340b. simplified

11 © 2013 SUNRx and MedImpact, Inc. All Rights Reserved.

Confidential, proprietary and possible Trade Secret of SUNRx and MedImpact (See Slide #1)

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.

© 2013 MedImpact, Inc. All Rights Reserved.

340B. Simplified.



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)



The SUNRx 340B Solution

Reporting &Compliance

VirtualInventory

Management

PlanDesignComplete

340B Management

Solution

PlanDesign

ProgramMarketing

Contract Pharmacies

PatientEligibility



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



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.)



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


Confidential, proprietary and possible Trade Secret of SUNRx and MedImpact (See Slide #1) 7 © 2013 SUNRx and MedImpact Healthcare Systems, Inc. All Rights Reserved. Confidential, proprietary and possible Trade Secret of SUNRx and MedImpact (See Slide #1)

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


Confidential, proprietary and possible Trade Secret of SUNRx and MedImpact (See Slide #1) 8 © 2013 SUNRx and MedImpact Healthcare Systems, Inc. All Rights Reserved. Confidential, proprietary and possible Trade Secret of SUNRx and MedImpact (See Slide #1)

Net Benefit for Hospital

Net Benefit

Third-party Benefit Example

Copay

Third-partyReimbursement



340B Virtual Inventory



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



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



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






https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTransactions.pdf





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



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



Important websites

340B Prime Vendor Program (Apexus)o https://www.340bpvp.com

Office of Pharmacy Affairso http://opanet.hrsa.gov/OPA/Default.aspx

https://www.340bpvp.com/

http://opanet.hrsa.gov/OPA/Default.aspx



Searching for Covered Entity



Searching continued



Marketing Your Program



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

340b. simplified

Documents

material medimpact

possible trade secret

medimpact healthcare

childrens hospitals

trade secrets

critical access hospitals

health resources

hospitals adt system