Promoting Integrity Access amp Value To deliver clinically and costeffective pharmacy services This educational product created by Health Resources and Services Administration Office of Pharmacy Affairs ID: 744990
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Optimizing The 340B Program
Promoting Integrity, Access, & ValueTo deliver clinically and cost-effective pharmacy services
This educational product created by:Health Resources and Services Administration | Office of Pharmacy Affairs340B Peer-to-Peer ProgramSlide2
340B Program Integrity
The Medicaid Exclusion File and Avoiding Duplicate DiscountsPurpose 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.Slide3
Topic Guide
Describe situations in which a duplicate discount might occur in errorIdentify the data entities provide for insertion in the Medicaid Exclusion File
Explore how to use the Medicaid Exclusion FileDescribe
the role of the Medicaid E
xclusion File in preventing duplicate discountsSlide4
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 priceIncludes 2 major prohibitions: Diversion to non-340B patients
Duplicate discounting
Requires mechanism t ensure that entities comply with duplicate discount prohibitionSlide5
Duplicate Discount on 340B Drugs
AndPurchased with an up-front 340B discount
Credited with a back-end transaction Medicaid rebate
When does a duplicate discount occur?
When the same drug is:Slide6
Examples of Duplicate DiscountsSlide7
Examples of Duplicate Discounts (
Cont’d) 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.Slide8
Medicaid Exclusion File
Mechanism
DRUG-PRICING PROGRAM340B
Congress
Legislation
Must Create
Department of Health and Human ServicesSlide9
340B entities may:
purchase drugs at 340B prices
purchase drugs at non-340B prices (“off contract”) using a separate accountOR
Purchasing Drugs for Medicaid PatientsSlide10
The Medicaid Exclusion File
Health Resources and Services AdministrationOffice of Pharmacy AffairsMedicaid Exclusion File
MaintainsSlide11
Criteria for Listing in Medicaid Exclusion File Slide12
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 Medicaid340B 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-for-Service MedicaidSlide13
Contract Pharmacy
340B EntityDrugs
Bill to
Ship to
Medicaid prescriptions filled using the contract pharmacy’s own non-340B inventory
Entity’s 340B-purchased drugs are not used to fill Medicaid prescriptions
No need to list pharmacy’s Medicaid number in OPA database
Medicaid Exclusion File & 340B Contract PharmaciesSlide14
http://opanet.hrsa.gov/opa/CERegister.aspx
340B Enrollment
Form
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.
Where should CEs indicate the required Medicaid billing information?