1. Covered Entity Search Start at www.hrsa.gov/opa Click on this link Select the entity type and enter data to find a specific entity

2. CE Decision to Not Use 340B Drugs Carve-Out When a CE enrolls, its data are entered in the CE database. If the entity is NOT using 340B- purchased drugs for their Medicaid fee-for-service patients, the form will indicate that the entity will not bill Medicaid for drugs purchased at 340B prices. CE Data

3. Most contract pharmacies and Medicaid agencies do not “establish an arrangement to prevent duplicate discounting.” Medicaid reimbursement formulas based on actual 340B cost may not provide margin sufficient to cover costs. Most clinics and pharmacies are aware that the Medicaid anti- kickback statute is very broad and are wary of including Medicaid prescriptions in their contracts. The Medicaid Exclusion File Reasons why most 340B entities exclude Medicaid prescriptions from their contract pharmacy:

4. CE Decision to Use 340B Drugs Carve-In If the entity is using 340B-purchased drugs for their Medicaid fee-for-service patients, the form must display the Medicaid number and state. When a CE enrolls, its data are entered in the CE database. CE Data

5. When a CE Has More Than One NPI The OPA database is capable of handling entities that have more than 1 NPI and wish to bill different state Medicaid agencies in a different manner (e.g., carve-out in 1 state, and use 340B for another). On the registration form, the entity must specify that the NPI is listed in association with particular states. When a CE enrolls, its data are entered in the CE database. CE Data

6. Alternative Agreement With State The CE must work with its state Medicaid agency and OPA to establish sufficient safeguards. To the extent that a CE is either: Unable to comply with standard methods discussed for reporting NPI Wishes to utilize an alternative method that will also prevent a duplicate discount OR

7. Medication Exclusion File Data Extract Go to: http://opanet.hrsa.gov/opa/default.aspxhttp://opanet.hrsa.gov/opa/default.aspx Click on “Search Medicaid Provider Numbers” http://opanet.hrsa.gov/opa/CEMedicaidExtract.aspx

8. Medicaid Exclusion File Data Go to http://opanet.hrsa.gov/opa/MedicaidExclusionFiles.aspx or the OPA’s home page and click on “Medicaid Exclusion Files”http://opanet.hrsa.gov/opa/MedicaidExclusionFiles.aspx

9. It is ultimately the responsibility of the 340B participating entity to ensure accurate reporting of Medicaid billing of any 340B drugs to OPA and the state Medicaid agency. Work with the Medicaid agency(ies) - 340B drugs identified - Rebates foregone Medicaid provider number used to bill Medicaid for all 340B-purchased drugs (e.g., entity may not “pick and choose”) If the appropriate Medicaid billing number is not listed on the OPA database and 340B drugs are used to fill Medicaid prescriptions, the entity should contact OPA immediately, so that the correct number can be included on the OPA exclusion file database The posted database information should be correct at all times. Any changes to how an entity bills Medicaid or inaccuracies in the Medicaid Exclusion File must be reported to OPA immediately CE Responsibility for Avoiding Duplicate Discounts

10. Avoiding Duplicate Discounts What can CEs and states do to avoid Duplicate discounts on 340B drugs? Become knowledgeable about duplicate discount prohibition by using HRSA and Prime Vendor Program (PVP) resources Evaluate your Medicaid billing practices: are you using 340B medications in ANY Medicaid prescriptions? Review your entry in the OPA database: does it correctly match your practices? Become knowledgeable about duplicate discount prohibition by using HRSA and PVP resources Have a knowledgeable 340B “go-to” person in the state Medicaid office who is available to communicate with 340B entities Review the Medicaid Exclusion File If discrepancies are noted, contact the CE for more information Provide clear direction to CEs about your Medicaid 340B reimbursement policy and their responsibilities Let OPA know if there are concerns or areas for improvement

11. Office of Inspector General (OIG) Report June 2011 Department of Health and Human Services OIG surveyed 50 state and DC Medicaid agencies about their policies and oversight activities related to 340B- purchased drugs Findings 25 states have no written Medicaid 340B-reimbursement policy Over half developed alternatives to using the Medicaid Exclusion File OIG Recommendations Centers for Medicare & Medicaid Services (CMS) should develop written Medicaid 340B policies OIG Recommendations HRSA, in conjunction with CMS, should improve accuracy and utility of Medicaid Exclusion File OIG. State Medicaid policies and oversight activities related to 340B-purchased drugs. June 2011. OEI 05-09-00321. Available at: http://oig.hhs.gov/oei/reports/oei-05-09- 00321.pdf. Accessed November 22, 2011.http://oig.hhs.gov/oei/reports/oei-05-09- 00321.pdf

12. 340B Resource Information https://www.340bpvp.com/ http://www.hrsa.gov/opa/ http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html ApexusAnswers@340bpvp.com 1-888-340-2787 Health Resources and Services Administration 340B Prime Vendor Program Managed by Apexus

13. Health Resources and Services Administration Office of Pharmacy Affairs 340B Peer-to-Peer Program Thank you for viewing this 340B tutorial developed by : You can view additional 340B educational products and tools specifically developed to assist 340B-participating entities create and maintain processes to ensure 340B program integrity at: www.hrsa.gov/opa/peertopeer/