form).
The MEF contains all covered entity sites that will bill Medicaid FFS for drugs purchased at 340B prices, and the state(s) and associated billing numbers listed on the claims to bill Medicaid FFS for 340B drugs. This may include the billing provider’s national provider identifier (NPI) only, state assigned Medicaid number only, or both NPI and state assigned Medicaid number.
Covered entities should refer to state Medicaid agencies as to whether a particular Medicaid billing identifier is appropriate under the particular circumstance.
In addition, if a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs. Continue Reading
FAQ ID: 2205
Last Modified: 04/08/2021
Q: Does HRSA expect covered entities to enter the Medicaid numbers of all 50 states to avoid duplicate discounts, or just the bordering states?
A: If a covered entity site does not plan to bill 340B drugs to a particular state Medicaid agency, it should not have the state listed on the HRSA Medicaid Exclusion File (MEF).
If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will th... If a covered entity site does not plan to bill 340B drugs to a particular state Medicaid agency, it should not have the state listed on the HRSA Medicaid Exclusion File (MEF).
If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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 for each covered entity site (340B ID) in OPAIS is used to generate a quarterly Medicaid Exclusion File, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs. Continue Reading
FAQ ID: 1433
Last Modified: 09/14/2020
Q: I'm new to 340B and need to know some basic resources for how to learn about program compliance. Where should I start?
A: We recommend individuals attend a 340B University session. Registration information is available here: https://www.340bpvp.com/340b-education The sessions are free to attend; the stakeholder would just need to get to the meet... We recommend individuals attend a 340B University session. Registration information is available here: https://www.340bpvp.com/340b-education The sessions are free to attend; the stakeholder would just need to get to the meeting. We try to hold these educational events in a variety of locations across the country. Apexus also offers 340B University onDemand, an online version with similar basic content to the live session. Additionally, we would recommend the entity review the tools and resources available here: https://www.340bpvp.com/resource-center/340b-tools . Specific FAQs, available publicly through a keyword search are here: https://www.340bpvp.com/hrsa-faqs A call center, offering confidential answers to 340B questions, is available and supported by experts in a variety of content areas. If one of the questions requires additional expertise to address, the call center specialists will escalate the inquiry to the appropriate expert. Call center information is available here: https://www.340bpvp.com/apexus-answers , and we look forward to helping you with 340B Compliance; please let us know how we can specifically assist you. Continue Reading
FAQ ID: 4312
Last Modified: 07/31/2020
Q: We do not bill Medicaid FFS at all. We do, however, use 340B for these patients; does HRSA expect us to answer “yes” to its Medicaid billing question?
A: In this situation, the entity should answer “no” to the Medicaid billing question, “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?”
FAQ ID: 1475
Last Modified: 07/23/2020
Q: Our entity is using 340B drugs for Medicaid patients at multiple outpatient facilities, and these patients have Medicaid eligibility in multiple states. How must we list our NPI and/or Medicaid provider numbers on the Medicaid Exclusion File to include all states in which we will use 340B drugs to bill Medicaid?
A: Covered entities are prohibited by section 340B(a)(5)(A) of the Public Health Service Act from billing 340B drugs to Medicaid if they are subject to a rebate claim by the state. Covered entities should address prevention of duplicate discounts, including state(s)’ requirements in their policies and ... Covered entities are prohibited by section 340B(a)(5)(A) of the Public Health Service Act from billing 340B drugs to Medicaid if they are subject to a rebate claim by the state. Covered entities should address prevention of duplicate discounts, including state(s)’ requirements in their policies and procedures.
If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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 numbers 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 for each covered entity site (340B ID) is used to generate a quarterly Medicaid Exclusion File, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs. Continue Reading
FAQ ID: 4309
Last Modified: 07/23/2020
Q: When will covered entity sites update their 340B OPAIS records to list each state being billed for 340B drugs, and the billing number(s) listed on the bill to the state?
A: Covered entity sites will be 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 340B OPAIS by the end of their next annual recertification submission. Covered entity sites will be 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 340B OPAIS by the end of their next annual recertification submission.
Covered entity sites will continue to be responsible for listing the billing number(s) used to bill 340B drugs to Medicaid fee-for-service on the HRSA Medicaid Exclusion File (MEF). In addition, covered entity sites may continue to submit change requests to change their information listed on the HRSA MEF. Note that a covered entity site may request a change to its listing on the HRSA MEF at any time; however, changes only take effect the following quarter, and only if OPA receives, approves, and processes the change request before the 16th day of the month prior to the start of the quarter. Continue Reading
FAQ ID: 4310
Last Modified: 07/23/2020
Q: If our covered entity site only bills 340B drugs to Medicaid Managed Care Organizations, how should we answer the Medicaid billing question in 340B OPAIS that is used to populate the Medicaid Exclusion File?
A: The covered entity site should answer “no” to the Medicaid billing question in 340B OPAIS. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS).
Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to sec... The covered entity site should answer “no” to the Medicaid billing question in 340B OPAIS. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS).
Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to section 340B(a)(5)(A) of the Public Health Service Act. HRSA recognizes the need to address covered entities’ role in preventing duplicate discounts when 340B drugs are billed to MCOs. Absent policy on MCOs, HRSA encourages covered entities to work with states and their respective MCOs to develop strategies to prevent duplicate discounts. In some cases, states have placed certain requirements on covered entities regarding the prevention of duplicate discounts for drugs billed to MCOs. Continue Reading
FAQ ID: 1369
Last Modified: 07/22/2020
Q: Must a covered entity submit its Medicaid provider number (MPN) or National Provider Identifier (NPI) to HRSA for inclusion on the HRSA Medicaid Exclusion File (MEF)?
A: A covered entity site must first choose whether it will bill Medicaid for 340B drugs for its Medicaid fee-for-service patients.
If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service fo... A covered entity site must first choose whether it will bill Medicaid for 340B drugs for its Medicaid fee-for-service patients.
If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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) is used to generate a quarterly Medicaid Exclusion File, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs.
If a covered entity site will not bill 340B drugs for any Medicaid fee-for-service patients, the covered entity site must answer “no” to the Medicaid billing question (At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices? ) In addition, the covered entity site is not required to submit any Medicaid billing number(s) to HRSA, and the covered entity site’s 340B ID will not be listed on the MEF.
Each covered entity site should notify HRSA prior to any change in Medicaid billing status. In addition, the method(s) used to prevent duplicate discounts, including any state Medicaid requirements should be documented in a covered entity’s policies and procedures. Continue Reading
FAQ ID: 1495
Last Modified: 07/22/2020
Q: If a hospital intends to have some clinics carve in (use 340B drugs for Medicaid patients) and other clinics carve out, should each clinic get its own NPI and/or Medicaid provider number?
A: If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” the site must also submit each Medicaid state it plans to bill and the billing number(s) it will list on... If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” the site must also submit 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 for each covered entity site (340B ID) will be used to generate a quarterly Medicaid Exclusion File, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs.
The information on the MEF should appropriately reflect the actual practice of each covered entity site (340B ID). In addition, the covered entity should document in its policies and procedures, the method(s) it uses to prevent duplicate discounts at each site, including any state Medicaid requirements.
If a covered entity plans to bill Medicaid with the same billing number(s) for certain sites (340B IDs) that carve in and other sites (340B IDs) that carve out, the covered entity should contact the state Medicaid agency to determine how Medicaid will distinguish between 340B and non-340B claims. Continue Reading
FAQ ID: 1533
Last Modified: 07/22/2020
Q: How does a covered entity carve out Medicaid?
A: To carve out Medicaid, a covered entity site does not provide drugs purchased at the 340B price to Medicaid patients.
In 340B OPAIS, a covered entity site that plans to carve out Medicaid fee-for-service should answer “no” to the question, “at this site, will the covered entity bill Medi... To carve out Medicaid, a covered entity site does not provide drugs purchased at the 340B price to Medicaid patients.
In 340B OPAIS, a covered entity site that plans to carve out Medicaid fee-for-service should answer “no” to the question, “at this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” Covered entity sites that answer “no” in 340B OPAIS (prior to the 16th day of the month prior to the start of the quarter) will not be listed on HRSA’s next quarterly Medicaid Exclusion File (MEF).
Covered entity sites should time any changes in actual 340B Medicaid billing practices to coincide with the first day of the next quarterly MEF. Continue Reading
FAQ ID: 1537
Last Modified: 07/22/2020
Q: Which Medicaid provider number and/or National Provider Identifier (NPI) should a covered entity submit to HRSA Office of Pharmacy Affairs for inclusion on the HRSA Medicaid Exclusion File (MEF)?
A: If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” the site must also provide each Medicaid state it plans to bill and the billing number(s) it will list o... If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” 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, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid for 340B drugs.
Q: We bill at an all-inclusive rate for Medicaid, no NDC is transmitted to Medicaid, and therefore no duplicate discount will occur. We do use 340B for these patients; does HRSA expect us to answer YES to its Medicaid question?
A: Covered entities that bill Medicaid fee-for-service for drugs purchased at 340B prices must answer “yes” to the Medicaid billing question, regardless of the rate at which they are reimbursed under Medicaid.
FAQ ID: 1373
Last Modified: 05/28/2020
Q: What actions does HRSA expect an entity to take if it loses 340B Program eligibility?
A: Covered entities should stop purchasing 340B drugs immediately upon losing eligibility. The entity must complete a termination request on 340B OPAIS and answer the following three questions: 1) The date the entity became ineligible; 2) The circumstances surrounding the loss of eligibilit... Covered entities should stop purchasing 340B drugs immediately upon losing eligibility. The entity must complete a termination request on 340B OPAIS and answer the following three questions: 1) The date the entity became ineligible; 2) The circumstances surrounding the loss of eligibility; 3) The last date 340B drugs were purchased.
Covered entities should work with the manufacturer to determine the most appropriate method for handling. There may be several options for handling the drug inventory once eligibility is lost. These options will depend upon the specific circumstances but may include transferring the inventory to an associated covered entity site/pharmacy that is still 340B registered, credit/rebill, return, or destruction according to state law. Covered entities should keep auditable records and ensure the process is transparent to manufacturers and wholesalers. Continue Reading
FAQ ID: 2353
Last Modified: 01/24/2020
Q: What educational resources are available to learn more about the 340B Program?
A: The 340B Prime Vendor Program, as part of its agreement with HRSA, provides online tutorials, templates, and other tools to aid in educating and informing 340B Program stakeholders about the program. Specifically, the 340B Prime Vendor offers educational programs, including 340B University and 340B ... The 340B Prime Vendor Program, as part of its agreement with HRSA, provides online tutorials, templates, and other tools to aid in educating and informing 340B Program stakeholders about the program. Specifically, the 340B Prime Vendor offers educational programs, including 340B University and 340B University OnDemand. They also operate a call-center and have a database of FAQs. These educational materials have been reviewed and approved by HRSA. Please visit the 340B Prime Vendor Program website for more information. Continue Reading
FAQ ID: 2385
Last Modified: 01/24/2020
Q: Who is tasked with imposing civil monetary penalties against manufacturers who knowingly and intentionally overcharge a covered entity?
A: Pursuant to a delegation of authority, the HHS Office of the Inspector General (OIG) has the authority to impose CMPs utilizing the definitions, standards, and procedures under 42 CFR Parts 1003 and 1005, as applicable. For additional information, see the delegation of authority Federal Register Not... Pursuant to a delegation of authority, the HHS Office of the Inspector General (OIG) has the authority to impose CMPs utilizing the definitions, standards, and procedures under 42 CFR Parts 1003 and 1005, as applicable. For additional information, see the delegation of authority Federal Register Notice at https://www.gpo.gov/fdsys/pkg/FR-2017-01-05/pdf/2016-31944.pdf (82 FR 1356, January 5, 2017). Continue Reading
FAQ ID: 1463
Last Modified: 12/23/2019
Q: How is the HRSA Electronic Handbook system used in the 340B recertification process?
A: Section 330 health center grantee and FQHC look-alike site names and addresses will be updated in the recertification process to match those on file in HRSA’s Electronic Handbooks (EHB) system. Authorizing officials will be able to review any changes before they are effective; any major discrepancie... Section 330 health center grantee and FQHC look-alike site names and addresses will be updated in the recertification process to match those on file in HRSA’s Electronic Handbooks (EHB) system. Authorizing officials will be able to review any changes before they are effective; any major discrepancies should be brought to OPA’s attention via e-mail to 340b.recertification@hrsa.gov (please include the affected grant number, 340B ID, and BPHC site ID).
OPA encourages covered entities to proactively notify their manufacturer/wholesaler partners of any changes in participation and/or name/address that may result from recertification. Questions on recertification can be directed to ApexusAnswers at 1-888-340-2787 or by e-mail to ApexusAnswers@340bpvp.com. Continue Reading
FAQ ID: 1386
Last Modified: 11/01/2019
Q: I am currently undergoing a 340B Program audit and am concerned the questions asked by the auditor are outside the scope of the 340B Program. Where do I direct my concerns?
A: Please write to HRSA Office of Pharmacy Affairs with specific information regarding the audit concerns. This information should be mailed to: Health Resources and Services Administration, Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857 - or send email to HRSA OP... Please write to HRSA Office of Pharmacy Affairs with specific information regarding the audit concerns. This information should be mailed to: Health Resources and Services Administration, Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857 - or send email to HRSA OPA at:
Q: How can a manufacturer get further information on the PPA Addendum?
A: Please send any questions to the 340B Prime Vendor Program at 1-888-340-2787, or by sending an e-mail to ApexusAnswers@340bpvp.com.
FAQ ID: 1207
Last Modified: 11/10/2014
Q: Is using a reverse distributor permissible for 340B drugs?
A: Using a reverse distributor is permissible for 340B drugs under the following conditions: Auditable records are maintained by the entity of the transaction; A licensed reverse distributor is used; All state laws are followed; All 340B statute and guidelines are followed; The entity is not attempting... Using a reverse distributor is permissible for 340B drugs under the following conditions: Auditable records are maintained by the entity of the transaction; A licensed reverse distributor is used; All state laws are followed; All 340B statute and guidelines are followed; The entity is not attempting to use the reverse distribution with the expectations of generating profit on 340B purchased drugs. If the entity has questions, we recommend that you work with the manufacturer directly Continue Reading
FAQ ID: 1411
Last Modified: 10/09/2014
Q: In an audit, is it sufficient to demonstrate compliance through documentation of the procedures for administration of specific drugs or will we be asked to show medical records?
A: 340B covered entities will be audited for all 340B Program requirements, including the maintenance of auditable records. Auditable records include specific documentation that all 340B Program requirements are met for every 340B drug.
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