Operations Manager: H&HS Director:

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1 CHCLC Policies & Procedures Manual This Policy Covers: X All Sites All Primary Care Sites School-Based Health Centers Dental Program AD-054a Ltr Section Issue Date: 8/15/2018 Replaces: Nursing Supervisor: CHCLC Manager: Medical Director: Operations Manager: H&HS Director: New Ltr Section SUBJECT: 340B Drug Pricing Program PURPOSE: The purpose of this 340B Policy & Procedure is to comply with Community Health Centers of Lane County s (CHCLC) obligations under Section 340B of the Public Health Service Act. Section 340B of the Public Health Service Act (1992) requires drug manufacturers participating in the Medicaid Drug Rebate Program to sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services. This agreement limits the price that manufacturers may charge certain covered entities, such as CHCLC, for covered outpatient drugs. The Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) administer the 340B Drug Program. As a participant in the 340B Drug Program, CHCLC: 1. Agrees to abide by specific statutory requirements and prohibitions. 2. May access 340B drugs. CHCLC has adopted the 340B Policy and Procedures (P&P) document developed by Apexus, HRSA s 340B Prime Vendor. The template P&P has been modified to reflect CHCLC s current 340B Drug Program operations. This Policy and Procedures document explains CHCLC s oversight of its 340B Drug Program and is used to maintain a compliant 340B Drug Program. POLICY: It is the policy of CHCLC to comply with all requirements and restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid, and the prohibition against transferring drugs purchased under 340B to anyone other than a patient of the entity. (REFERENCE: Public Law , Section 602, 340B Guidelines, 340B Policy Releases). CHCLC uses the 340B Drug Program savings generated to benefit patients and their families. These benefits include: 1. Medication vouchers for those unable to pay. 2. Maintain a team-based care model. 3. Discount prescriptions for uninsured patients. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 1 of 22

2 4. Operating expenses for maintaining the program. 5. Clinical pharmacy services for clinic clients. CHCLC has systems and processes in place to reasonably ensure ongoing compliance with all 340B requirements. CHCLC maintains auditable records and reports demonstrating compliance with the 340B Drug Program, which are reviewed as part of its 340B oversight and compliance program (see Monitoring Summary). This Policy and Procedures document will be updated and approved whenever there is a clarification or change in the rules, regulations or guidelines to the 340B Drug Program requirements. PROCEDURES: A. CHCLC ELIGIBILITY: To be eligible for enrollment in, and the purchase of drugs through, the 340B Drug Program, CHCLC must meet the requirements of 42 USC 256b(a)(4)(A). 1. CHCLC determines 340B eligibility on the following basis: 1.1. CHCLC has received a grant, or 1.2. CHCLC has a designation consistent with scope of grant with conferring 340B eligibility (See Appendix VIII for HRSA EHB Summary). 2. CHCLC has identified locations where it administers, dispenses and prescribes 340B drugs B ID: CH Associated Sites: See Appendix I 3. CHCLC ensures that the HRSA 340B Office of Pharmacy Affairs Information System (OPAIS) Database is complete and accurate for all 340B eligible locations including the parent entity, service sites, and contract pharmacies. 4. All contract pharmacy service sites that use 340B drugs are registered on the HRSA OPAIS 340B Database. 5. All main addresses, billing and shipping addresses, the Authorizing Official, and the Primary Contact information are correct and up to date. 6. CHCLC reviews its OPAIS 340B Database records annually and with each change. 7. CHCLC informs HRSA within one week of any changes to its information by updating the HRSA OPAIS 340B Database/Medicaid Exclusion File. 8. CHCLC annually recertifies information on HRSA s OPAIS 340B Database as directed by the HRSA Database Guide to Recertification. 9. CHCLC 340B officials are: 9.1. Authorizing Official: Lane County Director of Health and Human Services 9.2. Authorizing Agent: Program Services Coordinator B. ENROLLMENT, RECERTIFICATION AND CHANGE REQUESTS: Eligible community health centers must be registered on, and maintain the accuracy of, the HRSA OPAIS 340B Database to participate in the 340B Drug Program. CHCLC ensures the accuracy of its registration in the following ways: Covered Entity Enrollment 1. Review and determine whether CHCLC is eligible to participate in the 340B Drug Program and confirm grant documentation conferring 340B eligibility Identify upcoming registration dates and deadlines Ensure the 340B Authorizing Official and Authorizing Agent are both listed on HRSA website. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 2 of 22

3 1.3. Designated Authorizing Official completes registration on the HRSA OPAIS 340B Database. Registration Dates Effective Start Date January 1 January 15 April 1 April 1 April 15 July 1 July 1 July 15 October 1 October 1 October 15 January 1 2. CHCLC Annual Recertification Procedure 2.1. The designated 340B Authorizing Official recertifies information on the HRSA OPAIS 340B Database annually A recertification will be sent from HRSA to CHCLC's 340B Authorizing Official before the recertification deadline. The will contain links and recertification directions. The 340B Authorizing Official completes the recertification by following the directions Questions surrounding recertification can be directed to 340B.recertification@hrsa.gov. 3. CHCLC Enrollment Procedure: New Service Site and Facilities 3.1. CHCLC determines that a new service site or facility is eligible to participate in the 340B Drug Program with required criteria The service site criteria must: Be identified in the grant Have outpatient drug use Patients must meet the 340B patient definition. Contract Pharmacy Enrollment and Termination 1. A signed contract pharmacy services agreement, which will contain the 12 essential compliance elements found in the Contract Pharmacy Guidance, will be in place between the CHCLC and the contract pharmacy before registration on the HRSA OPAIS 340B Database See Appendix III for essential compliance elements. 2. CHCLC Authorizing Official and Primary Contact complete the online registration during one of four registration windows. See registration dates above. 3. Within 15 days from the online registration, the Authorizing Official certifies online completion of the contract pharmacy registration. 4. CHCLC begins using the contract pharmacy services arrangement only on or after the effective date shown on the HRSA OPAIS 340B Database. 5. If a contract pharmacy is terminated, the Program Services Coordinator will update the 340B OPAIS Database to reflect those changes immediately. Eligibility Changes to CHCLC Information in HRSA OPAIS 340B Database 1. HRSA will be immediately notified of any changes to CHCLC eligibility to participate in the 340B Drug Program (such as termination of grant or change in designation) B drug purchases will cease as soon as the change in 340B eligibility is identified. 3. CHCLC s 340B Program Services Coordinator will complete the online change request as soon as a change in eligibility is identified. 4. The 340B Authorizing Official will ensure changes are reflected on HRSA's 340B website after two weeks of submission of the changes/requests. If changes are not reflected, the 340B Authorizing Official will contact HRSA. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 3 of 22

4 C. PATIENT ELIGIBILITY DEFINITION: Per the Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility, 340B drugs are to be provided only to individuals eligible to receive 340B drugs from covered entities. 1. CHCLC validates site eligibility as described in Section B, Enrollment, Recertification, and Change Requests. 2. CHCLC does not dispense/administer medication to patients who are in-patients. Patient must be in out-patient status at the time the drug is dispensed/administered or prescribed to be eligible for 340B medication. 3. CHCLC defines an individual to be a patient of CHCLC if: 3.1. CHCLC entity maintains the patient s medical health record in the electronic health record The individual receives health care services from a health care professional in the past 24 months who is either employed by CHCLC or provides health care under contractual or other arrangements (see referral for consultation), such that the responsibility of care is with CHCLC The individual receives health care service or a range of services from CHCLC which is consistent with the service or range of services for which grant funding has been provided. 4. CHCLC determines provider eligibility The provider is employed by the entity, under contractual or other arrangements with the entity, and the individual receives a health care service (within the scope of grant/designation for which 340B status was conferred) from this professional such that the responsibility of care is with CHCLC CHCLC Credentialing Coordinator maintains a list of prescribers credentialed with CHCLC and shares the list with the CHCLC IT department CHCLC IT department updates the current prescriber list with the pharmacy and CHCLC contract pharmacy and third-party administrator (TPA) The prescriber file will contain First Name, Last Name, NPI, Date Active and Date Not Active The prescriber file will be sent to the contract pharmacy and TPA at least monthly CHCLC determines patient Medicaid status. See Section D, Prevention of Duplicate Discounts and Figure 1 referenced below. Figure 1 5. Referrals: A recommendation by the patient's primary health care provider that the patient sees another health care provider, often a specialist For the prescription to be eligible, the visit summary must be available in the patient's health record or via an electronically shared system, such as Care Everywhere, Epic, etc. (See CHCLC Policy & Procedures: 340B Drug Pricing Program Page 4 of 22

5 Figure 2 reference below). A referral request to the referral provider or clinic will be documented in the patient EHR Prescriptions issued by the referring provider are eligible for the 340B discount as long as there is a current referral visit summary no less than 12 months old If there is a change in the patient diagnosis from that noted on the initial referral, a new referral request should be issued. Figure 2: Capturing Referral Prescriptions D. PREVENTION OF DUPLICATE DISCOUNTS: 42 USC 256b(a)(5)(A)(i) prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. CHCLC has elected to dispense 340B drugs to its Managed Medicaid patients (carve-in) through its contract pharmacy. CHCLC does not have an in-house pharmacy. 1. Medicaid Carve-In 1.1. For clinic-administered medications that are purchased at 340B pricing and billed to Medicaid (carve-in), CHCLC has answered Yes to the question, Will you bill Medicaid for drugs purchased at 340B prices? on the HRSA Office of Pharmacy Affairs Information System (OPAIS). CHCLC Policy & Procedures: 340B Drug Pricing Program Page 5 of 22

6 Figure 3 HRSA OPAIS Database 2. Medicaid Carve-Out 2.1. CHCLC contract pharmacies do not dispense nor administer 340B purchased drugs to Medicaid Fee-for-Service patients. For Managed Medicaid patients, CHCLC will send a quarterly rebate exclusion file to the state through its third-party administrator. Trillium Health Plan will send the Medicaid exclusion file for 340B prescriptions at Walgreens (Carve-In). CHCLC 340B TPA will send the Medicaid exclusion file for 340B prescriptions for all other contract pharmacies. E. 340B DRUG PROGRAM ROLES AND RESPONSIBILITIES: Covered entities participating in the 340B Drug Program must ensure program integrity and compliance with 340B Drug Program requirements. 1. CHCLC has established a 340B Oversight Committee that is responsible for the oversight of the 340B Drug Program. 2. CHCLC 340B Oversight Committee: 2.1. Meets annually Reviews 340B regulatory changes/rules/guidelines to ensure consistent 340B policies and procedures Identifies activities necessary to conduct comprehensive reviews of 340B compliance Ensures that the organization meets compliance requirements of program eligibility, patient definition, 340B drug diversion, and duplicate discounts via ongoing multidisciplinary teamwork Integrates departments such as information technology, compliance, and patient financial services to evaluate standard processes for contract/data review to ensure program compliance Oversees the review process of compliance activities, as well as taking corrective actions based on findings B Oversight Committee assesses if the results are indicative of a material breach: see "340B Non-Compliance/Material Breach." 2.8. Reviews and approves work group recommendations (process changes, self-monitoring outcomes and resolutions). F. PROGRAM EDUCATION AND COMPETENCY: Program integrity and compliance are the responsibility of the 340B Oversight Committee. Ongoing education and training are needed to CHCLC Policy & Procedures: 340B Drug Pricing Program Page 6 of 22

7 ensure that these 340B Oversight Committee members have the knowledge to guarantee compliant 340B operations. 1. All CHCLC staff and/or representatives that are involved with the 340B Drug Program are engaged with 340B Drug Program compliance. At least one representative of CHCLC participating in the 340B Drug Program annually completes an initial basic training via webinar such as the 340B Prime Vendor program, Apexus 340B Basics Training, 340B University, attends the National 340B Coalition Conferences once to twice annually, Litmos training, etc B key stakeholders complete an initial basic training as needed. 3. Training and education records are maintained in Lane County's learning management system, LEAP and the records are available for review. G. INVENTORY MANAGEMENT: Covered entities must be able to track and account for all 340B drugs to ensure the prevention of diversion. CHCLC uses contract pharmacy services in accordance with HRSA requirements and guidelines and has obtained sufficient information from the contract pharmacy contractor to ensure compliance with applicable policy and legal requirements. The signed contract pharmacy services agreements all comply with the 12 contract pharmacy essential compliance elements. See Appendix III B inventory is procured and managed in the following settings: 1.1. Clinic site administration CHCLC uses the following inventory method: Stocks only 340B inventory Clinic staff will administer 340B drugs only to patients meeting all of the criteria as defined in Section C, Patient Eligibility/Definition Contract pharmacy CHCLC uses the following inventory method: Virtual inventory replenishment Pharmacist and pharmacy staff will dispense 340B drugs only to patients meeting all the criteria as defined in Section C, Patient Eligibility/Definition. Clinic Inventory Management B in-clinic inventory is maintained at each registered clinic site as per Medication Administration & Management Policy CL CHCLC identifies all accounts used for purchasing drugs in each practice setting (parent site and service sites). 3. CHCLC Reproductive Health Coordinator or Supply Clerk routinely performs inventory reviews and shelf inspections to determine a purchase order. Medical Support Staff may send requests for medications as needed to the Supply Clerk or Reproductive Health Coordinator. 4. Supply Clerk or Reproductive Health Coordinator place 340B drug orders. 5. Supply Clerk receives the shipment. 6. CHCLC Supply Clerk verifies quantity received with quantity ordered Identifies inaccuracies Resolves inaccuracies Documents resolution of inaccuracies. 7. CHCLC maintains records of 340B-related transactions for a period of three years in a readily retrievable and auditable format. These reports are reviewed by CHCLC annually as part of its 340B oversight and compliance program. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 7 of 22

8 8. Wasted 340B Medications. Staff documents wastage as per Disposal of Medications and Liquid Products Policy EC-012. Contract Pharmacy Inventory and Dispensing 1. CHCLC has entered into a contract pharmacy arrangement with third party administrators to facilitate both the design and implementation of the 340B contract pharmacy program. The executed contracts may be obtained from H&HS Administration. See Appendix IV for contract pharmacies. 2. CHCLC uses a virtual replenishment model for contract pharmacy services B-eligible prescriptions may be presented to the contract pharmacies via e-prescribing, hard copy, fax, or phone. The pharmacy verifies patient, prescriber, and clinic eligibility via the contract pharmacy administrator s switch provider, using pharmacy benefit manager (PBM)/BIN/PCN coding matched to a preloaded eligibility file or CHCLC encounter system. 4. The contract staff dispenses prescriptions to 340B-eligible patients using the contract pharmacy s non-340b drugs. 5. The contract pharmacy administrator places 340B orders on behalf of CHCLC based on an accumulator system. Orders are triggered by package size and placed with the designated wholesaler. 6. CHCLC pays the invoice to designated wholesaler for all 340B drugs. 7. The contract pharmacy receives 340B inventory by examining the wholesaler invoice against the order, and reports inaccuracies to the designated wholesaler and CHCLC staff within 14 days. 8. The contract pharmacy notifies CHCLC if they do not receive the 11-digit NDC replenishment order within 30 days of the original order fulfillment request. CHCLC will reimburse at a pre-negotiated rate for such drugs. 9. The inventory is protected by a security system. Only pharmacy employees have access to the pharmacy. 10. The contract pharmacy administrator provides real-time reporting tools to the CHCLC. H. CONTRACT PHARMACY OPERATIONS: Covered entity remains responsible for ensuring that its contract pharmacies operations comply with all 340B Drug Program requirements, such that the covered entity remains responsible for the 340B drugs it purchases and dispenses through a contract pharmacy. 1. CHCLC contracts with third party administrators to facilitate both the design and implementation of the 340B contract pharmacy program. 2. CHCLC has a written agreement in place for each contract pharmacy location. See Appendix IV for the names and addresses of the individual contract pharmacy locations identified in the executed contract pharmacy agreements. CHCLC registers each contract pharmacy location on HRSA s 340B OPAIS Database prior to the use of 340B drugs at that site. 3. CHCLC uses a replenishment model using an 11-digit to 11-digit NDC match. 4. The contract pharmacy is presented with a 340B-eligible prescription via e-prescribing, hard copy, fax, or phone. 5. The contract pharmacy verifies patient and prescriber and clinic eligibility via encounter data obtained from electronic medical records. 6. Updates are made via SFTP to the third party administrators. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 8 of 22

9 7. The contract pharmacy dispenses prescriptions to 340B-eligible patients using a virtual inventory replenishment model with a bill-to, ship-to arrangement with the contract pharmacies. The contract pharmacy orders 340B drugs based on 340B-eligible use as determined by the third party administrator s accumulator system from wholesale accounts. 8. Invoices are billed to CHCLC. 9. Contract pharmacy will receive the shipment and will verify quantity received with quantity ordered. The contract pharmacy will contact the TPA if there are inaccuracies in replenishment orders. 10. Contract pharmacies will notify the third-party administrator if they do not receive the 11-digit NDC replenishment order within 90 days of the original order fulfillment request. 11. CHCLC reimburses the contract pharmacy at a pre-negotiated rate for such drugs. 12. CHCLC receives and reviews the invoice for drugs shipped to its contract pharmacies. 13. CHCLC pays the invoice to the wholesaler for all 340B drugs. 14. The third-party administrator provides a real-time report via the 340B web portal. 15. The contract pharmacy, via the third-party, adjusts claims when a variance or discrepancy has occurred With CHCLC s knowledge and agreement, the contract pharmacy, via the third-party, uses approved reconciliation methods between inventory and invoices with adjustments as necessary to match changes Claim adjustments may occur only within 90 days of original billing and not without prior notice and approval of entity. 16. Contract pharmacies will not use 340B drugs for Medicaid Fee-for-Service patients (carve-out). 17. Contract pharmacies avoid duplicate discounts for Managed Medicaid claims. See Section D, Prevention of Duplicate Discounts. 18. The contract pharmacy, through the designated third-party administrator, will ensure the following eligibility criteria are met for each 340B prescription filled for accurate 340B eligible determination (See Figure 1): Service locations are registered with Office of Pharmacy Affairs The patient health record is maintained Active patient status Current prescriber relation status Service provided to patient is within scope of grant I. CONTRACT PHARMACY COMPLIANCE ELEMENTS: HRSA has provided essential covered entity compliance elements as guidance for the contractual provisions expected in all contract pharmacy arrangements. HRSA requires that all 340B covered entities, such as CHCLC, address the following essential elements with a contract pharmacy arrangement. See Appendix III for the Contract Pharmacy Compliance Elements. J. 340B DRUG PROGRAM COMPLIANCE MONITORING AND REPORTING: Covered entities are required to maintain auditable records demonstrating compliance with 340B Drug Program requirements. CHCLC uses the process developed by Apexus and as outlined in the 340B Compliance Self- Assessment: Self-Audit Process to ensure 340B Compliance. All documents are retained for three years for the demonstration of monitoring and the resolution of findings. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 9 of 22

10 1. Monthly Audits 1.1. Validation of Provider Relationship: CHCLC Technology Services (TS) Department notifies contract pharmacies/administrator of changes in providers when the change occurs per method established by administrators, i.e., , online form, data file, etc. To validate that only CHCLC providers are writing prescriptions under the 340B Policy, CHCLC requests a list of providers who ordered/wrote prescriptions and validates the provider is either employed by or under a contractual relationship with CHCLC Cost and True-up Reconciliation: Using contract pharmacies and CHCLC reports, the estimated 340B cost calculated during claim qualification is compared to the actual cost on the wholesaler invoice. The amount charged for true-ups and undeliverable products against estimated costs are reviewed. 2. Quarterly Audits 2.1. Patient and Medication Eligibility CHCLC screens 100% of all pharmacy claims for patient and medication eligibility. By utilizing exported file reports from the third-party administrator's portal site, a datasheet is generated identifying all 340B claims data during the audit period and placed into an audit input server folder. TS runs logic reports using eligibility criteria, based on prescriber NPI, patient name, date of birth, encounter date, and medical record numbers. Once logic criteria have been satisfied, claim files are labeled as "verified" and those claims that do not match are labeled as "exceptions." All claims labeled as "exceptions" undergo manual investigation to determine eligibility. The claims that cannot be further verified as eligible are removed from the 340B Drug Program The patient has a record of health care at CHCLC per patient definition. See Section C, Patient Eligibility definition CHCLC remains primarily responsible for the patients' health care, which results in a prescription for 340B drugs Patients receiving prescriptions were seen at CHCLC for health care Patients receiving prescriptions were treated by a health professional employed by CHCLC, (or have some contractual relationship with CHCLC provider) Patients did not solely receive laboratory, radiologic, or pharmacy services from or at CHCLC Review the qualification reason for each claim included in the 340B Drug Program. If the qualification reason is not valid, the claim(s) should be investigated and, if found to be ineligible, reversed from the 340B Drug Program Compliance Audits Randomly select a sample of 25 patients Using the accumulator, ensure and review that all products are being managed at the 11-digit NDC level Randomly select purchases and compare against products dispensed in the 340B Drug Program. 3. Annual Audits 3.1. Recertification Ensure the data and information related to CHCLC listed on the HRSA OPAIS website is correct Contract Pharmacies Ensure that a fully executed agreement is in place between CHCLC and each contract pharmacy. Agreements with chain pharmacies may use a single agreement that lists all included locations Review the HRSA OPAIS website and ensure that all contracted pharmacies are listed and that no pharmacies without a contract are listed. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 10 of 22

11 Review the agreements in place between CHCLC and wholesalers to ensure that all contract pharmacies are represented Review all communications and promotional materials for the 340B Drug Program to ensure that all patients have a right to choose their pharmacy Review 340B Policy and Procedures Assess if audit results are indicative of a material breach. Refer to Section K, 340B Material Breach Records of 340B-related transactions for the previous three years are readily retrievable and auditable. 4. CHCLC 340B Oversight Committee reviews audit results if the audit results are indicative of a material breach. MONITORING SUMMARY Area of Focus Activity Frequency (suggested) Eligibility No Diversion No Duplicate Discount Review of All HRSA OPAIS 340B Database Information for CHCLC Annually X Validation of Provider Relationship Monthly X X X Cost and True-up Reconciliation Monthly X Patient and Medication Eligibility Quarterly X X X Inventory Replenishment Quarterly X Contract Pharmacies Annually X Recertification Third Party Vendor External Audit of Covered Entity/Contract Pharmacy Annually X Annually X X X K. MATERIAL BREACH: Covered entities are responsible for contacting HRSA as soon as reasonably possible if there is any material breach by the covered entity or any instance of noncompliance with any of the 340B Drug Program requirements. 1. Materiality: A convention within auditing/accounting pertaining to the importance/significance of an amount, transaction, and/or discrepancy. Threshold: The point that must be exceeded, as defined by the covered entity, resulting in a material breach. 2. CHCLC defines a material breach of compliance that would require self-disclosure as a violation(s) that exceeds thresholds defined below. Violations identified through internal self-audits, independent external audits, or otherwise that meet or exceed this threshold will be immediately reported to HRSA and applicable manufacturers using the Apexus self-disclosure report template. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 11 of 22

12 2.1. Material breach: 5% of total impact to any one manufacturer. The percentage shall be calculated by the total impact dollars divided by the total covered entity savings. 3. CHCLC reports an identified material breach immediately to HRSA and applicable manufacturers. DEFINITIONS: The Apexus 340B Acronym Guide defines common acronyms used in the 340B Drug Program: REFERENCES: Section 340B Federal Register Notices: Section 340B of the Public Health Service Act, Public Law : Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) 340B Policy Releases: HRSA Notice Regarding 340B Drug Pricing Program Contract Pharmacy Services: HRSA OPA Annual Recertification and Guide: HRSA OPA Registration Instructions: Apexus 340B University: Defining Material Breach Documentation Tool: pdf Oregon Health Authority 340B Supplemental Chart for Public Health Service Providers: Apexus 340B Compliance Self-Assessment: Self-Audit Process to Ensure 340B Compliance: _DataTransactions.pdf Policy CL-023 Medication Administration & Management Policy CL-078 Dispensing Medications Policy EC-012 Disposal of Medications and Liquid Products CHCLC Policy & Procedures: 340B Drug Pricing Program Page 12 of 22

13 APPENDIX I: Community Health Centers of Lane County Associated Sites Site ID 340B ID Subname Address BPS-H80- CH Administration 125 E 8th Ave, Eugene, OR BPS-H CH10792B Springfield Schools HC th St, Springfield, OR BPS-H CH10792D RiverStone Clinic 2073 Olympic St, Springfield, OR BPS-H CH10792L Lane County Mental Health 2411 MLK, Eugene, OR BPS-H CH10792M Charnelton Clinic 151 W 7th Ave #100,Eugene, OR BPS-H CH10792N Brookside Clinic 1680 Chambers St, #103, Eugene, OR BPS-H CH10792P Delta Oaks 1022 Green Acres Rd, Eugene, OR CHCLC Policy & Procedures: 340B Drug Pricing Program Page 13 of 22

14 APPENDIX II: CHCLC 340B Committee Members Name/Title COMMUNITY HEALTH CENTERS OF LANE COUNTY 340B Committee Members Review Date Karen Gaffney, Director HHS (340B Authorizing Official) Jonathan Mattingly, Program Services Coordinator (Primary Contact) Carla Ayres, Manager Ron Hjelm, Manager Torey Lam, 340B Liaison Lisa Willis, Clinical Services Finance Manager Micah Brown, Information Systems Director CHCLC Policy & Procedures: 340B Drug Pricing Program Page 14 of 22

15 APPENDIX III: Contract Pharmacy Essential Compliance Elements Contract Pharmacy Compliance Elements HRSA has provided essential covered entity compliance elements as guidance for the contractual provisions expected in all contract pharmacy arrangements. (a) 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 laws. A ship to, bill to procedure is used in which the covered entity purchases the drug; the manufacturer/wholesaler must bill the covered entity for the drug that it purchased,but ships the drug directly to the contract pharmacy. In cases where a covered entity has more than one site, it may choose between having each site billed individually or designating a single covered entity billing address for all 340B drug purchases. (b) The agreement will specify the responsibility of the parties to provide comprehensive pharmacy services (e.g., dispensing, record keeping, drug utilization review, formulary maintenance, patient profile, patient counseling, and medication therapy management services and other clinical pharmacy services). Each covered entity has the option of individually contracting for pharmacy services with a pharmacy(ies) of its choice. Covered entities are not limited to providing comprehensive pharmacy services to any particular location and may choose to provide them at multiple locations and/or inhouse.'' (c) The covered entity will inform the patient of his or her freedom to choose a pharmacy provider. If the patient does not elect to use the contracted service, the patient may obtain the prescription from the covered entity and then obtain the drug(s) from the pharmacy provider of his or her choice. When a patient obtains a drug from a pharmacy other than a covered entity s contract pharmacy or the covered entity s in-house pharmacy, the manufacturer is not required to offer this drug at the 340B price. (d) The contract pharmacy may provide other services to the covered entity or its patients at the option of the covered entity (e.g., home care, delivery, reimbursement services). Regardless of the services provided by the contract pharmacy, access to 340B pricing will always be restricted to patients of the covered entity. (e) The contract pharmacy and the covered entity will adhere to all Federal, State, and local laws and requirements. Both the covered entity and the contract pharmacy are aware of the potential for civil or criminal penalties if either violates Federal or State law. [The Department reserves the right to take such action as may be appropriate if it determines that such a violation has occurred.] (f) The contract pharmacy will provide the covered entity with reports consistent with customary business practices (e.g., quarterly billing statements, status reports of collections and receiving and dispensing records). (g) The contract pharmacy, with the assistance of the covered entity, will establish and maintain a tracking system suitable to prevent diversion of Section 340B drugs to individuals who are not patients of the covered entity. Customary business records may be used for this purpose. The covered entity will establish a process for periodic comparison of its prescribing records with the contract pharmacy s dispensing records to detect potential irregularities. (h) The covered entity and the contract pharmacy will develop a system to verify patient eligibility, as defined by HRSA guidelines. The system should be subject to modification in the event of change in such guidelines. Both parties agree that they will not resell or transfer a drug purchased at Section 340B prices to an individual who is not a patient of the covered entity. See 42 U.S.C. 256b(a)(5)(B). CHCLC Policy & Procedures: 340B Drug Pricing Program Page 15 of 22

16 The covered entity understands that it may be removed from the list of covered entities because of its participation in drug diversion and no longer be eligible for 340B pricing. (i) Neither party will use drugs purchased under Section 340B to dispense Medicaid prescriptions, unless the covered entity, the contract pharmacy and the State Medicaid agency have established an arrangement to prevent duplicate discounts. Any such arrangement shall be reported to HRSA, by the covered entity. (j) The covered entity and contract pharmacy will identify the necessary information for the covered entity to meet its ongoing responsibility of ensuring that the elements listed herein are being complied with and establish mechanisms to ensure availability of that information for periodic independent audits performed by the covered entity. (k) Both parties understand that they are subject to audits by outside parties (by the Department and participating manufacturers) of records that directly pertain to the entity s compliance with the drug resale or transfer prohibition and the prohibition against duplicate discounts. See 42 U.S.C. 256b(a)(5)(c). The contract pharmacy will assure that all pertinent reimbursement accounts and dispensing records, maintained by the pharmacy, will be accessible separately from the pharmacy s own operations and will be made available to the covered entity, HRSA, and the manufacturer in the case of an audit. Such auditable records will be maintained for a period of time that complies with all applicable Federal, State and local requirements. (l) Upon written request to the covered entity, a copy of the contract pharmacy service agreement will be provided to the Office of Pharmacy Affairs. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 16 of 22

17 APPENDIX IV: Contract Pharmacies Pharmacy Name Address City State Zip Code Begin Date ALBERTSON'S LLC 5755 MAIN ST SPRINGFIELD OR /08/2017 ALBERTSON'S LLC 2000 MARCOLA RD SPRINGFIELD OR /12/2018 PAYLESS (PROPACPAYLESS) 2411 MARTIN LUTHER KING BLVD, STE 107 EUGENE OR /01/2017 PAYLESS (PROPACPAYLESS) SE 34 th ST, BLDG 2 VANCOUVER WA /13/2016 FRED MEYER INC 650 Q ST SPRINGFIELD OR /15/2014 FRED MEYER INC 3333 W 11TH AVE EUGENE OR /19/2017 FRED MEYER INC 60 DIVISION AVE EUGENE OR /19/2017 POSTAL PRESCRIPTION SVCS 3500 SE 26TH AVE PORTLAND OR /19/2017 SAFEWAY PHARMACY # PIONEER PKWY E SPRINGFIELD OR /15/2014 SAFEWAY PHARMACY # E MAIN ST COTTAGE GROVE OR /14/2017 SAFEWAY PHARMACY # E 18TH ST EUGENE OR /15/2014 WAL-MART CENTRAL FILL SPRING HILL DR, #3 STE 300 SPRING TX /24/2017 WAL-MART PHARMACY GREEN ACRES RD EUGENE OR /7/2017 WAL-MART PHARMACY OLYMPIC ST SPRINGFIELD OR /16/2015 WAL-MART PHARMACY WEST 11 TH AVE EUGENE (W) OR /7/2017 WAL-MART PHARMACY PARKSOUTH CT, STE 100 ORLANDO FL /24/2017 WALGREENS # MAIN ST SPRINGFIELD OR /15/2013 WALGREENS # MOHAWK BLVD SPRINGFIELD OR /15/2013 WALGREENS #10812 #6 WEST Q STREET SPRINGFIELD OR /15/2013 WALGREENS # COBURG RD EUGENE OR /15/2013 WALGREENS # E MAIN ST COTTAGE GROVE OR /15/ /15/2013 WALGREENS # RIVER RD EUGENE OR WALGREENS MAIL SERVICE, LLC 8350 S RIVER PKWY TEMPE AZ /8/2017 WALGREENS # S PRICE RD CHANDLER AZ /8/2017 CHCLC Policy & Procedures: 340B Drug Pricing Program Page 17 of 22

18 APPENDIX V: Identification to Prevent Duplicate Discounts Policy Issue Paper Issue: 340B CCO Claims File Identification to Prevent Duplicate Discounts Date: October 6, 2014 Background: Section 340B(a)(5)(A)(i) of 42 U.S.C prohibits duplicate discounts on 340B-purchased medications; therefore, manufacturers who are required to provide outpatient drugs to eligible health care organizations at a significantly reduced price, are not obligated to pay rebates on those same drugs. In addition, OAR (1)(d), endorses the federal requirement that prohibits covered entities and federally qualified health centers or their contracted agents, from billing Medicaid Fee-for-Service (FFS), above the 340B acquisition cost. Purpose: Develop an accurate reporting process to identify 340B-purchased drugs from the Coordinated Care Organization s (CCO) encounter claims data, in an effort to prevent duplicate discounts. Section 340B(a)(5)(A)(ii) required the Secretary to establish a mechanism to ensure that covered entities comply with the requirement prohibiting duplicate discounts. Policy: Currently, the State uses the Medicaid Exclusion File on the Health Resources and Services Administration (HRSA) website to identify Public Health Service providers (covered entities) that have indicated they are using 340B drugs for Medicaid clients. Medicaid FFS and CCO encounter claims from the covered entities, are excluded from the Medicaid rebate process. Covered entities that have indicated to HRSA that they are not using 340B drugs for Medicaid clients, will have both their FFS and CCO encounter claim utilization, included in the Medicaid rebate process. Covered entities and CCOs are required to work with the State in an effort to best allow covered entities to maximize the 340B Drug Program without risking sanctions due to duplicate discounts. Covered entities that will carve-in are required to inform HRSA (by providing their Medicaid provider number/npi) at the time they enroll in the 340B Drug Program that they will purchase and dispense 340B drugs for their Medicaid patients. If covered entities decide to bill Medicaid for 340B-purchased drugs with a Medicaid provider number/npi, then ALL (FFS and CCO) drugs billed to that number must be purchased under 340B and that Medicaid provider number/npi must be listed on the HRSA Medicaid Exclusion File. For covered entities that opt to purchase Medicaid drugs outside of the 340B Drug Program, (i.e., carve-out Medicaid prescriptions) ALL drugs billed under that Medicaid provider number/npi must be purchased outside the 340B Drug Program, and that Medicaid provider number/npi should not be listed on the HRSA Medicaid Exclusion File. Covered entities will not be allowed to utilize contract pharmacies to bill 340B drugs for Medicaid FFS claims, as the State will be collecting rebate on claims from those pharmacies. CCO s can allow covered entities to use contract pharmacies to bill 340B drugs for Medicaid clients; however, will be required to identify those claims to the State, to ensure they are excluded from the rebate process in order to prevent double-dipping. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 18 of 22

19 APPENDIX VI: 340B File Instructions 340B Claims File Notes Purpose: To provide a method for CCO s and/or PHS entities, who have elected to carve-in, to retroactively identify to the State which pharmacy encounter claims were filled with 340B drugs so the State vendor can exclude those claims from the Medicaid Drug Rebate process. Method: 1) All encounter pharmacy claims will continue to be submitted to the MMIS as they are currently done today. 2) CCOs, their PBMs, or PHS entities will submit subsequent claims file using the design layout described below to identify encounter pharmacy claims filled with 340B purchased drugs. 3) Each agency or provider submitting a 340B claims file must have a Trading partner ID and an EDI mailbox set up with the State. If they do not currently have a Trading Partner ID or EDI mailbox, they can contact the following: Dmap.rxquestions@state.or.us * NOTE: in the subject line please type - 340B MAILBOX REQUEST 4) 340B claims files can be submitted as often as the agency or provider chooses, but all 340B claims must be identified and sent for each calendar quarter within 30 days after the end of that quarter. For example, all encounter pharmacy claims submitted between January 1 and March 31 will be pulled into the first quarter rebate cycle. The 340B claims from January 1 to March 31 must be identified and submitted on the 340B claims file no later than April 30. 5) The State rebate vendor will use the 340B claims files to match up the original paid encounter claim and exclude that claim from the quarterly drug rebate process. 6) Any validations that fail due to an error in the file layout, unmatched record count, invalid data fields, or no matching encounter found will be reported back to the Trading Partner for correction. 7) In the event that a 340B claim was not submitted in time (prior to quarterly rebate process) or was submitted in error and is later identified as a remove (Claim Indicator = R) after the quarterly rebate cycle has run, the rebate vendor will flag the claim to have the rebate credited to the manufacturer in the following rebate cycle. CHCLC Policy & Procedures: 340B Drug Pricing Program Page 19 of 22

20 APPENDIX VII: 340B DMAP Exclusion File Design 340B Claims File Design Mstr Seq Nbr NAME OF FIELD Field Format Field Length Field Location From-To Definition of Field Value/Comments Notes HEADER RECORD 1 Record ID A/N 1 1 Identification used to specify the type of record. H = Header Record 2 Transaction ID 3 Trading Partner ID A/N Identifies file as an NCPDP 340B Claim File. A/N Sender Trading Partner ID. ID Should always be "NCPDP340B" (e.g. "MB123456") 4 Receiver ID A/N ORXIX Trading Partner ID. "ORDHS" 5 Transaction Date 6 Transaction Time 7 Record Count DT Date file was created. TM Time file was created. N Number of 340B claim records in file Format=CCYYM MDD Format=HHMMS S Leading zeros if Count less than 100,000 records. (ex. 150 records, use ) 8 Filler A/N Filler Spaces. DETAIL RECORD 1 Record ID A/N 1 1 Identification used to specify the type of record. 2 Medicaid ID A/N Unique identifier for the recipient. D = Detail Record Recipient ID Left justified with spaces after up to field length CHCLC Policy & Procedures: 340B Drug Pricing Program Page 20 of 22

21 Mstr Seq Nbr NAME OF FIELD Field Format Field Length Field Location From-To Definition of Field Value/Comments Notes 3 Dispense Date DT The date on which the pharmacy dispensed the drug to the recipient. Format=CCYYM MDD CHCLC Policy & Procedures: 340B Drug Pricing Program Page 21 of 22

22 APPENDIX VIII: Scope of Project HRSA EHB Summary CHCLC Policy & Procedures: 340B Drug Pricing Program Page 22 of 22