Covered Entity Search

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

2. CE Decision to Not Use 340B DrugsCarve-Out When a CE enrolls, its data are entered in the CE database. CE Data 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.

3. The Medicaid Exclusion File Reasons why most 340B entities exclude Medicaid prescriptions from their contract pharmacy: • 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.

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

5. When a CE Has More Than One NPI When a CE enrolls, its data are entered in the CE database. CE Data 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.

6. Alternative Agreement With State OR • The CE must work with its state Medicaid agency and OPA to establish sufficient safeguards.

7. Medication Exclusion File Data Extract Go to: http://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”

9. CE Responsibility for Avoiding Duplicate Discounts

10. Avoiding Duplicate Discounts What can CEs and states do to avoid Duplicate discounts on 340B drugs? States CEs • 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 • 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?

11. Office of Inspector General (OIG) ReportJune 2011 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.

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

13. Thank you for viewing this 340B tutorial developed by : Health Resources and Services Administration Office of Pharmacy Affairs 340B Peer-to-Peer Program 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/