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340B historical timeline2021 Special Committee on Federal 340B Drug ProgramDecember 8, 2021

today’s agendatoday’s presenterIntroductionsHistory of 340Bpolicy and guidanceDecade reviewQ/ALisa Scholz PharmD, MBA, FACHEHead of Industry RelationsCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction.2

my 340B journeyHospital/health system8 years Administrative Director of Pharmacy Leading practice 340B siteRetail pharmacy12 yearsPharmacist‐In‐Chargeand Pharmacy ManagerGov’t contractor to HRSA6 years Consultant Vice President, Government ProgramsAssociation Management3 yearsChief Operating Officerand Chief Pharmacy OfficerHealthcaretechnology6 yearsHead of Industry RelationsCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction.3

History of 340B policyand guidance

what is happening in 340B and why?FAQsGuidanceA market shift bymanufacturersAND pharmacybenefit managersRegulations340B LawCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction.5

340B historyOver the years, a number of challenges have emerged regarding new programrequirements, prohibitions, and integrity provisions340BintroducedContract pharmacy processManufacturer audit guidelinesPatient definitionMultiple pharmacies allowedACA becomes lawEligibility expandedHRSAauditsbeginOrphandrug legalchallengesOmnibusguidance &civil penaltieswithdrawnCivilmonetarypenaltiesTIPPING POINTOPA guidanceon clinicsMedicaid duplicatediscount clarifiedCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized Omnibus guidancedraft releasedOrphan druginterpretiverule vacatedMedicarePart B cutsAlternativedisputeresolution6

Decade review

340B trends over the decades:Guidance, oversight and the beginning of “self‐policing” Guidance Hospital outpatient facilities Patient definition Manufacturer audit guidelines ADAP Duplicate discounts One‐to‐one contract pharmacyCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction. Oversight OIG Audit: AIDS Drug AssistanceProgram and use of 340Bencouraged to optimize usage Miscellaneous No Wholesaler Acquisition Cost(WAC) accounts exist Purchase at 340B or GPO8

340B trends over the decades:Education, guidance and oversight Guidance WAC requirement (340B, GPO,and WAC) Duplicate discounts Education HRSA call center managed by AmericanPharmacist Association‐PharmacyServices Support Center 340B University started by ApexusCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction. Oversight OPAIS database changes to expand onchild site listings OIG audit: Mashantucket Pequot TribalUtilization of 340B OIG testimony to House E&CCommittee (Subcommittee onOversight and Investigations)9

340B trends over the decades:Education, guidance, judicial intervention, oversight, and regulations Judicial Regulations Orphan Drug Orphan Drug (2014) Medicare Part B Civil monetary penalties (final in 2019) Oversight HRSA audits begin (2012) Alternative dispute resolution (final in 2020) Guidance GAO Studies (9) Multiple contract pharmacy Congressional committee reports (3) Proposed Omnibus guidance not successfully launched “Policy releases” 2011‐2014 “Program updates” 2014‐2019 HRSA call center managed by Prime Vendor Program State law: PBM anti‐discriminatory languageCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction. Education Apexus individualized certificate program HRSA 340B Peer to Peer Program 340B software certificate programs10

340B trends over the decades:Government transition andpublic health emergency impactRisk ofaudit findings Potential federalregulatory changes/court rulings andadvisory opinion State regulatory action Increasing PBM andManufacturer influenceon limiting access andreducing reimbursement Judicial opinionsRetail/specialtypharmacies mandatingtechnology solutions Federal bulletin onduplicate discountsCONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction.11

CONFIDENTIAL 2021 Sentry Data Systems, Inc. No unauthorized reproduction.

thank yousentry data systems, inc., a Craneware company 800 Fairway Drive, Suite 400 Deerfield Beach, FL 33441www.sentryds.com 800.411.4566 phone 2021 Sentry Data Systems, Inc. All rights reserved. No unauthorized reproduction.About Sentry Data Systems, Inc. We provide technology solutions that help hospitals address their three biggest challenges:reducing costs, managing compliance and producing better outcomes. Sentry was acquired by Craneware Inc. in July 2021.

Dec 09, 2021 · 340B University started by Apexus Oversight OPAIS database changes to expand on child site listings OIG audit: Mashantucket Pequot Tribal Utilization of 340B OIG testimony to House E&C Committee (Subcommittee on Oversight and Inves