340B Drug Pricing Program - Preventing Duplicate Discounts. Disclosures

340B Drug Pricing Program - Preventing Duplicate Discounts Jane McLaughlin-Middlekauff, PharmD, BCACP, Tracey Cole, RPh, Jenny Clark, PharmD Richard Fons, RPh, AAHIVP, and Rachel Barhorst, PharmD 2 Disclosures Tracey Cole, Jane McLaughlin-Middlekauff, Jenny Clark, Richard Fons and Rachel Barhorst declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. Target Audience: Pharmacists ACPE#: 0202-0000-16-003-L04-P Activity Type: Knowledge-based The American Pharmacists Association is accredited by the Accreditation Council for Education as a provider of continuing pharmacy education. 3 4 Learning Objectives Describe duplicate discount statutory requirement Describe Medicaid carve-in/carve-out status and the Medicaid Exclusion File Outline 340B transaction identification and processes used to include or exclude 340B drugs Describe policies & procedures to prevent duplicate discounts at the covered entity and at contract pharmacies Discuss processes that Peer Mentors from the 340B Peerto-Peer Program use to test compliance with duplicate discount strategies to self-audit Per statutory requirements, which organization is responsible for the prevention of duplicate discount? A. State Medicaid Agency B. Covered Entity C. Contract D. Office of Affairs 5 6

When a CE chooses to bill 340B drugs to Medicaid OPA requires that the CE A. Answer no to the Medicaid question on the OPA database B. Answer yes to the Medicaid question on the OPA database and list all Medicaid Billing and NPI numbers used to bill Medicaid in the Medicaid Exclusion File C. Include the NDC of the drug provided in the Medicaid billing process D. Include a 340B identifier for the drug provided in the Medicaid billing process Why must a CE have a system in place to identify Medicaid as a primary, secondary or tertiary payor? A. To provide and bill a 340B drug if the CE carves-out B. To provide and bill a non-340b drug if the CE carves-in C. To validate carve-in or carve-out requirements of the CE s 340B eligibility determination system D. To comply with the CE s no answer to the MEF question on the 340B database 7 8 Which of the following should be included in policies & procedures related to the prevention of duplicate discounts? A. A statement of carve-in or carve-out practice for each operations environment of each site registered on the 340B database B. Detailed mechanisms used to prevent duplicate discount C. A description of the monitoring process used to validate that the entity s practice is consistent with its listing in the MEF D. All of the above True or False: Contract Pharmacies carve-out 340B claims from Medicaid unless they have an arrangement with the Covered Entity and State Medicaid agency and are listed as carve-in on the 340B database. A. True B. False 9 10 CE: CP: MEF: MFFS: MCO: NPI: MPN: Covered Entity Contract Medicaid Exclusion File Medicaid Fee-For-Service Medicaid Managed Care Organization National Provider Identifier Medicaid Provider Number Terminology Carve-In: CE bills Medicaid for drugs purchased up front at the 340B price. Medicaid excludes carve-in claims from manufacturer rebate requests. Carve-Out: CE bills Medicaid for drugs purchased at NON-340B price. Medicaid includes carve-out claims in manufacturer rebate requests. 340B Review of Duplicate Discounts American Pharmacist Association Annual Meeting March 6, 2016 Jane McLaughlin-Middlekauff, PharmD, BCACP LT, USPHS Office of Affairs (OPA) Healthcare Systems Bureau Health Resources and Services Administration U.S. Department of Health and Human Services 11

Program Integrity Areas of Focus Eligibility Group Purchasing Organization (GPO) Auditable records Duplicate Discount Diversion Duplicate Discounts Receiving the 340B Discount and Medicaid Rebate on same drug Medicaid Exclusion File on HRSA s public website Final Notice, Duplicate Discounts and Rebates on Drug Purchases published at 58 Fed. Reg. 34058 (June 23, 1993) Policy Release: 2014-1 Clarification of use of the Medicaid Exclusion File 12/12/2014 Duplicate Discounts Medicaid Exclusion File (MEF) must be complete and accurate Carve-In = use 340B drugs when billing Medicaid Carve-Out = do not use 340B drugs to bill Medicaid If contract pharmacy uses 340B drugs to bill Medicaid, the CE must make arrangements with contract pharmacy and state Medicaid agency and MUST notify OPA Covered entity must know how they bill Medicaid and how state prevents duplicate discounts Manufacturers Pharmaceutical Pricing Agreement (PPA) Must be signed by a manufacturer as a condition for participating in Medicaid Does not prohibit a manufacturer from charging a price for a covered outpatient drug that is lower than the 340B ceiling price A manufacturer may not condition the offer of 340B discounts upon a covered entity's assurance of compliance with section 340B Program requirements Prevention of Duplicate Discounts 3) the covered entity will comply with all requirements of Section 340B of the Public Health Service Act and any accompanying regulations including, but not limited to, the prohibition against duplicate discounts and diversion (sections 340B(a)(5)(A) and (B) of the Public Health Service Act) Medicaid Exclusion File (Policy Release 12/12/14) The 340B Medicaid Exclusion File is available on HRSA s public website to help 340B covered entities, states and manufacturers avoid duplicate discounts specific to Medicaid Fee- For-Service

Medicaid Exclusion File (Policy Release 12/12/14) MEF is a Key HRSA Compliance Component All covered entities are expected to have written policies and procedures pertaining to the prevention of duplicate discounts, and ensure their database listing is consistent with actual practice HRSA encourages 340B covered entities to work with their state to develop strategies to prevent duplicate discounts on drugs reimbursed through MCOs Medicaid Exclusion File (MEF) Regardless of state specific requirements, a covered entity s carve-in or carve-out practice must be consistent with its listing in HRSA s MEF 340B Database Practice Policies and Procedures Program Integrity Guiding Principles: Maximize oversight reach Manage compliance risk Strategy Initial certification Annual recertification Program audits Site Visits Resources Systems Staff Improvements in Program Integrity Processes and protocols Desk audits Training and Education Site visit questionnaire Program integrity analysts Manufacturer audits Things to Know About Audits Types of Audits Responsibility for 340B Program compliance Plan for oversight Policies and procedures compliant with 340B Program requirements Final Report Agreement Disagreement Corrective Action Plan (CAP) # of outpatient facilities # of contract Complexity of pharmacies program Risk- Based Volume of purchases

Types of Audits HRSA Audits by the Numbers as of February 2016 Reported Allegations FY 2012 FY 2013 FY 2014 FY 2015 Reported Violations Follow ups on CAPs Number of covered entities audited 51 94 99 200 Outpatient facilities/subgrantees 410 718 1476 2720 Contract pharmacies 860 1937 4028 4443 Number of finalized reports 51 94 99 178 Target- Based HRSA Audit Steps HRSA Audit Steps Pre-Audit Engagement letter Scheduling Data request Onsite Audit Opening meeting Staff interviews Data sample review HRSA Audit Steps Recap Post-Audit Preliminary Findings Notice and Hearing Corrective Action Plan (CAP) Final Report Attestation Pharmaceutical Pricing Agreement Carve-in Carve-out Covered entity responsibility Prevent duplicate discount Have accurate information on the MEF 30

Medicaid pays no more than the 340B ceiling price in one of two ways: Definition of a Duplicate Discount A duplicate discount occurs when the same drug is: Covered entity bills non-340b drug to Medicaid and Medicaid seeks rebate from manufacturer CE Carves-Out OR Covered entity bills 340B drug to Medicaid and Medicaid does not seek rebate from manufacturer CE Carves-In Purchased with an up-front 340B discount AND Credited with a back-end Medicaid Rebate Covered entities are responsible for prevention of duplicate discount. Duplicate discount can occur when Medicaid is primary, secondary or tertiary payor. 31 32 MEF - 340B Drug Pricing Program Notice December 12, 2014 Medicaid Fee For Service and Managed Care - 340B Drug Pricing Program Notice December 12, 2014 All covered entities are expected to have written polices and procedures pertaining to the prevention of duplicate discounts, and ensure their database listing is consistent with actual Practice. While Medicaid drug rebates were previously limited to MFFS drugs, section 2501(c) of The Patient Protection and Affordable Care Act (Public Law 111-148) amended the Social Security Act (SSA), extending Medicaid drug rebate eligibility to certain Medicaid manage care to help 340B covered entities, states and manufacturers avoid duplicate discounts specific to MFFS. HRSA provides the 340B Medicaid Exclusion File as the official data source to determine Whether 340B drugs are billed to Medicaid in order to prevent duplicate discounts. http://www.hrsa.gov/opa/programrequirements/policyreleases/clarificationmedicaidexclusion.pdf Some cases, states may place certain requirements on covered entities regarding the prevention of Duplicate discounts, HRSA encourages 340B covered entities to work with their state to develop Strategies to prevent duplicate discounts on drugs reimbursed through MCO s. http://www.hrsa.gov/opa/programrequirements/policyreleases/clarificationmedicaidexclusion.pdf 33 34 MEF is a Key HRSA Compliance Component 340B Database Record 340B Database Medicaid Exclusion File (MEF) Practice Will you bill Medicaid for drugs purchased at 340B prices? Regardless of state specific requirements, a covered entity s carve-in or carve-out practice must be consistent with its listing in HRSA s MEF Policies and Procedures 35 36

Consider This Statement If your entity bills Medicaid for drugs purchased at 340B prices that may be subject to a payment of a Medicaid rebate to a state, you must answer 'Yes' and submit to OPA the Medicaid Provider Number (MPN) and/or the National Provider Identifier (NPI) which is used to bill Medicaid for outpatient drugs. If you are unsure of your Medicaid Provider Number and/or NPI, please check with your State Medicaid agency. It is important that your Medicaid billing status is accurately reflected in the 340B database Medicaid Exclusion File to prevent Medicaid rebates on drugs that were purchased at 340B prices and to ensure that the state Medicaid Agency has accurate information for those drugs not purchased under the 340B Program. You must notify OPA prior to any change in your Medicaid billing status. For more information, go to: http://www.hrsa.gov/opa/programrequirements/medicaidexclusion. http://www.hrsa.gov/opa/programrequirements/medicaidexclusion Medicaid Exclusion File/Duplicate Discount Prohibition 1. Upon enrollment in the 340B Program If covered entities decide to bill to Medicaid for drugs purchased under 340B with a Medicaid provider number/npi, then ALL drugs billed to that number must be purchased under 340B and that Medicaid provider number/npi must be listed in the HRSA Medicaid Exclusion File. For covered entities that opt to purchase Medicaid drugs outside of the 340B Program, e.g., carve-out Medicaid prescriptions, ALL drugs billed under that Medicaid provider number/npi must be purchased outside the 340B Program, and that Medicaid provider number/npi should not be listed in the HRSA Medicaid Exclusion File. 37 38 http://www.hrsa.gov/opa/programrequirements/medicaidexclusion Medicaid Exclusion File/Duplicate Discount Prohibition 2. Report any changes in billing of 340B drugs to Medicaid to the Office of Affairs before implementing the billing change. It is your responsibility as a 340B covered entity to ensure that your information in the HRSA Medicaid Exclusion File is correct. 3. If you cannot comply or want to use alternative methods to prevent duplicate discounts, work with your State Medicaid agency and the Office of Affairs to establish sufficient safeguards. Consider the Following Statement In some regards, it is not the CE 340B ID that carves-in or carves-out, it is the MPN/NPI used by the 340B ID that carves-in or carves-out 340B eligible Medicaid FFS claims. 39 40 If No Answer to 340B Database Medicaid Question Carve-Out Entity Does not bill 340B drugs to Medicaid If Yes Answer to 340B Database Medicaid Question Carve-In Entity Bills 340B drugs to Medicaid. Must list all entity Medicaid and NPI numbers used to bill Medicaid for 340B drugs including multiple state Medicaid numbers if applicable. 41 42

340B Database MEF The MEF Database Quarterly MEF The MEF is created quarterly from covered entity 340B database entries http://opanet.hrsa.gov/opa/cemedicaidextract.aspx 43 44 Accessing the Quarterly MEF The quarterly MEF is the key HRSA compliance component (not the database record) Medicaid Exclusion http://www.hrsa.gov/opa/ 45 46 Accessing the Quarterly MEF Accessing the Quarterly MEF Choose MEF Quarter At the bottom of the page, click Search the Medicaid Exclusion File 47 48

The MEF Consider the Following Statement A quarterly snap shot of 340B ID s having at least one (carve-in) Medicaid Provider/NPI number. Detail includes all Medicaid Billing and NPI numbers by 340B ID 340B ID s not found in the MEF therefore carve-out. A covered entity may have multiple 340B ID s to represent the parent and child sites. Each 340B ID must include in the MEF the MPN and NPI numbers used to bill 340B drugs to Medicaid 49 50 CE Listing in the MEF CE Listing in the MEF? The 340B database takes a snapshot of carve-in/out decisions at 12:01am ET on the 15th day of the month prior to the start of each quarter, irrespective of weekends or holidays A change to the Medicaid Exclusion File may be requested at any time, but changes do not take effect until the first day of the following quarter and only if approved by OPA before the time it takes the quarterly snapshot of carve-in/carve-out decisions MEF governing the period 07/01/15-09/30/15 Medicaid Exclusion File_6_15_2015 Entities not found in the MEF are carve-out for the full quarter Entities found in the MEF are carve-in for the full quarter 51 52 MEF is a Key HRSA Compliance Component Key Practice Considerations Medicaid Exclusion File (MEF) Regardless of state specific requirements, a covered entity s carve-in or carve-out practice must be consistent with its listing in HRSA s MEF 340B Database Practice Policies and Procedures 1. Identify prescription/drug order as 340B eligible 2. Identify Medicaid as payor (primary, secondary, and tertiary) 3. Determine MPN/NPI listing on the MEF MPN/NPI on MEF provide 340B drug MPN/NPI not on MEF provide non 340B drug 4. Practice must be consistent with listing in MEF 5. Follow state billing requirements 53 54

340B Eligibility Determination Filters (Excludes ADAP) (Scope of Grant Applies to Grantees Only) Practice The Life Cycle of a Drug Order Drug Order Accurate 340B Eligibility Determination Bill to Payor Covered entities carving-out Medicaid must ensure that 340B drugs are not billed to Medicaid 340B or not 340B? That is the question. 55 56 Practice The Life Cycle of a Drug Practice DSH Operations Environments Order Bill to XPayor Outpatient Retail 340B ID DSH12345 Mixed-Use Outpatient Clinic Administration DSH12345A Cardiology DSH12345C Infusion Center DSH12345B Nephrology A duplicate discount cannot occur if a drug is not billed to Medicaid. What is the MPN/NPI number used to bill 340B drugs to Medicaid in each operations environment? 57 58 Practice CHC Operations Environments Consider the Following Statement 340B ID CH12345 Outpatient Retail Primary Care Clinic Administration Pediatrics 340B ID CH12345A HV56789 Ryan White Family What is the MPN/NPI number used to bill 340B drugs to Medicaid in each operations environment? In some regards, it is not the CE 340B ID that carves-in or carves-out, it is the MPN/NPI used by the 340B ID to carve-in or carve-out 340B eligible Medicaid FFS claims. 59 60

340B Eligible Prescriptions/Orders MPN/NPI in MEF Prescription/order is 340B Eligible Medicaid is payor Must provide and bill 340B drug Must ensure State does not request manufacturer rebate MPN/NPI in MEF Prescription/order is not 340B Eligible Medicaid is payor Provide and bill non-340b drug MPN/NPI not in MEF Medicaid is payor Never bill a 340B drug Rx Meets 340B Patient Definition? CE May Provide 340B and Non-340B Drugs to Individuals Carve-in or Carve-out NPI / Medicaid Billing # in MEF? Medicaid is Payor? YES IN YES YES YES YES OUT NO YES NO NO IN YES/NO YES/NO NO NO OUT YES/NO YES/NO NO When 340B patient definition = yes, practice must be consistent with MEF 340B Drug? Follow State Medicaid Billing Requirements 61 62 Scenario 1: CE has an outpatient retail pharmacy and provides 340B drugs to 340B eligible patients and non-340b drugs to 340B ineligible patients. The pharmacy has one NPI (123456) and one MPN (78910) listed in the MEF. Medicaid requires that the NPI, MPN and drug NDC number be included when the prescription is billed. A 340B eligible patient with Medicaid insurance presents a 340B eligible prescription that is on the Medicaid formulary. What should the pharmacy do? Scenario 2: CE has an outpatient retail pharmacy and provides 340B drugs to 340B eligible patients and non-340b drugs to 340B ineligible patients. The pharmacy has one NPI (123456) and one MPN (78910) listed in the MEF. Medicaid requires that the NPI, MPN and drug NDC number be included when the prescription is billed. A 340B eligible patient with Medicaid insurance presents a 340B eligible prescription that is not on the Medicaid formulary. The patient agrees to pay cash for the prescription. What should the pharmacy do? Dispense a 340B drug and bill Medicaid using NPI 123456, MPN 78910 and the NDC of the drug Dispense a 340B drug and not bill Medicaid 63 64 A CE s Practice Must Be Consistent With its Listing of NPI/Medicaid Billing Numbers in MEF Consider State Medicaid Requirements for Each 340B Drug Operations Environment Medicaid Exclusion File (MEF) 340B Database Practice Dispensation Follow State Requirements Mixed-Use In-house Retail In-house Closed Clinic Provider Dispensing/ Administration Policies and Procedures CE Outpatient Administration Inpatient & Outpatient 340B & non-b Outpatient 340B & non-b Outpatient 340B only Outpatient 340B & non-b 65 66

Examples of State Billing Requirements Outpatient May mandate carve-in or carve-out practice May address both FFS and MCO May mandate pharmacy claims 340B identification Benefits Manger (PBM) identifiers o Batch Identification Number (BIN) o Processor Control Number (PCN) o Group Numbers National Council for Prescription Drug Programs (NCPDP) codeshttps://www.ncpdp.org/ncpdp/media/pdf/340b_infor mation_exchange_reference-guide_v1-0.pdf o Submission clarification code 20 in Field 420-DK o Basis of cost determination value 08 in Field 423-DN Examples of State Billing Requirements Outpatient Administration/Dispensation May mandate carve-in or carve-out practice May address both FFS and MCO The National Drug Code (NDC) is required in order for a state to bill the manufacturer for rebate May mandate drug and 340B identifiers on office visit billing o NDC with 340B modifier such as UD o J-Code and other HCPCS codes that correspond or crosswalk to NDC s with a 340B modifier such as UD 67 68 Determine Your State s Medicaid Drug Rebate Practice/Requirements MDR Detail State Contact Information State: Agency: Policy Information Rebate Information Technical Information Contact Person Contact Person Contact Person Address Address Address Telephone # Telephone # Telephone # Email Email Email http://www.medicaid.gov/medicaid chip program information/bytopics/benefits/prescription drugs/downloads/xxx 4 drugcon.pdf Scenario 3: A DSH CE has a mixed-use pharmacy and provides 340B drugs to 340B eligible outpatients and GPO drugs to inpatients. The pharmacy has one NPI (234567) and one MPN (891011) listed in the MEF. Medicaid requires that the CE include NPI, MPN and drug NDC numbers with UD modifiers for 340B drugs when the drug is billed. A CE provider orders a drug to be administered by injection to a 340B eligible outpatient who has Medicaid insurance. The drug is on the Medicaid formulary. What should the pharmacy do? Provide a 340B drug. Include, NPI 234567, MPN 891011, drug NDC with UD modifier in Medicaid billing. 69 70 Scenario 4: A DSH CE has an outpatient retail pharmacy and provides 340B drugs to 340B eligible patients and WAC drugs to 340B ineligible patients. The pharmacy has one NPI (678910) and one MPN (54321) listed in the MEF. Medicaid requires that the NPI, MPN and a submission clarification code of 20 in Field 420-DK when the prescription is billed. A patient of the DSH presents with a prescription from a private practice provider. The patient has Medicaid insurance and the drug is on the Medicaid formulary. The pharmacy technician notes that there is no referral on file to demonstrate responsibility for care. What should the pharmacy do? Contract - Carve Out Contract pharmacies must carve-out unless the covered entity, the contract pharmacy, and the state Medicaid agency have established an arrangement to prevent duplicate discount and HRSA has been notified Dispense WAC drug. Include the NPI 678910, MPN 54321 and do not include a submission clarification code December 2014 Policy Clarification: Duplicate Discount http://www.hrsa.gov/opa/programrequirements/policyreleases/clarificationmedicaidexclusion.pdf 71 72

Practice at Contract (Excludes ADAP) (Scope of Grant Applies to Grantees Only) Do Not Bill 340B drugs to Medicaid at Contract Drug Order Accurate 340B Eligibility Determination Applies to primary, secondary and tertiary claims Mechanisms used to identify and exclude 340B Billing Codes BIN Numbers PCN Numbers Group Numbers Other Covered entities carving-out Medicaid must ensure that 340B drugs are not billed to Medicaid 73 74 Contract Carve-in A 340B Price or Rebate May Be Claimed By a Single Organization Covered Entities (CE) are responsible to prevent duplicate discount! ADAP CE Grantee CE RX $ Medicaid Hospital CE Only one can claim the 340B price or rebate! 75 76 AIDS Drug Assistance Programs (ADAP) MEF is a Key HRSA Compliance Component An individual may be an eligible patient of both an ADAP and another 340B covered entity such as a hospital or grantee. 340B Database? Medicaid Managed Non-ADAP Care Covered Entity (CE) Does the state ADAP collect a rebate for prescriptions dispensed from our sites or contract pharmacies? How do we identify 340B ADAP claims from non-340b ADAP claims? ADAP Covered Entity (CE) Are we paying non-adap CE s for 340B and/or non-340b drug claims from their sites and contract pharmacies? How do we identify 340B and non-340b claims? Medicaid Exclusion File (MEF) Regardless of state specific requirements, a covered entity s carve-in or carve-out practice must be consistent with its listing in HRSA s MEF Practice Policies and Procedures 77 78

Have and Follow Policies and Procedures That Include State Requirements Comprehensive Policy and Procedures for Prevention of Duplicate Discount Mixed-Use Inpatient & Outpatient 340B & non-b In-house Retail Outpatient 340B & non-b Provider Dispensing/ Administration Outpatient 340B & non-b Contract Outpatient 340B Define for each operations environment of each registered covered entity site and each contract pharmacy arrangement Statement of carve-in/carve-out billing practice and MEF listing consistent with billing practice include MPN/NPI numbers used and if listed or not listed in MEF Describe how often accuracy of MEF information is validated List all Medicaid FFS, MCO and ADAP programs the entity participates in Detail state requirements for Medicaid Fee For Service, Managed Care and ADAP as well as how claims are identified in entity s system(s) Detail mechanism(s) used to prevent duplicate discount Describe the monitoring processes implemented Describe corrective action when duplicate discount is identified 79 80 Maintain Auditable Records To Demonstrate Prevention of Duplicate Discount & Self-Audit Report Name Data Rationale To demonstrate prevention of duplicate discount HRSA s Medicaid Exclusion File Covered entity s HRSA MEF profile To verify accurate status on HRSA s Billing records/data 340B transactions Medicaid number /CMS certification Medicaid Exclusion File Communications between regulatory bodies letter To verify relevant information on OPA s as well as OPA and Medicaid agencies NPI(s) numbers used to bill Medicaid website is recorded accurately (every P&P describing mechanisms for DD Unique identifying number for the order / Medicaid number used to bill for 340B prevention prescription number drugs is listed) Drug / product name /strength To validate whether Medicaid was the Quantity issued payer and whether the transaction was Patient ID number identified as 340B (if carve in) Payer Ordering provider Date of service Documentation of internal self-audit Self-audit/test results documentation Elements verified To verify prevention of diversion Independent audit result Number of samples tested, from which To ensure that all 340B purchased drugs P&P describing CP s compliance oversight setting are accounted for. Testing results To verify prevention of duplicate discount What corrective action if deficiencies found 340B Audit Readiness Series: Developing and Maintaining Auditable Records to Demonstrate 340B Compliance AIDS Resource Center of Wisconsin Ryan White grantee 4 sites registered on 340B database Entity owned outpatient retail pharmacy serves ARCW patients and serves as a contract pharmacy to other covered entities Utilize contract pharmacy 3,450 HIV positive patients served Services offered: medical, nursing, behavioral health, dental, case management, housing, legal, quality assurance and food pantry 81 82 ADAP With Entity Owned Utilizes split billing software Carves-out Medicaid Fee For Service Medicaid Managed Care Excludes from 340B ADAP Quarterly Review of 340B Database and MEF Use a calendar reminder system that is recurring for the first few days of each quarter in January, April, July and October to check OPA database and the actual Medicaid Exclusion Excel File to ensure all information is correct ARCW carves-out Medicaid therefore not listed in MEF, we also check 340B database history tab to ensure that no changes made during 123456789 Mr. CEO 222-555-1212 MR. CFO 222-555-3434 Mr. COO 222-555-5656 MR. CMO 222-555-7878 Mr. Pres 222-555-0101 MR. CEO 222-555-1212 83 84

Policy and Procedure Duplicate Discount Prevention Audit of ARCW Claims Outlines 100% carve-out practice for all operations environments of each site including contract pharmacy Outlines quarterly review of 340B database and MEF listings for all sites Outlines practice consistent with state requirements Outlines self-audit to test covered entity and contract pharmacy claims Data test for duplicate discounts or ADAP claim payments Look-up Excel command to identify if a rebated payor is present (Medicaid, ADAP, MCO) If, Then Logic If flag claims where rebated payor AND payment made Then Exclude RX s where a payment was made from Medicaid, ADAP or MCO (yellow) Include RX s where no payment was made from Medicaid, ADAP or MCO (green) 85 86 Audit of Contract Pharmacies State of Wisconsin Few Medicaid Managed Care for HIV patients, almost all fee for services Medicaid claims identified at Contract by BIN & PCN How we monitor compliance at Contract Pharmacies Must have access to all claim data Audit each line as you audit your own pharmacy ARCW is responsible for auditing contract pharmacies We audit all claims at the Contract Pharmacies monthly 87 Family Health Services, CHC Four sites One entity owned outpatient pharmacy opened in 2002 Filled over 62,000 prescriptions last fiscal year Carve-in Medicaid No contract pharmacies Four full time pharmacists including a Comprehensive Medication Management Pharmacist with expanding clinical services 88 8 8 FQHC With Entity Owned Outpatient FQHC with an entity owned outpatient pharmacy Medicaid Carve-in Medicaid Fee For Service Carve-in Medicaid Managed Care Claims identification by NPI used to bill listed in the Medicaid Exclusion File Physician administered medications Outpatient dispensed medications How 340B Medicaid Claims are Identified and Excluded From Rebate? Physician-administered The Family Health FQHC Medicaid billing number and all NPI #s used to bill physician administered drugs are listed in the MEF Dispensed at outpatient pharmacy The Family Health NPI # used to bill 340B drugs is listed in the MEF The state requires unique BIN and PCN for Medicaid Managed Care plans. Claims submitted to the unique BIN and PCN from Family Health. 89 90

Self-Audit of Carve-In Outpatient Non-340B medications in pharmacy inventory are not used for Medicaid claims Monthly audits for in-house pharmacy stock Recently implemented perpetual inventory As of July 1 st, Managed Medicaid has unique identifiers for claims Plan Name RXBIN RXPCN RXGROUP Plan A 111111 MCAIDOH RX0797 Plan B 222222 MCAIDOH RX0714, RX0718 Plan C 333333 MCAIDOH RX6407, RX6408 Self-Audit of Carve-In Clinic Administrations Physician administered Clinic administered drugs are identified by NPI numbers associated with our registered sites The NPI numbers listed on the Medicaid Exclusion File are correct All NPI numbers being used are listed in the MEF The NPI numbers listed are the actual numbers being used Monthly audits of a clinic medication are reconciled against ordered quantities and claims billed to assure no diversion 91 92 Regular Review of OPA Database and MEF Anticipated New Child Site Process All sites where 340B drugs used OPA database and MEF checked Quarterly During annual recertification When changes are made Addition of a child site 10/1/2014 Authorizing official certified child site on OPA database 1/1/2015 Child site listed on OPA database Notification to us that registration was received 93 94 Actual Start Up of New Child Site Health Partners of Western Ohio Federally Qualified Community Health Center Organization 9 Locations in 6 Western Ohio Counties Multidisciplinary Integrated Care Model Primary Care Behavioral Health Comprehensive Services Dental Chiropractic Advocacy and Outreach In-House and Contract Models 95 96

Health Partners of Western Ohio Health Partners of Western Ohio Entity Claims Carve-In Medicaid Clinics In-House Entity Owned Pharmacies Carve-Out Medicaid Contract Pharmacies Rebate 97 98 Health Partners of Western Ohio - Parent Medicaid Question 340B Database Record Health Partners of Western Ohio - All Sites Medicaid Exclusion File Yes answer to the Medicaid billing question and lists all Medicaid billing and NPI numbers used to bill Medicaid Each child site answers yes to the MEF question on the 340B database and lists the Medicaid billing and NPI numbers used so that the MEF is complete and accurate for all sites. 99 100 Health Partners of Western Ohio Contract Pharmacies Health Partners of Western Ohio Third Party Software Rebate Ohio HIV Drug Assistance Program: o Contract pharmacy model o Patients in the program must use the OHDAP contracted pharmacy o HPWO is not a contracted pharmacy for OHDAP Contract Pharmacies 101 102

Auditing Entity Claims: All 340B, All Carved Out General Integrity Audits Daily: Clinic Perpetual Inventory Reconciliation Monthly: Clinic Stock Audits Claim Audits Quarterly: CE Database Verification Annually: Recertification Medicaid Conversation OHDAP Conversation Contract Pharmacies Integrity & DD Audits Weekly: Full Claim Audit in accumulator Wholesale Audit of invoices Quarterly: MMCO verification of BIN/PCN CE Database Verification Annually: On-Site CP Audit External Audit Example HRSA Audit Findings Incorrect Medicaid Number or NPI in MEF Duplicate Discounts Covered entity billing contrary to information in MEF Contract billing state Medicaid agency 103 Case Study Covered entity lists state Medicaid billing number on the MEF System in place that ensures that 340B drugs are used for every individual billed under Medicaid Policies and procedures match process Any issues or questions? Take Home Messages Be prepared Covered entity s responsibilities for oversight Eligibility includes maintaining auditable records showing compliance Methods to prevent diversion and duplicate discounts Resources Office of Affairs About 340B Program Audits of Covered Entities Policy Releases Office of Affairs Frequently Asked Questions 340B Peer-to-Peer Webinars 340B University with slides, notes and other tools Contact Information Office of Affairs (OPA) Main Office Phone Line: 301-443-4353 Web: www.hrsa.gov/opa Prime Vendor Program (PVP) Phone: 1-888-340-2787 ApexusAnswers@340bpvp.com Web: www.340bpvp.com 10

Questions? Per statutory requirements, which organization is responsible for the prevention of duplicate discount? A. State Medicaid Agency B. Covered Entity C. Contract D. Office of Affairs 109 110 When a CE chooses to bill 340B drugs to Medicaid OPA requires that the CE A. Answer no to the Medicaid question on the OPA database B. Answer yes to the Medicaid question on the OPA database and list all Medicaid Billing and NPI numbers used to bill Medicaid in the Medicaid Exclusion File C. Include the NDC of the drug provided in the Medicaid billing process D. Include a 340B identifier for the drug provided in the Medicaid billing process Why must a CE have a system in place to identify Medicaid as a primary, secondary or tertiary payor? A. To provide and bill a 340B drug if the CE carves-out B. To provide and bill a non-340b drug if the CE carves-in C. To validate carve-in or carve-out requirements of the CE s 340B eligibility determination system D. To comply with the CE s no answer to the MEF question on the 340B database 111 112 Which of the following should be included in policies & procedures related to the prevention of duplicate discounts? A. A statement of carve-in or carve-out practice for each operations environment of each site registered on the 340B database B. Detailed mechanisms used to prevent duplicate discount C. A description of the monitoring process used to validate that the entity s practice is consistent with its listing in the MEF D. All of the above True or False: Contract Pharmacies carve-out 340B claims from Medicaid unless they have an arrangement with the Covered Entity and State Medicaid agency and are listed as carve-in on the 340B database. A. True B. False 113 114