340b. simplified
DESCRIPTION
340B. Simplified. Defining 340B. Created in 1992 to: Expand access to affordable medications for low-income patients Enable hospitals to stretch their resources to provide more comprehensive care for the uninsured population Eligibility: Entities (must be non-profit) - PowerPoint PPT PresentationTRANSCRIPT
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The contents of this presentation are confidential and proprietary to SUNRx and MedImpact Healthcare Systems, Inc. and may contain material MedImpact considers Trade Secrets. This presentation may not be reproduced, transmitted, published, or disclosed to others without prior written authorization from SUNRx and MedImpact Healthcare Systems, Inc.
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340B. Simplified.
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Defining 340B
Created in 1992 to:o Expand access to affordable medications for low-income patientso Enable hospitals to stretch their resources to provide more comprehensive care for the
uninsured population
Eligibility:o Entities (must be non-profit)
• Federally Qualified Health Centers, Disproportionate Share Hospitals, Critical Access Hospitals, Children’s Hospitals and others
o Medications• Outpatient drugs only
o Patients• Only patients of covered entities
Oversight Responsibility:o Health Resources and Services Administration (HRSA)
• Office of Pharmacy Affairs (OPA)
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The SUNRx 340B Solution
Reporting &Compliance
VirtualInventory
Management
PlanDesignComplete
340B Management
Solution
PlanDesign
ProgramMarketing
Contract Pharmacies
PatientEligibility
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Patient Definition
HRSA Patient Eligibilityo The covered entity has established a relationship with the individual,
such that:1. The entity maintains records of the individual's health care2. The prescriber is either employed by the covered entity – OR3. The prescriber provides health care under contractual or other
arrangements (e.g., referral for consultation)4. The responsibility for the care remains with the covered entity
o Outpatients Only
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Data Elements Obtained to Determine Eligibility
Eligible Service Areas
o SUNRx will identify the hospital’s outpatient (OP) service areas that are on the Medicare Cost Report—used to code the VI system.
Eligible Events
o SUNRx will establish a real-time feed of the hospital’s ADT system to document patient visits to the hospital.
Eligible Timeframe
o SUNRx will assign the script an appropriate capture time frame based on the establishment of an Eligible Event (i.e., one year) and the provider type.
Eligible Providers
o SUNRx will obtain a list of hospital providers who are classified as employed, contracted or credentialed, and determine their exclusivity to the hospital. This determination will be used to define SUNRx’s prescription capture rules.
Eligible Pharmacy
o SUNRx will obtain data on all prescriptions filled for hospital patients at the contract pharmacy (either retrospectively or in real time.)
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Contract Pharmacies
Hospitals may set up a contract pharmacy network to serve their patients:
o Contract pharmacies (all types) supplement your outpatient pharmacyo Convenient pharmacy locations to expand access to the Self-Pay
populationo Working with a pharmacy chain will create efficiencies and greater access
Pharmacy Contractso Serves both cash and third-party patientso Paid a dispensing fee (prefer fixed), and drugs are “replenished” by the
hospital (bill-to, ship-to)o Strict diversion and inventory control management
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How it Works: Prescription Processing
Third-partyClaims
Capture claimsConfirm eligibility
Adjudicate toMedImpact / SUNRx
Contract Pharmacy
Adjudicate to third-party PBM
CashClaims
Opportunity
Savings
Covered Entity
Real-time Claims Processing
Retrospective Claims Processing
Adjudicate to MedImpact/SUNRx
Determine eligibilityLoaded 340BNetworkU&C
Confirm lowest cost
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Net Benefit for Hospital
Net Benefit
Third-party Benefit Example
Copay
Third-partyReimbursement
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340B Virtual Inventory
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Registration Period Start DateOctober 1st – 15th
January 1January 1st – 15th April 1April 1st – 15th
July 1July 1st – 15th October 1
150 days Minimum (Up to 210 days)
HRSA Registration
Period(15 days)
Contract thePharmacies
(30 days)
ImplementationPeriod
(75 days)
Wholesaler Setup(60 days)
Q1
Implementation Timeline
Q2
HRSAActive Date
• HRSA registration periods:– New covered entities– Off-site facilities– Contract pharmacies
340B Facility and Pharmacy Registration
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340B Guidance
HRSA Auditso HRSA conducts audits to assure entities are:
• Preventing diversion of 340B Drugs (use only for eligible patients)• Preventing duplicate discounts (Medicaid rebate + 340B discount)• Maintaining readily auditable records• Adhering to the GPO and Orphan Drug Exclusions
Internal Auditso HRSA expects entities to perform annual “independent” 340B auditso Self Audits—random audits of contract pharmacy claimso Self-Reporting of program violations to HRSA
Annual Facility Recertification—Entities should:o Assure that contact information is up to date on the HRSA websiteo Make sure OP facilities are registered with HRSAo Facilities are on their Medicare Cost Reporto Contracts are in place and annual audits are conducted
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Helpful Self-Audit Information
• 340B Audit information
https://www.340bpvp.com/content/contentSearch.html?category=content&Ntt=audit
• Sample Self-Audit Process for Rural Hospitals
https://docs.340bpvp.com/documents/public/resourcecenter/RuralHospital_340B_Compliance_SelfAssessment_DataTransactions.pdf
• Sample Self-Audit Process for DSHs https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTransactions.pdf
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Monitoring and Compliance
Every transaction should be tracked, creating a fully auditable records:
o Eligibilityo Medication dispensing historyo Reversals, re-billso Replenishment orderso Pharmacy Receipts
Program Performance Monitoring:o Captured claims by pharmacyo Program utilizationo Financial performance
Compliance Reporting
Dashboard Monitoring
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Maintenance of Auditable Data
• Eligible patients• Eligible events at the hospital• Eligible providers (by type)• Captured claims from eligible pharmacies• Reviewed and accepted ICD-9 matched claims• Wholesaler orders placed for drug, at each contract pharmacy• Pharmacy receipt of replenished drug• Documentation of all “blocked” Medicaid claims• Results of financial reconciliation
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Important websites
340B Prime Vendor Program (Apexus)o https://www.340bpvp.com
Office of Pharmacy Affairso http://opanet.hrsa.gov/OPA/Default.aspx
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Searching for Covered Entity
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Searching continued
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Marketing Your Program
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Re-Investing Resources
• Build clinics to help serve the indigent population• Fully supporting Free Clinic that lost federal funding (savings
passed along to patients)• Maintain patient assistance program which includes subsidy
for discharged script from ER (designated time frame)• Programs that bring care to the patients which is essential to
health (patient has minimal means to travel)• Contract with pharmacies in remote areas that provide home
delivery to patients at no additional cost• Increase in discussions around full subsidy indigent programs