The Medicaid Exclusion File

Report
Optimizing The 340B Program
Promoting Integrity, Access, & Value
To deliver clinically and cost-effective pharmacy services
This educational product created by:
Health Resources and Services Administration | Office of Pharmacy Affairs
340B Peer-to-Peer Program
340B Program Integrity
The Medicaid Exclusion File and
Avoiding Duplicate Discounts
Purpose of Activity
The purpose of this module is to explain the purpose of the Medicaid Exclusion File
and provide strategies on how states and covered entities can avoid duplicate
discounts.
Topic Guide
› Describe the role of the Medicaid Exclusion File in
preventing duplicate discounts
› Describe situations in which a duplicate discount might
occur in error
› Identify the data entities provide for insertion in the
Medicaid Exclusion File
› Explore how to use the Medicaid Exclusion File
340B Background
Established in 1992
statute (section 340B of
the Public Health Service
Act)
Requires manufacturers
to sell “covered
outpatient drugs” to
certain “covered entities
(CEs)” at greatly reduced
price
Includes 2 major
prohibitions:
• Diversion to non340B patients
• Duplicate discounting
Requires mechanism t
ensure that entities
comply with duplicate
discount prohibition
Duplicate Discount on 340B Drugs
When does a duplicate discount occur?
When the same drug is:
Purchased with an up-front
340B discount
And
Credited with a back-end
transaction Medicaid
rebate
Examples of Duplicate Discounts
Example 1:
Take-home
prescription
Example 2:
Provideradministered
• Patient receives 340B medication (prescription from
outpatient procedure)
• Medication is billed through the pharmacy’s billing system
• National Drug Code (NDC) level data are transmitted to
state Medicaid agency
• Medicaid agency submits NDC claim information to
manufacturer for rebate
• Patient is administered medication (by outpatient
procedure provider)
• Medication is billed through hospital or clinic billing system
• NDC level data are transmitted to state Medicaid agency
through billing system
• Medicaid submits NDC level claim for manufacturer rebate
Examples of Duplicate Discounts (Cont’d)
• Patient of Medicaid managed care organization (MCO) fills
outpatient prescription at 340B pharmacy
• MCO submits NDC level data from pharmacy claims to
Medicaid agency
Example 3:
Managed Care • Medicaid agency submits data from these claims to
Affordable
manufacturers for rebates
Care Act
MCO 340B
Exemption
1.
• Section 2501(c) amends section 1927(j)(1): “… certain
covered outpatient drugs in this section are not subject to
the rebate requirements … [if] subject to discounts under
section 340B of the Public Health Service Act.”1
CMS. Letter re: medication prescription drug rebates. April 22, 2010. Available at: www.ncsl.org/documents/health/42210PPACADrug_Rebate_​SMD.pdf.
Accessed November 22, 2011.
Medicaid Exclusion File
Congress
340B
Legislation
Department of Health
and Human Services
DRUG-PRICING PROGRAM
Must Create
Mechanism
Purchasing Drugs for Medicaid Patients
340B entities may:
purchase drugs at 340B prices
OR
purchase drugs at non-340B prices
(“off contract”) using a separate
account
The Medicaid Exclusion File
Health Resources and Services Administration
Office of Pharmacy Affairs
Maintains
Medicaid Exclusion File
340B Entities & Their Associated
Medicaid Provider Numbers
National Provider Identifies (NPI)
Criteria for Listing in Medicaid Exclusion File
Condition 1: Purchase drugs at the 340B price
Condition 2: Transmission of NDC level data to state
Medicaid office
If both conditions are met, Medicaid provider number and
NPI must be listed in Medicaid Exclusion File
Billing Medicaid
340B entities must decide
whether or not to use 340B drugs for Medicaid patients
YES, use 340B drugs for
Medicaid
NO, don’t use 340B drugs
for Medicaid
340B entities must decide how to bill Medicaid in a way that is
consistent with their state’s Medicaid program
All-inclusive
Rate
Managed Care
Medicaid
Traditional Fee-forService Medicaid
Medicaid Exclusion File & 340B Contract Pharmacies
340B Entity
Bill to
Drugs
Medicaid prescriptions filled using
the contract pharmacy’s own non340B inventory
No need to list pharmacy’s
Medicaid number in OPA
database
Ship to
Contract Pharmacy
Entity’s 340B-purchased
drugs are not used to fill
Medicaid prescriptions
340B Enrollment
Form
Where should CEs indicate the
required Medicaid billing information?
A 340B covered entity is required to indicate on
the 340B Enrollment Form if it intends to bill
Medicaid for Drugs purchased at 340B prices.
http://opanet.hrsa.gov/opa/CERegister.aspx
Covered Entity Search
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
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
[email protected]
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/

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