Covered Entity SearchStart 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

CE Decision to Not Use 340B DrugsCarve-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

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:

CE Decision to Use 340B DrugsCarve-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

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

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

Medication Exclusion File Data ExtractGo to: http://opanet.hrsa.gov/opa/default.aspxClick on “Search Medicaid Provider Numbers”

http://opanet.hrsa.gov/opa/CEMedicaidExtract.aspx

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”

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

Avoiding Duplicate Discounts

What can CEs and states do to avoid Duplicate discounts on 340B drugs?

CEs States 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

Office of Inspector General (OIG) ReportJune 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.

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

Health Resources and Services AdministrationOffice 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/