340 B CONTRACT PHARMACY BASICS JULY 13, …

1 340 B CONTRACT PHARMACY BASICS july 13, 2017 1:30 3:00 PM ACPE UAN: 0107-9999-17-088-L04-P hr 0107-9999-17-088-LO4-T hr Activity Type: Knowledge-Based Learning Objectives for Pharmacists and PHARMACY Technicians: Upon completion of this CPE activity participants should be able to: 1. Explain 340B program BASICS and commonly used terms 2. Discuss how to create a successful relationship with a 340B eligible entity 3. Describe HRSA policies and processes related to audits and expectations of the CONTRACT PHARMACY Speaker: Jason Atlas, RPh, MBA Jason Atlas, Apexus' Manager of 340B Education and Compliance Support, is responsible for educating directors of PHARMACY , clinicians, and hospital executives on the value of the 340B program and Apexus, as its 340B Prime Vendor.

2 He also educates stakeholders regarding 340B regulations, procedures, and operations to ensure compliance and program integrity. Mr. Atlas has spent over 20 years in a variety of PHARMACY practice settings including his family owned PHARMACY in Princeton, NJ. Since relocating to Colorado he has held leadership positions for a regional retail PHARMACY chain, a national publically traded long-term care PHARMACY , a national PHARMACY recruiting and staffing service provider, and most recently as the Director of Outpatient PHARMACY at Denver Health and Hospital Authority.

3 Mr. Atlas holds a BS degree in PHARMACY from Rutgers University and a Masters in Business Administration from the University of Colorado Boulder, School of Business. Speaker Disclosure: Jason Atlas reports that he is employed by Apexus, a 340B Prime Vendor Program. Off-label use of medications will not be discussed during this presentation. 6/26/171340B CONTRACT PHARMACY BASICSJuly 13, 2017 Jason Atlas, RPh, MBAA pexusManager of 340B Education & Compliance Support6/26/172 Disclosure Jason Atlas reports no actual or potential conflicts of interest associated with this presentationUpon successful completion of this activity.

4 Pharmacists and PHARMACY technicians should be able 340B program BASICS and commonly used how to create a successful relationship with a 340B eligible HRSA policies and processes related to audits and expectations of the CONTRACT pharmacyLearning Objectives6/26/173I am currently a CONTRACT PHARMACY for a 340B participant? Ye s NoWho are we?About Apexus Our Mission: Through collaboration, and innovation, Apexus delivers value to its customers by increasing access to medications and improving patient outcomes through the advancement of ambulatory PHARMACY solutions and support of compliant 340B programs.

5 Support YOUR program compliance and integrity6/26/174 Tools and ResourcesVisit to learn more about our tools and University OnDemand Education Visit to sign up for 340B University OnDemand6/26/175340B Statute Resulted from a 1992 federal statute Manufacturers participating in Medicaid Drug Rebate Program must sign a Pharmaceutical Pricing Agreement (PPA) with the Secretary of Health and Human Services The manufacturer agrees to charge a price for covered outpatient drugs that does not exceed the 340B price Who benefits from the 340B program?

6 Patients and Covered Entity How are 340B savings passed to the patient? Sliding Fee Schedules Additional service expansion340B Benefit6/26/176340B IntentTo permit covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive Rep. No. 102-384(II), at 12 (1992) Pricing Comparison100%79%64%51%42%100%50%0% BEST PRICE 63%AWPAMPGPOM edicaidRebate340 BVeteransAdministration66%ApexusPVPWAC83 %Disclaimer: Pricing comparisons listed are for estimation purposes only and may vary based upon GPO class of trade for an SECTOR PRICING6/26/177340B Covered Outpatient Drugs (COD) Outpatient drugs Over-the-counter drugs (with a prescription) Clinic administered drugs Biologics InsulinFederal Grantees/DesigneesCertain Hospitals Federallyqualified health center Federallyqualified health center look-alikes Title X family planning grantees State aids drugs assistance programs Ryan White care act grantees (A,B,C,D,F)

7 Black lung clinics Hemophilia treatment centers Native Hawaiian health centers Urban Indian organizations Sexually transmitted disease grantees Tuberculosis grantees Disproportionate share hospitals Children s hospitals Critical access hospitals Free standing cancer hospitals Rural referral centers Sole community hospitals340B Eligible Entities6/26/178I am currently a CONTRACT PHARMACY for the following type of 340B participant? Hospital(DSH, Children s ,Critical Access, Free Standing Cancer Center, Rural Referral Center, Sole Community) Community Health Center Title X Family Planning STD clinic Ryan White clinic OtherTell me more about youHRSA 340B Database: Statistics HRSA 340B Database April 1st, 2017 39,600 registered sites.

8 17,100 are non-hospital sites 19,340 unique CONTRACT pharmacies6/26/179 Registration Process New entities, entity sites, CONTRACT pharmacies, Medicaid information 2 week registration periods, quarterly updates made to HRSA 340B Database Change requests: changes to existing information, rolling basisUpdate OfficialOctober 1 January 1 April 1 july 1 Registration PeriodJuly 1 15 October 1 15 January 1 15 April 1 15 Duplicate Discount Prohibition340B priceMedicaid rebate6/26/1710 Targeting Program Integrity Can we use 340B for Medicaid patients at our CONTRACT PHARMACY ?

9 Who to talk to?6/26/1711 Who to talk to?Questions 2016 Apexus. Reproduction without permission is PHARMACY BasicsInitial CONTRACT PHARMACY guidance issued: 1 contracted site per covered entityCovered entities can apply to pursue alternatives to contracting with a single pharmacyNew CONTRACT PHARMACY guidance issued: Multiple CONTRACT pharmacies Independent of in-house pharmaciesHistory of CONTRACT Pharmacies1996 Federal Register2001: HRSA establishes AMDP(Alternative Methods Demonstration Project)2010 Federal Register6/26/1713 Bill To Ship To OverviewHRSA requires the covered entity to maintain ownership of the 340B medication up to dispensing to eligible patient Inventory via bill to ship to wholesale arrangement Covered entity receives invoice and T3 data CONTRACT PHARMACY receives inventory and T3 data without 340B pricing information Bill ToShip To WHOLESALERCOVERED ENTITYCONTRACT PHARMACYC onsiderations What are the stakeholder benefits from this arrangement?

10 How does the dispensing fee compare to current third party payers? How will this impact my third party receivables and cash flow? Do I pay fees to participate? What are the risks? Should I anticipate any impact to my current Cost of Goods from my existing wholesaler?6/26/1714 At a minimum, the CONTRACT PHARMACY agreement should address the following 12 Essential Elements for such agreements as outlined below and found here: The agreement states that the covered entity will purchase the drug, maintain title to the drug and assume responsibility for establishing its price, pursuant to the terms of an HHS grant (if applicable) and any applicable federal, state, and local ship to, bill to procedure is used in which the covered entity purchases the drug.