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
CE Decision to Not Use 340B Drugs
Carve-Out
When a CE enrolls, its data are
entered in the CE database.
CE Data
If the entity is NOT using 340Bpurchased 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.
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.
CE Decision to Use 340B Drugs
Carve-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.
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.
Alternative Agreement With State
To the extent that a CE is either:
Unable to comply with
standard methods discussed
for reporting NPI
OR
Wishes to utilize an
alternative method that
will also prevent a
duplicate discount
The CE must work with its state Medicaid agency and OPA to
establish sufficient safeguards.
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
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”
CE Responsibility for Avoiding Duplicate Discounts
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
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
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 340Bpurchased drugs
Findings
• 25 states have no written
Medicaid 340B-reimbursement
policy
• Over half developed alternatives
to using the Medicaid Exclusion
File
OIG Recommendations
OIG Recommendations
• Centers for Medicare &
Medicaid Services (CMS) should
develop written Medicaid 340B
policies
• 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-05-0900321.pdf. Accessed November 22, 2011.
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
1-888-340-2787
ApexusAnswers@340bpvp.com
https://www.340bpvp.com/
Managed by Apexus
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/