Standard Operating Procedures

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1 Standard Operating Procedures Policy Manual Version: July 2017 Prepared by: PANTHERx Specialty Pharmacy 24 Summit Park Drive Pittsburgh, PA Contact: Douglas Gebhard Vice President, Quality and Education

2 PANTHERx Specialty Pharmacy - Standard Operating Procedures - Table of Contents PANTHERx Policy # Policy and Procedure Title/Description PANTHERx Policy # Policy and Procedure Title/Description PS-01 PS-02 PS-03 PS-04 PS-05 PS-06 PS-07 PS-08 PS-09 PS-10 PS-11 PS-12 PS-13 PS-14 PS-16 PS-17 PS-18 PS-19 PS-20 PS-21 PS-22 PS-23 PS-24 PS-25 PS-26 PS-27 PS-28 PS-29 PS-30 PS-31 PS-33 PS-34 PS-35 PS-36 PS-38 PS-39 PS-40 PS-41 PS-42 PS-43 PS-44 PS-45 PS-46 PS-47 PS-48 PS-49 PS-50 PS-51 PS-53 PS-54 PS-55 PS-56 PS-57 PS-58 PS-59 PS-60 PS-61 PS-62 PS-63 PS-64 PS-65 PS-66 PS-67 PS-68 Clinical Oversight/Review Committee Dispensing Prescription Medications & Supplies Emergency Preparedness & Disaster Recovery Plan On Call Policy Frequently Asked Questions (FAQ) Patient Bill of Rights and Responsibilities Patient Services Management Program Policy & Procedure Standardization Process Quality Management Committee Scope of Operating Services Pharmacy Licensing Code of Business Conduct & Ethics Contractor Screening Policy Destruction of PHI materials Marketing Communication Overview Third Party Vendor Contracting Call Escalation and Customer Tracking Logs Disclosure Disposal of Unusable Drugs & Supplies Drug Substitution Electronic Prescribing Policy Member Communications Process Prescription Transfer of Another Pharmacy Returned Goods Verify Non-Contracted Accounts Pharmacy Technician Supportive Personnel Backup Procedures & Retention Client Satisfaction Computer Policy Confidentiality & Financial Incentive Attestation Policy Control of Quality Records Customer Grievance Tracking Form Customer Grievance Tracking Disclosure of PHI in Limited Data Set Employee Education Employee Information Confidentiality Employee Orientation Program Employee Performance Evaluation Health Record Security Storage & Confidentiality Hiring New Employees Member Complaint Process Network Security New Patient Care Management Assessment Patient Education Patient Reassessment Policy Prescription Verification Process Quality Evaluation and Reporting Policy Quality Improvement Program Backorder Process Delivery and Shipment of Products Electronically Submitting Claims Employee Safety Equipment Cleaning & Maintenance Hazardous Materials Initial Therapy Assessment Inventory Receiving Inventory Storage & Security Labeling & Packaging Finished Products Physical Inventory Plan of Care Prescription Screening Security Policy Internal & External Programs Policy Adverse Event Reporting PS-69 PS-70 PS-71 PS-72 PS-73 PS-74 PS-76 PS-77 PS-79 PS-80 PS-81 PS-82 PS-83 PS-84 PS-85 PS-86 PS-87 PS-88 PS-89 PS-90 PS-91 PS-92 PS-94 PS-95 PS-100 PS-101 PS-102 PS-103 PS-104 PS-105 PS-106 PS-107 PS-108 PS-109 PS-110 PS-111 PS-112 PS-113 PS-114 PS-115 PS-116 PS-117 PS-118 PS-119 PS-120 PS-121 PS-122 PS-123 PS-125 Clinical Appeal Policy Incident Reporting Mission Statement Adverse Audit Reporting Billing Procedure Compliance Compliance Program Customer Information Confidentiality Employee Personnel File Executive Leader Financial Budgeting, Retention and Accounting In Service Policy Infection Control Reship Policy Alternate Leader Policy Cultural and Communications Barriers Legal Authority Licenses & Permits Notice of Organizational Changes Organizational Chart Ownership and Management Pharmacy Services Utilities Management Plan Position Description Supervision of Direct Care Staff Usual & Customary Charges Strensiq (asfotase alfa) Packout Corrective & Preventative Actions Social Media IT Equipment Physical Access IT User Access IT Data Security IT Operating System Controls IT Disposal IS Backup Limited Distribution Products Cold Chain Process & Monitoring Telephone Performance Measurement Benefits Investigation & Prior Authorization Process Data Reconciliation Audit Document Preparation and Submission Corrective Action & Discharge Family Medical Leave Fitness for Duty Non-Retaliation Travel & Expense Reporting Password Policy Password Protection Policy Software Installation Policy Acceptable Use Policy Mobile Device (BYOD) Policy 2017 PANTHERx Specialty, LLC 1

3 CLINICAL OVERSIGHT/REVIEW COMMITTEE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-01 URAC PC 2,32; CSCD 4; SDrM 2; Pharm Op 5; PM 3,4 ACHC DRX 6-1A, 6-1B CPPA 4.1 PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 10/8/2014 Scope The Clinical Oversight/Review Committee will be responsible for reviewing all Patient Care Management modules, policies and procedures, payer and manufacturer based medication programs and formulary decisions for PANTHERx Specialty Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure POLICY: The Committee will be composed of the following PANTHERx Specialty Pharmacy employees: a. Vice President, Quality & Education b. Director, Pharmacy Operations c. Registered Clinical Staff Pharmacist d. Lead Pharmacy Technician e. Other representatives, as deemed necessary, may be asked to join a meeting if their input will benefit the meeting agenda PROCEDURE: Responsibilities of the Committee 1. Review all Patient Care Management Program Modules and Materials 2. Review all therapeutic aspects of medications provided by PANTHERx Specialty Pharmacy. 3. Assist with development of drug or disease based programs or forms as requested by a provider (such as a payer, manufacturer) or a prescriber. Documents that are created for an outside provider/prescriber will be reviewed by this committee initially and then forwarded to the Pharmacy and Therapeutics Committee or Medical Director for the provider or prescriber. 4. Act as an advisory group to provide guidance for a. Clinical management of the patient b. Safe provision of medications c. New medications added to the formulary d. New medication educational documents 5. Review Quality Improvement Metrics related to Patient Care Management in coordination with Quality Management Committee. 6. If PANTHERx Specialty Pharmacy contracts directly with a payer or health plan that doesn t have a Pharmacy and Therapeutics Committee or a preferred drug list for formulary, PANTHERx Specialty Pharmacy will provide a drug list and/or clinical oversight process to clients. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

4 7. Should PANTHERx Specialty Pharmacy create a preferred drug list, it will provide it on its website. This list, if created, will be provided in written form upon request. Additions and/or changes to the preferred drug list, if created, will be overseen by the Clinical Services Team. 8. PANTHERx Specialty Pharmacy will coordinate with plan providers and clients to offer services benefiting patients if requested. If allowed, communications and materials will be offered through the client about PANTHERx Specialty Pharmacy services and offerings. 9. The committee will meet at least quarterly and on an as needed basis. The Patient Services Management Program will be reviewed at least annually. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 10/08/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

5 DISPENSING PRESCRIPTION MEDICATIONS & SUPPLIES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-02 URAC PC 4; SDrM 6; Pharm OP 2, 3, 4, 5, 6, 13, 15, 16 ACHC DRX 5-11B, 5-18B, 7-9B, 7-18A, 7-21A CPPA 1.7d, 2.2a, 2.2d, 2.2e, 2.2f, 3.10a, 3.4b, 4.1g PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 10/8/14 Scope Drugs shall be dispensed safely and appropriately to the patient for whom they are prescribed. Dispensing procedures will be in accordance with Federal and State Pharmacy Laws. A physician's order shall be required for the dispensing of prescription medications, devices and/or supplies. Verbal/written orders for prescription drugs may only be taken from a physician or an agent of the physician. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure General 1. A prescription item is any item which possesses the federal legend, "Federal Law Prohibits Dispensing without a Prescription". When a physician's order is received for a prescription medication, supply, or device, the prescription shall be immediately reduced to writing or entered into an approved electronic patient prescription record, as applicable. a. A prescription must meet State and Federal requirements to be a legal prescription. In addition, a prescription must be issued in a legal manner and must be complete before it can be filled. 2. An agent of the physician is a person under the direct supervision of the physician. A home care nurse is not an agent of the physician; orders relayed by a home care nurse are not legally acceptable and must be verified with the physician. 3. The physician shall be contacted by the pharmacist for clarification of any orders which are questionable, unclear or otherwise require additional information from the physician. 4. Every effort will be made to prevent contamination, which includes cross-contamination of drugs during the dispensing process. Prescription Order Entry 1. When a new prescription order is received in writing, by fax, electronic, mail, telephone, or a patient walk-in the following procedure will be followed: a. The prescription will be scanned and entered per the operating system training manual b. If the order is for a schedule II controlled substance, notify the prescriber that at this time PANTHERx does not dispense controlled substances. c. Pennsylvania State laws for prescription record storage must be followed by all PANTHERx Specialty Pharmacy s. 2. The Pharmacist/technician shall enter the new prescription in the patient s electronic medical record in the operating system per the training manual. Prescription Review 1. The pharmacist shall review the prescription for safety and accuracy of the dose. Prescription Processing 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

6 1. The pharmacist/ technician shall confirm correct patient (A minimum of 2 patient identifiers, all necessary prescription information for accurate filling, ancillary supplies needed and accurate delivery address. 2. The pharmacist/technician will verify the correct medication has been entered into the computer. The use of look alike, sound alike lists and tools will be used to make sure the wrong drug was not selected in error. 3. The pharmacist should collaborate with the referral source and reimbursement personnel to select an appropriate drug delivery system for the patient. 4. The pharmacy personnel should collaborate with the referral source and patient to coordinate the appropriate delivery method and time. a. This is done over the phone with either a call out to the patient or upon receiving a call back from the patient. At this point the PANTHERx staff member with verify that who they are speaking with is either the patient or verified by the patient as an authorized contact person, in the event that they are not available or under the age of 18, and also verify at minimum 2 patient identifiers. If the person attempting to set up the prescription delivery is unable to verify a minimum of 2 patient identifiers, no further information will be provided and the prescribing office will be contacted. 5. The pharmacist or pharmacy technician shall prepare the prescription label using the computer software system; it is the pharmacist s responsibility to review the label for clarity and accuracy. 6. The pharmacist or pharmacy technician shall obtain / retrieve the necessary items for the prescription. 7. The pharmacist or pharmacy technician shall prepare the prescription. 8. To prevent cross contamination, toxic drugs such as chemotherapy will be counted using separate counting trays. All trays will be cleaned daily with alcohol and chemotherapy trays will be cleaned after every use. 9. PANTHERx Specialty Pharmacy does not compound any medications, both sterile and non-sterile. 10. When filling of the prescription is completed, the pharmacy technician shall affix the prescription label to the product. a. Cold chain products will then be placed in the refrigerator to await the pharmacist checking procedure. 11. The pharmacist shall check the filled prescription for the following per policy and procedure: a. Accuracy i. Correct patient ii. Correct medication and package size (NDC# verification) iii. Correct route of administration iv. Correct dose and strength v. Correct administration schedule or time (Directions for use) vi. Correct lot and expiration b. Integrity of the container c. Proper ingredients d. Appropriate visual appearance Prescription Storage before Delivery 1. The pharmacist is responsible for storing the prescription item under the appropriate environmental conditions (temperature, lighting, etc.) to maintain the integrity of the item prior to delivery to the patient. Prescription Refills 1. When a prescription is not new, but is a refill, it may be identified or requested by the home care nurse, the patient's physician, the patient or the patient s caregiver. 2. During a refill call the PANTHERx Patient Care Coordinator will ask if the patient has had any difficulties to date with the drug therapy and if so, escalate call to the pharmacist. 3. The PANTHERx pharmacist should collaborate with the prescriber office, patient or caregiver to determine if a change in therapy or care plan is needed. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

7 4. To dispense a prescription refill, utilize the following procedure: a. The pharmacy personnel must determine that the patient has doses left to dispense based on the current physician orders. b. The pharmacy personnel must determine that the prescription is not expired under applicable state law or regulation. c. If the prescription is over 1 year old, it has expired. A new prescription is required and a new prescription number must be assigned to the new order 5. The pharmacist or pharmacy technician shall prepare the prescription label for new prescriptions above. 6. The pharmacy staff will proceed with preparing, labeling, checking and delivering the medication as discussed above for new prescriptions. 7. The pharmacy staff will monitor the delivery of packages via traceable methods (FedEx Tracking) to ensure timely delivery and accuracy of shipping. REMS or Manufacturer Limited Prescriptions: 1. When a prescription is received that is classified as REMS, Limited Distribution Product or considered High Risk, the prescription will be processed and pharmacy personnel will consult the PANTHERx Specialty Pharmacy Clinical Management team to make sure all dispensing criteria per Manufacturer is followed. 2. No exceptions will be permitted unless Manufacturer or assigned Hub approves dispense as an exception and sends written documentation stating such. 3. All PANTHERx Specialty Pharmacy clinical management drugs; disease specific, MUST go through PANTHERx Specialty Pharmacy s new project implementation process to assure all criteria is met. Human Growth Hormone, Controlled Substances and Methamphetamine Precursor Drugs 1. PANTHERx Specialty Pharmacy does not dispense, nor stock, Controlled Substances, but will dispense Human Growth Hormone when a valid prescription is received 2. PANTHERx Specialty Pharmacy does not dispense OTC products that could be identified as precursors to the manufacture or compounding of illegal drugs 3. PANTHERx will adhere to all Federal dispensing procedures related to Human Growth Hormone and will only dispense for conditions indicated by the FDA 4. It is PANTHERx s policy that all prescriptions received for Human Growth Hormone must be filled using the patient s pharmacy insurance and will not be filled via a cash plan in order prevent off-label use or diversion of product 5. When a prescription is received that is classified as Human Growth Hormone, the prescription will be processed and pharmacy personnel will consult the Pharmacy Manager to ensure all dispensing criteria is followed 6. If there is any reason to question the validity, accuracy or authenticity of any prescription drug order, the employee will call the licensed practitioner s office and document the result of the encounter 7. PANTHERx reserves the right to not fill the prescription and notify appropriate authorities if they believe there to be inappropriate use or inappropriate distribution of the Human Growth Hormone product Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

8 Approvals/Change History Last Edited by: Title Date Version Matthew Barletta Clinical Pharmacist 10/08/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 4

9 EMERGENCY PREPAREDNESS & DISASTER RECOVERY PLAN STANDARD OPERATING PROCEDURE POLICY NUMBER PS-03 URAC PC 14; Pharm Op 4, 14 ACHC DRX 7-4A, 7-4C, 7-9A CPPA 1.15a, 1.15b, 1.15c, 1.15d PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/28/14 Scope To establish a plan that will allow for the continuation of services in the event of a disaster affecting PANTHERx Specialty Pharmacy or the community Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure POLICY: Emergency: A natural or man-made event that significantly disrupts the environment of care such as damage to the organization s buildings or grounds due to a severe storm or earthquake; that significantly disrupts care and services such as loss of utilities due to floods, civil disturbances, accidents or emergencies within the organization or community; or that results in sudden, significantly changed or increased demands for the organization s services such as bioterrorist attack, building collapse, or a plane crash in the organization s community. Hazard Vulnerability Analysis: The identification of potential emergencies and the direct and indirect effects these emergencies may have on the health care organization s operations and the demand for its services. Mitigation Activities: Those activities an organization undertakes in trying to lessen the severity and impact of a potential emergency. Preparedness Activities: Those activities an organization undertakes to build capacity and identify resources that may be utilized during an emergency. Emergency Phone Tree: First call: Jonathan Ogurchak, Vice President, Business Operations ( ) If no answer or not available: Austin Russian, Director, Pharmacy Operations ( ) If no answer or not available: Tim Davis, General Manager ( ) If no answer or not available, repeat phone tree from the beginning until someone answers. PLANNING PROCESS: 1. Company leadership will conduct a hazard vulnerability analysis to identify potential emergencies that could affect the need for services or the ability to provide services. Key systems used to make management decisions to enact levels of disaster recovery plan are as follows: a. Facility power b. Pharmacy Operating System c. Drug Storage (Refrigeration) d. Telecommunication Systems (Phone/Fax) 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

10 e. Internet connectivity f. HVAC systems 1. Based on the hazard vulnerability analysis and community planning activities, the following general emergency plan may be enhanced or revised based on identified potential emergencies and planning activities: a. The decision to implement the emergency preparedness plan will be made by the Vice President, Business Operations, General Manager or designee upon becoming aware of any emergency situation. b. An alternate site will be designated in the event the office must be evacuated or is not accessible due to the emergency. c. The clinical supervisors and/or designee(s) will be responsible for triaging all patient care according to the following categories: Level I: Patients whose medication is life sustaining and cannot safely forego care and require health care intervention regardless of other conditions. Level II: Patients with recent exacerbation of disease process; patients requiring moderate level of care, but whose medication is non-life sustaining. Level III: Patients that require a low level of care, but whose medication is non-life sustaining. PROCEDURE: 1. Once the decision has been made to implement the emergency preparedness plan, the Vice President, Business Operations and/or designee will initiate the Emergency Phone Tree. Additionally, as able, staff is to report to the office or alternate site if the office building is not accessible and normal communication systems are not working. 2. Alternate roles, responsibilities and reporting of staff during emergencies will be identified. 3. The clinical supervisors and/or designee(s) will assign category classifications for all current patients. 4. The clinical supervisors and/or designee(s) will assign all available, qualified personnel to care for Level I patients and the inbound phone system will be modified with the emergency message and instructions for patients to follow. 5. New patients will not be accepted for care until the emergency situation is controlled or staffing levels permit. 6. In the event of a prolonged emergency situation, the Vice President, Business Operations and/or designee will: a. Determine staffing availability and limitations including assistance available from external staffing agencies. b. Identify those patients who could be discharged from service earlier than anticipated. c. Determine course of action based on above information. d. Identify patients with continuing care needs. e. Triage patients who require an emergency fill including distribution and delivery of medications to a patient. f. The organization will notify patients if they will not be able to provide prescriptions or services. They will make transfer or discharge arrangements as indicated, notifying patients and families/caregivers as appropriate. g. In prolonged emergency situations, the company will retain only those patients for which it can safely and adequately provide care. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

11 7. Safety of patients and company personnel will take priority in all emergency situations. a. Weather and road conditions will be monitored via local weather reports and state patrol reports. b. Natural or community disasters will be monitored via the Emergency Broadcasting System, reports from local authorities, reports from other local health care facilities in the event there is no telephone communication. c. In the event the office building is determined to be unsafe, the Vice President, Business Operations or designee will communicate the location to which all employees are to report for work. d. In the event of a bioterrorist emergency the Vice President, Business Operations or designee will coordinate organizational activities with the local affiliate Hospitals, Local County and State Health Departments and Law Enforcement. 8. In all emergency situations, the General Manager or designee will maintain communications and act as the spokesperson between other facilities, media, community and safety authorities. 9. Company leadership will provide orientation and education of all personnel regarding participation in the emergency preparedness plan. Education will be provided during orientation and annually. Plan Evaluation and Testing: 1. This emergency management plan will be tested annually. 2. The drill will be announced. 3. A meeting will be held after the drill to evaluate the plan s effectiveness and efficiency Patient Education and Preparation: 1. On admission, the pharmacy staff will obtain the name and telephone number of an emergency contact for the patient that lives outside the patient s home, if available. 2. On admission, the patient will be advised of the telephone number(s) to contact during an emergency and to report to the nearest emergency medical provider in the event that they cannot contact PANTHERx Specialty Pharmacy and are in need of supplies or medication during an emergency. 3. (information website on emergency preparedness) Preparing for an Imminent Disaster: 1. Anticipated emergencies typical or appropriate for the geographical area. 2. The pharmacy will follow response directives set forth by local government agencies, City Police, State Police, and Governor of Pennsylvania. 3. Call patients triaged as above in an attempt to make immediate plans for delivery of enough supplies to last through the expected severe condition (if known), plus an additional 3-4 days. Emergencies and Disasters Local to the Patient: 1. When an emergency or disaster occurs in a patient location only, replacement medication may be necessary. PANTHERx Specialty Pharmacy will send a replacement refill as soon as possible and will work with the patient s insurance company to cover the cost. 2. If the patient does not have a home address due to destruction or natural disaster, PANTHERx Specialty Pharmacy will coordinate shipment of the refill with the patient and an alternate location. Possible alternate locations that the medication can be shipped to are a: 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

12 a. Family members home b. Physician s Office c. Local Hospital Pharmacy d. Local Sheriff s Department e. Emergency Red Cross location 3. If it is not possible to wait for a shipment or an alternate shipping location cannot be coordinated, PANTHERx Specialty Pharmacy will work with the patient and coordinate with local pharmacies or hospitals to obtain a local supply of medication. Staff Communication during Disasters: 1. Regular phone communication will be attempted. 2. If unsuccessful, cellular phones and social media will be used. Each staff member should have a list at home of all other staff s cellular phone numbers. 3. If cellular phone communication is not available, the staff will be instructed to listen to the local radio station for instructions. Internal Pharmacy Emergencies: 1. Certain emergency situations are internal to the pharmacy, such as a building fire or other occurrence that prevents the pharmacy from operating as per its usual routine. 2. The Director, Pharmacy Operations will notify all staff members of the emergency. 3. The Director, Pharmacy Operations will assign duties to staff members as needed during the emergency. 4. If necessary, medical records will be removed from the pharmacy as soon as feasible to protect their integrity and security. The Director, Pharmacy Operations will select an alternate secure location. 5. If patients are to be serviced by an alternate provider during the emergency, the patients involved will be notified by telephone by a staff member. Coordination with Other Organizations: In our community, the agency responsible for coordination of resources during emergencies is: Name North Fayette Police Department, Lieutenant Michael Hamm Telephone Address 400 North Branch Road, Oakdale PA The person at our pharmacy that is responsible for communication with this agency before and during emergencies is: Jonathan Ogurchak Procedures after an Emergency: 1. Patients will be called to obtain a status report. 2. Resume a normal delivery schedule. 3. Discuss the efficiency of the emergency plan during the next Quarterly Quality Committee meeting. 4. Respond promptly to any detected problems and take corrective action as needed after both Emergency & Disaster drills/testing and actual emergencies or disasters. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 4

13 Business Continuity Plan: 1. The pharmacy will have a plan that prepares the pharmacy management to continue critical business operations in the event of a disaster that destroys or severely compromises the work environment. 2. Any employee who is made aware of a potential disaster at the pharmacy will notify the senior-most level manager to begin a telephone call down procedure. 3. Humans Resources will maintain a list of employees and contact telephone numbers at home. This list will be updated annually and as needed. 4. Staff members will perform delegated functions as determined by this plan unless otherwise instructed. 5. Staff members will not disclose information to the media unless delegated as the media contact person. Emergency Notification System: Method for contacting fire department and emergency medical services in all areas serviced, and at the pharmacy location: Fire and burglar alarm company and telephone number: Person(s) notified by these companies if an intrusion or fire are detected: List members of your emergency recovery team (those who are to report to the pharmacy to assess damage and formulate a business continuity strategy based on that assessment): 911 or activate emergency button on our alarm system Tyco Integrated Security ( ) Jonathan Ogurchak, Austin Russian, Tim Davis Jonathan Ogurchak, Austin Russian, Tim Davis Internal Staff Communication: Person to coordinate the communication of information to employees regarding reporting for duty: Person to communicate with media (TV, radio, newspapers) if needed: Jonathan Ogurchak Jonathan Ogurchak Back Up Equipment: Owners of back up equipment that may be used if necessary: Office space/desks/computers Printer/fax machine/copier Refrigerators: Generator: Jonathan Ogurchak Jonathan Ogurchak Jonathan Ogurchak Jonathan Ogurchak Important Business Telephone Numbers: Insurance carrier and telephone number Pharmacist Mutual Insurance Company Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 5

14 Insurance carrier policy number: BOP Telephone number for designated TV station (staff communication): Telephone number for designated radio station (staff communication): Alternate phone/cell to be used to accept PANTHERx Specialty Pharmacy calls in the event that telephone service needs to be forwarded by the phone company: WPXI ( ) WDVE ( ) On-Call Cell Service for: Jonathan Ogurchak ( ) Austin Russian ( ) Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 11/11/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 6

15 ON CALL POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-04 URAC CSCD 7, 9, 11 ACHC DRX 2-10F CPPA 4.1 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 10/24/2014 Scope: Patients, physicians, referral sources, and other healthcare providers, will be able to contact a Pharmacist twenty four (24) hours per day, seven (7) days per week. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Office staff will answer all telephone calls during normal business hours, transferring any calls requiring a licensed pharmacist to one of our staff pharmacists. Either by recording or live person, the customer will be instructed to: a. Remain on the phone to wait for the Pharmacist b. Leave a message for the Pharmacist c. Hang up and dial 911 or emergency services in the event of an emergency situation. 2. After hours, patients, physicians or other health care providers will be greeted by the following recording: a. Thank you for calling PANTHERx Specialty Pharmacy. You have reached our after-hours line. If this is an emergency, please hang up and proceed to your nearest emergency room. If you are a patient looking to place a reorder for your medications, please press one. If you have an after-hours clinical question, please press 2. b. If you have a question that is clinical in nature and for a pharmacist, please remain on the line. If you are looking to place a reorder for your medications, please press 1 now to be directed to our reorder system. 3. Upon selecting the pharmacist prompt, the phone call will be directed immediately to the cell phone of the On-Call Pharmacist. The system will prompt for a voic to be left with a callback number. The On-Call Pharmacist is responsible for returning all phone calls within 30 minutes of receipt to the on-call phone. a. The On-Call Pharmacist has access to pharmacy software and electronic clinical references as if they were in office during normal business hours. i. References include, but are not limited to: MicroMedex, UpToDate, LexiComp, Pharmacist Letter, Pink Sheet, and Medscape. Clinical Concerns for Pharmacist 1. Determination to transfer a call to a pharmacist during normal hours or after hours is determined by the nature of the call which could include any of the following: a. Emergency situation b. Patient is out of medication c. Transferring a prescription to another pharmacy d. Pill identification e. Counseling regarding side effects or adverse reactions 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

16 f. Review of stability or damaged medication g. Any potential Class/Error Pharmacist Response and Responsibilities 1. Retrieving information from voic 2. Resolving call calling patient or pharmacy in a timely manner 3. Document in SWFT the resolution within one business day 4. If an escalated issue that may have a severe outcome (such as hospitalization), immediately contact on-call Pharmacist Manager 5. Ability to provide information to consumer regarding claims related information Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 01/24/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/16/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

17 FREQUENTLY ASKED QUESTIONS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-05 ACHC DRX 1-4A, 5-5G CPPA 3.9a, 3.9b, 2.3a, 3.1a, 3.1b, 3.10a, 3.10b, 3.5h PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 10/28/14 Scope To explain the frequently asked questions Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Frequently Asked Questions How do I contact you? Please call us if you have any questions or concerns concerning order status, copay amount, claims submissions and benefit coverage. If you have any adverse effects to the medication you were given, please contact your prescribing physician or your pharmacist. PANTHERx Specialty Pharmacy Phone: (855) and Fax: (855) Or visit us on the web at https://www.pantherspecialty.com When is PANTHERx Specialty Pharmacy Open? A PANTHERx Specialty Pharmacy employee is available to answer any questions you may have either during normal business hours or through 24-hour Pharmacist-on-Call support. Business Hours of Operation: Monday through Friday 8am to 8pm EST PANTHERx Specialty Pharmacy 24 Summit Park Drive, Suite 101 Pittsburgh, PA Evening, Weekends, Holidays: Pharmacist-on-Call Policy 24-hour coverage at (855) A Pharmacist-on-Call is available 24 hours a day/7 days a week for any question you may have. Pharmacists are available for emergency and clinical situations such as side effects and medication assistance as well as complaint resolution. They also have access to all pharmacy systems and can answer any questions regarding order and copay status, claims submissions and benefit coverage. In addition, Pharmacists have access to PANTHERx Specialty Pharmacy facility if patient need would require support from the systems and/or prescription fulfillment process. How do I order a new prescription? 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

18 Your prescriber must send a valid prescription to our pharmacy via their preferred means. When a valid prescription is on file, you may call into our pharmacy to place your order and setup a shipment during regular business hours. During business hours, you can call the pharmacy to speak with a staff member or follow the prompts to request your refill by leaving a voic with all pertinent information as requested in the message. o After hours, you can follow the prompts to request a refill by leaving a message for the pharmacy staff requesting medication refill. Please include in your message medication name, your first and last name, address, date of birth, daytime phone number, and additional requested information per the voic recording. Your doctor can e-scribe or fax a new prescription to us. Please note, certain controlled substance medications cannot be faxed and PANTHERx does not currently dispense controlled substances. In the event that PANTHERX begins to dispense controlled substances, the paper copy of these prescriptions must be sent to the pharmacy. Your prescription may be filled with a generic equivalent substitution based on state law, equivalency rating and in accordance with company policy. Please ask a pharmacist if you have any questions or concerns. A PANTHERx Specialty Pharmacy employee will let you know if PANTHERx Specialty Pharmacy is unable to fulfill the medication request. Suggestions and guidance on where the medication may be available will be given upon request. How long does it take to receive my prescription? Our standard processing time at PANTHERx Specialty Pharmacy is normally less than 24 hours. This does not include delivery time. If processing time is delayed longer than 24 hours, we will contact you to notify you of your options so you don t go without medication. A PANTHERx Specialty Pharmacy employee will immediately let you know if there are any issues that may delay fulfillment such as prior authorizations or quantity limits imposed by your insurance company. PANTHERx Specialty Pharmacy employees will work with you and your physician to try and get any Prior Authorizations completed as quickly as possible. If your insurance company will not allow a quantity override due to unforeseen circumstances, a PANTHERx Specialty Pharmacy employee will help determine the best way to get the medication you require. Medications are sent via FedEx. Priority Overnight is available or required for some medications. Prescriptions are shipped Monday through Friday for next day delivery, including Saturday, and if permitted by the delivery zip code. Medication delivery is a complimentary service at no additional charge to you. Some medications will require your signature for delivery. A PANTHERx Specialty Pharmacy staff member will coordinate with you to schedule the most convenient delivery time to ensure your availability to sign for the prescription. How do I refill my prescription? PANTHERx Specialty Pharmacy will call to schedule your refill order ~10 days before you should run out of medication. If you run out prior to PANTHERx Specialty Pharmacy contacting you, or you would like to go ahead and order your refill, please contact us. Please have your prescription number(s) available to place your order. If you have signed up for the complimentary PANTHERx web portal, refills can be requested through the web portal. Please provide additional comments if there are any specific delivery instruction or requests. If there are any additional questions, clarifications, or missing elements on the web portal refill form, a PANTHERx Specialty Pharmacy staff member will contact you directly to gather the required information. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

19 An automated refill option is available 24 hours a day/7 days a week. If ordering an automated refill, please also leave a message with any specific delivery instructions or request PANTHERx Specialty Pharmacy staff contact you prior to medication being shipped. Please let a PANTHERx Specialty Pharmacy employee know if you have run out of refills and would like a call to your physician to be made for a new prescription. Please remember to always inform PANTHERx Specialty Pharmacy and the Patient Management Program of any insurance, address or health changes. If you need your prescription immediately, please let a PANTHERx Specialty Pharmacy employee know so your order can be expedited. If you cannot wait for a shipment, you may ask about having your prescription transferred to a local pharmacy. The prescription can be transferred back to PANTHERx Specialty Pharmacy the next time it is needed. How much will my prescription cost? Prescription cost will vary depending on your insurance. Because drug pricing can change daily, a final determination of your co-pay cost cannot be made until your claim is processed. You may also call the Member Services phone number on your prescription insurance card to get the most current information. If you are unable to afford the out-of-pocket cost for your prescription, PANTHERx Specialty Pharmacy will work to identify co-pay card assistance, patient assistant programs, or other support and/or charitable organizations. Visit the PANTHERx Specialty Pharmacy s For Patients section of our website to learn about Patient Assistance. The cost may also vary depending on the quantity of medication. Your prescription will be filled for the amount of medication that the physician prescribes. Please be sure to advise your physician to prescribe for the maximum amount/days supply allowable by your insurance coverage (days allowed may vary by plan). If you have Medicare Part D drug coverage, the cost of your prescription will change significantly as you meet your deductible and initial co-pay, progress through the donut hole and reach total out-of-pocket expense. Reimbursement Specialists can assist you in determining and understanding your options. Visit our website to learn more about these services. How can I pay for my prescription order? PANTHERx Specialty Pharmacy accepts all major credit cards, check, or money orders. If mailing payment, please do not mail cash. How can I safely dispose of my medications? Visit the website below to view a list of medications that can safely be flushed down the toilet or see the handouts given in the welcome packet: Medicine/SafeDisposalofMedicines/ucm htm If your medication is not on this list, please see the handout included in your Welcome Packet on how to properly dispose of your unwanted or expired medications. You will be notified by a PANTHERx Specialty Pharmacy employee if there is a recall on your medication and given instructions on what to do. What is the Patient Management Program? The Patient Management Program is included at no cost to you and you are automatically enrolled as a patient of PANTHERx Specialty Pharmacy. You may opt out at any time. Pharmacists will work with you on any problems, concerns or questions you may have regarding your medication therapy. Issues discussed include disease overview, medication, dose, dose frequency, 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

20 interactions, side effects, physical assessments and coordination of care with your physician when appropriate, etc. The potential health benefits of this program include managing side effects, improved overall health, increased disease and medication education and awareness, increased medication compliance and when coordination of care with your physician is necessary, your pharmacist will have all the information needed to help make informed decisions regarding what is best for you as the patient. The potential limitations of this program are dependent on you as the patient. You must be willing to follow the directions of your physician and pharmacist, be compliant with taking your medication and willing to discuss the details of your disease, medical history and current practices with your pharmacist so he can have a full understanding of the situation. Please let your physician know you are a patient of PANTHERx Specialty Pharmacy and are enrolled in their Patient Management Program. A good relationship between your physician and your pharmacist will benefit everyone involved in your care. To contact the Patient Management Program, please call PANTHERx Specialty Pharmacy. Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 10/28/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 4

21 PATIENT BILL OF RIGHTS & RESPONSIBILITIES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-06 URAC PC 35, 36, 37 CSCD 1, 4, 7 SDrM 1, 2, 3 PM 3, 6, 11, 12 ACHC DRX 2-1B, 2-2A.01, 7-17A CPPA 3.1b, 3.4a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/23/14 Scope Define the companies Patient Bill of Rights for providing Specialty Pharmacy Services Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy A copy of the Patient Bill of Rights and Responsibilities is given to every new patient with their first prescription. It is included in the Welcome Kit and packaged with their first shipment of medication and supplies. Procedure PANTHERx Specialty Pharmacy customers have a right to be notified in writing of their rights and obligations before care/service is initiated. PANTHERx Specialty Pharmacy has an obligation to protect and promote the rights of their customers to care, treatment and services within their capability and mission, and in compliance with applicable laws, regulations and standards, including the following: Patient Rights You have the right to be fully informed in advance about care/service to be provided, including the disciplines that furnish care and the frequency of visits, as well as any modifications to the plan of care. You have the right to be informed, both orally and in writing, in advance of care being provided, of the charges, including payment for care/service expected from third parties and any charges for which the client/patient will be responsible. You have the right to get important information about your care appropriate to your age, understanding and language (If you have vision, speech, hearing and/or other impairments, we can provide support to ensure your needs are met) You have the right to receive information about the scope of services that the organization will provide and specific limitations on those services You have the right to receive administrative information regarding changes in or termination of the patient management program. You have the right to participate in the development and periodic revision of the plan of care You have the right to refuse care or treatment after the consequences of refusing care or treatment are fully presented You have the right to be informed of client/patient rights under state law to formulate an Advanced Directive, if applicable You have the right to have your property and person treated with respect, consideration, and recognition of client/patient dignity and individuality You have the right to be able to identify visiting personnel members through proper identification 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

22 You have the right to be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of client/patient property You have the right to have grievances/complaints regarding treatment or care that is (or fails to be) furnished, or lack of respect of property investigated You have the right to confidentiality and privacy of all information contained in the client/patient record and of Protected Health Information You have the right to be advised on agency s policies and procedures regarding the disclosure of clinical records You have the right to choose a health care provider, including choosing an attending physician, if applicable You have the right to receive appropriate care without discrimination in accordance with physician orders, if applicable You have the right to be informed of any financial benefits when referred to an organization You have the right to be fully informed of one s responsibilities You have the right to speak with a health professional You have the right to identify the staff member of the program and their job title, and to speak with a supervisor of the staff member if requested You have the right to decline participation, revoke consent, or disenrollment at any point in time. Patient Responsibilities You are responsible for providing as much information about your health and medical history as possible, including your other medications, vitamins, herbs and supplements, and allergies You are responsible for asking questions, especially if you do not understand or need more information You should treat our staff with courtesy and respect You should actively participate in your care and follow the instructions for taking medication as directed. You are responsible for the outcomes of not following your plan of care You are responsible for meeting your financial responsibility You are responsible for communicating side effect to your pharmacist or prescriber right away You are responsible for storing your medications appropriately You are responsible for disposing unused medication in a safe method (Our pharmacists can provide instructions for disposal if necessary) You are responsible for submitting any form that is necessary to participate in the program, to the extent required by law. You are responsible for giving accurate clinical and contact information and to notify the patient management program of changes in this information. You are responsible for notifying your treating provider of your participation in the patient management program, if applicable. Customer Information: After-Hour Services: Specialty Pharmacy s normal business number (855) , the patient will hear prompting to direct them to the appropriate line of after hour business. A pharmacist will return your call 24 hours/7 days a 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

23 week. You may leave a message for non-urgent manners or refill request at the normal business number (855) at any time by following designated prompts. Complaint Procedure: 1. You have the right and responsibility to express concerns, complaints, or dissatisfaction about services you receive or fail to receive without fear of reprisal, discrimination, or unreasonable interruption of services. Call the company corporate office at (855) and ask to speak with the pharmacy manager during regular business hours or the company representative if you are calling outside of regular business hours, including weekends and holidays. 2. The formal grievance procedure of PANTHERx Specialty Pharmacy ensures that your concerns/complaints will be reviewed and an investigation started within 5 business days of receipt of the concern/complaint. Every attempt shall be made to resolve all grievances within 14 days. You will be informed in writing of the resolution of the complaint/grievance. If more time is needed to resolve the concern/complaint, you will also be informed verbally and in writing. 3. If you feel the need to discuss your concerns, dissatisfaction or complaints with a party other than PANTHERx Specialty Pharmacy staff, please file a complaint with the Pennsylvania Board of Pharmacy complaints division. The hours of operation are Monday through Friday 8:30 a.m. to 4:30 p.m. The telephone number is or you can Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Austin Russian, PharmD Clinical Pharmacist 10/23/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 05/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

24 PATIENT SERVICES MANAGEMENT PROGRAM STANDARD OPERATING PROCEDURE POLICY NUMBER PS-07 URAC PC 2, 28, 32 SDrM 1, 2 PM 1,2,3,4,5,6,8,9,10,11,14,15,16 ACHC DRX 4-15B, 5-1A, 5-1B, 5-1D, 5-2G CPPA 1.11a, 1.2b, 3.4a, 1.14a, 3.1a, 3.2a, 3.2b, 3.4f, 3.4d, 3.4e, 3.4g, 3.5a, 3.5c, 3.6a, 3.6b, 3.9a, 3.9b PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 10/23/2014 Scope To describe the Patient Management Program (PMP) services provided by PANTHERx Specialty Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy will develop and implement core clinical services for all patients and enhanced clinical services for specific medications or disease states. New programs and services will be developed as deemed necessary by the Clinical Oversight/Review Committee and PANTHERx Specialty Pharmacy for targeted disease states of patient populations. The Oversight/Review Committee is led by the Vice President, Quality & Education. Program enhancements and reporting outcomes will be reviewed and reassessed during quarterly Quality Management meetings, or at least annually. The Quality Management Committee and Vice President, Quality & Education oversee the Clinical Oversight/Review Committee and if applicable, external reporting requirements. Components of the program and modules include: 1. Patient conversation guidelines Initial (See New Therapy Assessment; PS-59) Ongoing (See Patient Reassessment; PS-48) 2. Medication and Disease Management based on best available science and demonstrated published practice guidelines. Sources used in interventions are available and provided upon request to patients and may include, but are not limited to: Clinical appropriateness based off manufacturer package insert National treatment guidelines & corresponding evidence levels Clinical Pharmacology Manufacturer education materials Formularies and plan management guidelines from any of the following a. Health Insurance Plans b. State Insurance Plans and Programs c. Employer Groups d. Pharmacy Benefit Manager 3. Company educational materials Welcome Kit is given to all patients with their first prescription, either in person or included in their shipment a. About Us Letter including Continuum of Care Cycle b. HIPAA Privacy Statement including acknowledgement to sign and return c. Rights & Responsibilities d. Assignment of Benefits e. Frequently Asked Questions f. mypantherx Portal Instructions g. Proper Disposal of Medications and Sharps Flyer 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

25 h. Emergency Supply List i. Grievance Communication Information Medication starter kits from the manufacturer when appropriate/available Medication Information Guides when appropriate Patient handouts obtained from MediSpan Information on community resources and support as needed and available Additional supporting materials as deemed necessary based on disease state or medication 4. Documentation All materials and information provided will be documented in patient profile Prior to enrolling any patient into the Patient Management Program (PMP) and dispensing any medications, the prescription will be reviewed by the pharmacist for therapeutic appropriateness and patient safety. Possible referral sources for patients to be referred to PANTHERx Specialty Pharmacy would include but are not limited to: 1. Patients 2. Prescribers 3. Insurance Plans 4. Pharmacy Benefit Programs 5. Pharmaceutical Manufacturers through drug or disease specific initiatives PMP Program Components Patients enrolled in the PANTHERx Specialty Pharmacy PMP will receive service tailored to the individualized needs of the patient, the medication provided, and the disease process for which the medication is prescribed. At risk patients (non-compliant, adverse events, inappropriate use, etc.) are encouraged to participate in the patient management program. These services are based on disease state/medication and may include but are not limited to: 1. Disease Education a. Disease overview b. Disease/Drug patient advocacy groups 2. Medication Education a. Dose Strength b. Drug c. Dose Frequency (daily, twice a day, three times a day) d. Side effects and their management e. Drug to Drug interactions f. Drug to Disease interactions g. Drug to Food interactions h. Alternative product consideration due to adherence i. Safe disposal of medications and supplies (if appropriate) 3. Medication handling guidelines 4. Access to Specialty Drugs by assisting with a. Obtaining refill prescriptions b. Discussing possible alternative therapy due to insurance coverage with your physician c. Prior Authorizations with your insurance company d. Patient Assistance Programs offered through manufacturer and healthcare companies 5. Medication Administration Education a. Subcutaneous training program (if appropriate) b. Medication Adherence i. Taking the medication at the same time every day 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

26 ii. What to do in the event of a missed dose 6. Patient Assessment a. Physical assessment (weight, other parameters related to specific medication or disease process) b. Vaccination Status c. Medication tolerance and adverse events d. Clinical assessment of disease process (Initial and Ongoing) e. Patient questions or concerns regarding medication and disease process 7. Therapy Evaluation a. Therapy evaluation should consider any drug-related problems and may include but not be limited to: i. The therapeutic appropriateness of the patient s drug regimen ii. Any therapeutic duplication in the patient s drug regimen iii. The appropriateness of the route and method of administration. iv. Any drug-drug, drug-food, or drug-disease interactions v. Recommended changes and/or additions to therapy. vi. Calculations used to evaluate appropriate dosing methods 8. Impediment to therapy a. Financial b. Logistic c. Literacy/language 9. Identification of At Risk Patients a. Lack of adherence b. Potential for abuse, misuse c. Adverse Effects 10. Support Materials a. If needed, Information on community resources and support when available All information gathered in conjunction with the PMP such as the care management plan will be stored electronically in the patient record within the pharmacy management software. If the client is a minor, records are to be kept for the greater of seven (7) years the time required by State Board of Pharmacy law from the time the client turns 18 years of age. Coordination of Patient Care 1. Communication regarding the care of the patient will be provided by the pharmacy to the patient and all appropriate members of his or her health care team (prescriber, caregiver, and ancillary health care providers) either verbally or via fax, EMR or other PHI/PCI protected method as deemed appropriate by the pharmacist managing the patient. Patient care conferences with the prescriber, payer, or other health care team members are to be held, with the Pharmacy acting in a clinical advisory role as needed, in order to discuss the following: a. Medication intolerance b. Adverse events c. Disease progression d. Routinely scheduled communications e. Noncompliance f. Reimbursement changes 2. Multidisciplinary patient care conversations can be held, as needed, in order to facilitate communication among the clinical staff and, when appropriate, other healthcare providers, to discuss any specific patient care problems or difficulties which have been identified. 3. If there are multiple medication therapies available for a disease state, the pharmacist will discuss with the physician and patient to decide which therapy is appropriate based on: 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

27 a. Testing or reporting required b. Side effects c. Dosing schedule d. Cost 4. When a multidisciplinary patient care conversation is held, documentation of patient problems is to be maintained in the pharmacy management software of the patient s profile which describes the specific patient care problems or difficulties identified 5. In the event that a change in patient care results from a coordination of care between the provider and PANTHERx, the patient will be made aware at the time of their next refill, prior to receiving the medication in question. Discharge of the patient The patient will be discharged from the PMP upon: 1. Patient request to stop therapy 2. Doctor discontinues therapy 3. Completion of therapy 4. Transfer of prescription to another pharmacy Quality Improvement As an organization, PANTHERx Specialty Pharmacy has a quality management program which encompasses many aspects of quality improvement. (Refer to Quality Management Committee Policy; PS-09). Key indicators for quality improvement related specifically to the PMP would be: 1. Patient Satisfaction 2. Patient Compliance 3. Adherence to manufacturer reporting guidelines Program Value and Reporting Ability to demonstrate patient management program value through several perspectives and available to current and prospective clients/payers upon request. Program value and benefits can be articulated through a range measures based on the internal/external stakeholder needs including clinical outcomes, financial benefits, and patient satisfaction. The evaluation has the ability to leverage objective data sets (i.e. prescription fill history, blood pressure, readings, financial data) and subjective data sets (i.e. self-reported data) Ability to leverage internal and external data sets in order to provide current clients a view into historical performance as well as prospective clients insights into the benefit the Patient Management program can add Details of program value reporting is available upon request to current and prospective clients including reporting methodology, description of the strengths and limitations based on the data set or methodology employed Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 4

28 Approvals/Change History Last Edited by: Title Date Version Austin Russian, PharmD Clinical Pharmacist 10/23/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 09/23/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 5

29 POLICY & PROCEDURE STANDARDIZATION PROCESS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-08 URAC PC 3, 4, 28 CPPA 1.2d, 1.2e PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 10/28/2014 Scope To meet all federal, state, local and business laws and regulations. To explain the process of creating and updating SOPs to ensure compliance and adherence companywide. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. FORMAT: The format header above contains the elements needed in a policy and procedure (P & P): Policy Name: Be as specific as possible as it makes searches easier. Title should be five words or less. Policy Number: Numbering has been established to determine consistency and portability of procedures on an on-going basis. Accrediting Standard: Represents the appropriate standards to which URAC/ACHC accreditation may be tied Effective Date: This will be the date the SOP was implemented Policy Owner: This is who will be responsible for approving the original document and updates. They will ensure that the document adheres to PANTHERx practice and recommend changes to policy or practice so that the desired outcome is attained. They will also determine at the time of implementation or at the time that changes are made what staff will be affected. Scope: This section will state the reason for the policy PROCEDURE: 1. Policies and Procedures should be written and assigned to the person most knowledgeable about the process. All required information is filled in on the template header. The categories in the body of the template should be completed. 2. The policy & procedure is submitted to the Vice President of Quality & Education who is responsible for approval and ongoing management for all new and revised P & P s. 3. New proposed P & P s as well as changes to existing P & P s will be reviewed during the quarterly Quality Management meeting following submission with the Quality Management Committee where they will be either be approved for implementation or changes requested. 4. The communication process for the information is planned to include any people directly or indirectly affected by the procedure or policy. Communication should occur prior to the implementation and subsequent training will be scheduled if necessary and documented when complete. Communication can occur at department meetings, through , or by conference call. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

30 5. After implementation, the author will follow up with affected staff to ensure the directions are being followed, information is clear, and adjustments are made as necessary. 6. When notification of a revision is sent out, the old policy should be replaced by a copy of the revision which is printed and inserted into its place in the hard copy Policy Manual for states that require hard copy policies. Where hard copies are not required, the Policy Manual should be updated with the revision P & P and the old policy moved and retained in the archive P & P folder. 7. The PANTHERx Specialty Pharmacy corporate share drive P & P Master List folder will be used as the current reference for policies, where version and change history will be tracked, where historical/archived versions of the P & P s will be maintained all of which will be stored in a non-editable format and accessible to all colleagues. 8. Annually, each P & P will be reviewed by the supervisor of the area that generated it and signed off by the Vice President of Quality & Education to ensure continued accuracy and relevance as well as retirement of outdated P & P s. 9. Regular department meetings will contain an agenda item to review new and revised P & P s when changes have been made. 10. Proof of annual review of policies will be maintained via the Approval/Change History at the conclusion of each approved P & P. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 10/28/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 07/27/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 01/25/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

31 QUALITY MANAGEMENT COMMITTEE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-09 URAC PC 18, 19, 20 SDrM 6 Pharm Ops 1 ACHC DRX 2-7A, 6-1A, 6-1B, 6-1C, 6-1E, 6-1F, 6-3F, 6-6A CPPA 4.1a, 4.1f 4.2, 1.13c, 2.2g PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 10/23/2014 Scope The purpose of this policy and procedure is to document the composition and responsibilities of the Quality Management Committee. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. The Quality Management Committee (QMC) shall be comprised of managers and team leads, as well as one member from outside the organization, based on accreditation requirements. The internal teams that will be represented are as follows: a. Quality & Education b. Business Operations c. Human Resources d. Pharmacy Operations e. Patient Care Coordinators f. Order Management g. Billing & Reimbursement h. Provider Relations Liaison i. Other representatives, as deemed necessary, may be asked to join a meeting if their input will benefit the meeting agenda 2. The Vice President, Quality & Education has authority and responsibility for the overall operation of the Quality Management Program and Committee, with authority given to members of Quality Management Committee to design, implement, and support Quality Management projects. The Vice President, Quality & Education as well as the Quality Management Team are responsible for the evaluation and effectiveness of the Quality Management Program. 3. The scope of the Quality Management Committee is serve as the governing body and provide oversight for all efforts regarding quality and continuous improvement within PANTHERx Specialty Pharmacy. 4. The Quality Management Committee is comprised of the same membership as the Compliance Committee as Compliance supports overall Quality and will be reviewed and discussed during each quarterly meeting. These members are managers, supervisors and leads from every department in the company and it is their responsibility to disseminate the information discussed at these quarterly meetings to their teams. 5. During the quarterly quality meetings, The Quality Management Committee will be responsible for review and oversight for any new or updated activities that occurred since the previous documented quality meeting that can include, but are not limited to the following areas and agenda items: Logistics and Oversight a. Quality Management Committee will meet at least once each quarter b. Maintain and publish approved meeting minutes c. Provide annual program evaluation report to Senior Management for review and feedback 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

32 d. Determine when outbound communication is warranted to prescriber, patient, or other stakeholders based on quarterly quality findings related to potential consumer safety events, errors, and overall quality Compliance, Policy and Procedure Review e. Discuss any changes to documented policy or procedures f. Discuss plan to communicate to colleagues g. Review any findings from mock compliance audits h. Review any issues identified related to Privacy/Security; fraud, waste, and abuse; or infractions on accreditation standard i. Receive and review reports or analyses of complaints and appeals j. Monitor and review any ethical issues that have been reported Operational Monitoring and Metrics k. Review Quarterly Telephone Performance Metrics l. Review Quarterly Cost Avoidance Metrics m. Review findings or results from Cold Chain Process monitoring n. Receive and review reports or analyses of complaints related to grievance process and any other issues reported o. Review any concerns with the performance of pharmacy information systems and technology. Quality Improvement Management p. Provide guidance to staff on Quality Management priorities and projects q. Approve Quality Management and Improvement Projects to undertake and ensure that no less than two quality improvement projects that address opportunities for error reduction or performance improvement related to the services under current URAC accreditation standards r. Review updates and progress on Quality Management and Improvement Projects at least annually s. Reassess modules, evaluate and approve program enhancements, and monitor reporting outcomes for the Patient Services Management Program in coordination with the Clinical Oversight Committee, at least annually. Clinical and Safety Monitoring t. Monitor quality and safety findings of drug inventory and distribution u. Review safety incidents documented on the report of Occupational Injury with Human Resources v. Review new infectious disease log occurrences w. Review aggregated Drug Utilization reporting x. Review Adverse Event and Error reporting y. Review published safety literature for prevention recommendations and best practices regarding quality and error management at least on an annual basis or as needed 6. The Quality Management Committee will review annual performance metrics to include, but not limited to: a. Number of prescriptions dispensed b. Number of patients receiving prescriptions c. Number of prescriptions per payer d. Cumulative quality improvement opportunities reported e. Call center metrics f. Satisfaction surveys g. Average shipping time 7. The Quality Management Committee was approved by the Director of Pharmacy Operations on the date of December 12, Ownership and oversight of the Quality Management Committee was transitioned to the Vice President, Quality & Education on June 1, Training 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

33 This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Austin Russian, PharmD Clinical Pharmacist 10/23/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 4/6/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 4/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

34 SCOPE OF OPERATING SERVICES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-10 URAC PC 32, 34; CSCD 7, 9; SDrM 1; Pharm Ops 1, PM 3 ACHC DRX 2-10F, 3-4A, 4-14G CPPA 1.3a, 4.1 PANTHERx Specialty Pharmacy Policy Owner Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date 10/30/14 Scope To describe the services provided by PANTHERx Specialty Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. PANTHERx Specialty Pharmacy is a privately held national specialty pharmacy with a history of dedicated delivery of care and therapy management for chronically ill patients. 2. PANTHERx Specialty Pharmacy provides services in all 50 states. 3. PANTHERx Specialty Pharmacy focuses on specialty treatment of transplant, Hepatitis C, oncology, multiple sclerosis, rheumatoid arthritis, HIV, women s health, movement disorders and other rare, chronic conditions. 4. PANTHERx Specialty Pharmacy has programs developed to provide a proactive approach to disease management and to result in improved patient outcomes. These programs are comprised of the following core components: a. Medication therapy management b. Medication adherence monitoring/counseling/tools c. Patient education d. Enhanced communication between providers, payers, patients and the organization 5. All programs meet accrediting standards where applicable. 6. Day to day services and business operations are provided based on physician orders during the hours below, Monday - Friday 8:00am to 8:00pm Saturdays & Sundays: Pharmacist-on-Call Support Holidays: Pharmacist-on-Call Support (unless otherwise announced) Pharmacist on Call Emergency - 24 hour coverage at (855) Pharmacist available for immediate consultation Monday-Friday 8:00am to 8:00pm at (855) Pharmacist services and support are available during the hours and channels listed above, with emergency support available through 24 hour coverage to service any patient related need 8. Pharmacist personnel have access to PANTHERx Specialty Pharmacy and systems 24 hours a day, 7 days a week and have the ability to support all patient needs in the event of medical emergencies and/or underlying circumstances that would require the personnel to have access to the PANTHER Specialty Pharmacy facility 9. Personnel are always available during business hours of operation for inquiries regarding questions or concerns patients have including order status, complaint resolution, and drug therapy. PANTHERx Specialty Pharmacy personnel are also available to discuss insurance benefits information such as co-pays, claims processing, benefit coverage, claims submission, and claims payment. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

35 10. Personnel are available for emergency calls after business hours of operation and during weekends and holidays 24 hours a day, 7 days a week to respond in a timely manner to situations that may expose consumers to health and safety risks. 11. PANTHERx Specialty Pharmacy accepts Medicare, Medicaid, private insurances and private pay patients. Insurance coverage is verified before services are provided and patients and/or their families are notified of any out-of-pocket expenses for which they may be responsible before the services/products are delivered. 12. PANTHERx Specialty Pharmacy website is: https://www.pantherspecialty.com 13. Prescriptions are accepted 24 hours, 7 days a week by fax and electronic prescribing. The company phone numbers are: Pharmacy Phone: (855) Pharmacy Fax: (412) PROCEDURE: 1. Patients/families/caregivers are provided with information about the charges covered by their insurance companies (Medicare, Medicaid, and private insurance) and of the charges for which they may be responsible, before the products and/or services are provided. Receipt of this information is documented in the patient record. 2. PANTHERx Specialty Pharmacy employees receive information about current policies during orientation and are advised of any changes/updates as they become available. 3. All PANTHERx Specialty Pharmacy employees and management personnel receive information about PANTHERx Specialty Pharmacy s scope of services during orientation and are expected to be familiar with the information in order to respond accurately to all inquiries. As new products and/or services are added, information is provided to all pertinent company personnel. 4. Customer service goals are to maintain the following goals and phone call stats: ASA of 30 seconds or less Abandonment Rate of < 5% Customer Satisfaction rate of above 95% Customer complaints of < 1 per 1000 prescriptions filled Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 10/30/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

36 PHARMACY LICENSING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-11 ACHC DRX 1-7A, 5-1C CPPA 1.1a, 1.1g, 1.1i PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 10/28/2014 Scope To meet all federal, state, local and business laws and regulations, including state specific Prescription Drug Monitoring Program (PDMP) requirements. Guidelines PANTHERx Specialty Pharmacy (PANTHERx) employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure State Licensure A current copy of pharmacy rules and regulations for the states where the pharmacy is licensed and provides services are maintained in the pharmacy at all times. Each licensed pharmacy manager/pharmacist-in-charge (PIC) or wholesale designated representative is responsible for knowing their state specific pharmacy laws and regulations. It is the responsibility of the pharmacy manager/pharmacist-in-charge (PIC) or wholesale designated representative to communicate changes in pharmacy state laws and regulations to the Company legal and regulatory departments. All required licenses and/or permits are current and on display in an appropriate and conspicuous place at all times. Such licenses and/or permits will include, but are not limited to: a. State pharmacy licenses b. Controlled substance licenses c. DEA licenses d. Licenses of practicing pharmacists and technicians (if applicable) e. Wholesale licenses f. Business licenses g. Other licenses or permits required by state or local law and regulations Pharmaceutical services will be provided through one of the following methods: o A licensed Company pharmacy o A written agreement with an outside licensed pharmacy or pharmacies (preferably URAC and/or ACHC accredited) A combination of the two preceding methods shall govern company activities o If dispensing into other states, pharmacy personnel will comply with all rules and regulations pertaining to those states. o Pharmacy personnel are aware of, and compliant with, company policies and procedures to the extent necessary and required in performing their jobs. o Pharmacy personnel are aware of, and compliant with, accepted ethical and professional practices, and all applicable federal, state, local and business laws and regulations. o Pharmacy personnel will comply with practices required by government reimbursement 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

37 o programs. Action is taken on recommendations or citations made from any governing body or regulatory agencies. This may include, but not be limited to: Boards of Pharmacy, DEA, FDA, OSHA, The Joint Commission, DOT, and other federal, state or local agencies or accrediting organizations. The organization will verify via primary source verification of current licensure or certification via the issuing organization of staff whose job description requires licensure or certification upon hire, and thereafter no later than the scheduled expiration date. Status of licensure and/or certificates will be verified annually. Pharmacy personnel are aware of and comply with company policy and procedures to the extent necessary and required in performing their job. Personnel are required to notify their immediate supervisor or HR within 24 hours of any adverse changes in licensure or certification. Adverse changes in licensure and certification will be handled by HR on a case by case basis. In the event that PANTHERx enters into a contract with a pharmaceutical manufacturer, all employees will be required to complete training on product and/or service, as required by the contract. Prescription Drug Monitoring Program Prescription Drug Monitoring will be managed and maintained on a state by state basis along with state licensure by the Pharmacy Quality & Compliance team led by the VP, Quality & Education PANTHERx Specialty Pharmacy does not dispense controlled substances; therefore, it is the company s policy to maintain waivers and exemptions in the states where PANTHERx holds a state license Current waivers and exemptions will be reviewed on a monthly basis along with licensure in order to ensure continued compliance States that require re-approval or re-attestation, a request will be submitted along with state licensure renewal or using the specific PDMP application prior to expiration in order to maintain continued compliance with PDMP requirements In states where PANTHERx does not hold a waiver or exemption, PANTHERx will comply with zero reporting requirements on the interval that is required by the state In the event that PANTHERx begins to dispense controlled substances, all states where PANTHERx holds an exemption or waiver as well as states where PANTHERx dispenses medication, notice will be sent to the states and PANTHERx will initiate compliance with state specific PDMP reporting requirements Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

38 CODE OF BUSINESS CONDUCT & ETHICS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-12 URAC PC 4,15,16,30,33,36 ACHC DRX 1-8A, 3-2A CPPA 1.1h, 1.1i PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager, Human Resources Effective Date: 6/23/17 Scope PANTHERx Specialty Pharmacy maintains a Code of Conduct that governs the actions of individuals employed by or associated with the company. The written guidelines which are based on the company s values outline how its leaders, employees, and associates are to conduct themselves when providing services, doing business, or acting on behalf of the company. This Code also works in conjunction with all relevant company standard operating procedures, policies, laws, and compliance standards. All leaders, employees or associates of PANTHERx Specialty Pharmacy are responsible for understanding and acting in accordance with the standards outlined in the Code of Conduct. This Code works in conjunction with the Corrective Action and Discharge standard operating procedure. Values PANTHERx Specialty Pharmacy embraces and enforces a set of Values as listed below. 1. Genuine Integrity: We conduct ourselves with sincerity, transparency, and honesty. 2. Uncompromising Quality: We insist on attention to detail in every aspect of delivering excellent patient care. 3. Respectful Culture: We foster a culture of humility, gratitude and trust. 4. Authentic Dedication: We sincerely care. 5. Disruptive Innovation: We responsibly approach challenges with creative, tailored strategy to consistently exceed expectations. 6. Mutual Growth: We commit to relentlessly educate our patients, our providers, our partners and ourselves. 7. Supportive Ambition: We value effective teamwork. Guidelines More specifically, in accordance with the above Values, PANTHERx Specialty Pharmacy endorses and enforces this Code of Conduct because: A. We demonstrate honesty, fairness, dignity and respect to everyone within a safe and healthy work environment. B. We communicate honestly, accurately, timely and appropriately at all times. C. At the core of our business we are focused on establishing and retaining the highest possible level of public confidence and trust in the care, treatment and services. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

39 Policy D. We avoid all conflicts of interest, real and perceived. E. We comply with all applicable laws, compliance standards, and policies. F. We demonstrate respect for those decisions of our superiors, which are made in the best interest of the company. G. We value the patient and provider relationship and demonstrate accountability for patient safety and safeguard patient trust. Based on the above listed Values and Guidelines, PANTHERx Specialty Pharmacy will not tolerate intimidating, disruptive, unprofessional, inappropriate, or unethical behavior from any of its associates. Examples of unacceptable behaviors include, but are not limited to: A. A failure to uphold or the intentional disregard of the company values as listed. B. Violating or failing to conduct business in accordance with all federal, state, and local laws, internal regulations, standard operating procedures, compliance standards, or policies that govern and guide company protocol. C. Demonstrating any malicious, injurious, offensive, demeaning, intimidating, threatening, belittling, disruptive and or abusive disposition toward a leader, manager, employee, or any representative of the company. D. Harassment through physical contact, verbalizations, gestures, or electronic / nonelectronic media. E. Breaching confidentiality of a patient or violating the patient confidentiality standard operating procedure. F. Exhibiting behavior or engaging in activity that could compromise patient safety including those that are malicious, careless, neglectful, or risky. G. Falsifying records including medical records, patient documentation, financial or expense reports, governmental reports, or any business-related documentation. Intentional recording or reporting of inaccurate data. A failure to follow record retention policies and or procedures. H. A failure to conduct government and state business with the highest degree of integrity and honesty. I. Creating or contributing to an unsafe or unhealthy working environment. J. Making inappropriate advances or engaging in sexual misconduct. K. Misusing electronic media including , text messaging, instant messaging, or internet technology to include sending or receiving pornography, obscene jokes or sexually harassing content. L. Destroying property, or not safeguarding property against damage. M. Violating the Conflict of Interest standard operating procedure. N. Engaging in activities that have any potential to constitute fraud. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

40 O. Failing to engage in ethical and fair competition. Neglecting to avoid unfair trade practices which are defined as using deceptive, fraudulent or unethical methods to increase or obtain revenue. P. A failure to treat all associates of the company with dignity and respect always, regardless of position, title, relationship, or business goal. Q. The use of company assets for personal reasons. R. A failure to embrace the value of ongoing development and education or neglecting to stay current with required trainings to include but not limited to annual training on Fraud, Waste and Abuse. Relevant Standard Operating Procedures: PS-42 PS-56 PS-66 PS-115 PS-117 PS-118 PS-119 PS-120 PS-123 Health Record Storage, Safety and Confidentiality Employee Safety Security Policy Corrective Action and Discharge Fitness for Duty Non-Retaliation Travel & Expense Reporting Password Policy Acceptable Use Policy Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet. Violation/Disciplinary Action Violations of this Code of Conduct will be investigated by Human Resources. This policy works in conjunction with the corrective action and discharge SOP and associates who violate this policy are subject to disciplinary action up to and including discharge. Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Manager, Human Resources 06/23/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

41 CONTRACTOR SCREENING POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-13 URAC PC 6, 7, 9 ACHC DRX 4-11C, 4-11D CPPA 1.1a, 1.4a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/28/14 Scope To ensure that all contractors are screened prior to entering into a contract with PANTHERx Specialty Pharmacy Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Procedure A Contractor Screening Acknowledgement form is expected to be completely filled out and signed by a potential contractor. All acknowledgement forms will be screened for the following: 1. OIG Check a. Go to https://exclusions.oig.hhs.gov Which is the U.S. Department of Health and Human Services Office of Inspector General i. Type in the contractor s name in the box provided ii. Hit Search iii. If no results have been found, follow the same process as above. iv. If there are search results found, 1. The Pharmacist in Charge (PIC) will review to determine if contractor agreement should be entered into or not. 2. Follow up with contractor for more information. 2. Excluded Parties List System Check a. Go to https://www.sam.gov b. This is the Excluded Parties List System maintained by the GSA i. Type in the contractor s full name ii. Type in the contractor s EIN iii. Click on Search 1. If no results have been found, follow the same process as above. 2. If there are search results found, a. The PIC will review to determine if contractor agreement should be entered into or not. b. Follow up with contractor for more information. 3. State License Check (If Applicable) a. This search will be determined by the specific entity or license being checked. License check will be done on primary verification source. i. Type in contractor s name in the box provided. ii. Hit search iii. If license if valid, a screen print or copy will be printed and filed iv. If no results have been found, follow the same process as above. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

42 v. If there are search results found, 1. The PIC will review to determine if contractor agreement should be entered into or not. 2. Follow up with contractor for more information. 4. Other verification checks as deemed necessary. a. Accreditations b. Insurance 5. Before signing the contractor agreement, PANTHERx Specialty Pharmacy may elect to perform an on-site inspection (review of policy and procedures, verify adherence to policies and applicable laws and regulations), check references or perform other background checks to ensure contractor is applicable to perform support services. 6. On at least an annual basis, contractors will be rescreened to ensure they are eligible to provide support for PANTHERx Specialty Pharmacy. The screening process will include review of policies and procedures and quality activities related to delegated functions. Any financial incentives of the vendor will also be reviewed to ensure quality of care and services. If deemed necessary, on-site inspections may be deemed necessary to ensure contractor adherence to PANTHERx Specialty Pharmacy s contractual agreement. Contractor review is the responsibility of the quality team. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

43 DESTRUCTION OF PHI & PCI MATERIALS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-14 ACHC DRX 2-5A, 5-1C CPPA 1.14e, 1.14b PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/28/2014 Scope Purposes of the policy include destruction of documents which no longer need to be retained. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure This Policy represents the policy of PANTHERx Specialty Pharmacy with respect to the destruction of documents and other records, both in hard copy and electronic media (which may merely be referred to as documents in this Policy). Procedure 1. PANTHERx Specialty Pharmacy will inspect all the following items to determine if they contain Protected Health Information (PHI) or Payment Card Industry (PCI) and, if so, the pharmacy will follow the procedures in this Policy and Procedure: a. Paper documents b. Labels (prescription or shipping) c. Prescription vials d. Audio Recordings e. Hard disk drives (and the computers that contain them) f. Back-up tapes g. CD/DVD-R h. CD/DVD-RW i. Video recording media 2. PANTHERx Specialty Pharmacy will seek the approval of the Privacy Officer for PHI/PCI Media destruction. The Privacy Officer will determine if the PHI/PCI Media being destroyed is needed for some other purpose, including, but not limited to, the following: a. Investigations b. Documentation duration has not elapsed c. Judicial or administrative proceedings d. Other 3. Identification of materials to be destroyed a. PANTHERx Specialty Pharmacy will identify which documents, containers, labels, packaging and media types need to be destroyed. 4. Storage of Documents and Media for Destruction a. PANTHERx Specialty Pharmacy will store all documents and media which are awaiting destruction in an area designated for destruction, such as a shredding bin. 5. Process for Destruction of PHI/PCI: a. PANTHERx Specialty Pharmacy utilizes Iron Mountain for the destruction of the PHI/PCI materials. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

44 b. A PANTHERx Specialty Pharmacy employee will escort the Iron Mountain representative throughout the facility to collect the documents for destruction and will observe the destruction of all company documents. c. The PANTHERx Specialty Pharmacy employee will obtain a proof of shredding document once all document destruction is complete. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/012/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

45 MARKETING COMMUNICATION OVERVIEW STANDARD OPERATING PROCEDURE POLICY NUMBER PS-16 URAC PC 10 ACHC DRX 2-1A, 2-1B, 2.2A.01 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/28/14 Scope The Vice President, Business Operations will be responsible for reviewing all Patient Care Management modules, policies and procedures, payer and manufacturer based medication programs and formulary decisions for the PANTHERx Specialty Pharmacy (PANTHERx) Policy/Procedure Process Overview The Vice President, Business Operations reviews any new or enhanced marketing materials and communications with the pharmacists and patient-facing staff. Upon review, it is then discussed with the management team prior to distribution. Utilizing the Flesh-Kincaid Readability Score, all marketing materials, both print and online, are required to be written at less than an 8 th grade reading level. Vendor Management 1. PANTHERx Specialty Pharmacy will secure and support appropriate internal and external resource(s) to maintain industry standard quality publications, online presence, trade show support, and cost-effective printing and advertising. 2. Only organization approved or designated vendors will be utilized to procure marketing and advertising materials. Outside advertising agencies are not to be used without prior approval from PANTHERx. Marketing Communications Review 1. All communication materials intended for use with existing and prospective patients and prescribers, including advertising materials and promotional giveaways, shall require review and approval through PANTHERx s communications review. This also includes a review of all marketing material by senior management, before distributed or put into production. This process shall safeguard against misrepresentation about organization services and/or ownership and ensure compliance with applicable legal and regulatory guidelines. 2. All approved communications shall be identified by a unique numeric designation to be established by PANTHERx. A record of all approved communications will be maintained by PANTHERx to be used for communication tracking and version control. 3. The Vice President, Business Operations is responsible for the approval of all organizational material. 4. Following approval, PANTHERx will determine, in collaboration with the business user, the best promotional strategies for the approved communication with a working marketing plan (as needed) to enhance support. 5. Any report of an inaccuracy is immediately addressed by PANTHERx. This includes removing the material from circulation within 72 hours of notification and advising corporate legal, if necessary. Should correction notices be warranted, Marketing, IT and legal will collaborate and devise a notification method. 6. All approved marketing communications will be reviewed at least annually. At each review cycle, program content shall be reviewed for any material misrepresentations or requirement for edit based on newly available reference documentation. This process shall be coordinated with PANTHERx s clinical operations team to ensure all changes to communications applicable to the delivery of patient care are supported by up-to-date clinical documentation from recognized sources. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

46 Marketing Communications 1. PANTHERx s marketing department, or designated vendor, will support the stakeholders with the creation and production of communication materials for consumers, clients and event promotions. Materials may include any/all of the following: a. Traditional media letters, posters, flyers, brochures, pamphlets. b. Newspaper c. Media Releases - Must be approved and routed through the Management team d. Website On-going maintenance of PANTHERx s website. Update information, current promotional events, changes of hours, etc. Program Managers are responsible for submitting informational changes. e. Social Media review and maintenance of PANTHERx s presence on social media, including (but not limited to) Facebook, Twitter, LinkedIn, Google+ and Pinterest. f. Welcome Kits Given to all patients with their first prescription, either in person or included in their first shipment About Us Letter including Continuum of Care Cycle HIPAA Privacy Statement including acknowledgement to sign and return Rights & Responsibilities Assignment of Benefits Frequently Asked Questions mypantherx Portal Instructions Proper Disposal of Medications and Sharps Flyer Emergency Supply List Grievance Communication Information 2. Upon identifying the need for new marketing materials, the business requestor shall notify the marketing department, or designated vendor, of this need. PANTHERx s marketing department will coordinate with the requestor in the development of the marketing materials and will be responsible for all copy, layout/design, graphics, endorsement phrases and any disclaimers pertaining to PANTHERx and/or its services. 3. PANTHERx will ensure approval of any incurred expenses through departmental and divisional leadership to include: a. Specialty Pharmacy PIC (if applicable) b. Sales Management and/or Director of Pharmacy c. Compliance Officer d. Chief Executive Officer Please note that budget approval does not mean expenses will be authorized. PANTHERx Specialty Pharmacy s Marketing will not support print or material requests that are not budgeted or that cannot be ROI justified. Web Page 1. Information contained in PANTHERx s website is provided as a service to existing and prospective customers of PANTHERx as well as internal stakeholders. The purpose of PANTHERx s website is to provide information about PANTHERx, its mission and services, facilities, events and programs. In addition, PANTHERx website provides resources to Service Members, families and other persons or organizations utilizing PANTHERx s services. 2. PANTHERx s management has specific responsibilities for management of PANTHERx s website, but the presence on the web is a collaborative effort involving marketing and information technology. All website content undergoes an annual formal review. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

47 3. PANTHERx s website template is required in order to comply with graphic standards and cannot be altered. 4. Marketing, in collaboration with IT, is responsible for checking the website for vulnerabilities and other sensitive information that may be dated/expired and should be deleted. 5. PANTHERx requires that the website be reviewed at least annually. Training This policy will be posted on the PANTHERx Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 10/28/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 11/10/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

48 THIRD PARTY VENDOR CONTRACTING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-17 URAC PC 8, 9, 11 CSCD 5, 6 ACHC DRX 4-11C, 4-11D, 4-11E CPPA 1.4a, 1.6a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 10/23/2014 Scope To establish a process whereby the requirements of contracted vendor services are delineated and monitored. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy 1. PANTHERx Specialty Pharmacy shall maintain on file signed contracts/agreements with all clients where there are services purchased from or sold to another entity resulting in shared responsibility 2. All contracts that allow business associates to have access to Protected Health Information (PHI) as required by HIPAA and applicable laws and regulations, or access to Payment Card Industry (PCI) information, shall be accompanied by signed Business Associate Agreements. 3. PANTHERx Specialty Pharmacy requires that subcontracted/delegation of services to other organizations are relevant to the scope of URAC accreditation. Pre-delegation 1. PANTHERx Specialty Pharmacy management will meet to discuss the scope of delegation and establish criteria for pre-delegation review of potential delegates. The Pharmacist in Charge will make the final decision to delegate. 2. The pre-delegation oversight will review: a. Their policies and procedures b. The capability and capacity to provide services c. Proper licensing d. Proper staffing e. Security 3. A Contractor Acknowledgement Form will be completed by all potential delegates as outlined in the Contractor Screening Policy. 4. Services for which contracts may be required include but are not limited to: a. Contract employees b. Personnel firms, etc. Contracts 1. All contracts/agreements shall comply with usual and customary business practices and applicable laws, regulations, and standards. 2. Each individual/organization contract shall be maintained in a separate file. 3. All contracted service agreements shall be accompanied by copies of the individual s/organization s current professional liability insurance, if applicable. 4. At a minimum the following information shall be specified in the contract: 2017 PANTHERx Specialty, LLC 1

49 a. Name of the individual/organization with whom the contract is formed; b. Name and type of service/care to be provided; c. Responsibilities of each organization; d. The manner in which care/services will be controlled, coordinated, and evaluated by the primary organization; e. The amount and procedures for payment for care/service furnished under the contract; f. PANTHERx Specialty Pharmacy will track all financial incentives for each third-party agreement along with providing EDI reports or manual as required; g. Compliance with all organization policies, including applicable personnel policies; h. Requirements to meet CMS Conditions of Participation, if applicable; i. Overall responsibility for supervision of staff if applicable; and, j. Adherence to any other applicable laws, regulations, and standards. k. PANTHERx Specialty Pharmacy will require notification from any third-party organization of any material change in the contractor s performance of delegated functions. Procedure 1. All contracts shall be reviewed at least annually and whenever there is a change in the type of care/services to be provided and/or there is a change in the amount and/or procedures for payment. Evidence of such review may be accomplished by a notation on the initial contract/agreement that includes the date of review and signatures of both parties, or by development of an updated contract. 2. Data and outcomes from contract monitoring activities are included in the company s annual evaluation. 3. PANTHERx Specialty Pharmacy has the right to conduct surveys of the contractor, as needed. 4. PANTHERx Specialty Pharmacy requires that the contractor submit periodic reports to PANTHERx Specialty Pharmacy regarding the performance of its delegated responsibilities. 5. PANTHERx Specialty Pharmacy will outline recourse and/or sanctions if the contractor does not make corrections to identified problems within an agreed upon specified resolution period. 6. PANTHERx Specialty Pharmacy will specify the circumstances under which activities may be further delegated by the contractor, including any requirements for obtaining permission from the organization before any further delegation and services provided. 7. PANTHERx Specialty Pharmacy specifies that, if the contractor further delegates organizational functions, those functions shall be subject to the terms of the written agreement between the contractor and the organization and in accordance with accreditation standards. 8. PANTHERx Specialty Pharmacy will cooperate and allow third party payers to verify PANTHERx Specialty Pharmacy records to ensure accuracy and compliance with contract terms. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Austin Russian, PharmD Clinical Pharmacist 10/23/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ PANTHERx Specialty, LLC 2

50 Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 3

51 CALL ESCALATION & CUSTOMER TRACKING LOGS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-18 URAC CSCD 7,9 ACHC DRX 2-10F CPPA 4.1 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/14 Scope To ensure all escalated, clinical questions (drug information questions, medication ID, medication storage/stability, etc.), urgent and emergency patient concerns and/or feedback is addressed in the appropriate timeframe and to the satisfaction of the patient, the following procedure will define how Specialty Tracking Logs will be handled each day. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Customer Clinical Questions A patient will be transferred to a live clinician for any clinical questions or concerns with their therapy. Examples of clinical questions include but are not limited to: 1. Side effects 2 Medication identification (pill ID) 3. Proper administration of medications (injection, mixing, etc.) 4. Proper storage and stability Incident Reporting A Quality Improvement Opportunity (QIO) report will be generated for any patient that expresses dissatisfaction with the Specialty process including: 1. Delays or errors in any pharmacy processing area or function including: a. Rx Requests/Processing b. PA Requests/Processing c. Insurance Requests/Processing d. Dispensing Requests/Processing e. Supply Items Requests/Processing 2. System errors of any type that result in a negative customer experience 3. Billing errors or issues that result in a negative customer experience 4. Shipping errors or issues that result in a negative customer experience 5. Customer Service issues, complaints or concerns as a result of interaction with individual staff member(s) 6. Any other matter in which a patient expresses dissatisfaction with PANTHERx Specialty Pharmacy s services. Incident Reporting Process/Escalations QIO reports should be promptly submitted to the assigned leadership team member(s) on duty for the shift for review and resolution. If a call is escalated or a patient requests a Supervisor, the call should be transferred per the defined Escalation Pathway or to any member of leadership currently on duty for the shift in any area PANTHERx Specialty, LLC 1

52 *Note: Escalated calls should always result in a QIO report being generated 1. Incident Reports will be reviewed and resolved same-day including all patient contacts and submitted to Manager for final review and approval of outcomes. 2. QIO reports will be entered into a Tracking Spreadsheet and summarized based upon reason and ed to defined Specialty leadership team members. 3. Each quarter, a meeting will be held to discuss the previous quarter s QIO reports, short-term and long-term resolutions and other action plans required. 4. Completed QIO reports will be summarized and sent to the Quality Management Committee as a notice of issues identified and addressed. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Rob Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

53 DISCLOSURE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-19 URAC CSCD 5,6 ACHC DRX 2-5A, 5-1C PANTHERx Specialty Pharmacy Policy Owner: David Stasiowski, Vice President, Business Development & Managed Markets Effective Date: 11/07/2014 Scope PANTHERx Specialty Pharmacy will disclose the following information to all contractual organizations upon request and when appropriate in order to verify the organizations records are comprehensive and accurate, per the terms of the contractual organizations contract. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy has the ability to disclose the following information to requesting contractual organizations upon request, when appropriate, and permitted by PANTHERx Specialty Pharmacy: 1. In the event PANTHERx Specialty Pharmacy enters into a payor contract and the following disclosures are included in the contract. a. The existence of organizational arrangements that could potentially create a conflict of interest that affects clinical or financial decisions b. Purchase discounts c. Pricing structure for pharmacy services including rebate structure and administration fees d. Delegation of services to other organizations relevant to the scope of Accrediting Organizations. 2. Any Conflict of Interest that affects clinical or financial decisions may include financial relationships with vendors, partnerships with other entities or monetary incentives. 3. Drug pricing is determined based off current fair market rates. 4. Any purchase discounts, rebates or administration fees that PANTHERx Specialty Pharmacy receives. 5. Any delegation of services or subcontracting to other organizations relevant to the scope of URAC and ACHC accreditation. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ PANTHERx Specialty, LLC 1

54 Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ Panther Specialty, LLC 2

55 DISPOSAL OF UNUSABLE DRUGS & SUPPLIES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-20 URAC CSCD 1 Pharm Op 8, 9, 12 ACHC DRX 7-7A CPPA 1.7h PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope To outline the procedure followed by PANTHERx Specialty Pharmacy to handle unusable drugs and supplies Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Inventory is to be checked on a regular basis and all expired, recalled, discontinued, damaged, adulterated, unacceptable, and misbranded medications, inventory determined to be counterfeit, waste from compounding, and unusable supplies and devices shall be promptly removed from the pharmacy inventory. These items shall be stored in a well-marked designated area within the pharmacy to prevent further use prior to disposal. 2. Drugs, supplies and devices which have been recalled shall be processed per Returned Goods once notified by the manufacturer and/or the FDA. 3. All items which are removed from the pharmacy inventory due to defects, discontinuation or expiration shall be returned to the vendor or an approved reverse distributor, EXP, for credit when possible. 4. Items which cannot be returned to the vendor, such as discontinued patient medications, broken items and waste from compounding shall be destroyed using a reverse distributor, EXP. 5. All medications, compounding supplies and cleaning supplies which are cytotoxic, or potentially hazardous, will be disposed of per State Board of Pharmacy & regulatory guidelines. 6. The appropriate staff is made aware of any unusable inventory and is instructed on what to do with any affected inventory. 7. Inventory waiting to be shipped and in transit will be reviewed and inventory removed if anything unusable is found. 8. Any customers that are determined to be affected by expired, recalled, discontinued, damaged and/or unacceptable medications, inventory determined to be counterfeit, and unusable supplies and devices will be notified. If appropriate, their providers will be alerted and any action needed will be discussed. Procedure 1. Under no circumstances will drugs that have left the control of PANTHERx Specialty Pharmacy be returned to the pharmacy inventory. 2. Items for return to the vendor will be returned as directed. a. Medications and supplies that need to be returned will be properly returned by a third party i. PANTHERx Specialty Pharmacy contracts with EXP to return unusable inventory. 3. Items which cannot be returned will be destroyed as allowed by law and regulation: a. Medications and supplies that need to be destroyed will be properly destroyed by a third party i. PANTHERx Specialty Pharmacy contracts with EXP to dispose of unusable inventory. b. Supply items that are not hazardous to the public can be discarded in the regular trash PANTHERx Specialty, LLC 1

56 4. Recordkeeping for State or Federal Law a. Refer to local State laws as applicable. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

57 DRUG SUBSTITUTION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-21 URAC CSCD 1 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope This document describes when drug substitution is performed. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Policy PANTHERx Specialty Pharmacy will practice generic substitution based on the following criteria in order of significance: 1. As required by State laws, if applicable 2. FDA equivalency rating 3. Therapeutic category if identified by the Clinical Department. 4. Prescriber preference 5. Patient preference 6. 3 rd party payor requirements In the event that a therapeutic substitution is determined to be the best course of action, both the prescriber and the patient will be made aware prior to the substitution being made. Definitions Generic bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. A Rating FDA Rating of generics which have been shown in clinical study data to demonstrate bioequivalence in addition to other traits identified in generic definition. DAW Dispense as Written. Indication can limit or prevent generic substitution. Responsibility Patient Intake - initial interpretation and entry of any applicable DAW code. Pharmacists Clinicians References and Documentation Drug Add Worksheet (includes FDA Rating Orange Book) Procedure 1. PANTHERx Specialty Pharmacy will automatically substitute a generic equivalent which carries any A rating as indicated by the FDA Orange Book when allowed by State or Statutes and as allowed by the prescription. 2. PANTHERx Specialty Pharmacy may limit generic substitution regardless of FDA equivalency rating if the Clinical Services team determines this is appropriate based on therapeutic considerations. a. For example, certain immunological agents used for transplant therapy PANTHERx Specialty, LLC 1

58 b. In these instances, no substitution will take place unless requested by the third-party payor. 3. If the third-party payor requests or requires substitution of a non-a rated generic, PANTHERx Specialty Pharmacy will consult with the prescriber prior to generic substitution. Process Controls RPH Screening Records Original Rx (System Record Scan or Hard Copy) Rx processing software Patient File Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 01/27/ PANTHERx Specialty, LLC 2

59 ELECTRONIC PRESCRIBING POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-22 URAC CSCD 13 Pharm Op 2 ACHC DRX 5-1C, 5-10A CPPA 1.13b, 1.12a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/07/2014 Scope This list of approved electronic prescription formats will be used by PANTHERx Specialty Pharmacy s licensed pharmacist in determining legality of prescription written by that electronic system. All legal requirements for filling prescriptions written electronically must be followed as deemed by the Pennsylvania State Board of Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Policy 1. Electronic prescription transmission systems allow prescriptions to be sent electronically from a prescriber to a pharmacy. The prescriber can send the prescription directly from his/her computer to a pharmacy computer or facsimile machine. 2. Some of the systems are office-based, some are web-based, and some use a switching station to route the prescription to the pharmacy. a. The office-based systems allow the prescriber to send a prescription electronically directly from his/her office to the pharmacy. b. The web-based systems allow the prescriber to log onto a website, enter a prescription, and the website sends the prescription to the pharmacy. c. Systems utilizing a switching station allow the prescriber to enter a prescription that is transmitted to a switching station. The switching station identifies the prescriber using specific data elements and then sends the prescription to the pharmacy. 3. Prior approval by the Board of Pharmacy is required for all electronic prescription transmission systems and pharmacy systems receiving electronic prescriptions. However, pursuant to a system meeting the Drug Enforcement Agency s (DEA) requirements noted in section 21 C.F.R to send and receive electronic prescriptions for both controlled and non-controlled substances shall be considered approved by the Board. 4. The Board s electronic prescription transmission system approval process includes reviewing that each system has true positive identification of the prescriber sending the prescription, that every system has security and accountability of all confidential information, that the pharmacist receiving the prescription can identify that the system has approvable status with the Board of Pharmacy, and that the pharmacist receiving the prescription can identify that the prescription is legitimate. 5. Please note, that the Board s approval processes for electronic prescription transmission systems and pharmacy computer systems does not replace the need to meet the requirements of section 21 C.F.R to send and receive controlled substance electronic prescriptions. Some important information you should know about electronic prescription transmission systems: 1. No controlled substances may be sent to a pharmacy using an electronic prescription transmission system unless the system meets the DEA requirements noted in section 21 C.F.R PANTHERx Specialty, LLC 1

60 2. No controlled substances may be received by a pharmacy using an electronic prescription transmission system unless the system meets the DEA requirements noted in section 21 C.F.R Dispense as Written or DAW does not have to be handwritten on a prescription sent through an electronic prescription transmission system. It does, however, require a positive action by the prescriber to physically select Dispense as Written or DAW when creating an electronic prescription. The electronic prescription transmission system cannot automatically default to Dispense as Written or DAW. 4. You may, or may not, see a signature on a prescription sent to a pharmacy by a prescriber using an electronic prescription transmission system. Electronic signatures are not recognized as a means of positive identification and therefore are not required. If a signature is present, the prescription must indicate that the signature was computer generated. 5. A prescriber may elect to print a prescription from the electronic prescription transmission system in his/her office and give it to the patient to personally present to a pharmacy. The prescription must be issued as any written prescription. These prescriptions may contain a schedule II controlled substance, there can only be one controlled substance per prescription blank, Dispense as Written or DAW must be handwritten, and the actual handwritten signature of the prescriber must be on the prescription. Printed and manually signed prescriptions for both non-controlled and most controlled substances can still be legally sent from a prescriber facsimile machine to a pharmacy facsimile machine. Note 1: The approvable status applies ONLY to the electronic prescription transmission system and NOT to any other related electronic products, such as an electronic medical record Note 2: The Board s approval process for electronic prescription transmission systems does NOT replace the need to meet the requirements of section 21 C.F.R to send controlled substance electronic prescriptions): 6. An electronically transmitted prescription is created, transmitted, recorded or stored by electronic means such as facsimile or computer systems. 7. PANTHERx Specialty Pharmacy s e-prescribing system will be compliant with all regulatory requirements including all NCPDP standards for transactions. Including provider ID s, security standards as well as safe and effective prescribing. PANTHERx Specialty Pharmacy will also have the ability to handle e- prescriptions in the case the system is inoperable. 8. The system will also collaborate with physicians and other care organizations with alerts for unsafe situations such as: a. drug-drug interaction b. patient allergies c. inappropriate dosing d. other key factors that negatively affect patient outcomes 9. PANTHERx Specialty Pharmacy s e-prescribing system will also help manage patient benefits and formulary choices to help with treatment options to maximize pharmacoeconomic options. 10. Patient records and history will be able to be communicated via the e-prescribing system with other HIPAA compliant healthcare providers. Notifications will be able to be generated from the e-prescribing system to help monitor compliance and adherence. 11. Without special safeguards, transmissions do not independently assure the required confidentiality of patient records and do not, therefore, meet the definition of an electronically transmitted prescription in the new rules and regulations. a. If a pharmacist has reason to question the authenticity of the electronically transmitted prescription, the pharmacist's professional judgment must prevail. b. If verification is not possible, the pharmacist can choose not to accept the electronically transmitted prescription and can request transmission by another means from the prescriber PANTHERx Specialty, LLC 2

61 Procedure 1. Prescriptions transmitted by e-prescription or facsimile may be verified by phone: a. Calling the prescriber's office to verify a prescription if the prescriber is not known to the pharmacist; b. Accepting a phoned in prescription in lieu of the faxed or computer transmitted prescription; c. Asking for proof of identity if the person picking up the prescription is not known to the pharmacist; d. Asking prescribers in the area to use an identifier on the faxed prescription form that indicates recopying or re-transmittal. Such marks are commonly used to indicate if that document has been copied from an original; e. Ensuring that the prescribed medication, based on quantity, directions for use, etc., is consistent with the patient's medication profile; f. Using other methods such as installing "Caller ID" on the phone line that is used to receive fax prescriptions; g. Considering whether the prescribed medication is one with an abuse potential or otherwise has "street value." 2. Just as other records must be maintained under existing laws; printed copies of electronically transmitted prescriptions must be maintained for five (5) years. Likewise, facsimile copies must be maintained in a readable fashion for five (5) years. 3. All pharmacies, including those providing prescriptions through a mail order service, are required to maintain a medication profile for each patient and to check for adverse drug reactions. Each licensee must practice per his or her best professional judgment and the law. If there are concerns that a prescription can cause harm to a patient, a pharmacist may contact the prescriber. If a pharmacist believes that a prescription can cause harm to a patient, even after discussion with the prescriber, the pharmacist can choose not to fill the prescription. 4. If a prescriber cannot legally order the prescription based upon the prescriber's scope of practice, the pharmacist must not fill the prescription. 5. A prescription for a controlled substance may not be transmitted electronically pursuant to Article 33 of the Public Health Law. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

62 MEMBER COMMUNICATION PROCESS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-23 URAC CSCD 11 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope To describe the services provided by PANTHERx Specialty Pharmacy regarding member communications. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Patient Communications with PANTHERx Specialty Pharmacy: 1. Notification (mail, fax, or call) sent from any member, physician, or payer to PANTHERx Specialty Pharmacy. 2. PANTHERx Specialty Pharmacy s customer service representative will provide a response to the member within specified time needed to resolve, but no later than 1 business day from receipt of communication. 3. PANTHERx Specialty Pharmacy will contact the member directly to discuss, resolve, and answer the questions and help resolve issues satisfactorily. 4. Each communication is logged into the operating system. If any future communications come in the staff will be able to access and have information for questions that may arise during future service requests. 5. Any request by a patient to be transferred to a pharmacist or management will be honored by a staff to properly assist patients with their requests or needs. 6. PANTHERx will provide information to consumers in multiple formats to include printed materials, mail, telephonic counseling, and translation services to different languages. Further, this information will also be available to inbound calls for emergency situations. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ PANTHERx Specialty, LLC 1

63 Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Panther Specialty, LLC 2

64 PRESCRIPTION TRANSFER TO ANOTHER PHARMACY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-24 URAC CSCD 1, 4 PM 3, 8 ACHC DRX 5-12A, 5-15C CPPA 1.12a, 3.3a PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope To ensure that the prescription is transferred correctly to another pharmacy in accordance with applicable state and federal laws, and to assure that duplication of prescriptions does not occur. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Policy 1. The Pharmacy Manager/PIC will be responsible for reviewing the applicable state pharmacy laws that apply to prescription transfer to another pharmacy and that all prescription transfers are in compliance with those laws. 2. Only a pharmacist can transfer the prescription to another pharmacist. 3. PANTHERx Specialty Pharmacy will coordinate health and service offerings for each patient. If a prescription can t be filled by PANTHERx Specialty Pharmacy for coverage or medication access, PANTHERx Specialty Pharmacy will coordinate with the patient s provider or other health care provider to assist the patient with their health needs. This also includes providing materials, support, and communications for existing insurance benefits as well as other charitable options that patients may qualify for based off eligibility (co pay assistance, free medication, counseling, support). 4. PANTHERx Specialty Pharmacy does NOT do any compounding (non-sterile AND sterile), and therefore if we were to receive a prescription for a compounded product, we would follow the below procedure to transfer to an alternative pharmacy. Procedure 1. A pharmacist may transfer a prescription by direct communication between pharmacists or by electronic files if allowed by applicable state pharmacy laws. 2. In states where prescription transfer is not allowed, prescription data may be given for informational purposes only, if law allows this. The pharmacy filling the prescription must call the physician to obtain a new prescription, or may receive the new prescription by other means per law (i.e., facsimile, or printed, physician signed prescription). 3. If a prescription is transferred either electronically or verbally, the pharmacy that is transferring the prescription will render their electronic prescription void so that duplication cannot be made. This will be done by discontinuing the order in CPR+ with the reason transfer. The transferring pharmacist is responsible for documenting all state required information regarding the prescription transfer in the patient chart using the progress note titled RPH- Prescription Transfer (Outbound). Some states require additional information concerning the prescription transfer to be recorded. In these cases, in addition to the above, the 2017 PANTHERx Specialty, LLC 1

65 required information provided to/from the transferring pharmacy can be documented within the CPR+ system and electronic prescription record or recorded on the hard copy per state law. 4. If applicable law allows, the pharmacy that establishes an electronic file for prescriptions, which is shared with, or accessible to, other pharmacies, will post a notice in a place conspicuous to and readily readable by prescription consumers. 5. In the event that PANTHERx Specialty Pharmacy is unable to service a patient, the prescriber will be notified within 3 days if services ordered cannot be provided. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

66 RETURNED GOODS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-25 URAC CSCD 1 Pharm Op 12 ACHC DRX 7-7A, 7-7B PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope To establish procedures for return goods including all recalled (discontinued, contaminated) expired, damaged, unused, unacceptable, and returned medications/supplies. This policy provides accountability and appropriate documentation. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Drug Recall Classifications Class 1 Recall: Reasonable probability that use of the drug will cause a serious adverse health consequence or death. Class 2 Recall: Using the drug may cause temporary or medically reversible adverse health consequences; serious adverse health consequences are unlikely. Class 3 Recall: Using the drug is not likely to cause any adverse health consequences. Policy/Procedure Product returned to PANTHERx Specialty Pharmacy (PANTHERx) may be the result of damaged or expired goods, overstock, or recalls. In the event of a Product Recall, the following will apply. 1. Remove any affected item(s) from inventory, affix a RECALL DO NOT DISPENSE label to all affected containers, and quarantine them. This includes active inventory, quarantined inventory, and prescriptions in the fulfillment process but not shipped. a. There will be cold chain and non-cold chain specific quarantine areas located within the pharmacy. 2. If the recall is a patient level recall, the Pharmacy Manager will be responsible for reviewing the records and identify all patients and prescribers who received the recalled item(s). 3. If the recall is a patient level recall, the Pharmacy Manager will be responsible for recording the name, address, and telephone number of each patient and prescriber identified and place the information in a Recall File maintained in the pharmacy. 4. If the recall is a patient level recall, the Pharmacy Manager will be responsible for recording the prescription/invoice number, date of dispensing, and quantity dispensed and file the information in the Recall File. 5. If the recalling entity (i.e. FDA or manufacturer) requires immediate notice the affected parties will be contacted within the same business day as the receipt of the notification, not to exceed 24 hours from notification. Call the patients and prescribers who received the item(s) and request that the protocol defined below is followed: a. Retrieve the affected item(s). b. Determine the number of doses of affected medication/item(s) they have. c. Notify the patients and prescribers not to use the remaining doses of the affected medication/item(s), if medically appropriate. d. Document all calls in the patient record. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

67 e. Call again within 24 hours of initial outreach any person who cannot be reached. f. Arrange for the immediate return of the remaining doses of affected medication or equipment. Record the method of retrieval and enter the information into the patient record. g. Place a RECALL DO NOT DISPENSE label on all doses of the affected item(s) that are returned and quarantine them. 6. If the recalling entity (i.e. FDA or manufacturer) does not require immediate notice, notify all affected patients and prescribers of the recall in writing, being sent within one business day of receiving the recall notice. The recall letter, provided by the manufacturer or wholesaler, should include the following information: a. The designation of URGENT RECALL placed at the top of the recall letter in prominent typeface b. The name of the item(s) subject to the recall c. The manufacturer s lot numbers (if applicable) and the lot numbers on the label identifying the item(s) subject to the recall d. Instructions on how to sequester and return affected doses/item(s) e. Any additional information that is appropriate, such as: i. Reason for the recall ii. Information related to the reason for the recall to the medical care of the patient or the patient s state of health iii. Relevant warnings iv. Instructions to patients regarding contacting their physician if applicable v. Procedures for obtaining replacement item(s) if applicable vi. Whom to call at the pharmacy if they have questions 7. Instructions for return of recalled product will be provided by the manufacturer or wholesaler, and the Pharmacy Manager is responsible for returning product as per the directions provided to PANTHERx. 8. Upon discussion with affected patients and prescribers to retrieve affected product, PANTHERx will determine best means for replacement of recalled product to prevent missed doses a. If alternative lot number is available through the same manufacturer, PANTHERx is to dispense product and NOT bill patient s insurance plan, if replacement approved by manufacturer. b. If alternate manufacturer is available for the same drug/strength/quantity, PANTHERx will contact patient s payer to determine if they will provide an approval for early reimbursement. If the patients insurance does not provide reimbursement and product is not available for replacement by manufacturer, a pharmacist will notify the prescriber and counsel the patient on missed doses. 9. Upon notification of recall for any discontinued, damaged, or unused medication, PANTHERx shall: a. Send the written notification to patients and physicians by USPS mail with return receipt requested b. Attempt, immediately, to get an updated address for the prescriber or patient if the notice is returned without having been delivered c. Place a telephone call to the recipient to determine the status if there is no response from the prescriber or patient within three days. 10. In the event that an expired product is returned to PANTHERx: a. Any return goods, damaged or expired product that is returned to PANTHERx should be returned through an approved Reverse distribution agents (i.e.: EXP Pharmaceutical Services, Inc.) in accordance with state law and regulation. Pharmaceutical waste is to be disposed of through use of reverse distribution agents or appropriately licensed waste disposal companies. b. Return goods, damaged or expired product is to be segregated from inventory and stored in a specially labeled area. Return goods, damaged or expired products are not to be dispensed for any reason 11. In the event a product is found to be counterfeit, PANTHERx will follow all Federal guidelines. Please see DSCSA Policy found in Panther Specialty SOP PS-60 Inventory Receiving. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet 2017 PANTHERx Specialty, LLC 2

68 Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 07/27/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/5/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/16/ PANTHERx Specialty, LLC 3

69 VERIFY NON-CONTRACTED ACCOUNTS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-26 URAC CSCD 4 CPPA 2.1a, 2.1f, 3.3a PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope The purpose of this policy is to define the operational process to do the benefit investigation for non- contracted patients and to provide excellent Customer Service and Operational Services related to prescriptions dispensed by PANTHERx Specialty Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. A reimbursement specialist will call the phone number listed on the enrollment form to obtain eligibility 2. Once eligibility is obtained, the reimbursement specialist will opt to speak w/ a rep to obtain benefits and determine if the medication will be considered a medical or pharmacy benefit a. If the medication is considered to be a medical benefit the reimbursement specialist will need to determine if we are able to provide without penalizing the patient (out of network). i. If the medication is considered to be a pharmacy benefit, the reimbursement specialist is responsible for finding out who the processor is (Caremark, Express Scripts, etc.) and call the correct party for benefit and authorization information ii. Once eligibility information has been obtained, the reimbursement specialist should update the patient record with the policy number, group number, person code, relation code, and benefit information. 3. If an authorization is required, the reimbursement specialist or physician relation liaison (PRL) is responsible for working with a pharmacist, the processor, and the physician to obtain approval. Once approval is obtained, the reimbursement specialist should: a. Update Prior authorization effective & term date in patient s record if authorization is approved b. Contact patient to inform of any co-pay responsibility c. If it is not approved, the reimbursement specialist or PRL should notify the referral source to make aware and discuss next steps 4. The reimbursement specialist or PRL will log notes in call tracking 5. The reimbursement specialist is responsible for checking all pending benefit investigations every 48 hours a. Physicians should be contacted after the third attempt to initiate a benefits investigation with a patient. 6. PANTHERx Specialty Pharmacy has a Contracts Manager who is responsible for obtaining contracts for each payor for which we do business with. In the event that an employee receives a rejection for noncontracted services, he/she will escalate claim detail to the Contracts Manager. a. Contracts Manager will reach out to plan to make reasonable efforts to obtain contracting for PANTHERx Specialty Pharmacy PANTHERx Specialty, LLC 1

70 POINTS TO REMEMBER FOR NON- CONTRACTED PLANS 1. If the reimbursement specialist is informed that PANTHERx Specialty Pharmacy is unable to provide, it is the reimbursement specialist s responsibility to find out who is able to provide for the patient. Once the provider information is obtained, the reimbursement specialist will notify a pharmacist to transfer the order to the appropriate provider and notify the physician. 2. The reimbursement specialist should also give detailed information to the Networks and/or Account Management to get a contract as an in-network provider if PANTHERx Specialty Pharmacy is not currently participating. 3. The reimbursement specialist must obtain a billing address for claims if the medication is a medical benefit, or a BIN and PCN if the medication is a pharmacy benefit. 4. If a new plan must be built, the verifier will build the new plan. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

71 PHARMACY TECHNICIAN SUPPORTIVE PERSONNEL STANDARD OPERATING PROCEDURE POLICY NUMBER PS-27 ACHC DRX 4-2E, 4-14C CPPA 1.5m PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope To ensure that PANTHERx pharmacy technician scope of responsibilities and tasks comply with regulatory requirements in assisting the pharmacist in the technical functions of pharmacy practice. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Policy This policy applies to all supportive staff including Pharmacy Technicians or Certified Pharmacy Technicians. Pharmacy supportive personnel responsibilities will be as defined by the pharmacy's State Board of Pharmacy or other designated regulatory agency. Pharmacist supervision of supportive personnel is required and is defined by the local State Board of Pharmacy regulations. Final verification of all technician assigned functions including accuracy, validity, completeness, and appropriateness must be completed by the supervising pharmacist prior to deliver of medication to the patient or patient representative. Ultimate responsibility for technician pharmacy supportive tasks remains with the supervising pharmacist for that pharmacy technician. Procedure A qualified pharmacist currently licensed in the state will supervise pharmacy technical supportive personnel. An adequate number of competent and qualified licensed pharmacists will be employed based on the staffing model. o The staffing model will be based on monthly operations performance which measures call metrics, prescription quantity and shipment quantity. o o The number of full time and part time technicians shall be adjusted based on these metrics Monthly, the effectiveness of the staff resources will be tracked any evaluated. Each month, the following metrics will be calculated on the Monthly Operations Scorecard Outbound Calls Inbound Calls Total Calls Average Calls per Day Outbound Call Duration Inbound Call Duration Average Call Duration Average Speed to Answer Abandonment Rate 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

72 o Service Level (%) Average Time to Fill (days) Total Rx Dispensed Total Shipments Total Shipment Cost Average Cost per Shipment Average Rx per Day Average Shipments per Day Average Inventory Cost Total FTEs These metrics are collected to evaluate pharmacy workload and performance data. This data is utilized to improve patient safety and evaluate the effectiveness of staff resources and our staffing model, including resources for quality improvement. They will be employed on a full-time, part-time, fee for service, or per-diem basis to ensure the provision of safe and effective pharmacy services while supervising supportive staff in the ratio as defined by state licensure requirements. Sufficient pharmacy technical supportive personnel will be available in order to minimize the use of pharmacists in non-judgmental tasks in accordance with applicable state pharmacy law. Pharmacy supportive personnel will receive appropriate orientation and training, and will demonstrate competency prior to performing any pharmacy tasks. Training will be documented and kept on file as validation of competency. The Director, Pharmacy Operations, who ensures the competency of all assigned staff in relation to the required pharmacy services and care, supervises all pharmacy staff including supportive technical personnel. Pharmacist supervision with in-process, final checks, and sign offs is required for all technician tasks. The following functions are tasks that may be performed, but not limited to, by pharmacy technical supportive staff when allowed per state regulations. o Tasks that are manipulative and repetitive in processing a prescription o Prepackaging and labeling of medication doses pursuant to appropriate procedures o Maintenance of dispensing records including filing and updating of logs and prescription files. o Assist the pharmacist in preparation of the prescriptions including: Entry of the prescription information into the patient information system Collection of pertinent patient information and entry into the patient information system Preparation of labels and affixing of labels to drug, device or associated supply items Preparation of the prescription for drugs, devices and related supplies for dispensing by the pharmacist Deliver or retrieval of drugs, devices and related supplies in an established process to ensure proper safety is maintained Initiate communication with prescribers for refill requests pursuant to local State Board of Pharmacy regulations Initiate communication with prescribers for clarification of missing prescription elements when directed by the pharmacist and allowed under local State Board of Pharmacy regulations Inspection of drug supply or storage areas Accept refill requests from patients Retrieve, count, measure drugs, devices, and related supplies from stock Order, transmit, and receive pharmacist approved orders with suppliers Other, as allowed by local State Board of Pharmacy regulations. Pharmacy supportive technical personnel are not allowed to complete the following pharmacy tasks: o o o o Final verification of the prescription for dispensing Drug utilization review evaluation Patient counseling or consultation on patient specific drug information Make any decision that would require the pharmacist's professional judgment in interpreting or applying information 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

73 Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/5/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/23/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

74 BACKUP PROCEDURES & RETENTION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-28 URAC PC 13 Pharm Op 14 ACHC DRX 5-1C, 7-9A CPPA 1.13a, 1.13d, 1.14b PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/07/2014 Scope To establish a protocol for the proper backup of pharmacy database systems, and the retention of purged data. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Pharmacy database systems (including prescriptions records maintained in pharmacy software, electronic signatures, HIPAA Notice of Privacy Policy (NOPP) acknowledgments, and any other database pertinent to the operation of the pharmacy) shall be copied to an off-site storage area under PANTHERx Specialty Pharmacy s control at the conclusion of each workday. 2. Back-up of facility systems include the following: a. If the facility loses power, the back-up generator will be used to provide power to critical systems and temperature sensitive products including pharmaceutical refrigerators and freezers. b. If the facility phone system goes down, the phone company will be contacted directly and instructed by the Vice President, Business Operations, to forward all incoming calls to the pharmacist in charge or on-call s cell phone. 3. Prior to purging any records from any pharmacy databases, the current system shall be backed up and/or mirrored onto removable media and labeled accordingly. A hard copy printout may accompany the removable media 4. Mirrored removable media and/or backup devices includes the following: a. Data or tape backup devices and/or cartridges b. Removable or External Hard drives/files Servers c. USB disk and/or flash drives d. Remote backups through a secure shell or other secure mirroring protocol. 5. Automatic backups are to be checked and log files monitored. 6. Backup to other systems inside PANTHERx Specialty Pharmacy s network can be done without encryption provided the data is either transmitted via PANTHERx Specialty Pharmacy s network encryption devices or never leaves the building/network under organizational control. 7. Backup & data retention documented in the (4) bullets above also provides an alternate data access point in case of an emergency. This allows pertinent customer prescription, drug profile along with other key information to be accessed from different locations. 8. Destruction of system information (electronic) includes: a. After computer reclamation without repurposing, hard drives are removed from the devices and sent to an approved vendor for destruction. 9. Destruction of information (paper): 2017 PANTHERx Specialty, LLC 1

75 a. PANTHERx Specialty Pharmacy will contract with an approved vendor for destruction, as detailed in policy PS-14; Destruction of PHI & PCI materials Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Rob Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

76 CLIENT SATISFACTION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-29 URAC PC 12, 39 ACHC DRX 6-3C CPPA 4.1 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope To ensure quality home health care and customer service consistent with PANTHERx Specialty Pharmacy s Mission and patient rights. Staff members encourage patients, payers, referral sources, and physicians to freely express any concerns about care or services, either verbally or in writing, without fear of discrimination, reprisal, or interruption of service. All complaints/concerns are kept confidential Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure (The levels described in the procedure should be used as a guide for tracking purposes but are not mandatory). 1. Staff: A. Provide written information and ensure that an organization representative explains the complaint process to patients upon admission; The complaint process information provided includes escalation process to patients (including state agencies, health plan, URAC or other pertinent agencies) for the nature of their complaint. B. Listen to concerns expressed by patients/others; C. Give information regarding expressed concerns immediately to the Pharmacist-in-Charge or immediate supervisor. All complaints are reported on the Incident Reporting Form by the employee or by a supervisor as related by the employee. 2. The PANTHERx Specialty Pharmacy Pharmacist-in-Charge/designee: A. Reviews all verbal and documented concerns, including those identified on the satisfaction surveys. All reported concerns are documented and then reviewed for improvement opportunities by the Quality Management Team. B. Initiates a problem-solving process to deal with patient concerns: i. Informs the patient within one business day of receipt that the patient s concern has been received and will be reviewed thoroughly. ii. Discusses with the patient/other all information/facts related to their concerns. Through discussion with those involved (patient, staff), the Pharmacist-in-Charge/designee will obtain all necessary information/facts. iii. Assesses the probable cause of the concern or complaint. iv. Where applicable, immediately notifies the other agency(ies) involved in the receipt of the complaint. Determination of the nature and level of the complaint is made: Level 1: No health risk to the patient; patient/other may be inconvenienced, but there has been no overall risk or impact on the quality/outcome of care. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

77 Level 2: Potential health risk exists; patient/other dissatisfied and/or there has been an impact on the short-term quality of care/outcome of care. Level 3: Actual or immediate health risk; or potential for a legal claim. v. Notifies other appropriate Senior Staff. Level 1: Notification of the Pharmacist-in-Charge/designee at the end of each month by submitting the completed complaint/event form. Notification of the Pharmacist-in- Charge within two business days following initial notification of a complaint/concern if assistance is needed to investigate and/or achieve resolution. Trend analysis is done as needed. Level 2: Verbal notification of the Director of Pharmacy Operations within two business days following initial notification of a complaint/concern; verbal notification of General Manager if resolution not achieved within five business days. Level 3: Verbal notification of Director of Pharmacy Operations as soon as possible, but within one business day. Level 3 complaints will be reviewed by the General Manager. vi. Investigates thoroughly with the input from the P.I. staff and other staff as appropriate. vii. Implements a corrective action plan as necessary. viii. Evaluates and implements corrective action plan to determine if the patient concern has been alleviated and documents any follow up activities. ix. Upon completion, responds to patient/other regarding resolution of the complaint: Level 1: Response from PANTHERx Specialty Pharmacy Senior Management within three business days. Level 2: Response from PANTHERx Specialty Pharmacy Senior Management within two business days Level 3: Response from PANTHERx Specialty Pharmacy Senior Management within one business day or as directed by General Manager or designee x. Documents complaint, intervention(s), and outcome on the complaint report form. xi. Forwards complaint/event report (original) and any related information to the Performance Improvement Staff or representative for logging. Forwards copies to designated operations Sr. Staff as requested. xii. Forwards any information related to employee performance to Human Resources for placement in the individuals personnel file. xiii. Maintains a Pharmacy Administrative file of all complaints including the service category and disposition of the complaint. 3. Performance Improvement staff compiles summary reports and reviews information with PANTHERx Specialty Pharmacy Senior Management. Performance metric such as response time to each complaint is measured and reviewed for Performance Improvements Reports. This information is utilized in the quality improvement process. Individual Identifiable Information is not part of the Performance Improvement Reports. 4. Any identified undesirable patterns or trends in performance will be recognized as opportunities for performance improvement and will be operationally addressed as such. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

78 Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Rob Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

79 COMPUTER POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-30 URAC PC 15 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope To ensure employees understand the companies Computer policies. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. PANTHERx Specialty Pharmacy s computer system and system are intended to be used for proper business or educational purposes only; use for personal reasons is permissible only within reasonable limits. Employees should remember that all messages or any other information stored, compiled, or collected on computers, computer disks databases, disk drives, networks or otherwise ("Electronic Information") are the property of the pharmacy and the pharmacy may use, inspect, destroy, delete, publish or otherwise dispose of such Electronic Information as the pharmacy determines to be in the pharmacy's best interest. 2. All electronic information is considered to be a pharmacy record and, therefore, should be transmitted only to individuals who have an appropriate need to receive them. Additionally, as a pharmacy record, Electronic Information is subject to disclosure to third parties. Consequently, employees should always be sure that the information contained in Electronic Information is accurate, appropriate and lawful. Inappropriate or offensive material is prohibited. Abuse of the computer system or system, through excessive personal use, or use in violation of law or the pharmacy policies, will result in disciplinary action up to and including discharge. 3. The use of unauthorized codes or passwords to gain access to another's Electronic Information is prohibited. However, PANTHERx Specialty Pharmacy retains the right to access any employee's Electronic Information and to use any employees' password or authorized code. While the pharmacy does not intend to regularly review employees' Electronic Information, employees have no right or expectation of privacy in Electronic Information. PANTHERx Specialty Pharmacy owns the computer system and the system and permits employees to use them in the performance of their duties for the pharmacy. 4. PANTHERx Specialty Pharmacy reserves the right to review any Electronic Information and to disclose it to others without notification to or permission from the employees creating, saving, sending or receiving Electronic Information. As a condition of continued employment, all employees consent to the pharmacy's review and disclosure of Electronic Information. 5. PANTHERx Specialty Pharmacy provides Internet access to employees to be used for educational or business purposes only; use for informal or personal reasons is permissible only within reasonable limits. All downloaded Internet files are considered pharmacy records and are subject to review by the pharmacy or disclosure to third parties. The pharmacy reserves the right to review employee Internet usage and to disclose information about an employee's Internet usage to others without notification to or permission from the employees sending or receiving the files. As a condition of continued employment, all employees consent to the pharmacy's review and disclosure of Internet usage. Use of pharmacy property or equipment to access inappropriate or offensive Internet sites is prohibited. Abuse of Internet privileges, through 2017 PANTHERx Specialty, LLC 1

80 excessive personal use, or use in violation of law of the pharmacy's policies, will result in disciplinary action up to and including discharge. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

81 CONFLICT OF INTEREST STANDARD OPERATING PROCEDURE POLICY NUMBER PS-31 URAC PC 9, 16, 33 ACHC DRX 1-2A, 1-3A, 4-7A PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager Human Resources Effective Date: 11/07/2014 Scope All employees, committee members and/or board members of PANTHERx Specialty Pharmacy will sign a Conflict of Interest Attestation upon hire and annually. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All members of the governing body, committee members, and all employees of PANTHERx Specialty Pharmacy shall a. Adopt a high ethical standard of conduct in performance of duties b. Observe laws and regulations governing business transactions c. Compete fairly with others d. Use company funds only for ethical, legitimate purposes 2. Employees of the company must also avoid incurring any financial or personal obligations that may affect (or appear to affect) their judgment in dealing, on PANTHERx Specialty Pharmacy s behalf, with other companies or individuals. 3. In the event of proceedings that require input, voting, or decisions, the individual(s) with a conflict of interest will be excluded from the activity. In case of exclusion the information will be documented to include the individual excluded, the reason for exclusion and the proceeding excluded from. 4. The company will comply with Medicare statutes, regulations, and disclosure requirements and other requirements codified at 42 CFR through Select areas of concern include: a. Holding an interest, directly or indirectly, in a firm that is in competition with PANTHERx Specialty Pharmacy or a firm with which PANTHERx Specialty Pharmacy does business. b. Receiving gain from any purchase or decision made by PANTHERx Specialty Pharmacy. c. Accepting favors, financial or otherwise, from an outside person or organization that may affect the employee s judgment in making decisions related to PANTHERx Specialty Pharmacy. d. Using information to which an employee has access by reason of his or her position by disclosing such information to competitors (e.g., financial information, technical information, or trade secrets) or using such information for his or her own benefit. 6. Offering consulting services or serving as an employee of another organization. 7. Anything that affects objectivity between the organization s financial interests and the organization s obligations to the patient and/or payer source. 8. To assess potential conflicts and to ensure that those employees engaging in outside employment or other activities inform management, all such employees will complete the Conflict of Interest Disclosure 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

82 Statement at time of hire. If a change in outside employment or other activities occurs, it is the employee s responsibility to complete a new Disclosure Statement. 9. The Conflict of Interest Disclosure Statement will be reviewed and completed by the Manager, Human Resources. The Manager, Human Resources will take appropriate action, if indicated. The completed Disclosure Statement will be placed in the employee's personnel folder. 10. All employees, committee members, and board members will sign a Confidentiality and Financial Incentive Attestation and a copy will be kept in their personnel file. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Manager, Human Resources 6/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

83 CONTROL OF QUALITY RECORDS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-33 URAC PC 13 ACHC DRX 5 PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/07/2014 Scope This procedure applies to all records that support the PANTHERx Specialty Pharmacy Quality Management System. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Responsibility 1. Department Managers - Identify the need for documentation, including records, in their area of responsibility. Has ownership of the controlled documentation that exists for his or her business area. Review and approve documentation prior to release or revision to ensure adequacy and correctness. 2. All Associates Responsible for reviewing documents they use and understand what records are required at the completion of a task, how they are to be identified and stored, etc. Process Overview General Quality records provide evidence that a task or activity has been completed, acts as an archive of the results that were achieved, demonstrates that output conformed to requirements, and may be used as an indicator of how a quality management system is performing. Ownership of Records 1. Each department manager is responsible for ensuring that required records are collected, stored and controlled per the requirements of this procedure. 2. Required Quality records are those specifically required to support PANTHERx Specialty Pharmacy procedures or work instructions or as required by Federal/State Law, Regulatory Compliance Standard or Accreditation Standard. Format and Identification of Records 1. Record formats are generally prescribed by the procedure or work instruction that establishes the need for creating the record. 2. Typical formats include, but are not limited to, forms, reports, meeting minutes, logs, databases, or other forms of electronic documents. 3. Other forms of records, such as logs or electronic files, should be named or identified in such a way that the purpose of the record can be easily determined. 4. Some record collection occurs within the system software utilized. In these cases, the system software will be referenced in the procedure or work instruction. Protection and Control of Records 1. Protection and control of records are collected, organized, and managed by the department that generates or controls the record PANTHERx Specialty, LLC 1

84 2. Standard operating procedures or working process documents related to the management or control of quality document are reviewed and audited by the Quality & Education Department in order to ensure that appropriate steps are taken to maintain compliance to the procedure and maintenance of records 3. Documents required for compliance, licensure, accreditation, and other regulatory agencies are collected, organized, and managed by the Quality & Education department. Distribution of Records to a Third Party 1. Requests for copies of records by authorized manufactures, vendors, or other interested third parties or auditors will be supplied by the department that retains the record unless HIPAA guidelines prohibit. 2. Records should only be shared with a third party who has a vested interest in the data collected on the record and only if HIPAA guidelines are not compromised. 3. Any questionable requests are decided by the Compliance Officer. Archiving or Destruction of Records 1. At an interval determined by the department manager, process owner, or specified by State/Federal Law, or per regulatory statutes, records are periodically reviewed to determine if the minimum retention time has elapsed. 2. Records should not be removed or discarded unless the minimum retention time has passed. 3. If the minimum retention time has passed, the department manager or process owner should coordinate the removal of the records from the storage location and determine the disposition to take following the retention period. Typical dispositions include, but are not limited to: a. Delete (electronic files) b. Destroy (specify to shred if necessary). c. Off-site (long-term storage at an external facility). 4. Records being sent to an off-site storage facility should be suitably packaged by the department manager or process owner and identified with a range of contents, the department the records pertain to, and the date of destruction for the contents of the package. 5. Any files containing patient information or confidential company data must be removed, after shredding if applicable, by the PANTHERx Specialty Pharmacy selected secured destruction company. Process Controls 1. Records are collected and maintained as necessary to provide evidence of conformity to requirements or compliance standards and the effective operation of the quality management system. 2. Records are legible, identifiable, and retrievable during their required retention time. 3. There are no non-conformances identified during internal or external audits due to a lack of available records to provide evidence of conformity, or failure to control records as defined by this procedure. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ PANTHERx Specialty, LLC 2

85 Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

86 CUSTOMER GRIEVANCE TRACKING FORM STANDARD OPERATING PROCEDURE POLICY NUMBER PS-34 URAC PC 28 PM 5 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope Website script Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times Policy/Procedure See attached Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 4/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/24/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

87 CUSTOMER GRIEVANCE TRACKING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-35 URAC PC 21, 34, 35 ACHC DRX 2-4A, 2-4B PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope The purpose of this policy is to define operational process on how use the Customer Service Tracking Log and ensure that any patient/client concerns are addressed in a timely fashion and resolved. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. When a member has a complaint about our service, the PANTHERx Specialty Pharmacy employee is to fill out a Customer Service Tracking Log, which is then reviewed by either the Manager of Pharmacy Operations or the Director of Pharmacy Operations 2. The tracking logs are reviewed periodically by the Manager of Pharmacy Operations or the Director of Pharmacy Operations throughout the day for any unsatisfactory resolutions. o o o Grievances, complaints, or concerns will be reviewed as promptly as possible. At a minimum, each event will be reviewed and investigated within 5 days of the initial report In the event that a grievance, complaint, or concern is reported after hours, it will be immediately followed up on by the Manager of Pharmacy Operations or the Director of Pharmacy Operations within 48 hours. If the grievance, complaint, or concern is of grave serious nature and requires immediate review, the Director of Pharmacy Operations is to be contacted afterhours to resolve the issue. Should the Director of Pharmacy operations be unavailable, the on-call Pharmacist is to contact the General Manager. 3. On a monthly basis, all Customer Service Tracking Logs are reviewed by the Quality Team member to examine internal processes and procedures that may need to be updated or changed to improve operations and customer satisfaction and track and trend issues. 4. On a quarterly basis member issues are compiled to a report for review by the management team, complete with the process changes implemented. 5. The Director of Pharmacy Operations is to follow-up with the client within 5 business days, or sooner, of resolution of the issue to insure it was handled satisfactorily for the client. o The Director of Pharmacy Operations will document completion and close the case, which will be reviewed and presented in the annual PI report. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

88 6. PANTHERx Specialty Pharmacy will maintain logs of all events, which will be kept for 5 years and a summary report will be presented in the annual PI report Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 4/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

89 DISCLOSURE OF PHI & PCI IN LIMITED DATA SETS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-36 URAC PC 16 ACHC 5-1C PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/07/2014 Scope To ensure that PANTHERx Specialty Pharmacy is in compliance with the HIPAA Privacy Rule PANTHERx Specialty Pharmacy may disclose patient Protected Health Information (PHI) in a Limited Data Set, and Payment Card Industry (PCI) information, if it enters into a Data Use Agreement with the recipient of the Limited Data Set and complies with the other requirements of the HIPAA Privacy Rule governing the use and disclosure of Limited Data Sets. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Definitions Limited Data Set means PHI/PCI that excludes the following direct identifiers of an individual, or his or her relatives, employers or household members: (1) Names (2) Street address (but not town, city, state or zip code) (3) Telephone numbers (4) DOB (5) Fax numbers (6) addresses (7) Social Security numbers (8) Medical record numbers (9) Health plan beneficiary numbers (10) Account numbers (11) Certificate / license numbers (12) Vehicle identifiers and serial numbers (including license plate numbers) (13) Device identifiers and serial numbers (14) Website addresses (URLs) (15) addresses (16) Internet protocol address numbers (17) Biometric identifiers (e.g., fingerprints and voice prints) (18) Full-face photographic images and any comparable images Explanation 1. The HIPAA Privacy Rule permits PANTHERx Specialty Pharmacy to use or disclose, without patient authorization, patient PHI/PCI in a Limited Data Set for purposes of research, public health or healthcare operations. PANTHERx Specialty Pharmacy is permitted to use patient PHI/PCI to create the Limited Data Set or to disclose PHI/PCI to a Business Associate for that purpose, whether or not the Limited Data Set is to be used by PANTHERx Specialty Pharmacy. 2. With a Limited Data Set, research and others involved in public health studies have access to dates of admission and discharge, as well as dates of birth and death for a patient. Birth information should only be disclosed where the researcher and PANTHERx Specialty Pharmacy agree that it is needed for the purpose 2017 PANTHERx Specialty, LLC 1

90 of the research. The Limited Data Set also may include the five-digit zip code or any other geographical subdivision, such as state, county, city, precinct and their equivalent geo codes, except for the patient street address. 3. PANTHERx Specialty Pharmacy is permitted to disclose patient PHI/PCI in a Limited Data Set if it enters into a Data Use Agreement and/or Business Associates Agreement with the recipient of the Limited Data Set. 4. A Data Use Agreement between PANTHERx Specialty Pharmacy and the recipient of a Limited Data Set must: a. Establish the permitted research uses and disclosures of the Limited Data Set (the Data Use Agreement may not authorize the recipient to use or further disclose the information in a manner that would violate the HIPAA Privacy Rule if done by PANTHERx Specialty Pharmacy; b. Establish who is permitted to use or receive the Limited Data Set; and c. Provide that the recipient will: i. Not use or further disclose the information other than as permitted by the Data Use Agreement or otherwise required by law; ii. Use appropriate safeguards to prevent use or disclosure of the information other than as provided by the Data Use Agreement; iii. Report to PANTHERx Specialty Pharmacy any use or disclosure of information not provided for by the Data Use Agreement of which the recipient becomes aware; iv. Insure that any agents, including subcontractors, who are provided the Limited Data Set agree to the same restrictions and conditions with respect to such information; and v. Not identify the information or contact the individual. Procedure 1. PANTHERx Specialty Pharmacy may disclose patient PHI/PCI in a Limited Data Set for purposes of research, public health, or healthcare operations. In disclosing PHI/PCI in a Limited Data Set, PANTHERx Specialty Pharmacy should enter into a Data Use Agreement with the recipient of the Limited Data Set and should comply with the other requirements of the HIPAA Privacy Rule governing Limited Data Sets. 2. PANTHERx Specialty Pharmacy may use patient PHI/PCI to create a Limited Data Set or it may disclose patient PHI/PCI to a Business Associate for such purpose, whether or not the Limited Data Set will be used by PANTHERx Specialty Pharmacy. 3. In creating a Limited Data Set, PANTHERx Specialty Pharmacy should exclude the following direct identifiers of the patient or of relatives, employers, or household members of the patient: a. Names; b. Postal address information, other than town, city, state or zip code; c. Telephone numbers; d. DOB e. Fax numbers; f. Electronic mail addresses; g. Social Security numbers; h. Medical record numbers; i. Health plan beneficiary numbers; j. Account numbers; k. Certificate / license numbers; l. Vehicle identifiers and serial numbers, including license plate numbers; m. Device identifiers and serial numbers; n. Web Universal Resource Locaters (URLs); o. Internet protocol (IP) address numbers; p. Biometric identifiers, including fingerprints and voice prints; and q. Full-face photographic images and any comparable images PANTHERx Specialty, LLC 2

91 4. In creating a Limited Data Set, PANTHERx Specialty Pharmacy should comply with the Minimum Necessary Rule by limiting the patient PHI/PCI to that information that is reasonably necessary to accomplish the purpose for which the Limited Data Set is created. 5. PANTHERx Specialty Pharmacy should include the birth date of a patient only where the researcher and PANTHERx Specialty Pharmacy agree that such information is needed for the research. 6. Before disclosing PHI/PCI in a Limited Data Set, PANTHERx Specialty Pharmacy should enter into a Data Use Agreement in the form approved by legal counsel. 7. Before disclosing patient PHI/PCI in a Limited Data Set, PANTHERx Specialty Pharmacy should determine that the recipient will use and disclose the Limited Data Set for research, public health, or healthcare operations. 8. PANTHERx Specialty Pharmacy is not required to track and account for any disclosures of PHI/PCI in a Limited Data Set under the patient s right to obtain an accounting of disclosures. 9. If PANTHERx Specialty Pharmacy learns of a pattern of activity or practice of the Limited Data Set recipient that constitutes a material breach or violation of the Data Use Agreement, PANTHERx Specialty Pharmacy should take reasonable steps to cure the breach or end the violation, as applicable. If such reasonable steps are unsuccessful, PANTHERx Specialty Pharmacy should: a. Discontinue disclosure of PHI/PCI to the recipient; and b. Report the problem to the Secretary of the Department of Health and Human Services. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

92 EMPLOYEE EDUCATION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-38 URAC PC 25, 27 ACHC DRX 4-7A, 4-8A, 4-15B, 7-1A, 7-2A CPPA 1.5g, 3.8b, 1.14b, 3.8a PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/07/2014 Scope To provide ongoing education for the staff of PANTHERx Specialty Pharmacy that; develops and enhances staff skills, broadens and increases staff knowledge base, maintains and improves staff competency, and is responsive to staff identified needs. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. PANTHERx Specialty Pharmacy has a commitment to all staff to promote excellence in service delivery. 2. Employee education is an ongoing process that commences upon hire and continues during the staff member s term of employment. 3. An annual education program calendar is planned and implemented in response to identified learning needs i.e. performance evaluations, data obtained from staff surveys, performance improvement results, changes in the industry, etc. 4. Education programs may be obtained in a variety of methods, including but not limited to: in house lectures and presentations, internet learning, home study programs. 5. Staff wishing to attend external education programs during regular working hours must obtain prior approval. 6. PANTHERx Specialty Pharmacy maintains a Clinical Resource Center for staff to maintain currency of knowledge and information. 7. All employees receive ongoing education appropriate to their job descriptions, responsibilities, and recognized needs. 8. Clinical service personnel are required to complete the minimum continuing education annually as required by their professional license and/or certification in order to maintain professional competency. 9. All other staff members are required to attend or provide proof of attending any company run in-service educational programs. At minimum, these educational programs will include: a. Fire Safety b. Current URAC standards as appropriate to job function c. Business Ethics, Fraud and Abuse Prevention/Corporate Compliance d. Confidentiality of Information and HIPAA Privacy Regulations 10. Other topics that might be offered include: a. New equipment and/or supplies that are added to the company s product line b. Changes in company policies and procedures c. Results of Quality Improvement findings and plans of action 2017 PANTHERx Specialty, LLC 1

93 Procedure 1. In order to receive credit for attending education programs offered in-house, employees must sign their names on the sign-in sheet provided at each meeting. 2. Records of education programs are retained in each location and will include the following information: a. Names and signatures of all employees who attended the program b. Title of the program c. Name of the individual conducting the program d. Dates and times the program was conducted e. Description of the contents of the program 3. Supervisors are expected to attend education programs to enhance their supervisory skills. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

94 EMPLOYEE INFORMATION CONFIDENTIALITY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-39 URAC PC 16 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/07/2014 Scope To ensure employees understand PANTHERx Specialty Pharmacy s information confidentiality policy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Employees of PANTHERx Specialty Pharmacy may become privy to confidential operating procedures, marketing strategies, patient information, and other knowledge. All employees are required to maintain such information in strict confidence. This policy protects both the pharmacy and employee by safeguarding confidential, unique, and valuable information from competitors and others. 2. PANTHERx Specialty Pharmacy also uses preventative measures to ensure information confidentiality. The pharmacy system has log in and password restrictions that prevent non-authorized users from obtaining access to confidential information. PANTHERx Specialty Pharmacy does not allow the use of any personal computers or media devices without the completion of personal device policy, which is kept on file with the employee personal file. This personal device policy is reviewed annually and controlled through a central mobile device management software, managed by the information technology department, which allows for security enforcement policies, access to corporate and management of corporate approved applications. 3. PANTHERx Specialty Pharmacy utilizes Veeam Backup & Replication on premise that encrypts data using AES 256bit standards and copies backup data to a 3rd party datacenter. Infrastructure involved is protected by perimeter firewalls, Intrusion Detection, Anti-Virus and Anti-Malware tools. Should an occasion arise in which an employee is unsure of their obligations under this policy, it is the employee s responsibility to consult with their manager for guidance. Failure to comply with this policy could result in disciplinary action, up to and including termination. 4. PANTHERx Specialty Pharmacy s management team and IT personnel will periodically assess confidentiality risks and vulnerabilities. IT will also test to make sure system integrity is in place. Testing of the availability of information is also conducted on a regular basis. All assessments and testing will be reviewed during the quarterly quality meetings. As part of the quality team review, IT will also suggest prevention and security opportunities that can be implemented to prevent confidentiality and security breaches. 5. If a confidentiality or security violation is identified, PANTHERx Specialty Pharmacy s management team must be notified immediately. Once identified, IT will work to detect issue, contain, and correct any security breaches immediately. These identified issues will be reported as part of the assessment report to the quality team for proper follow up and tracking to prevent future occurrences. 6. Supervisors are expected to attend education programs to enhance their supervisory skills. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

95 Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

96 EMPLOYEE ORIENTATION PROGRAM STANDARD OPERATING PROCEDURE POLICY NUMBER PS-40 URAC PC 27 ACHC DRX 1-2A, 4-2I, 4-6A, 4-7A, 7-1A, 7-2A, 7-4A, 7-4C CPPA 1.2b 1.5a, 1.5e PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager, Human Resources Effective Date: 11/07/2014 Scope To provide an effective and systematic orientation program for all newly-hired staff. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy 1. All newly-hired staff will participate in a general orientation program appropriate to the classification of employee and the services he/she will be providing, during the first week of employment at PANTHERx Specialty Pharmacy. 2. Department leads are designated with the responsibility for coordinating the general orientation program, along with assistance from the Human Resources Department. 3. Department and job-specific orientation is provided prior to the staff member assuming independent service responsibilities. 4. The general orientation program includes the following topics: a. Organizational Chart/Lines of Supervision b. Mission, vision, values of the organization c. Types of services and products provided d. Written policies and procedures e. Record keeping and reporting f. Communication with management during and after regular business hours g. Ethical issues h. Patient rights and responsibilities i. Conflict of interest j. Confidentiality of patient, staff, and company information k. Job descriptions, responsibilities, and role in organization l. Job specific training requirements m. Training for specialized disease processes n. Performance evaluations o. Competency evaluations p. Professional boundaries q. Quality improvement plan r. OSHA requirements s. Fire safety and prevention t. Workplace safety u. Emergency management plan 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

97 Procedure 1. A completed orientation checklist signed by both the employee and his/her supervisor or Human Resources which serves as verification that the topics have been discussed with the individual. 2. The completed orientation checklist is filed in each employee s personnel file. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 10/28/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Manager, Human Resources 06/23/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

98 PANTHERx Specialty Pharmacy Onboarding Checklist Welcome New Employee Introductions Directors Department Managers Call Center Employees Business Center Employees Clinical Center Employees Pharmacy Employees Introduction to organization Schedule welcome for next employee meeting Tour of Facility Restrooms Kitchen Area Call Center Business Center Clinical Center Pharmacy Introduction to the Organization History Products & Service Resources for Company Information Mission & Vision Statement Introduction to the Department Purpose Relation to other departments Organizational Chart Procedures for leave, overtime, etc. Introduction to the job Workspace Work hours, breaks, mealtimes and other rules Equipment Telephone number Copier Fax Printers Job Description 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

99 Duties, Responsibilities, Purpose Handling Confidential Information Performance Expectations / Goals Promotions / Transfers Safety / Emergency Procedures Emergency Exits Injury Prevention Reporting Injuries Introduction to Manager. (Managers Name) Training Software Systems Training Login CPR+ Login Microsoft Login LinkedIn Login Paychex Login for Employee handbook Telephone System Voice Mail Alexion Training Training of Applicable Vendors Staff Strensiq Valve Access Training Strensiq Pricing and Access FAQ Strensiq Product Receipt Training AE/PC Training Product Quality Complaint Reporting Training Package Safety Testing of Equipment Emergency / Disaster Handling Complaints Infection Control (TB) Cultural Diversity Communication Barriers Ethics Workplace Safety Client / Patient Safety Client / Patient Rights & Responsibilities OSHA Right to Know Quality Assurance / Error Prevention Fraud, Waste, & Abuse HIPAA Training with Access Bloodborne Pathogens Training Sexual Harassment Training 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 4

100 Performance Improvement Training General Timeclock Parking ID Card / ID fob Credit Card Alarm Code / Procedure Employment Paperwork CPR Training / Exemption Application / Resume W-4 I-9 Reference & Education Check Acknowledgement Job Description Background Check / Exemption OIG Reference Employee Handbook Receipt TB Test Documentation Hepatitis B Vaccination Documentation National Sex Offender Registry Reference Conflict of Interest Attestation Competency Assessment Verification of Licensure Orientation Checklist Confidentiality Agreement Employee Information Form Technician Protocol Offer Letter Confidentiality & Financial Incentive Attestation Background Check Authorization Drug Test Other Items I hereby acknowledge each of the aforementioned items has been discussed with me. Employee Signature: Supervisor Signature: Date: Date: 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 5

101 EMPLOYEE PERFORMANCE EVALUATIONS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-41 URAC PC 26, 29 ACHC DRX 4-2J, 4-7A CPPA 1.5e, 1.5f, 3.8b PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager, Human Resources Effective Date: 11/07/2014 Scope It is the policy of PANTHERx Specialty Pharmacy to measure and reward employee performance in support of our mission to transform lives by delivering medical breakthroughs, clinical excellence and access solutions to patients afflicted with rare and devastating conditions. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times with the exception of temporary and contracted staff. Policy The purpose of performance management is to provide an ongoing, consistent process and corresponding tools to link job responsibilities with mission, vision, values, goals and company performance standards. This is done through regular review and maintenance of a job description for each position that reflects accurate job related responsibilities. Performance Management tools under this policy include an Annual Performance Review that includes a set of goals and competencies discussed with each staff and leadership member during the review meeting and a Performance Improvement Plan. Procedure 1. RESPONSIBILITY Performance management is a shared responsibility between managers and each staff member. A manager is responsible for setting performance expectations, initiating the performance management planning process, providing ongoing performance feedback, documenting performance through use of the performance management tool, determining applicable merit increase and discussing the review with the staff member. A manager is further responsible for identifying any and all performance deficiencies, advising the staff member of the need for improvement, and establishing expectations for performance improvement. Each staff member is responsible for providing input into the planning process, submitting a self-evaluation where applicable, and discussing the review with his/her manager. Each staff member is further responsible for owning his/her performance and for actively participating in the performance improvement process. 2. PERFORMANCE REVIEWS Performance planning takes place during each staff member s orientation period as well as at the beginning of each new performance review period (one year from date of hire) on an annual basis. Staff will receive a comprehensive performance appraisal that shall be used by the department manager/supervisor and the employee to evaluate the employee s performance, suggest improvements, set goals and objectives for the future, and to make any changes to the job description for which they are being evaluated. At the twelve-month review and subsequent annual reviews thereafter, each staff member is eligible for the merit increase program, unless otherwise noted. Merit increases are effective on the first day of the pay 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

102 period following the review date. Error rates, complaints, negative client outcomes, or other performance based behavioral markers can be used by a manager to evaluate performance. Each staff member new to a job through employment, reemployment, promotion or demotion, receives a six-month performance review without eligibility for a merit increase. After the six-month performance review, a twelve-month review is required with annual performance reviews required thereafter. A staff member who is on a leave of absence when their performance review becomes due will not be considered late until 30 days after the staff member has returned to work. 3. PERFORMANCE IMPROVEMENT PLAN (PIP) A Performance Improvement Plan may be utilized in cases where a staff member, below the Director level, exhibits performance deficiencies and must make changes to achieve an acceptable level of performance in order to remain in the role. Among the performance deficiencies that may be addressed through a PIP include repeated human errors that could or do affect patient safety. A manager may identify these performance deficiencies during the staff member s performance review, or during the course of the performance period. When the need for a PIP is identified, the manager should engage Human Resources regarding the areas of performance concern. Human Resources will partner with the manager to review the performance deficiencies and will work with the manager to identify the appropriate course of action (e.g., none, informal coaching, Performance Improvement Plan, or other Corrective Action). If a Performance Improvement Plan is determined to be the appropriate course of action, the manager is responsible for drafting the PIP, and Human Resources will review and approve the plan in advance of delivery to the staff member. The plan should include: 1. Specific examples of the observed performance deficiencies 2. Details regarding the acceptable level of performance 3. A specific plan by which the staff member is to achieve the accepted level of expected performance 4. The timeframe by which performance improvement must be achieved. A Performance Improvement Plan may not exceed a timeframe of more than 45 calendar days, except as outlined under a plan extension. Human Resources will work with the manager to determine the appropriate duration, track each plan s timeframe and the overall status of that staff member. If a staff member is placed on an approved leave of absence during the timeframe of the PIP, the plan will be placed on hold until the staff member completes the leave of absence; upon the staff member s return from the leave of absence, the plan will be reinstated for the time remaining. At the conclusion of the Performance Improvement Plan, the manager and Human Resources will determine the appropriate plan resolution based on the staff member s achievement/non-achievement of the plan and in accordance with the appropriate approval process outlined in the Corrective Action and Discharge Policy. Resolution options include: Achievement of plan Manager reinforces positive performance. Encourages sustained performance, and the staff member is removed from plan. Plan extension Staff member has shown improvement in most areas defined by plan, but has not fully achieved the plan; extension not to exceed 30 calendar days. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

103 Demotion Manager may make the determination, where appropriate, based on a business need, and in the existence of a vacant position, to demote the staff member. The demotion should occur within the pay period following the conclusion of the performance improvement plan. Termination Staff member does not achieve plan and option for demotion is not available. Post Plan Action If a staff member does not sustain acceptable performance for at least 12 months following successful completion of a Performance Improvement Plan (PIP) the staff member will be subject to termination of employment. 4. TRANSFERS A staff member on an active performance improvement plan will not be eligible to transfer to another position. Any exceptions must be approved by Human Resources. If the staff member successfully achieves the performance improvement plan, management will determine the eligibility of a staff member to transfer to another position during the 6 months after the conclusion of the performance improvement plan. 5. OTHER CORRECTIVE ACTION If a staff member on an active performance improvement plan receives Corrective Action while on a performance improvement plan, he/she will be subject to immediate termination of employment. If the staff member receives Corrective Action during the 12-month period following the conclusion of the performance improvement plan/ he/she will be placed, at a minimum, in Final Written Warning status. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet. Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge. Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 07/21/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

104 HEALTH RECORD SECURITY, STORAGE, & CONFIDENTIALITY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-42 URAC PC 15 ACHC DRX 2-5A, 5-1C CPPA 1.13e, 1.13f, 1.8 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope To recognize and protect the patient s right to privacy. To provide direction and guideline for the security and safeguarding of health information against loss, destruction, tampering, and unauthorized access and use. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All PANTHERx Specialty Pharmacy employees are subject to the administrative policy on confidentiality and to protect confidential information (paper and electronic). Employees are given the acknowledgement of confidentiality for review and for signature to verify understanding of patient confidentiality. 2. PANTHERx Specialty Pharmacy is responsible for the safety and storage of all patient health records (electronic and paper), private health information (PHI) and payment card industry (PCI) information to protect them from loss, defacement, tampering, and unauthorized disclosure. 3. PANTHERx Specialty Pharmacy will provide adequate space for employees to communicate over the phone with patients in a manner that maintains privacy and confidentiality. This space will also allow for employee privacy and will minimize interruptions to allow the employee to focus on their workflow. 4. PANTHERx Specialty Pharmacy has a duty to protect the confidentiality and integrity of confidential medical information as required by law, professional ethics, and accreditation requirements. This policy defines the guidelines and procedures that must be followed for the storage of PHI/PCI. a. Outside of regular working hours, PANTHERx Specialty Pharmacy personnel must clean desks and working areas such that all PHI/PCI is properly secured, unless the immediate area can be secured from unauthorized access. b. When PHI/PCI is being released through teleconference or video feed, PANTHERx Specialty Pharmacy personnel must treat the protection of PHI/PCI is the same manner as PHI/PCI recorded on paper, thereby securing access to the teleconference or video to authorized personnel only. c. PHI/PCI stored in medical equipment must be kept secure and disposed of per Disposal of PHI/PCI. d. When not in use, PHI/PCI must always be protected from unauthorized access. When left in an unattended room, such information must be appropriately secured. e. If PHI/PCI is to be stored on the hard disk drive or other internal components of a personal computer or mobile device, it must be protected by either a password or encryption. Unless encrypted, when not in use, this media must be secured from unauthorized access. f. If PHI/PCI is stored on diskettes, CD-ROM or other removable data storage media, it cannot be commingled with other electronic information. 5. Only authorized PANTHERx Specialty Pharmacy personnel involved in the direct care/service of the patient will be permitted access and/or to make entries in the electronic medical record. Additional access authorization includes: a. Professional/Medical Advisory Board b. Performance Improvement 2017 PANTHERx Specialty, LLC 1

105 c. Utilization Review by the health plan or its authorized designee which provides health benefits to the patient d. Medical Records personnel e. Official personnel conducting review for evaluation and certification (e.g., Medicare, State Health Department, health regulatory agencies, etc.) f. Corporate/regional staff responsible for administrative operations 6. Passwords for PANTHERx Specialty Pharmacy employees will be assigned on an individual basis for individual use only with appropriate access levels. Passwords are not to be shared between employees. Passwords will be required to meet certain security criteria and will be changed on a periodic basis. 7. Corrections or revisions to information in PANTHERx Specialty Pharmacy information system will be processed only by those employees with appropriate access under the direction of the Pharmacist-in- Charge or designee. 8. As the electronic medical record is considered a legal document, all entries will be considered final upon completion and may not be altered or removed. Appropriate corrections are acceptable and should be made via these steps: a. Verification of the correct information (via computer, pharmacist, etc.) b. Acknowledgement in the addendum that corrected information has been entered. 9. In the event of fire, water, and other damage, and records will be accessed as maintained on an alternate server, off site. a. When records/data are destroyed inadvertently, the Pharmacist-in-Charge or designee will notify all patients affected in writing. b. A retention plan will be developed based on what records are recoverable. Legal opinions will be solicited from legal counsel as needed. 10. In accordance with the HITECH Act, in the event of a breach of PHI/PCI the event will be investigated and any patient or client that is determined to be affected will be notified. Procedure 1. Individual access codes, which are managed by senior level personnel and the system administrator, control access and retrieval of information to the system/electronic medical records. Menu controlled access levels allow limited access to levels of information and to data updates. Access level is granted depending on the individual s functional responsibilities. Confidentiality of data is maintained by allowing access to certain data portions on a need to know basis. Retrieval of back up/ stored electronic PHI/PCI information is facilitated through the IT department. 2. All discharged/inactive Medical Records for patients who are 18 years of age or older will be retained for 10 years. Such Medical Records of patients who are less than 18 years of age ( minors ) will be retained for 10 years after the patient reaches the age of maturity (18 years of age). 3. Planned destruction of electronic and paper records/data shall be carried out per the approved record retention schedule and policy and procedures of PANTHERx Specialty Pharmacy. This process shall be carried out under the direct supervision of the Pharmacist-in-Charge or designee. No further approval for the destruction of records/date shall be required when such destruction is in accordance with the approved record retention schedule. a. Hardcopy destruction will be completed by Iron Mountain. b. Data stored in electronic storage media will be destroyed by Iron Mountain per policy and procedure. 4. When electronic and paper records/data are destroyed inadvertently (such as with flood or fire), notifications shall be made as follows: a. Pharmacist-in-Charge 2017 PANTHERx Specialty, LLC 2

106 b. Vice President, Business Operations c. Director, Pharmacy Operations 5. Security to the building is maintained by a controlled entry system. All visitors will obtain a visitor s badge at the receptionist s desk. All visitors will be escorted while in the building. Only authorized personnel will have access to the building after business hours. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Jonathan Ogurchak, PharmD, MBA VP, Business Operations 6/13/ PANTHERx Specialty, LLC 3

107 RECRUITMENT AND SELECTION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-43 URAC PC 41 ACHC DRX 4-1B, 4-2C, 4-2D, 4-2H, 4-2K CPPA 1.5d, 1.5i, 1.5j PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager, Human Resources Effective Date: 11/7/2014 Scope It is the policy of PANTHERx Specialty Pharmacy to have a standardized process associated recruiting and selecting talent as well as to define employment guidelines and hiring practices. Guidelines PANTHERx Specialty Pharmacy employees and management are expected to understand and adhere to this standard operating procedure at all times. Human Resources is responsible for coordinating all talent acquisition and recruitment efforts through a standardized process. All offers of employment must be handled by Human Resources. Policy It is the policy of PANTHERx Specialty to attract and identify the most qualified candidates for job vacancies. All employment is without regard to race, color, religion, ancestry, national origin, age, sex, genetics, sexual orientation, gender identity, disability or veteran status. All hiring at PANTHERx Specialty Pharmacy is in a manner consistent with the Department of Labor, Equal Employment Opportunity Commission. All employees of PANTHERx Specialty Pharmacy are considered at will which means that all the employment relationship may be terminated at any time. At no point, should any promise of employment exist outside of this structure and all contracts of employment will be reviewed and administered through human resources. Procedure 1. SERVICE DATE This date (date of hire) is used to determine eligibility for transfer into any position other than which the staff member was hired into. 2. JOB POSTINGS All job postings will include the minimum requirements for the job, and an approved job description including an accurate list of responsibilities. All job vacancies will be posted for seven days on the company website. During this time the position will also be posted internally and externally to begin the development of an applicant pool. All internal applicants that meet the minimum qualification of the position will be considered for each vacancy. Positions that do not need to be posted internally include the following: o Vacancies that are a result of company reorganization. o Any position that is identical to another position posted within the last thirty days PANTHERx Specialty, LLC 1

108 o o o Position reclassifications where current staff are identified based on role. Posting of a Vice President vacancy or a position that is organizationally higher than a Vice President. Posting of a Pharmacist position that includes the promotion of an already existing Intern that has exceeded performance expectations in the intern program. 3. TRANSFER REQUESTS Staff are eligible to apply for internal positions six months after their date of hire into a new position. All internal applicants must apply online and submit any additional experience and or certifications/education via an updated application. Internal applicants must wait six months from receiving corrective action at the written warning level before requesting transfer to another position. Transfer requests will be treated as confidential. 4. SELECTION PROCESS / CRITERIA The most qualified candidates will undergo screening/selection activities as appropriate. All job openings will be filled with the most qualified candidates based on skills, experience, and education, and who have demonstrated that they are a good fit for and supportive of the company mission and values. No staff member will be hired into a position if they are a family member of the person that the position reports to. The employment of an individual who is not a citizen of the United States requires special attention. Human Resources will provide guidance in this circumstance. All applicants must apply to the website if the position has been posted to be considered. 5. HIRING MANAGER RESPONSIBILITES It is the responsibility of the hiring manager to communicate with human resources regarding required documentation, interview notes, tracking of applicant flow and applicant follow up. Managers should only interview applicants that have applied online and should direct all interested candidates to the company website. All recruitment agencies or related vendors need to be directed to Human Resources. Requests for use of a search firm will be submitted to the VP of Business Operations. 6. OFFERS OF EMPLOYMENT AND ONGOING EMPLOYMENT REQUIRMENTS All job offers will be extended by the Manager, Human Resources. All offers of employment are contingent upon successful completion of the following: a. employment history check, licensure and reference checks. b. a criminal background check, National Sex Offender Registry check, and OIG Exclusion check. c. successful completion of an employee health screening which includes a substance abuse urinalysis. Direct Care: At PANTHERx Specialty Pharmacy a direct care employee is defined as an employee who has direct contact with a customer or customers home environment during set up of durable medical equipment or training on how to use durable medical equipment. A direct care employee can also encounter the customer during medication administration or training on medication administration depending on the job title or responsibilities of the employee PANTHERx Specialty, LLC 2

109 Employees of PANTHERx Specialty Pharmacy who are involved in direct care must have the following and offers of employment will be contingent upon: a. TB (PPD) skin test b. Access to Hepatitis B vaccination program and post-vaccination antibody titer per Federal CDC and OSHA standards at time of hire. (If a direct care employee chooses not to become vaccinated with the Hepatitis B vaccination within 10 working days of employment they must sign a declination statement. This statement will be filed in the employee s record.) Circumstances under which the company is exempted from making the vaccination available are 1) The complete Hepatitis B vaccination series was previously received 2) Antibody testing shows the employee to be immune 3) The vaccine cannot be given to the individual for medical reasons or the individual cannot receive antibody testing. c. Annual verification that the employee is symptom free by use of a TB screening tool or annual PPD skin test will be documented in their Personnel File. d. Ongoing background checks to include a state criminal check every three years for any additional addresses held. If an employee is convicted of a crime while working for PANTHERx: a. The company may restrict the employee s participation in their job duties if the incident does not support immediate termination. b. The company reserves the right to terminate employment if the offense leading to conviction will diminish trust in the staff member s ability to do their job or jeopardizes a required license. c. The staff member must report the conviction directly to the Manager, Human Resources, and/or Compliance Officer. 7. REHIRES All employees that leave the organization in good standing are eligible to be considered for vacant positions if they meet the minimum qualification as listed in the job description if they apply for the position and are selected to advance in the interview process. Employees that are terminated from PANTHERx involuntarily are considered ineligible for rehire. Employees who are rehired within 30 days of their date of termination will retain their date of service and continue benefits accordingly. All employees being rehired will need to undergo the employee health requirements upon rehire regardless of original date of hire. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ PANTHERx Specialty, LLC 3

110 Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Human Resources Manager 6/26/ PANTHERx Specialty, LLC 4

111 MEMBER COMPLAINT PROCESS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-44 URAC PC 12, 34, 35 CSCD 7, 11 ACHC DRX 2-3A, 2-4A,7-11A PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope To describe the services provided by PANTHERx Specialty Pharmacy regarding member and product complaints. Guidelines PANTHERx Specialty Pharmacy (PANTHERx) employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Patients are notified how to submit or notify PANTHERx Specialty Pharmacy of any complaints, grievances or incidents in the Welcome Kit that is provided to all new patients in their first shipment. Member Complaint Resolutions from PANTHERx Specialty Pharmacy: 1. Notification is received (e.g. fax, mail, , or call) of complaint received at PANTHERx from patient/caregiver or physician or healthcare provider. 2. PANTHERx staff member, pharmacist or Pharmacy Director, will provide a response to the patient within specified time necessary to reach resolution, but no later than 5 business days from original receipt of notification. PANTHERx will ensure the patient has the necessary medication on hand and discuss any further details the patient may have regarding the complaint. 3. All attempts are made to satisfactorily resolve the complaint within 14 business days from original receipt of notification. The patient will be notified in writing or verbally of the final result with an explanation to the member. 4. If a patient would like further review, the patient will be given options for escalating the issue to senior management or appropriate PANTHERx personnel to address patient concerns. The patient will also be informed of their right to notify other parties, such as the State Board of Pharmacy, if they feel their complaint was not satisfactorily resolved. 5. Each complaint is logged into the Quality Improvement Opportunity (QIO) database. The log is reviewed daily by a pharmacist and monthly by a Pharmacy Director. Examination of internal processes and procedures that may need to be updated or changed to improve operations and customer satisfaction are addressed in Quality Assurance meeting. Product Complaints: In the event that PANTHERx is notified of a product complaint (e.g. missing vial, broken vial, packaging complaints, etc.), the PANTHERx employee will document the relevant information that the patient is able to provide, which may include: Detailed description of the complaint Date received Date of complaint Product(s) affected 2017 PANTHERx Specialty, LLC 1

112 o Product name o Quantity o Lot Number o Expiration Whether patient administered medication 1. The patient will be transferred to a pharmacist to confirm details of complaint and the pharmacist, or his/her designee, and will begin the process of approving a replacement shipment. 2. The pharmacist will determine if product is subject to replacement via the manufacturer in the event of a product complaint. a. If so, the pharmacist will contact the manufacturer for approval of complimentary replacement product and place documentation in the patient record. i. The pharmacist may refer to subsequent Working Practice Documents (WPD), for manufacturer specific product replacement policies. ii. The pharmacist will notify the Director of Pharmacy Operations b. The Director of Pharmacy will keep a log, manufacturer specific, and this will be reviewed on a quarterly basis to track and trend. 3. Once approved by the manufacturer for replacement product, in the event of a product complaint, an outbound call will be made to the patient to setup replacement shipment. a. If approved by manufacturer for complimentary replacement, PANTHERx is to dispense product and NOT bill patient s insurance plan 4. A PANTHERx representative will provide patient with instructions on how to return affected product to PANTHERx or direct to manufacturer (if required) at no cost to the patient. a. Upon receipt of product, PANTHERx will refer to manufacturer specific WPD for how to handle product return to manufacturer, if required. In the event of a product replacement, which is no fault of PANTHERx or manufacturer (i.e. patient loss or negligence), PANTHERx will contact patient s payor to determine if they will provide an approval for early reimbursement. If the patient s insurance does not provide reimbursement and product is not replaced by manufacturer, a pharmacist will notify the prescriber and counsel the patient on missed doses. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

113 NETWORK SECURITY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-45 URAC PC 15 Pharm Op 14 ACHC DRX 4-1A CPPA 1.13g PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope To ensure complete patient confidentiality, the pharmacy computer network shall be well protected from malicious computer hackers. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Access to the pharmacy s server(s) and network shall be restricted via: a. Username and Password combinations b. Internet IP address c. Hardware firewalls d. VPN software 2. Dedicated internet access shall be provided to the pharmacy network from a dedicated standalone gateway provided by a reliable third party internet access provider. The gateway may or may not be under PANTHERx Specialty Pharmacy control. 3. A firewall shall protect the pharmacy network from the Internet Access gateway. The firewall will be able to produce reports and control all TCP/UDP ports as well as ICMP traffic. 4. All critical network components (example: Internet Access gateway, firewall, Switches, Hubs) will be placed on a UPS power system and backup generator. 5. All administrative passwords should be stored in in an approved technology platform. If there is any compromise, all administrative passwords are to be changed immediately. 6. All non-used services and ports shall be shut down on any network device. 7. All network components must be checked at least once a month for updates. If it is deemed safe, auto updates may be turned on for a network component. 8. Following breaches in network security, this entire policy should be re-addressed and evaluated, and a complete incident report should be filled. 9. All remote access systems must access the PANTHERx Specialty Pharmacy network using encryption methods. Either VPN or SSL encryption transmission is acceptable. All communications containing patient data must be carried through these approved transmission methods only. 10. All wireless system must have full WPA encryption with a key of at least 8 characters in length. If a laptop with the wireless code is lost or stolen, all keys that the laptop had access to must be changed immediately. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

114 Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

115 NEW PATIENT CARE MANAGEMENT ASSESSMENT STANDARD OPERATING PROCEDURE POLICY NUMBER PS-46 URAC PC 28 PM 5 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope Provides overview of information collected and documented during new patient care management assessment Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times Policy/Procedure The initial plan of care is documented within Pharmacy Management Software, and may include but not limited to: Start of care date Demographic information Diagnosis information Medications: dose/frequency/route Allergies Prescription order information Equipment and supply information, if applicable Expected outcomes/goals Monitoring Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Jonathan Ogurchak, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 09/23/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

116 PATIENT EDUCATION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-47 URAC PC 38; CSCD 1, 5, 7, 10, 12; SDrM 1, 2, 3; Pharm Op 5; PM 2, 3, 7, 8, 9, 10, 11 ACHC DRX 2-5B, 2-8A,8B, 5-5A, 5-5E, 7-1A, 7-2B, 7-9C, 7-10C PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/7/14 Scope To provide the patient and/or caregiver with information that can enhance their knowledge, skills, and those behaviors necessary to optimize the benefit from the medical products provided by PANTHERx Specialty Pharmacy. To provide patients/caregivers with sufficient information in an understandable language and/or format to make informed as well as shared decisions with clinicians, and to take responsibility for selfmanagement/management activities relative to patient needs, and thereby promoting improved patient outcomes. This service will be provided as a standard of care to all patients regardless of any agreements associated with particular therapy. NOTE: All patient management programs including training and/or education related to prescription medications shall be supervised and delivered only by a licensed Pharmacist. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. PANTHERx Specialty Pharmacy s staff will assist the patient/caregiver at the start of service in gaining the knowledge and skills needed to safely and appropriately use the medical equipment, products and/or supplies based on the best available medical or scientific evidence, and/or clinical practice guidelines/protocols. a. Any immediate threats to consumer safety identified during the education process and during routine communications and patient assessments will be escalated to a pharmacist or appropriate health care or counseling expert for appropriate action immediately with patient present. Examples of immediate threats include but are not limited to: i. suicide threats ii. threats to consumers or others iii. domestic violence iv. child abuse v. drug recalls vi. medical emergencies or other safety issues 2. All patients are to be offered these services regardless of any agreements that may be associated with certain therapies. 3. The education/training may be performed by a PANTHERx Specialty Pharmacy employee or coordinated with another organization/facility/health care provider/ if applicable, for coordination of care. 4. All medical products provided by PANTHERx Specialty Pharmacy shall be labeled with the company s name and contact information. 5. All medical products provided by PANTHERx Specialty Pharmacy shall be accompanied by written instructions, and any appropriate self-care measures if applicable. 6. The patient education process, which includes the expected time of delivery of equipment, products and/or supplies, shall begin at or prior to the time of delivery and continues throughout the time of services/products being provided by PANTHERx Specialty Pharmacy. This also includes logistics on how to obtain their medication based on processing and shipping procedures. 7. Patients shall be instructed according to their level of understanding, and in a language and/or format they can reasonably understand. The pharmacy utilizes the Fleish-Kincaid Index to help determining the literacy 2017 PANTHERx Specialty, LLC 1

117 level to assess patient communications materials and make necessary enhancements. The literacy level goal is 8 th grade or below. 8. The patient/caregiver s knowledge and compliance with instructions shall be monitored on an ongoing basis, documented in the patient record, and appropriate additional instruction shall be provided as necessary. 9. The instructional process may include, but is not limited to: a. Written instructions, including manufacturer manuals as described in the Patient Management Program b. Verbal explanations c. Illustrations d. Demonstration by company personnel e. Return demonstration by the patient/caregiver 10. Written instructions for equipment provided may include, but may not be limited to: a. Description of the equipment and its operation b. Troubleshooting guidelines if applicable c. Potential hazards in the use of the products/supplies d. Parameters regarding physician notification and/or medical intervention when appropriate e. Basic home safety i.e. electrical safety, mechanical safety f. Storage, handling, cleaning and disposal of equipment and/or supplies based on state and federal laws and regulations Note: By checking the radio button at conclusion of patient education, the pharmacist acknowledges that he/she counseled patient on all clinical points. Procedure General: 1. All education or instructions provided to the patient/caregiver shall be documented in the patient s medical record. 2. Patients needs shall be incorporated into the plan of service. 3. The patient/family are provided with information regarding the following: a. Company ownership, hours of operation and scope of services provided b. Accessibility to company personnel after hours c. Patient Rights and Responsibilities d. How to notify PANTHERx Specialty Pharmacy of any problems, concerns, complaints or suspected errors e. How to access specific program representatives f. Advance directives g. Financial responsibility h. Emergency management i. Hazardous waste materials disposal j. Type and frequency of services to be provided k. How patients can obtain their medications l. Patient medication information leaflet i. explains proper use ii. how to administer the medication (oral, injection) iii. side effects iv. contraindications v. safety precautions vi. proper storage of medication m. How to properly dispose of any unused medication and used syringes 2017 PANTHERx Specialty, LLC 2

118 i. PANTHERx does not provide patients with sharps disposal containers but will provide instructions on how to handle and dispose of used syringes, if applicable to the patient s therapy. All states and counties vary on rules, so patients will be referred to their local agencies and municipalities for additional details and restrictions on disposal. Information can also be found at 4. Pharmacy personnel provide instructions to the patient/family/caregiver before and during care, and treatment in strategies/skills/behavior that effectively address healthcare needs. 5. The patient record will include documentation of all teaching, patient s response to teaching, and the patient s level of progress/achievement of goals/outcomes. 6. These instructions may include, but are not limited to: a. Expanding the patient s/family s/caregiver s knowledge and understanding of the skills and behaviors that promote, maintain or improve patient health, manage disease or symptom progression as well as the benefits of participating in the patient management program through interaction and information received in PANTHERx Specialty Pharmacy s medication therapy management. b. How and when to take medications in a safe and effective manner and any specific precautions related to their use of i. multiple prescription medications ii. drug interactions ii. over the counter medications iii. avoiding sun iv. drowsiness v. appropriate actions to take if a medication/treatment reaction and/or side effects occurs vi. any special requirements in handling prescribed medications (washing hands after handling, don t touch without gloves if you are pregnant or breastfeeding, protect from light/air, storage temperature) c. Nutritional interventions, dietary requirements and any potential interactions with medications, and oral health d. Clearly informing patients/family members/caregivers in a manner and format understandable to them of their rights and responsibilities to actively participate, as appropriate, in the patient s ongoing care, treatment and/or services particularly before the patient s discharge from Pharmacy Services e. Proper use, safety hazards, and infection control issues related to the use and maintenance of any equipment provided f. Plan of care g. How to notify PANTHERx Specialty Pharmacy of problems, concerns, and complaints h. Emergency preparedness information i. When to seek and how to obtain follow-up or continuing care, treatment or services as appropriate j. Providing an opportunity for the patient/family/caregiver to ask questions that allow them to make informed decisions concerning the patient s care, treatment and/or services k. Promoting maximum achievable recovery and functioning l. Opt in or Opt out opportunities, as applicable 7. The Quality Management Committee serves as one resource to review and revise as necessary organization wide policies relating to patient education, to assure that patient/family education is coordinated among the various disciplines, and to plan continuous quality improvement activities related to patient/family education. 8. Review of patient education materials will be done by Clinical Oversight/Review Committee on an as needed basis but at least annually. 9. Patient/family education is documented in the patient s medical record by all disciplines providing education to the patient/family/caregiver, using standardized teaching tools/formats when appropriate and available PANTHERx Specialty, LLC 3

119 10. Documentation of the patient education process includes: a. Patient/family/caregiver demonstrated ability to understand, i.e., recall and restate, use and apply the information provided b. Evaluation of the outcome(s) of previous instruction c. Continuing learning needs 11. Patients /family members /caregivers progression along the learning continuum is communicated at regular and appropriate intervals to other members of the healthcare team. General Patient Assessment Protocols 1. Pharmacists, or other professional staff, will initiate a learning needs assessment of the patient, significant other, and/or the caregiver / parent / guardian as appropriate. 2. The results of the learning needs assessment will be used to plan current and future teaching activities. 3. The learning needs assessment will address, as appropriate: a. Language barriers b. Functional limitations (Cognitive/Physical Impairment) c. Literacy levels d. Cultural differences e. Other pertinent factors 4. Language barriers will be assessed and an interpreter will be made available if necessary. If a staff member or family member is not able to provide interpretation, a language hotline will be used 5. The patient/caregiver will be also notified of any potential financial obligations to PANTHERx Specialty Pharmacy which may apply. Specialty Therapy Teaching Plan 1. A teaching care plan will be developed in conjunction with the patient/caregiver based on learning ability and specific needs in order to allow for shared decision making and ongoing self-management. 2. The teaching process for the patient and caregiver may include written instruction, verbal explanation, demonstration, evaluation and documentation of the patient s competency and proficiency in performing therapy related procedures and self-monitoring/self-management activities. 3. Teaching / learning strategies which may be used to facilitate the education/learning process may include: a. Actively involving the learner in the process b. Utilizing vocabulary that can be easily understood c. Breaking down the content into small increments d. Positively reinforcing successes e. Promoting a calm, quiet, stress free environment f. Progressing from the simple to the complex g. Presenting education at appropriate times according the availability of the patient/caregiver and individual attention spans h. Reinforcing instruction given with written information when possible i. Evaluating the patient/caregiver response to instruction by observation of return demonstration and verbalized understanding. 4. Patients will be educated according to the criteria outlined in the patient teaching plan. The clinician will individualize and expand upon the teaching as necessary to reflect the patient s individual therapies, problems, needs and how it will impact daily living. 5. Written education materials, specific to the prescribed therapy, will be provided when possible including: a. Introducing the patient to PANTHERx Specialty Pharmacy and the services available, including 24/7 on-call availability (as applicable to the care/services provided) b. Reinforcing teaching guidelines for the specific therapies c. Routine and emergency phone numbers for reaching PANTHERx Specialty Pharmacy staff (crisis calls, drug recalls) d. Important information will be highlighted and emphasized in a way that is easily understood for appropriate patient understanding and memory. e. Materials provided will be documented in care management plan 2017 PANTHERx Specialty, LLC 4

120 6. Patient understanding teaching may be validated by demonstration of a technique or verbal feedback of material taught. Specialty Documentation 1. A pharmacist will document the patient s response to teaching. 2. Documentation of therapy teaching is to be completed and signed by patient after return demonstration has been completed for all that apply for prescribed therapy and/or treatment. 3. The therapy teaching documentation form will be filed in the patient s clinical records as a hard copy in the paper chart. 4. It is acceptable for the patient / caregiver to sign at the bottom of the teaching document form as long as it represents the completion of the training for that segment of care. If additional therapies are added, a new form must be initiated or teaching shall be noted in the nursing notes. 5. Any problems with any part of the training process should be documented, as well as any recommendations or corrective action taken or to be performed later. Specialty Equipment Education 1. Patients/caregivers will receive training by the appropriate personnel in the proper operation of equipment according to the patient/caregiver s ability to comprehend the information and follow instructions. Equipment related training will include the following topics, at the appropriate level as determined above: a. Any special structural or environmental requirements for proper equipment operation b. Proper setup, power requirements and backup provisions, operational verification and safety checks and connection of the equipment (if appropriate) c. Alarms generated by the equipment and the appropriate response d. Safety and emergency considerations, including use of extension cords and two prong adapters, what steps to take in the event of a power outage and how to reach appropriate company personnel for routine and emergency situations e. How to set up and administer medications with the infusion device f. Proper disconnection and disposal / return of equipment (as applicable) 2. Verbal instruction will be supplemented with written information as appropriate to the type and use requirements of the equipment. Drug Education Materials The pharmacy will provide the patient with written medication instructions for medications dispensed, as appropriate or required by law. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/7/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ PANTHERx Specialty, LLC 5

121 Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/16/ PANTHERx Specialty, LLC 6

122 PATIENT REASSESSMENT POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-48 URAC PC 28 SDrM 3, 6 PM 3, 4, 5 ACHC DRX 5-2I CPPA 4.1, 3.4c, 3.4f, 3.4d, 3.4e, 3.4g, 3.7a, 4.1h PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/7/14 Scope Patients receiving care/services will be reassessed on an ongoing basis pursuant to the needs of the patient in reaching the desired therapeutic endpoint. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Patients and/or caregivers receiving care/services will present unique and individualized problems and needs initially and on an ongoing basis. 2. It is important to be able to recognize the patient s changing care/service requirements and to plan corresponding actions to address the recognized problems and/or needs as quickly as possible through a patient reassessment process. This includes the appropriateness of current therapy, response to therapy and progression/improvement in disease or medical condition. a. Appropriateness of continuing medication will be established by asking questions similar those such as, but not limited to: i. Has anything changed since the last time this medication was filled? a. Pregnancy, allergies, new diagnosis, etc. ii. Have you added any new medications to you daily regimen? iii. Have you noticed any side effects from your medication? b. Effectiveness will be established by asking questions similar those such as, but not limited to: i. Have you noticed an increase or decrease in symptoms? ii. Have you been taking the medication as prescribed? iii. How many doses of medication do you have remaining? c. Additional questions may be asked as needed to determine if anything else may be affecting the outcome of the patient s care/service plan d. Questions can change or vary in verbiage, but the objective or assessing appropriateness and effectiveness of therapy will remain consistent. 3. Patient reassessments can occur: a. During monthly follow-up outreach when determining if the subsequent refills are still required b. When information is obtained during each patient encounter that require additional support c. When communication takes place with the physician and/or other healthcare providers involved in the care/services of the patient. d. When clinical monitoring is performed. e. Additional and appropriate information is gathered by a clinician. 4. The degree to which a patient assessment must be done will be dependent upon several factors including, but not limited to: a. The type of therapy, treatment or equipment the patient is receiving. b. The complexity of the therapy, treatment or equipment the patient requires. c. The patient s potential predisposition to problems 2017 PANTHERx Specialty, LLC 1

123 d. Other pertinent factors impacting the outcomes of the conversation 5. A clinician is responsible for evaluating each patient on a case-by-case basis and planning subsequent reassessments as needed. 6. All patients will be reassessed when analysis has identified changes in: a. Patient s physical and/or psychological condition b. Patient s response to care i. Adverse events ii. Side Effects iii. Drug interactions iv. Improvements in patient labs, etc. c. Patient s outcomes/ efficacy related to the care/services being received i. Effectiveness ii. Ineffectiveness d. Inappropriate use of the medication e. Patient s diagnosis, therapy, treatment and/or equipment requirements including alternative drug products and treatment options. f. Patient s environment or care support structure g. Other pertinent changes (ex. compliance and adherence), as appropriate. For example, if alternative drug products or treatment options are available that could improve outcomes or adherence, PANTHERx Specialty Pharmacy will recommend and coordinate necessary modifications to treatment plan. h. When it s appropriate to medication reconciliation to identify the most accurate list of medications the patient is currently prescribed, such as after discharge from the hospital or nursing home 7. Routine patient reassessments will be documented in the patient profile 8. Changes in the plan of care for the patient will be documented as required by law and regulation and may be reflected in the patient profile. Profile will be screened for receipt of required documentation (i.e. PHI/PCI and AOB and be verbally counseled on follow up call to request provided documentation as soon as possible). 9. Should a patient be re-admitted to a medical facility or have extensive changes in therapy, treatment, and/or equipment needs, a comprehensive patient reassessment may be needed as determined by the clinician. Note: By checking the attestation button at conclusion of patient education, the pharmacist acknowledges that he/she counseled patient on all clinical points. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ PANTHERx Specialty, LLC 2

124 Douglas Gebhard, PharmD, MBA VP, Quality & Education 09/23/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

125 PRESCRIPTION VERIFICATION PROCESS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-49 URAC PC 13 SDrM 4, 5, 6 Pharm Op 2, 3, 5 ACHC DRX 5-2B, 5-10A, 5-18B CPPA 1.10a, 1.10b, 1.10c, 1.12a PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope 1. Define the 11-point check for prescription verification. 2. Define steps required to ensure validity of received prescription. 3. If these steps are not followed, several critical errors could occur which could cause harm to the patient and/or jeopardize the distributing licenses of the company including; a. Accepting and processing a fraudulent prescription b. Accepting and processing a prescription that is not in compliance with State Board of Pharmacy laws and regulations. c. Entering the prescription data incorrectly d. Filling the prescription inaccurately Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Definitions 2. DUR (Drug Utilization Review) CPR+ software based review of the patient s profile for allergies, contraindications, duplicate therapies, max dosing, etc. 3. MediSpan- a comprehensive database of drug data files and clinical information that is configured for needs that span the health care continuum. MediSpan files are updated systemically and include pricing, quantities, package size, DURs, medication guides and patient information leaflets (PIL). PANTHERx has subscribed to weekly updates from MediSpan. Policy/Procedure Check the Validity of the Rx Circumstances that should alert the pharmacists to question the validity, accuracy or authenticity of a drug order are: Written Prescription Orders a. Photocopied prescription blanks b. Directions written in full, with no abbreviations c. Use of different color inks or written in different handwritings d. Quantities, directions or dosages that differ from usual medical usage e. Prescription orders written on hospital blanks f. Date on prescription is not a reasonable length of time since prescriber wrote it g. DEA registration number is invalid Telephone Prescription Orders a. Quantities, directions or dosages that differ from usual medical usage b. Invalid call back phone # or reluctance to give full name 2017 PANTHERx Specialty, LLC 1

126 c. DEA registration number is invalid Faxed Prescription Orders a. Directions written in full, with no abbreviations b. Use of different handwritings c. Quantities, directions or dosages that differ from usual medical usage d. Prescription orders written on hospital blanks e. Lack of Physician header or Cover sheet with fax f. Date on prescription is not a reasonable length of time since prescriber wrote it g. DEA registration number is invalid or missing If there is any reason to question the validity, accuracy or authenticity of any prescription drug order, the employee will call the licensed practitioner s office and document the result of the encounter. Validation of the legality of the Prescription 1. Patient s full name and address as well as Date of Birth 2. Minimum prescription data elements (e.g., drug name, strength, dosage form, quantity, refill instructions), 3. Instructions regarding substitution, 4. Prescriber s name, address, phone number, DEA number for controlled substances. The prescriber is verified when entered into the patient s profile, either as a prescriber that has previously written for this patient or another in the system, or by searching for them in a valid NPI directory to obtain and verify all the demographic information provided on the prescription. Verification of System Entry 1. The pharmacist will review all information attached to the order (enrollment forms, insurance paperwork, cover letters, patient letters, etc.). 2. All prescriptions entered into the pharmacy operating system by an intake representative will be reviewed by a pharmacist. A review must be completed for all prescriptions on the patient s order. 3. The Pharmacists compares the system image of the prescription to the entered data utilizing an 11-point check. This includes verifying: a. Patient name/account Two patient identifiers verified. (DOB, SS#, Phone #, Address, Acct #, Previous Rx #) b. Doctor/Prescribers Name/Licensure (DEA, NPI, Medicaid ID, etc.). c. Date of prescription issuance d. Drug Name e. Drug Strength f. Drug Dosage Form/Route of Administration g. Quantity h. Directions, including correct administration schedule or time i. Refills j. DAW code k. Day supply 4. If any discrepancies are found, the pharmacist will deny the Rx, and will subsequently be sent back to the pharmacy technician to perform re-data entry for the Rx. Step 3 will be repeated until Rx passes 11-point check. 5. All comments regarding the patient s preferences/shipping instructions/precautions should be reviewed to ensure complying with the patient s requests. Generic Substitution 2017 PANTHERx Specialty, LLC 2

127 1. Every new product added to inventory is reviewed and approved by a pharmacist to ensure the product is systematically linked to the appropriate brand or AB rated generic medication. 2. A call will be placed to the doctor office when the patient requests a non-ab rated generic. Upon the approval of the prescriber, a pharmacist will document the approval and select the non-ab rated generic. Drug Utilization Review and Reporting 1. The system performs a DUR and is reviewed by a pharmacist at least every 30 days, or sooner if there is a change. 2. The pharmacists perform a manual DUR review to verify the MediSpan results and to establish the clinical significance of any DUR rejects. The manual review includes: a. Checking patient profile to ensure there are no contraindications with the current therapy b. Therapeutic appropriateness c. Over and Underutilization d. Generic use e. Therapeutic interchange f. Duplication of therapy g. Drug-Drug interactions h. Drug-Allergy interactions i. Drug-Disease contraindications j. Drug dosage k. Treatment Duration l. Abuse or misuse m. Drug-age precautions n. Drug-gender precautions o. Drug-pregnancy and Lactation precautions p. Regulatory limitations 3. If it s a refill Rx, the pharmacist compares the previous fills for consistency. 4. Any prescription corrections or clarifications will be communicated to the provider s office and documented on the hard copy and in the patient profile. 5. Drug Utilization findings will be documented and retained for review during quarterly Quality Management meetings with the Quality Committee in order to identify opportunities and improvements for future prevention 6. During the quarterly Quality Management meetings, or at least on an annual basis, the Quality Committee will review and provide oversight for issues/events related to Drug Utilization Management and reporting 7. Drug Utilization Management Reporting can include aggregated findings or analysis of specific occurrences such as: i. Volume of utilization reviews ii. Instances addressing negative responses identified during DUR (i.e. over/under use) iii. Specific data elements required for DUR, but not provided/available Approval 1. When all steps are completed, the prescription order is marked verified by the pharmacist. The operating system logs the pharmacist s initials. 2. Order is routed to the next processing area. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet 2017 PANTHERx Specialty, LLC 3

128 Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 01/25/ PANTHERx Specialty, LLC 4

129 QUALITY EVALUATION & REPORTING POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-50 URAC PC 21 PM 4 ACHC DRX 6 PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/7/14 Scope To facilitate timely, accurate, and complete documentation; timely notification of management team as appropriate to ensure timely and complete follow up; and to provide necessary, timely intervention(s) when a Quality Improvement Opportunity occurs. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Quality Improvement Opportunities (QIOs) are measured and the following procedure should be used as a guide. These reports will be reviewed monthly by the department managers and quarterly during quarterly Quality Management meetings. The Quality Management Committee will track and trend measurements below and evaluate for improvements. An annual report will be compiled and be available for senior management. This report will also be available for current and prospective clients if requested. Quality & Patient Satisfaction Evaluation: All patient quality related events are reported as soon as possible with a Quality Improvement Opportunity (QIO)submission form via the PANTHERx intranet 1. All patient quality related events are considered confidential. 2. All patient quality related events are reported on the QIO form by the employee that has been notified of the error. 3. Completed Quality Improvement Opportunity Tracking Log (QIO Tracking Log) is submitted to the department managers as appropriate for review, investigation and corrective action if necessary. The department manager initiates a problem-solving procedure to determine the course of action based on the event reported: a. Reviews all QIOs b. Obtains necessary information/facts related to the event and identifies the probable cause of the QIO. c. Determines the nature and the level of the QIO i. Investigates events thoroughly with input from others as appropriate. ii. Develops and implements a corrective action plan as necessary. iii. Documents action taken, follow up activities and provides reports to the Quality committee for review and evaluation. iv. Evaluates corrective action plan to determine if action will deter similar events in the future. Quality Improvement Opportunity submission process Note: This process details the steps needed for report, review and follow-up, if necessary, of a member reported QIO. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

130 When a member has a complaint about our service or a grievance, pharmacy staff will fill out a Quality Improvement Opportunity submission via the PANTHERx intranet. This document and submission fields include: 1. Member ID 2. Date of complaint 3. Point in the prescription process where the error occurred 4. Details of what occurred and the resolution that was reached If a mutual resolution is not reached the QIO is escalated. This is indicated on the form and a manager will be made aware of the situation and attempt to resolve. Escalation Process a. A manager will follow up with the member within 24 hours of being made aware of the error b. The issue that was reported will be discussed and a resolution will be reached c. The manager will document the resolution and time to resolve the situation Review Process a. Every Quarter the QIOs are reviewed by the Quality Management Committee and examined to determine if processes and procedures may need to be updated or changed to improve operations and customer satisfaction. b. Any procedural changes are implemented and reviewed daily to monitor their effectiveness. Customer and Client Surveys: Internally supported Customer Surveys are sent out with the 1st fill and annually after initial fill for specialty patients and feedback is used to measure Customer Satisfaction and gather Customer input for improvements. Survey results are tabulated and reviewed by the quality committee on a quarterly basis. In addition, an External Patient satisfaction survey is conducted with a third-party vendor on a Quarterly basis. Results are provided back to PANTHERx and reviewed with the leadership team and internal staff for quality improvement opportunities. Statistics: Operational statistics are also reported and monitored on a regular basis. These may include: Average speed to answer calls (ASA) Call abandonment rate Call monitoring scores Dispensing accuracy Turnaround time On time delivery Medication possession ratio (MPR) Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

131 Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

132 QUALITY IMPROVEMENT PROGRAM STANDARD OPERATING PROCEDURE POLICY NUMBER PS-51 URAC PC 17, 21, 34 SDrM 2 Pharm Op 1, 15 PM 13, 14, 15, 16 ACHC DRX 6-1A, 6-1B, 6-1C, 6-1E, 6-2A, 6-3B CPPA 4.1a, 4.1b, 4.2a PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/7/14 Scope PANTHERx Specialty Pharmacy maintains a Continuous Quality Improvement program that promotes objective and systematic measurement, monitoring, and evaluation of internal and external processes and services. Based on findings, unsatisfactory results require Quality Improvement Plans or Projects. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Introduction The following Quality Plan serves as the foundation of PANTHERx Specialty Pharmacy s commitment to continuously monitor and improve the quality of processes required to provide a positive patient experience. PANTHERx Specialty Pharmacy is committed to the ongoing measurement and improvement of the quality of care to its patients. Key areas of focus are addressed in Goals and Objectives. While the continuous quality improvement efforts are managed within the quality team and the Quality Management Committee, all PANTHERx Specialty Pharmacy s employees are responsible for identifying and contributing in continuous quality improvement initiatives. Quality Improvement Plans. The quality team implements Quality Improvement Plans to address issues raised that are time sensitive. Examples include incorrect client reporting, internal procedural errors and contracted services not being delivered. Quality Improvement Plans usually require investigation, root cause analysis and short term and permanent corrective actions. Results are reported weekly to Executive Team. Quality Improvement Projects. PANTHERx Specialty Pharmacy, directed by the Quality Management Committee, implements and reports on Quality Improvement Projects designed to create new or improve current processes or services tied to key areas of focus. Quality Improvement projects require a goal, actionable items, quantifiable measures, beginning and end dates and results. Results are discussed quarterly with the Quality Management Committee. Leadership The following describes how the leadership of PANTHERx Specialty Pharmacy provides support to quality improvement activities. The Vice President, Quality and Education reviews progress of Quality Improvement Projects and Plans on as needed basis no less than quarterly and provides knowledge and input to the quality team as a means of continually improving performance. They also provide leadership as follows: Supporting and guiding implementation of quality improvement activities in PANTHERx Specialty Pharmacy; and Reviewing, evaluating and approving the Quality Plan on an annual basis PANTHERx Specialty, LLC 1

133 The Quality Management Committee provides ongoing operational leadership of continuous quality improvement activities in the pharmacy and other internal departments. The committee meets on a quarterly basis and measures progress on all quality improvement projects in progress. See Policy & Procedures for more details on the Quality Management Committee and related activities. Goals and Objectives The Quality Management Committee identifies and defines goals on specific objectives to be accomplished each year. A meeting is held with the Committee in Q4 to define Quality Improvement Projects and Plans for the following year. These goals can include global or department-specific training needs, education and awareness, and quality improvement initiatives. Key Areas of Focus: The ongoing long term goals for PANTHERx Specialty Pharmacy s Quality Improvement Program are tied to key areas of focus and measurements may be reviewed on a quarterly basis no less than annually. They include: 1. Improving service levels a. Review of key performance indicators/metrics 2. Reducing error rates 3. Improving client satisfaction 4. Improving patient outcomes a. Medication overuse b. Medication underuse c. Adverse drug events d. Compliance and adherence e. Assess clinical and health-related benefits of program with key measures i. Previous clinical and health-related outcomes ii. Current clinical and health-related outcomes iii. Projected clinical and health-related outcomes iv. Relevant lab values and health screening data v. Patient self-reported data vi. Physician s office lab values and chart information (vitals, etc.) 5. Assessment of financial benefits of programs utilizing performance measures a. Cost savings of assisting patient with enrolling in patient assistance programs i. Previous financial outcomes ii. Current financial outcomes iii. Projected financial outcomes 6. Assessment of impact of other clinical assessment program performance measures as deemed necessary a. Quality of life b. Productivity (sick days/lost work) c. MPR s d. Employee retention 7. Improving patient satisfaction 8. Increasing efficiency of processes 9. Cost effectiveness of drug use (side effects/adverse drug monitoring to decrease overall health care costs, proper medication storage, dispensing appropriate days supply to reduce waste, etc.) 10. Performance of pharmacy information systems and technology. Education and Awareness: The sharing of Quality Improvement data and results through a planned and shared communication approach promotes awareness and input into ongoing and future Quality Improvement initiatives. Planned communications may take place through the following methods: Story boards and/or posters displayed in common areas; Participants in Quality Management Committee reporting back to their departments/staff Meetings; Sharing of the pharmacy s annual Quality Improvement Plan evaluation; 2017 PANTHERx Specialty, LLC 2

134 SharePoint postings, Newsletters Internal training/educational programs. Performance Management As part of the Quality Management Plan, results will be assessed by the Quality Management Committee. It involves identifying processes, systems and outcomes that are integral to performance, selecting KPIs and analyzing information related to these indicators on a regular basis. Performance measures are being captured in all Quality Improvement Projects. They include quantifiable baseline measures, quantifiable goals associated with the measure, improvement strategies, measurement of progress, changes in the improvement strategy and beginning and end date. Evaluation of Program Progress in meeting the goals and objectives of each Quality Improvement Project is an important part of the annual evaluation. An evaluation is completed at the end of each calendar year. The evaluation will be provided to both current and prospective clients/payers upon request. The evaluation summarizes the goals and objectives of the Quality Improvement Plan, the quality improvement activities conducted during the past year, including the targeted process, status of project, systems and outcomes, the performance indicators utilized, findings/data aggregation, assessment and analysis processes, and the quality improvement strategies taken in response to the findings if complete. The information below should be included in the evaluation: 1. Summary of the progress towards meeting the Annual Goals/Objectives. a. Clinical Benefits (Outcomes) Compliance and Adherence MPR s b. Quality Improvements Strength of evaluation methodology which may include that the evaluation was based on actual data and the initial review of data being completed quarterly to facilitate immediate action prior to the annual evaluation. Weaknesses or limitation of evaluation methodology which may include the reliance on patients to self-report complaints, side effects, medication compliance and up to date medical history. 2. Summary of progress on each goal and comparing to baseline of the first-year results. The first meeting will be comparing actual first year s data to the goal indicated in the Performance Measurement. 3. Summary of the findings for each of the indicators and actions taken in response to these outcomes. The summary will be presented (live meeting, or voting tool) to the quality management team members for review and feedback. 4. Any opportunities for improvement that are identified will be addressed during the meeting and a Quality Improvement Plan will be developed to address any deficiencies or failures to meet the intended goals. Metrics may be redefined to increase standards if goals are consistently met and exceeded. 5. Based upon the evaluation, the quality team will provide recommendations on actions necessary to improve the effectiveness of the Quality Plan. They will also work with pertinent staff and leadership to improve or correct identified problems so PANTHERx Specialty Pharmacy can meet or exceed acceptable performance levels. 6. Results of the Quality Improvement Plan and Evaluation will be communicated to the relevant staff via interdepartmental communications (newsletters, , live-meetings). 7. The quality management program description, methodology and evaluation reports will be made available to current and prospective clients upon request and will be provided in a timely manner PANTHERx Specialty, LLC 3

135 Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 4

136 BACKORDER PROCESS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-53 URAC Pharm Op 6, 9 CPPA 3.9c PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To ensure there is a standard process in place for processing a prescription that is on manufacturer backorder and for proper patient communication. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. When PANTHERx Specialty Pharmacy cannot obtain a medication from the wholesaler to fulfill an order, the item will be removed from the order and pharmacy personnel will contact the patient. The following steps will occur: a. Pharmacy personnel will contact the patient and inform him/her of the manufacturer backorder. b. Pharmacy personnel will offer the patient the following options: i. Place the order on hold until the product is back in stock and send it once available. No further calls will be made to the patient unless the product is discontinued from the manufacturer. ii. If the order has the potential for an alternative therapy per Pharmacists recommendation, suggest to the patient the possibility of having a different product dispensed. If the patient would like to try the alternative therapy, the pharmacy will coordinate with the physician to dispense a suitable product for the patient s indication. iii. Ask if there is a local pharmacy that patient would like called to check for medication. iv. Suggest a call to the physician for samples. Scripting: Hello, this is (Pharmacy Personnel Name) calling from PANTHERx Specialty Pharmacy. Recently you placed an order for (Drug Name), but this medication is currently not available from the manufacturer due to a backorder issue. The ETA is (estimated date). Will you have enough medication to last you through this date? If No: The Pharmacist suggested a possible change your x medication. Would you like us to call your MD and see if he/she agrees? Alternately, you may call your MD to see if you can pick up samples. Or, we can see if the medication is in stock at a pharmacy close to you. (If yes, get pharmacy name and phone#). If Yes: Continue to Placing order on Hold Placing Order on Hold Scripting: When this item becomes available, we can ship this out to you automatically. Would you like us to set this up for you now? If Yes: I will have the order held until the estimated release date (or an agreed upon time with the patient). If the medication is not available on the (release) date, we will call you and inform you of the new (ETA Date). Then you can decide if you want us to keep this prescription on hold or if you would like to make other arrangements to get this medication. If the manufacturer stops producing this medication, we will let you know. If No: You are welcome to contact us to check if the medication is available at any time. We will be happy to assist you PANTHERx Specialty, LLC 1

137 Ending the call: Is there anything else I can help you with? Have a good day. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

138 DELIVERY & SHIPMENT OF PRODUCTS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-54 URAC Pharm Op 4, 6 ACHC DRX 5-11A, 5-11B, 7-9B, 7-14A CPPA 1.7i VIPPS Criterion 15, 16 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope To explain the standards of shipment management to include timeliness of shipping, shipping errors, turnaround time and lost shipments. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Contacting the Patient: 1. PANTHERx Specialty Pharmacy will track on-hand quantities and previous ship dates to determine the patient s need by date and will begin calling the patient approximately 10 days prior to expected exhaust to set up a shipment. 2. The patient will be notified of the shipment method (i.e. FedEx) and the expected date of the delivery. At this time the patient will have the option of requesting signature required upon delivery. 3. The ship date and method will be permanently logged into CPR+ and the patient can call at any time to check on the status of the shipment. Packaging: 1. A Delivery Ticket is generated as a result of prescription processing. The Delivery Ticket contains the following information pertinent to delivery/shipping: a. Name and address of patient b. Special delivery instructions, if requested c. Medication name and quantity d. Ancillary supplies, if required e. Payer specific information, if required 2. Fulfillment pharmacy personnel will pick and gather all items listed on the Delivery Ticket for a particular patient delivery. 3. All medications will be packaged as appropriate to size of dose and convenience for patients. 4. Packaging methods should ensure product integrity is maintained. a. Light sensitive medications will be packaged in light resistant containers. b. Medications that need to be refrigerated are to be packed per the approved packouts for each individual type of cooler. All packages that are to be delivered or shipped must have adequate and appropriate packaging material to ensure that drug stability, potency, integrity and proper temperatures are maintained throughout the delivery process. Medication that need refrigeration are to be delivered or shipped same day or overnight NEVER use a 2 or 3-day delivery. 5. All medications will be properly labeled, clearly readable and have proper precaution and storage requirements on the labels. 6. Before the medications and supplies are packed into the shipping box, the pharmacist will check the items against the Delivery Ticket and stamp the Delivery Ticket to indicate that correct items and amounts have been picked for delivery PANTHERx Specialty, LLC 1

139 7. All materials/supplies that are to be shipped/delivered to the patient should be placed in an appropriate sized corrugated cardboard carton, disposable insulated cooler, or sufficiently padded package. 8. The packing of medications and ancillary products for shipment/delivery should be such that: a. The heavier items are placed on the bottom of the carton and the lighter items on the top. b. The cartons should not be packed so they are overly heavy. If necessary, divide the shipment into two (2) or more equal portions for packing. c. Do not pack sharp objects next to fluid containing bags or containers. This will decrease the chances of punctures and breakage. d. For shipments that are going to be handled by a delivery agent, pack the products/supplies/equipment using an absorbent, cushioning material to avoid excessive movement during shipment. 9. Patients are to be provided instruction regarding directions for inspecting the package containing medications when received. If any defects are noted, the patient is instructed not to use the potentially defective products and to contact the pharmacy immediately. 10. The cartons are to be labeled properly with correct and complete information 11. A double check process is to be used to verify that the contents of the final package match the label and destination to ensure that the package goes to the right patient. 12. Medications and supplies are packaged to ensure accuracy and drug stability, potency, and integrity are maintained up to and through delivery to recipient. 13. Maintenance of temperature in transit via the selected modes is periodically reviewed to verify that medication integrity is maintained. Shipping durations and exposure conditions encountered are considered and temperature maintenance in packaging utilized is validated. Shipment of Medications, Equipment and Supplies: 1. Each shipment is assigned a tracking number which is stored in CPR+ and a PANTHERx representative will be able to track a shipment at any point, if requested to do so. 2. Electronic verification reports (FedEx/UPS) are maintained in a readily retrievable file and PANTHERx is made aware of any shipment exceptions that could potentially delay the shipment. a. If the shipment is delayed, PANTHERx will place a delay call to the patient to advise them of the delay and document it in their chart. b. PANTHERx will ensure that the client has a continuous supply of medication at all times. If the shipment is delayed or lost, a replacement shipment is sent to the patient based upon need. Delivery of Medications and Medical Supplies: 1. Patients should plan to be present for their delivery or make alternative delivery arrangements for receipt by an agent of their choice. 2. Upon delivery of the medication(s), medical equipment and/or medical supplies, the delivery agent will properly identify himself/herself to the patient/caregiver or patient's designee. The patient/caregiver, agent or guardian of the patient/caregiver will provide sufficient evidence to ensure the shipment is delivered to the proper recipient. 3. Upon delivery, the recipient of the shipment will compare the contents of the shipment to the listed items on the Delivery Ticket for any discrepancies and damages as educated by pharmacy personnel and store products per the instructions that have been provided. 4. If the patient has requested that the delivery be left with an agent of the patient or alternative delivery instructions, the shipper s confirmation will suffice as a confirmed delivery. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History 2017 PANTHERx Specialty, LLC 2

140 Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/26/ PANTHERx Specialty, LLC 3

141 ELECTRONICALLY SUBMITTING CLAIMS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-55 URAC Pharm Op 11 ACHC DRX 3-6A, 5-1C CPPA 1.13b PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope Overview of steps to submit pharmacy medication claims electronically Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. The pharmacy computer system is capable of electronically transmitting pharmacy medication claims compliant with the HIPAA compliant NCPDP D.0 standard protocol. Whenever possible, this online adjudication system shall be utilized when billing third party payors. 2. Utilizing the NCPDP D.0 standards, and adjudicating pharmacy medication claims electronically, in real time, ensures that the items are covered prior to dispensing to the patient, and most third party payors will perform additional edits at the time of adjudication such as: a. Refill Too Soon b. Duplicate Therapy/Ingredient c. Drug Allergy Alerts Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

142 EMPLOYEE SAFETY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-56 URAC Pharm Op 14 ACHC DRX 6-3F, 7-1A, 7-2A, 7-11A PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope To detail the safety precautions taken by PANTHERx Specialty Pharmacy to protect employee and patients Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All employees are instructed to abide by appropriate safety precautions. 2. All employees receive safety training during orientation and at least annually thereafter. 3. The topics addressed for all staff include but may not be limited to: a. Proper body mechanics b. Company fire safety and evacuation plan c. Workplace security building safety and security d. Personal safety techniques i. Eye wash stations ii. Hand washing techniques e. Environmental hazards i. Emergency Spill Kits f. Office equipment safety 4. All employees will be shown where and how to use personal safety equipment such as eye washing stations. 5. Emergency Spill Kits are readily available and all employees will be instructed on when, where and how to use them. 6. Patients and/or their caregivers are instructed in safety measures appropriate to the services provided. Safety instructions are documented in the patient record. 7. Safety incidents are documented on the report of Occupational Injury with Human Resources. Summary reports are submitted to the Quality Committee monthly. 8. Safety issue/incident summary reports are included in the company Annual Evaluation. 9. No employee shall be required to work in an unsafe situation or atmosphere. 10. While in the field, if conditions are felt to be unsafe, the employee should leave the area, go to a safe location and contact organizational management who may then contact and inform the client by phone that the employee is unable to make the visit. 11. Employees shall report hazards which could jeopardize the safety or well-being of employees and/or clients to their supervisor. 12. All management personnel and employees shall comply with specific worker safety policies put forth by the Occupational Safety and Health Act. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge x 2016 PANTHERx Specialty, LLC 1

143 Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

144 EQUIPMENT CLEANING & MAINTENANCE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-57 URAC Pharm Op 10 ACHC DRX 4-14F, 7-12A, 7-14A CPPA 1.9a PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope This work instruction outlines the steps required for equipment cleaning and maintenance. Guidelines PANTHERx Specialty Pharmacy (PANTHERx) employees are expected to understand and adhere to this standard operating procedure at all times. Policy PANTHERx is to take appropriate preventative and ongoing actions to maintain all pharmacy equipment to meet manufacturer operating guidelines including but not limited to: Cleaning Recalibration Manufacturer recommended maintenance Responsibility Pharmacy/Dispensing technicians are responsible for the routine cleaning of assigned surfaces and equipment. The Pharmacist (or designate) is responsible for repair or calibration as required by the manufacturer or as indicated by error code. Randomized testing/audits shall be completed by the fulfillment lead or supervisor to validate and test this policy. Location and Equipment Pharmacy dispensing area. Materials and Tools Pharmacy dispensing/counting equipment Refrigerators Freezer Designated cleaning tools (spatula, dish mop tool, etc.) Manufacturer manual(s), references, set-up guide Procedure Required maintenance (including recalibration) is maintained per manufacturer guidelines by the fulfillment lead or supervisor. All errors will be reported to the pharmacist. Any error codes will be access and fixed by a contracted manufacturer representative. All stations are cleaned daily by pharmacy employees. The responsible party maintains all documentation on applicable logs indicating service and cleaning has been performed. Any required maintenance is scheduled per manufacturer guidelines PANTHERx Specialty, LLC 1

145 Record of employee training will be maintained by PANTHERx. Records Daily/ Weekly cleaning logs System error codes Daily/Weekly/Monthly maintenance logs Employee training logs Training This policy will be posted on the PANTHERx Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

146 HAZARDOUS MATERIALS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-58 ACHC DRX 2-8A, 7-1A, 7-6A, 7-6B CPPA 1.7e PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To provide means of safe handling and transport of hazardous drugs (i.e., antineoplastic) that protects transport personnel from harm. Patient/caregiver, staff, delivery agents and general public are protected from potentially hazardous products. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Products are packaged and labeled to assure safe handling during delivery or shipment. Delivery agent performance is periodically reviewed to ascertain proper transportation and efficiency. 2. This policy is a supplement to Pharmacy Management Policy on the Delivery and Shipment of Products 3. Emergency Spill Kits are available on-site and stored in a separate area designated for such equipment/supplies. 4. PANTHERx Specialty Pharmacy has designated Eye Wash stations available in the pharmacy. 5. Employees are notified of any hazardous substances in the workplace, and their potential exposure to the substance. Packaging: 1. Packaging methods should ensure product integrity is maintained. 2. Hazardous drugs will be packaged in single units (one dose per bag) and then put into another bag to prevent contamination if breakage/leakage should occur. A chemo label is affixed to each dose and each outside bag, and to the packaging box that contains the hazardous drug. 3. All medications and heat sealable bags will be properly labeled, clearly readable and have proper precaution, beyond use dating and storage requirements on the labels. 4. Do not pack sharp objects next to fluid containing bags or containers. This will decrease the chances of punctures and breakage. 5. All packages containing hazardous drugs must have labels on the outside containers that clearly identify the contents as hazardous drugs. Storage: 1. All hazardous materials and cleaning supplies are stored in a separate locked cabinet. Appropriate protective equipment and supplies are available and stored with the hazardous materials. Hazardous materials will be handled carefully and in accordance with manufacturer issued MSDS sheets as well as all state and local laws. 2. Hazardous materials and waste are appropriately labeled with the identity of the material and the appropriate hazard warnings as required by applicable laws, regulations and guidelines, and are securely stored in areas separate from other facility areas. 3. A Pharmacy staff member is responsible for: a. Identifying hazardous substances in the workplace and notifying employees of same 2017 PANTHERx Specialty, LLC 1

147 b. Maintaining a current list of all hazardous materials and substances present in the workplace c. Access to MSDS resource on line to current information on materials and substances d. Obtaining a copy of the Material Safety Data Sheet (MSDS) for each hazardous material and substance present in the workplace, from either the supplier(s) or manufacturer(s) of the materials or substances. e. Keeping all Material Safety Data Sheets current. f. Conducting periodic training programs for employees about potentially hazardous materials or substances in the workplace, and the use of appropriate personal protective equipment. Handling Biohazardous/Biomedical Waste: 1) Any non-sharp contaminated equipment/supplies shall either be: a. Placed directly into red bags if the size of the allows it to be placed into red bags; or, b. Cleaned at the curbside and labeled with the biohazardous symbol before being placed into the dirty area of the delivery van. 2) All employees who handle contaminated equipment/supplies are to use appropriate personal protective equipment (PPE) to reduce exposure to hazardous drugs. Select the appropriate PPE based on the material being handled. Ask the Director of Pharmacy Operations or clinical pharmacist for guidance when unsure. PPE can include: a. Eye and face protection such as goggles and face shields b. Sleeve, hair and shoe covers c. Respiratory protection d. Gowns e. Gloves 3) Any equipment/supplies contaminated with biomedical/biohazardous waste that is designated to be disposed of shall be labeled appropriately and stored in a separate area designated for such equipment/supplies. 4) The Vice President, Business Operations is responsible for arranging disposal through a contracted off-site waste hauler. Employee s Right to Know Policy/Procedure The Occupational Safety and Health Administration (OSHA) requires that employers have a Right to Know program. Pennsylvania is not a state plan state; that is, it does not have a federally approved occupational safety and health regulatory program. Consequently, the federal OSH Act governs workplace safety and health in private (private businesses and nonprofit organizations) sector workplaces in the state. For information on the federal requirements, see the national sections HAZARD COMMUNICATION STANDARD, MATERIAL SAFETY DATA SHEET, and OSHA. The Right to Know law requires that an employer's program provide a means to identify and evaluate a hazard and to communicate appropriate information to employees. Employees shall be provided, and have access to, information concerning any hazardous material they work with, as well as any protective equipment necessary to prevent overexposure. The primary source of information concerning hazardous materials is the material safety data sheet (MSDS). MSDSs are documents that identify hazardous constituents of a product, instructions for emergency response, and information pertaining to health hazards, flammability, and reactivity. MSDSs are required to be sent by the manufacturer of a hazardous material upon shipment of the material and upon request of an individual. Individual departments should have access to MSDSs available for materials used by PANTHERx PANTHERx Specialty, LLC 2

148 https://www.osha.gov/dsg/hazcom/index.html Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 3

149 INITIAL THERAPY ASSESSMENT STANDARD OPERATING PROCEDURE POLICY NUMBER PS-59 URAC Pharm Op 2 PM 3, 5 ACHC DRX 5-1A, 5-1B, 5-1D, 5-2A, 5-2B, 5-2C, 5-2G, 5-4A, 5-4B CPPA 1.10a, 1.10b, 1.10c, 2.3b, 3.4a, 3.6c VIPPS Criterion 10 PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/14 Scope To identify patients needs for treatment and/or services within an appropriate time frame in compliance with applicable laws, regulations and standards. To ensure that an assessment is performed appropriate to the patient s therapy needs, diagnosis, treatment, and/or services provided by PANTHERx Specialty Pharmacy. The Initial Pharmacy Patient Assessment is utilized as a baseline reference tool for ongoing drug therapy monitoring, and as an evaluation tool for determining and driving quality patient outcomes. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. A Patient Assessment is completed prior to initiation of therapy 2. The primary role of the pharmacist is to ensure the safe and appropriate use of medications. The Patient Assessment enables the Pharmacist to comprehensively document appropriate interventions to increase drug efficacy, minimize potential risks/adverse reactions of drug therapy, and to promote positive patient outcomes. Evaluation of the information obtained on the Patient Assessment aids in the development of the patient care plan. 3. The Pharmacist is responsible to ensure that a Patient Assessment is completed on patients that are new to PANTHERx and/or new to therapy. Procedure Patient Assessment: PANTHERx Specialty Pharmacy s Patient Assessment is used for measuring all patient assessment data including projected clinical and health related outcomes. Information collected is specific to disease state or therapy and may include, but not limited to: 1. Patient demographics i.e. name, address, telephone number 2. Emergency contact and telephone number 3. Age, sex, height, weight 4. Allergies: To include all prescription drugs, over-the-counter drugs, food and environmental allergies 5. Vaccination Status 6. Therapy Review: A pharmacist will perform a review of new, current and past medications (changed/discontinued) as well as any OTC products. This review of therapy will not only take place during initial assessment but will occur during reassessment (refill) too and will cover, but is not limited to: a. Medication review b. route of administration c. frequency, dose d. Therapeutic duplication 2017 Pantherx Specialty, LLC 1

150 e. Any drug-drug, drug-food, or drug-disease interactions 7. History of Present Illness/Medical History and Outcomes from both current and previous health care providers: The written history of an illness should embody all the facts of medical significance in the life of the patient. 8. Financial Assessment: PANTHERx Specialty Pharmacy will also evaluate the financial situation and eligibility of the patient to ensure their ability to pay for the medication. If a need is identified, alternative support and payment options will be assessed to improve financial outcomes for current and future medication needs. 9. Other current and projected outcome assessments will be evaluated as deemed necessary for specific patients. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 09/23/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Pantherx Specialty, LLC 2

151 INVENTORY RECEIVING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-60 URAC Pharm Op 6, 9, 15 ACHC DRX 7-9A CPPA 1.7b, 1.7f PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To explain the process for receiving inventory items. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Receipt of Inventory Items: 1. When product physically arrives at a facility, the shipment should be inspected to ensure that there is no visible damage to the cartons and that expiration dates on the products exceed a minimum of six (6) months dating. If either are contrary, the Pharmacy Manager must be notified prior to acceptance of shipment. 2. Number of packages must coincide with the purchase order provided by the wholesaler. Any discrepancies will be noted on the invoice. Any inventory discrepancy must be reported by the Pharmacy Manager to the source of product (i.e. wholesaler, manufacturer, etc.) within 48 hours. 3. The packing list must be located for the purchase order to be received. All inventory items being received should be separated and matched to the invoice. Any discrepancies must be noted and reported to pharmacy management. Pharmacy management must follow-up with the wholesaler or manufacturer within 48 hours. 4. The purchase order and invoice become the source documents for receipt of inventory into the inventory database. Receipt cost must reflect actual invoiced price. Product must be received into the inventory database the same day. 5. In the event that a manufacturer provides Patient Assistance Product (PAP), the product must be clearly labeled with a PAP label and delineated appropriately. 6. Products that require refrigeration will be prioritized and checked into the system immediately. Subsequently, these will be stored per package insert, which will occur within 30 minutes of arrival to facility. Counterfeit Monitoring 1. Verify that products are received from quality wholesalers and manufacturers per Drug Supply Chain Security Act (DSCSA) Medication purchases will be limited to licensed wholesalers, licensed distribution channels, or drug manufactures to ensure drug authenticity 2. Continuously monitor authenticity of drugs from suppliers by tracking NDC codes and lot numbers through pharmacy operating system. Pharmacy will also maintain pedigree paperwork from the supplier as per DSCSA. 3. Upon receipt of medication, the following will be evaluated to try and identify any signs of counterfeit products Packaging Does anything look off or compromised? Labeling Is it different or crooked? Medication Appearance Are tablets/capsules damaged or a different color/shape? 2017 PANTHERx Specialty, LLC 1

152 4. If counterfeit drugs are identified, PANTHERx Specialty Pharmacy will remove the affected product and place them in a well-marked designated area within the pharmacy to prevent further use prior to disposal. 5. PANTHERx Specialty Pharmacy will then contact the following to alert them of the counterfeit drugs and will follow the instructions of the authorities on any further actions: Supplier Manufacturer, if applicable State Board of Pharmacy NABP, DEA and the FDA s Med Watch program 6. Monitor industry news and alerts for counterfeit and recalled drugs. 7. Contact doctor and patient for all out of stock products to determine if the patient can wait for the product to be ordered or if it must be found immediately at another pharmacy. 8. Determine products that are on back order and contact doctor to determine course of action he/she would like to take. Then contact patient to discuss new course of action. 9. Return products that will not be dispensed to the vendor after receiving authorization from the vendor. 10. Products that leave the pharmacy and are dispensed to patient may not be returned and re-dispensed. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

153 INVENTORY STORAGE, SECURITY & CONTROL STANDARD OPERATING PROCEDURE POLICY NUMBER PS-61 URAC Pharm Op 4, 6, 8, 9, 12, 15 ACHC DRX 7-9A, 7-9B CPPA 1.7a, 1.7b PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope The purpose of this policy is to outline the process for inventory storage, handling, security, and temperature variations. Guidelines PANTHERx Specialty Pharmacy (PANTHERx) employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Equipment and Supplies Required Inventory shall be stored in accordance with all state and federal regulations as well as manufacturer recommendations in a secure facility that is clean, well-lighted and appropriate for the products that are being held for distribution by PANTHERx. At all times, inventory shall be physically organized and separated with clear boundaries. Procedure 1. Inventory must be stored in a manner that preserves the integrity of all inventory and prevents losses due to theft, contamination, or spoilage. 2. The Quality Management Committee (QMC) will monitor the quality and safety of drug inventory and distribution during quarterly meetings. This will be done using the grievance process, error rates, and any other issues reported. The QMC will identify and address any concerns of quality and safety and take corrective action as needed. 3. All inventories received and accepted for distribution shall be stored within a secure area in the facility that receives the inventory. a. Only approved medications are received, stocked and stored b. Product from the manufacturer and/or vendor with less than six (6) months dating will not be received or stocked unless authorized from pharmacy manager. 4. All inventories shall be rotated when they are placed into storage. 5. All new inventory shall be placed in the designated active stock area using the first expiration date, first out (FEFO) logic. When FEFO is not feasible, assigned staff shall rotate the stock based upon first in, first out (FIFO). 6. Inventory shall be stored in accordance with the manufacturer s label and MSDS instructions for handling and storage recommendations. If there are any questions regarding the proper storage conditions for any inventory, consult with the pharmacist and manufacturer to determine the correct storage conditions for the product PANTHERx Specialty, LLC 1

154 7. Any special handling requirements such as protective clothing, gloves, safety glasses, cleaning protocols, etc. will be utilized during the handling of inventory to prevent cross contamination and address any employee safety issues. 8. The area where inventory is stored shall have the following characteristics: a. The area shall be cleaned on a regular basis, free from trash, exterminated as needed, well-lit and protected by a monitored, perimeter security system that is based upon restricted access controls that are changed as employees leave their employment with PANTHERx. b. The area will contain appropriate refrigeration units and HVAC units whose performance will be monitored and recorded daily. Separate thermometers shall be used to monitor each unit s performance. Malfunctions in these systems shall be addressed promptly with the refrigeration and HVAC service companies engaged by PANTHERx for maintenance services. c. The ambient temperature and humidity of the pharmacy area will be monitored and logged daily. Any deviation from the acceptable temperature range will addressed promptly with the HVAC service companies engaged by PANTHERx for maintenance services. d. The area shall only be accessible to employees who have a business purpose or job description that requires access to the inventory area. e. Separate counting trays for chemo therapeutic drugs are to be used at all times. All trays are to be cleaned and sanitized daily. 9. The area shall be supervised by a registered pharmacist who has been designated the pharmacist-incharge of the organization facility where the inventory is stored. 10. Inventory that is unable to be dispensed for whatever the reason shall be stored in a separate area and shall be physically segregated from all other medication inventory storage areas in the facility. Physically segregated means caged, hard-walled, or separated by clear boundaries. 11. The segregated area shall be prominently labeled as NOT FOR PHARMACY USE. 12. Subsections of the secured PAP area that is also physically segregated shall be labeled as Quarantine Area - FOR DESTRUCTION OR RETURN and Quarantine Area PENDING RELEASE. 13. Temperature will be monitored in all company refrigerators, freezers, and the ambient room temperature. a. All refrigerators and freezers will be linked into the backup generator system. Daily s will be sent with temperature recordings. b. All refrigerators, freezers, and ambient room temperature will be linked to a temperature alarm system. In the event that there is a temperature excursion, the Pharmacy Manager and/or On-Call Pharmacist will be immediately notified via and/or text message to rectify the event. Temperature ranges are as follows: Refrigerators 2 to 8 C (36 to 46 F) Freezers -30 to -10 C(-22 to 14 F) c. Ambient room temperature and humidity is monitored by a wall mounted hygrometer. Temperature and humidity ranges are as follows: Ambient Room 20 to 25 C (68 to 77 F) Humidity 45% ± 5% rh d. All temperature excursions will be recorded and investigated appropriately PANTHERx Specialty, LLC 2

155 14. PANTHERx does not currently dispense controlled substances. In the event that PANTHERx begins to dispense controlled substances, receipts will be handled in accordance with regulatory requirements. Documentation will be completed and placed on file as required by state and federal statutes. Documentation must include required signatures by location pharmacist validating receipt as required by state and federal law. Training This policy will be posted on the PANTHERx Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/26/ PANTHERx Specialty, LLC 3

156 LABELING & PACKAGING FINISHED PRODUCTS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-62 URAC Pharm Op 4 ACHC DRX 7-9C CPPA 1.7d PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To assure that all necessary and required information is included on the prescription medication label for safe and accurate administration and to assure the appropriate transportation and storage of prescription medications. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All pharmaceuticals and related supplies that are dispensed as a prescription item shall be labeled appropriately. 2. Labels will meet applicable professional standards and legal requirements. In addition to patient specific information, prescription labels must clearly state the medication name and total dose (if applicable, concentration of medication, type of diluent, total volume of the solution and rate of infusion to be included as well). 3. Labels will contain clear, concise and comprehensive instructions that promote proper use and storage of medications. Appropriate auxiliary labeling will be used. 4. Labels will be clean, legible, and professional in appearance and well attached to each medication container. 5. Pharmacist identification will be included on the label per state specific regulatory requirements. 6. Labels will clearly define beyond use date and time as part of the expiration dating. Contents of Labels 1. Labels affixed to all legend drugs and supplies shall include at minimum: a. Name, address, and telephone number of dispensing pharmacy b. Date dispensed c. Prescription/Serial number d. Full name of the patient e. Name of the drug, strength, and quantity dispensed f. Directions for use g. Name of the prescriber h. Other pertinent information or cautionary labels i. Pharmacists name j. Refills remaining k. The statement Discard after (insert appropriate date, normally 1 year) l. The statement CAUTION: Federal law prohibits the transfer of this drug to any person other than patient for whom it was prescribed m. Special storage instructions (if applicable) n. The generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized PANTHERx Specialty, LLC 1

157 o. If the dispensed drug is a tranquilizer or sedative, it should bear the warning The consumption of alcoholic beverages while on this medication can be harmful to your health if the prescriber so directs on the prescription. p. If the prescription is dispensed in a container other than the manufacturer s original container, a discard date, which shall be the earlier of one year from the date dispensed or the manufacturer s expiration date, whichever is earlier. q. If the prescription is dispensed in the manufacturer s original container, the label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container. r. Route of administration (i.e. by mouth, IV. IM, SC) 2. Additional requirements for labels to include: a. Facility name b. Drug lot number c. Drug expiration date d. Patient room number (if applicable) 3. Additional requirements for labels affixed to parenteral medications include: a. All ingredients b. Flow rate (if applicable) Scheduled date and time of administration c. Compound expiration date 4. Additional requirements for labels affixed to cytotoxic drugs include: a. The statement CAUTION: CHEMOTHERAPY Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

158 PHYSCIAL INVENTORY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-63 ACHC DRX 7-9A CPPA 1.7g PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To provide a consistent and uniform procedure for conducting a thorough and accurate physical inventory. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All activity having any effect on inventory levels MUST be completed prior to beginning the physical inventory count. This activity includes but is not limited to the following: a. Delivery Verification Report b. Wholesale Ship Order Entry c. Receipts of Purchase Orders d. Inventory Transfers e. Miscellaneous Inventory Transactions f. Completion of open prescriptions, transfers, sales orders, shipments, etc. g. Ensure all cycle count or expired product adjustments are completed. 2. The following activities SHOULD NOT be scheduled from the time final inventory activities have been posted until after the physical inventory has been completed: a. Wholesale Shipments b. Receiving c. Lot selection orders d. Picking of orders 3. Perform the physical count for each item and write the information on the count sheet. Count sheets should have the initials of the person who did the actual count, as to prevent double counts by the same person. 4. If an item is on your shelves but not listed on the inventory count sheets, it must be entered through a "Post Physical Adjustment" upon approval from pharmacy management 5. Upon completion of the physical count, inventory quantities will be entered into the Excel version of the inventory count sheet. Inventory count sheets should then be ed to pharmacy management. 6. All manual and electronic count sheets should be saved and kept at the pharmacy for reconciliation and audit purposes. 7. Variances from this report should be reviewed. Any variance greater than $100 should be validated for accuracy. Any variances greater than $1000 must be explained to corporate accounting. Common mistakes are; counting the wrong product, entering the count on the wrong line, miscounting the quantity etc. 8. Corrected mistakes should be adjusted via Post Physical Adjustment. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 2017 PANTHERx Specialty, LLC 1

159 Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

160 PLAN OF CARE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-64 URAC Pharm Op 5 PM 3, 6, 8, 9, 14 ACHC DRX 2-8A, 4-9D, 5-2A, 5-2C, 5-2G, 5-2I, 5-4A, 5-4B, 5-7A, 5-7A.01, 7-18A, 7-21A CPPA 2.2d, 2.2e, 2.2f, 2.2g, 3.5a, 3.5b, 3.6c, 2.3b, 3.4a, 3.4b, 3.2d, 3.6d, 4.1g, 4.1h PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 11/7/14 Scope 1. To provide the patient and/or caregiver with information that can enhance their knowledge, skills, and those behaviors necessary to optimize the benefit from the medical products, equipment and/or supplies provided by PANTHERx Specialty Pharmacy and to provide patients/caregivers with sufficient information in an understandable language and/or format to make informed and shared decisions with clinicians, and to take responsibility for self-management/management activities relative to patient needs, and appropriate to the medical products, equipment and/or services provided and to promote patient safety, thereby promoting improved patient outcomes. 2. To acquire pertinent information from patient s past and present medical information that needs to be considered by the Pharmacist before formulation of the patient specific care plan; to determine if the patient will receive clinical monitoring; and to optimize therapeutic outcomes by promoting continuity of care, using the patient-centered model, while collaborating with health care providers whenever necessary. 3. This pharmacy assessment program (patient educational materials and programs, assessment protocols, etc.) will be evaluated and approved on an annual basis by the Quality Management Committee and the Clinical Oversight/Review Committee to help improve programs for current and prospective patients and clients. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Patients will be clinically monitored prospectively on all new fills and on selected refills and all patients will be offered prospective drug monitoring/drug utilization review, using one of any number of Pharmacy Assessment formats maintained in operating system (based off clinical activity and outcomes, financial costs and benefits of therapy, evaluation of assessment protocols). This function shall be performed/initiated, to the extent possible, prior to the initiation of therapy. Information should include but is not limited to: a. Patient demographics i.e. name, address, telephone number b. Emergency contact and telephone number c. Age, sex, height, weight and lean body weight (LBW) d. Allergies: To include all prescription drugs, over-the-counter drugs, food and environmental allergies e. Therapy: Medications, route of administration, frequency, dose, and intended length of therapy as per referring physician orders 2. A Risk Evaluation Mitigation Strategy (REMS) patient assessment shall be completed on each patient identified as being on a particularly high risk medication prior to dispensing any new prescription. High risk patients are identified by the organization as being on specific REMS drugs, i.e., Revlimid and Thalomid. The Quality Management Committee (QMC) or its designated senior clinical pharmacist, ensures, on at least annual basis, that the REMS assessment content is consist with current FDA/REMS criteria. 3. The pharmacist or his/her designee is responsible for collection, either directly or indirectly, of all pertinent clinical information necessary to conduct the Pharmacy Patient Assessment for new and current patients including, but not limited to: a. Patient-specific disease and drug information, b. Previous medical history, 2017 Pantherx Specialty, LLC 1

161 c. Previous and current clinical and health related outcomes (adverse events, side effects, compliance and adherence), d. Interactions, e. Relevant lab values and health screening data f. Self-reported patient therapy responses. g. History of Present Illness/Medical History and Outcomes from both current and previous health care providers: The written history of an illness should embody all the facts of medical significance in the life of the patient. If the history is documented in chronological order, recent events should be given priority; if documented in a problem-oriented approach, the problems that are clinically significant to the home therapy should be documented in order of significance and used to help project improved clinical outcomes for current and future patients. 4. The pharmacist shall analyze and evaluate this information and identify actual/projected outcomes related to the drug therapy. The drug-related outcomes to be addressed include, but may not be limited to: a. untreated indications b. adverse drug reactions, drug interactions c. appropriate drug selection d. appropriate drug regimen, including dosing e. compliance/adherence to the prescription 5. Additional assessments and the need to gather further data related to patient condition may be identified on the Patient Assessment. Additional assessment and further information may be provided by licensed caregivers (MD, DO, CRNP, RN, Pharm D) or case/disease management programs offered as needed. 6. The patient will be clinically monitored by PANTHERx Specialty Pharmacy to the extent that clinical data is made available to the pharmacist. Procedure 1. Obtain copy of referral and other available sources of patient-specific clinical information. (Patient Assessment, Medication Profile) 2. Conduct preliminary screening of patient data, compare to patient selection criteria and determine the patient s needs. 3. Initiate pharmacy clinical record and incorporate into the patient s electronic medical record. 4. The Pharmacist will complete the Patient Assessment after review of data from the initial screen. The pharmacist may identify potential problems, the need for further assessment and categorize a patient as to the level of monitoring required. 5. The goal is to collect adequate information about the patient, their medical problems and their drug therapy, enabling the pharmacist, in conjunction with the nurse and the physician, to identify drug-related problems and to establish measurable and realistic goals for their home therapy. 6. The findings and recommendations from the Patient Assessment, including actual and/or potential problems, clinical monitoring parameters and changes in drug therapy are documented in the patient s progress notes and are communicated collaboratively to other individuals as needed and per HIPAA laws. Such communications will be made verbally to the physician, or his authorized agent, by secure faxes or via electronic medical record. 7. The pharmacist completing the Patient Assessment electronically signs and dates the document and places it in the patient s profile. 8. PANTHERx Specialty Pharmacy will evaluate the financial benefits of the patient therapy to ensure cost effectiveness and benefits to improve outcomes. If an issue is identified, alternative support and therapy p 2017 Pantherx Specialty, LLC 2

162 options will be assessed to improve financial outcomes for current and future medication needs. Financial assessment for new, current and prospective patients including, but not limited to: a. Copay assistance b. More cost effective alternative therapies (generics, extended release products, less expensive alternative) c. Coordination of multiple benefits or insurance coverage d. Provided in accordance with any 3 rd party payer coverage policies 9. Other current and projected outcome assessments will be evaluated as deemed necessary for new, current and prospective patients. The evaluations of outcome measurements could include but not limited to if deemed necessary: a. Medication Possession Ratio (MPR)/Proportion of Days Covered (PDC) b. Quality of life c. REMS Management d. Adverse Event/Side Effect outcomes e. Discontinuation of therapy Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 09/23/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ p 2017 Pantherx Specialty, LLC 3

163 PRESCRIPTION SCREENING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-65 URAC Pharm Op 2,3 PM 3 ACHC DRX 5-10A PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To define the steps in screening prescriptions for potential adverse reactions or interactions Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. It is the responsibility of the pharmacist to verify the validity of the prescription. If there is any doubt about the validity of the prescription, the pharmacist will verify the validity of the prescription with the physician s office. 2. It is the responsibility of the pharmacist to ensure that the prescriptions received are a result of a physical examination. PANTHERx handles specialty medications that require previous examination and lab results as a part of the enrollment and billing process. This information is gathered during the patient s visit to the prescriber s office. In the event that this information is not provided with the enrollment forms the pharmacist will call the prescriber s office. 3. It is the responsibility of the pharmacist to obtain known drug allergies. 4. It is the responsibility of the pharmacist to ensure that a complete current medication list (OTC, prescription, herbal products, etc.), allergies, previous therapies have been obtained for the patient. The pharmacist will screen the patients medication profile for possible problems and enhancements for improving outcomes. The pharmacist s knowledge may be aided by an electronic screening process incorporated into the medication profile database. 5. It is the responsibility of the pharmacist to evaluate and document any adverse drug effects or drug interactions in a timely manner. These interactions are to include potential problems with existing medications including over the counter medications, foods, or laboratory tests. 6. If potentially serious adverse or drug reactions are present, it is the responsibility of the pharmacist to contact the physician/prescriber. Any recommendations or decisions regarding drug therapy shall be documented either on the prescription or electronically on the patients medication profile. 7. The pharmacist shall inform other healthcare professionals involved in the patient s care of potential adverse reactions, drug interactions, and recommendations. 8. Patients shall be instructed to watch for the appropriate adverse effects and how to contact a healthcare professional should they occur. 9. If any potential problem does occur, the physician/prescriber shall be immediately notified. 10. The pharmacist is responsible for ensuring that all prescribers have licenses in good standing with their respective state Licensing Board of Medicine 2017 PANTHERx Specialty, LLC 1

164 Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 01/25/ PANTHERx Specialty, LLC 2

165 SECURITY POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-66 URAC Pharm Op 4, 8, 14 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope This document describes the security requirements for the pharmacy perimeter and the assets contained within it. This policy and procedure will identify who has access into the pharmacy and the measures taken to secure the pharmacy, its employees, and the inventory. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. PANTHERx Specialty Pharmacy operates with a licensed, registered pharmacist inside the pharmacy at all times. 2. The pharmacy doors remain locked at all times and are opened only by approved pharmacist. 3. All areas within the pharmacy are accessible to all employees of PANTHERx Specialty Pharmacy as long as a licensed pharmacist is present. 4. The closing pharmacist must be the last individual to leave the pharmacy area and is responsible for securing the pharmacy. 5. PANTHERx Specialty Pharmacy does not dispense or stock any Control II-V substances (Narcotics) Definitions Pharmacy Area: A zone which covers the pharmacy area and shipping warehouse Responsibilities 1. The Vice President, Business Operations designates alarms codes to the staff pharmacists so that they may open and close the Pharmacy for each business day. 2. Director, Pharmacy Operations, reviews badge access to ensure only authorized pharmacy personnel has access inside the pharmacy perimeter. 3. The Pharmacist in Charge maintains the pharmacist s schedule to ensure that a licensed, registered, pharmacist is present at all times during pharmacy hours of operation. 4. The scheduled closing pharmacist verifies that all persons have left the pharmacy and shipping area each night before shutting off the lights and setting the pharmacy security alarm. 5. The Pharmacist ensures the doors and loading docks are closed and locked at all times except when receiving/sending a delivery. Input Requirements 1. During off-business hours, the Pharmacy alarm is set by the closing pharmacist. 2. The Pharmacy alarm uses a motion sensor to detect intrusions after hours. 3. PANTHERx Specialty Pharmacy s alarm service shall immediately contact the on-call pharmacist to notify of a potential intrusion, and dispatch local police accordingly PANTHERx Specialty, LLC 1

166 Beginning of Business Day 1. The opening pharmacist deactivates the alarm that encompasses the pharmacy and shipping perimeter. 2. Upon entering the pharmacy, all lights are turned on to alert incoming associates that a pharmacist is present in the pharmacy. 3. If lights are out, employees are instructed to wait until a staff pharmacist arrives. End of Business Day 1. The closing pharmacist must remain within the pharmacy and shipping perimeter until all associates have exited. 2. Upon leaving, the closing pharmacist logs off any computers, shuts off the lights, closes all doors tightly and verifies that they are locked. 3. The closing pharmacist immediately sets the alarm for the pharmacy and shipping perimeter. Pharmacy Visitors 1. All visitors are required to sign-in with the receptionist and obtain a visitor name badge upon arrival. 2. A member of the pharmacy personnel shall escort visitors through the pharmacy to their destination and escort them out of the pharmacy area. Cameras 1. Video cameras are installed and running in both the pharmacy and shipping area and remain on twenty-four (24) hours per day. 2. These cameras are monitored periodically by designated management staff. Terminated Employees 1. Pharmacy personnel turn in any access keys at the time of termination. 2. All individuals shall immediately have all accesses to the building and pharmacy fulfillment systems removed at the time of termination. Output Requirements 1. Narcotic storage is not conducted at PANTHERx Specialty Pharmacy; however, in the event of a change in policy, dispensing shall be done according to federal and state regulations. 2. The Pharmacy is a highly regulated, restricted area. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

167 INTERNAL & EXTERNALPROGRAMS POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-67 URAC CSCD 5 PM 8 PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 11/7/2014 Scope To ensure employees understand the company s internal and external policies surrounding available patient programs. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. All PANTHERx Specialty Pharmacy employees will offer assistance with any internal and external programs that customers may be eligible for based on their patient record and verbal communications. 2. If PANTHERx Specialty Pharmacy is unable to provide any service to customers, a referral will be made to any and all external heath care facilities necessary in order to ensure continuity of care. 3. Employees will be trained in company developed programs upon orientation, when any changes are made and annually. Employees will be encouraged to learn about externally available programs whenever possible. 4. Internal and external programs available include but are not limited to: a. patient management services b. manufacturer co pay and patient assistance programs c. health plan programs i. tobacco cessation programs ii. disease management iii. pain management iv. suicide prevention/behavioral health programs 5. External heath care referrals include but are not limited to: a. Dieticians b. Pain Specialists c. Mental Health Services d. Social Services e. Other Specialty Pharmacies f. Follow-Up care with their own prescriber 6. PANTHERx will create a custom reporting solution to purchasers or customers, when requested or required to demonstrate the results of the patient management program to include metrics that include, but are not limited to: a. Financial outcomes associated with the program b. Clinical health-related outcomes c. Use of relevant laboratory values and health screening data. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 2017 PANTHERx Specialty, LLC 1

168 Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

169 ADVERSE EVENT REPORTING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-68 ACHC DRX 6-3F CPPA 4.1d, 4.1e, 4.1s PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope Documenting, reviewing, and reporting of Adverse Events Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy s approach for Adverse Event collection will remain consistent across all therapies, while data elements documented may vary based on internal needs, manufacturer requirements, and FDA requirements for reporting of identified or suspected adverse events. Documentation: When an adverse event is reported to PANTHERx Specialty Pharmacy, PANTHERx will utilize internal systems, manufacturer created forms, and FDA approved forms to document all the required data elements to successfully submit the adverse event to the intended recipient. These forms may include, but are not limited to: 1. FDA MedWatch Forms 2. Manufacturer Provided Adverse Event Forms 3. Internal Documentation/Tracking forms Adverse events will be categorized internally based on severity per the following criteria: Mild: asymptomatic or mild symptoms that require clinical or diagnostic observation only and do not require therapy or a medical evaluation; signs and symptoms are transient. Moderate: symptoms that require minimal, local, or noninvasive interventions such as a change in therapy or laboratory monitoring Severe: severe, medically significant, disabling, or life-threatening events that require systemic drug therapy, hospitalization, or result in life-threatening consequences or death Review: Adverse events are reviewed by either the Manager of Pharmacy Operations or the Director of Pharmacy Operations for overall awareness and to ensure appropriate documentation and reporting processes are followed. Monthly, adverse events are reviewed by a Clinical Team member to examine internal processes and procedures that may need to be updated or changed to improve documentation, reporting, and customer support related to adverse events. On a quarterly basis, adverse events are reviewed by the Clinical Review Committee during quarterly meetings in order to determine if appropriate actions were followed by the internal team, identify recent 2017 PANTHERx Specialty, LLC 1

170 trends in adverse event reporting by product, as well as identification of additional processes/activities that could be implemented to better service the patient. o o Summary counts of adverse events will be reviewed across all lines of the PANTHERx Specialty Pharmacy business in order to better understand trends within various products as well as to ensure consistency in the documentation approach across various teams. All Adverse events categorized as Severe will be reviewed in detail to ensure that information was reported to the appropriate channels and that all appropriate actions were followed for the manufacturer, stakeholder, and, FDA. Reporting: Completed adverse event forms will be delivered to the required recipients as defined by the service-level agreement between PANTHERx Specialty Pharmacy, impacted stakeholders, and the FDA. Reporting of adverse event details will be delivered to the Clinical Review Committee in parallel to other stakeholder submission in order to aggregate and discuss at a subsequent meeting. FDA MedWatch Reporting: When an adverse drug event is reported to PANTHERx Specialty Pharmacy and deemed appropriate to be reported to FDA, employees utilize and follow the guidelines of the FDA Med Watch program that is detailed out below. The event is reported manually and submitted via fax or online via the MedWatch website (http://www.fda.gov/safety/medwatch/howtoreport/default.htm). 1. Voluntary Reporting by Health Professionals a. MedWatch website should be used to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure suspected to be associated with the use of an FDA-regulated drug, biologic, medical device or dietary supplement. b. In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses this data to maintain our safety surveillance of all FDA-regulated products. c. Your report may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the drug or device and leads to increased patient safety. 2. What to Report on an FDA 3500 Voluntary form a. The FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously during clinical care, not events that occur during IND clinical trials or other clinical studies. Those mandatory reports are to be submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions. 3. To submit your voluntary report: a. Complete the voluntary form online or b. Complete form and fax or mail or 4. What Not to Report on an FDA Voluntary form a. Vaccines Should use the Vaccine Adverse Event Reporting System (VAERS) b. Veterinary Medicine c. Investigational (study) Drugs- Should be reported as required in the study protocol to designated contact person 2017 PANTHERx Specialty, LLC 2

171 External Stakeholder Reporting When an adverse drug event is reported to PANTHERx Specialty Pharmacy that meets the criteria defined by an external stakeholder, employees utilize and follow the guidelines for the specific line of business based on the stakeholder requirements 1. Stakeholder Reporting: a. Reporting of adverse events to external stakeholders such as manufacturers will follow the specific process, layout, and frequency as defined by the specific stakeholder. 2. Prescriber Reporting a. All adverse events categorized as Severe that are reported to any employee of PANTHERx Specialty Pharmacy must be reported to patient s prescriber(s) Internal Reporting All adverse drug events reported to PANTHERx Specialty Pharmacy should be documented using internal tracking forms and documentation tools in addition to FDA and Stakeholder requirements stated above Internal reports will aggregate summary counts of adverse events across all severity categories and lines of the PANTHERx Specialty Pharmacy business in order to support a review by the Clinical Review Committee Reporting will help internal teams under understand trends within various products as well as to ensure consistency in the documentation approach across various teams Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Rob Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/15/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

172 CLINICAL APPEAL POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-69 URAC SDrM 1 PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date 11/7/2014 Scope This procedure is designed to detail the process of notifying members serviced by PANTHERx Specialty Pharmacy that have the right to appeal a drug utilization management that results in denial, termination, or limitation of covered services. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy 1. The patients serviced by PANTHERx Specialty Pharmacy have the right to appeal a drug utilization management that results in denial, termination or limitation of covered services. 2. PANTHERx Specialty Pharmacy will assist with educations of patients, caregivers, and prescribers regarding coverage, appeals and drug therapy. 3. The patient with a written consent authorizes the health care provider or prescriber to provide the appropriate, pertinent clinical information for the appeal request. 4. The clinical information shall be communicated to PANTHERx Specialty Pharmacy Prior Authorization Team in verbal or written format. 5. PANTHERx Specialty Pharmacy has two types of clinical appeal normal and escalated. a. Normal clinical appeal is processed by the Prior Authorization Team. b. Escalated clinical appeal is processed by the Insurance Resolution Specialists. i. Escalated clinical appeal is an appeal of a denied utilization management request that requires additional or extensive clinical pharmacotherapeutic research, or advanced clinical analysis. Procedure 1. Initial or primary prior authorization request denied by a third-party payor. 2. In the situation of an escalated clinical appeal, the manager or the lead-pharmacist of the Prior Authorization Team transfers the appeal request along with all clinical information to Insurance Resolution Specialist and sends a notification by facsimile to the health care provider stating the request is in review by the client or the Insurance Resolution Specialists. Thereafter, all communications shall be accomplished between the Insurance Resolution Specialist and the health care provider or the agent of the health care provider. 3. Prior to transferring the case to the Insurance Resolution Specialist, the Prior Authorization Team initiates the request. 4. The Insurance Resolution Specialist reviews the information provided by the prescriber or the agent of the prescriber. a. Upon receipt of all pertinent information, the coverage is determined if there are sufficient clinical experiences to demonstrate safety, efficacy, and the lack of a formulary alternative. Clinical experiences can be based on clinical literatures or expert consensus. b. In the situation of insufficient information received, a notification of additional information is communicated verbally or by facsimile to the prescriber. The coverage is not determined until all pertinent information has been received within 10 business days. c. In the situation of insufficient information received and no additional information is provided within 10 business days, the review of the request is terminated PANTHERx Specialty, LLC 1

173 5. The Insurance Resolution Specialist determines the drug coverage. a. The drug utilization coverage is determined within three (3) business days upon receipt of all required information. b. The request is terminated after 10 business days from the initiation of the escalated clinical appeal and without a drug utilization coverage determination. c. In the situation where the coverage cannot be determined, the Insurance Resolution Specialist shall transfer the request to the plan. 6. The Insurance Resolution Specialist sends the notification or confirmation regarding the drug coverage to the prescriber. a. For an approved escalated clinical appeal request, a confirmation of the coverage determination is sent by facsimile to the prescriber. The confirmation includes name of the member, member identification, date of birth, gender, carrier name, drug name, the length of approval, additional notes, date of determination, prescriber s name, agent of the prescriber, prescriber s fax number, prescriber s telephone number, and the initial of the Clinical pharmacist who reviewed the request. The coverage is synchronized with the system for retail claim adjudication. b. For a denied escalated clinical appeal request, a notification of the coverage determination is sent by facsimile to the prescriber. The notification includes name of the member, member identification, date of birth, gender, carrier name, drug name, reasons of the denial, date of determination, prescriber s name, agent of the prescriber, prescriber s fax number, prescriber s telephone number, and the initial of the Clinical pharmacist who reviewed the request. The denial is synchronized with the system for retail claim adjudication. c. For a terminated escalated clinical appeal request, a notification is sent by facsimile to the prescriber. The notification includes name of the member, member identification, date of birth, gender, carrier name, drug name, reasons to terminate the request, prescriber s name, agent of the prescriber, prescriber s fax number, prescriber s telephone number, and the initial of the Clinical pharmacist who reviewed the request. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Clinical Pharmacist 11/07/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 2

174 INCIDENT REPORTING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-70 URAC SDrM 5 Pharm Op 15 ACHC DRX 2-3A, 6-3F, 7-11A CPPA 4.1q, 4.1r PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/07/2014 Scope The purpose of this policy is to create a process that effectively reports external errors to the proper management personnel while striving to create an error free work environment and to maintain the highest level of patient safety. The following is the adopted procedure for external error reporting. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Patient informs PANTHERx Specialty Pharmacy s staff that they feel an error has been made after receiving their prescription order. a. If an error is identified, either during a review of pharmacy operations or during reassessment and review of a patient s medication history, the employee is required to report their findings. b. Once the extent and cause of the error is identified, the pharmacist-in-charge will disclose any errors of clinical significance to the patient and/or caregiver affected. The patient will be notified and any corrective action necessary will be discussed. If necessary, the physician will be notified as well to discuss further action or concerns. 2. At this point, PANTHERx Specialty Pharmacy s staff must notify and transfer the call to the pharmacist on duty. The staff should warm transfer the call to the pharmacist giving the pharmacist the patient name and MRN number as well as any information the patient has thus far stated. 3. The pharmacist now must ascertain the details of the alleged error by reviewing the patient charts and records. 4. The pharmacist will then interview the patient to determine what actions need to be taken to rectify the situation. a. It is important for the pharmacist to remain calm and ask open-ended questions. b. It is also important to document if the patient consumed any of the incorrect medication and the events surrounding that. c. If the patient received the incorrect medication or an error of clinical significance, a phone call will immediately be placed to the patient s physician to inform them of the occurrence. PANTHERx Specialty Pharmacy will work with the patient/caregiver and physician to get the patients needs addressed to improve outcomes of treatment. The pharmacist will then authorize the reshipment of the correct medication to be delivered by Next Day Air as well as a postage paid envelope for the return and processing of the prescription error. 5. The Quality Improvement Opportunity (QIO) form must then be completed via employee intranet, which is forwarded to the Pharmacist Manager to proceed with an additional in-depth investigation, if that is determined to be necessary. 6. The Pharmacist Manager will complete the investigation and where possible, determine the cause of the error. 7. The prescription process will be examined and modifications to the process will be made to avoid the error in the future PANTHERx Specialty, LLC 1

175 8. Persons responsible for the error will be informed of the incident and counseled and dependent upon any previous occurrences, disciplinary action may be taken. (Refer to the employee handbook) 9. All QIO s are reviewed by the appropriate members of the management team and the pharmacist in charge. These QIO s will be reviewed by the quality committee for improvements and prevention when applicable to opportunities for quality and error management in the facility. 10. During the quarterly Quality Management Committee meetings, or at least on an annual basis, the Quality Committee will review and provide oversight related to issues/events identified involving quality concerns or accuracy of errors that have been escalated through the process defined above. 11. Records of errors are confidential information and will be kept on file at the facility in the possession of the pharmacist in charge. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Matthew Barletta, PharmD Sr. Pharmacy Manager 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 2

176 MISSION STATEMENT STANDARD OPERATING PROCEDURE POLICY NUMBER PS-71 URAC PC 2 PM 1 CPPA 1.2b, 1.2c, 1.3a PANTHERx Specialty Pharmacy Policy Owner Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date 10/23/2014 Scope To describe the mission, vision, and values of PANTHERx Specialty Pharmacy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Our Mission: PANTHERx Specialty transforms lives by delivering medical breakthroughs, clinical excellence, and access solutions to patients afflicted with rare and devastating conditions. Our Vision: PANTHERx Specialty will become the national leader in specialty pharmacy for rare and devastating conditions by providing unrivaled care to our patients, service to our providers, and attention to our partners. We will: Reinvent Specialty by creating solutions based on our stakeholders real-time needs. Revolutionize Pharmacy through bold innovation in care and technology with unparalleled investment in tools and talent. Redefine Care by integrating novel clinical services with the life-transforming therapies we deliver. Our Values: GENUINE INTEGRITY: We conduct ourselves with sincerity, transparency, and honesty. DISRUPTIVE INNOVATION: We responsibly approach challenges with a creative, tailored strategy to consistently exceed expectations. UNCOMPROMISING QUALITY: We insist on attention to detail in every aspect of delivering excellent patient care. MUTUAL GROWTH: We commit to relentlessly educate our patients, our providers, our partners, and ourselves. RESPECTFUL CULTURE: We foster a culture of humility, gratitude and trust. SUPPORTIVE AMBITION: We value effective teamwork. AUTHENTIC DEDICATION: We sincerely care. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet as well as physically posted in the pharmacy area. This policy will be reviewed at least annually to ensure that is continuously correlates with PANTHERx mission, vision and values PANTHERx Specialty, LLC 1

177 Approvals/Change History Last Edited by: Title Date Version Austin Russian, PharmD Clinical Pharmacist 10/23/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 12/05/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Panther Specialty, LLC 2

178 ADVERSE AUDIT REPORTING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-72 ACHC DRX 1-10A PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 4/6/2015 Scope To establish a protocol for reporting outcomes negatively affecting compliance of regulations or licenses Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure The Vice President, Quality & Education will report to the Governing Body and PANTHERx Specialty Pharmacy management any outcomes from audits or other activities which negatively affect continued compliance of any regulation or license within 24 hours of finding. Findings will be reviewed and discussed with the Quality Management Committee and Compliance Committee during the subsequent quarterly Quality Management Meeting and/or Compliance Meeting. Associated Federal and State regulatory agencies will be informed within 30 days of such outcome. ACHC Accreditation Company will be sent a written report within 30 days of finding for any of the following events. The report will include all actions taken and associated plans of correction. Revocation of Medicare, Medicaid or any Third-Party Provider Number Any license suspension or sanction Civil penalties awarded against the company in the amount of $10,000 or more License probation or any conditions of restriction to License(s) Non-compliance with Medicare or Medicaid regulations identified during survey process or by another regulatory body. Evidence of an adverse event will be documented in quarterly Quality Management meeting minutes, copy of reports to Accreditation Body, Federal Agency and State License Agency reports and/or inspections from authorized regulatory and accrediting bodies. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ PANTHERx Specialty, LLC 1

179 Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

180 BILLING PROCEDURE COMPLIANCE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-73 ACHC DRX 3-1A, 3-2A PANTHERx Specialty Pharmacy Policy Owner Austin Russian, Director, Pharmacy Operations Effective Date: 4/6/2015 Scope To establish a protocol for proper billing procedures Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx maintains compliance with all rules and regulations to ensure proper billing procedures based on requirements/regulations of specific payer. Procedures included (but not all inclusive): o o o o o o o o Proper intake documentation/information Assignment of Benefits (Assigned Claims) Release of Information Proof of Delivery Signed/Dated Documentation Required Proof of Medical Necessity Proper Claim and Modifier Generation Posting of Payments / Subsequent Co-insurance Claim production Denial Follow-up Billing procedures are monitored as part of the company s PI Program. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

181 COMPLIANCE PROGRAM STANDARD OPERATING PROCEDURE POLICY NUMBER PS-74 ACHC DRX 2-9A PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 4/6/2015 Scope: To establish a Compliance Program and Internal Controls for Ongoing Quality Monitoring and Management Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure The organization has an established Compliance Program that provides guidance to the various internal anti-fraud and abuse controls. The Compliance Program identifies and discusses numerous compliance risk areas particularly susceptible to fraud and abuse. The Governing Body is responsible for the oversight of PANTHERx Compliance Plan. PANTHERx is committed to conducting its business with integrity and in accordance with all federal, state and local laws. PANTHERx will continually monitor applicable state and federal laws and regulations to ensure compliance of current operating procedures. PANTHERx will investigate and report any occurrence of unethical or unlawful behavior when detected. Management or Staff involved in any unethical or unlawful activity will be disciplined to the extent appropriate up to, and including, termination. PANTHERx will educate its staff on their Compliance Plan and will designate a compliance officer to oversee the program. The compliance officer is accountable to the governing body and PANTHERx Specialty Pharmacy management All staff involved in patient care, billing or claims processing will be trained on fraud and abuse laws. PANTHERx will conduct internal audits to assure that billing processes are compliant with requirements. Evidence of compliance activity will be documented with the Compliance Plan, Performance Improvement Plan and monitoring activity, employee orientation records and in-service records. The Compliance Program details actions the organization takes to prevent violations of the fraud and abuse laws, privacy and security, as well as standards related to continued accreditation compliance. Implementation of written policies and procedures and standards of conduct Designation of a Compliance Officer, as defined in a job description and Compliance Committee (The committee is comprised of the same membership as the Quality Management Committee as Compliance supports overall Quality). Conducting effective training and education programs Development of open lines of communication between the Compliance Officer or Compliance Committee and organization personnel for receiving complaints and protecting callers from retaliation Performance of internal audits and mock accreditation reviews to monitor compliance Establishing and publicizing disciplinary guidelines for failing to comply with organization standards and policies and applicable statutes and regulations Prompt response to detected offenses through corrective action 2017 PANTHERx Specialty, LLC 1

182 Monitoring of applicable and current accreditations for changes to existing standards or requirements, which include organizations such as URAC, ACHC, CPPA and VIPPS. Monitoring is accomplished via multiple channels including, but not limited to: o Newsletters o communication o Quarterly review of accrediting standards via website/portal o Any changes are then reported to the Compliance Committee and necessary updates are made. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 6/16/ PANTHERx Specialty, LLC 2

183 CUSTOMER INFORMATION CONFIDENTIALITY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-76 ACHC DRX 2-5A, 2-5C CPPA 1.14a, 1.14d PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 4/6/2015 Scope To provide a process for confidentiality within PANTHERx Specialty Pharmacy Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx shall treat all information regarding customers as confidential. On the start of services/intake, each customer will receive a HIPAA Notice of Privacy which will explain how PANTHERx may use or disclose Protected Health Information or Payment Card Industry information (Paper PHI/PCI or Electronic EPHI/PCI). On set up, PANTHERx will obtain verbal consent (as appropriate) for Release of Information which allows PANTHERx the sharing of information with client s family members such as a spouse or children, care givers, physician or other organizations/individuals which require such information for activities such as billing. Sharing of information includes, but is not limited to, providing refill assistance over the phone or requesting a printout of the patient s account information. The patient will be made aware of the level of accessibility and will have the ability to set restrictions if they choose. Staff will be required to participate in training on patient confidentiality as part of orientation and will be noted in personnel file. Security of customer records including PHI/PCI will be maintained at all times. Storage accommodations minimizing the potential for fire or water damage will be utilized. Customer information (PHI/PCI) will not be left in public areas. Any non-employee person having need to access customer records (i.e., billing company, contracted perdiem staff) will be required to sign a PHI/PCI Privacy Agreement (Business Associate Agreement) and will be kept on file. It will be the responsibility of the company to monitor such agreement. Original customer records may not be removed from the location of storage without written consent of the compliance officer. In the case removal from location is required, customer files will be boxed and secured and signed out by the person removing the files noting the date, reason, destination and name of customer record. (Customer Record Offsite Destination Log) All Governing Body members and staff are required to sign a confidentiality/privacy statement The Compliance Officer is responsible for seeing that confidentiality and privacy policies and procedures are adopted and followed Staff member seeing customer first will provide written information and will discuss confidentiality/privacy of customer s Personal Health Information A signed Release of Information by the customer/authorized rep will be filed in customer record PANTHERx requires a Business Associate Agreement (BAA) for all Business Associates who may have access to PHI/EPHI/PCI in compliance with HIPAA and other applicable laws and regulations 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

184 Additional Info: HIPAA Statement handout for customers Your Right to Privacy This information describes how medical information about you may be used and disclosed, and how you can get access to this information. Please read carefully. PANTHERx is committed to protecting the privacy of all customers we serve. PANTHERx treats all personal health information (PHI/PCI) as confidential. There are times; however, when we are allowed by the Health Insurance Portability and Accountability Act (HIPAA) to share your personal health information with other entities. They are: When authorized by you When it is required or permitted by law When necessary to perform treatment, health care operations or process payments PANTHERx receives personal health information in a number of ways. It may be received directly from you through prescription orders, survey responses or by calls placed to our Customer Service Department or clinical staff. At any time, you can request information as to whom and when PANTHERx has shared or exchanged your PHI/PCI. At times, PANTHERx, may receive, send or exchange personal health information with other entities including physicians, medical groups, retail pharmacies, health plans, pharmacy product manufacturers and benefit plan sponsors, primarily for these reasons: 1. For Treatment. PANTHERx may contact your physician to verify information on a prescription. Treatment can also include other services; such as refill reminders. 2. To Process Claims for Payment. PANTHERx may use your personal health information to process a claim for payment to your insurance carrier. 3. To Perform Health Care Operations. PANTHERx may use your personal health information in the PANTHERx day to day operation. Activities may include training, auditing, formulary, management of the business, administrative activities, and quality improvement activities. In these cases, the results are presented in a summary format and to not identify you as an individual. 4. Prescription History. PANTHERx may review your individual prescription history in order to offer related products that may be of interest to you. These offers are sent or given to you in the form of a flyer. 5. Government Agencies or Legal Firms. There may be times when PANTHERx is required to share or exchange personal health information with government agencies or legal firms to comply with subpoenas, to prevent fraud, or to protect public health and safety. PANTHERx Protects your Information. PANTHERx has security procedures in place to protect your PHI/PCI; it is only seen by individuals who have a need to see it. Your information is protected by locked cabinets and a secure setting. Our computers are protected by network security, passwords and data encryption for electronic transmissions. Only staff who need this information to perform specific job tasks are allowed access to it. If any staff violates PANTHERx s privacy policies, they are subject to disciplinary action. You Can Restrict Disclosure. It s your Right. Every customer has the right to confidentially view his/her own PHI/PCI such as prescription claims history. You can also request that PANTHERx not share your PHI/PCI with certain entities or individuals by writing a request to restrict disclosures to Compliance Officer of EIRIS Health Services. PANTHERx is not required to agree to a requested restriction; and you cannot restrict the sharing of information that is necessary for treatment, payment or health care operations. Upon written request, you can also revoke a previously written authorization. If you believe that your privacy rights have been compromised, 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

185 PANTHERx s clinical staff or Owner can assist you. If PANTHERx cannot resolve your concern, the Department of Health and Human Services in your area can assist you. PANTHERx is bound by law to abide by this notice and to maintain the privacy of PHI/PCI. PANTHERx reserves the right to change this notice; and changes will apply to all PHI/PCI maintained at PANTHERx. If PANTHERx makes any changes to this privacy policy, updates will be posted on location. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/23/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 3

186 EMPLOYEE PERSONNEL FILE STANDARD OPERATING PROCEDURE POLICY NUMBER PS-77 ACHC DRX4-1A, 1B, 1C PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager Human Resources Effective Date: 5/3/17 Scope To provide a list of all documentation needed within an employee s record Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy maintains employee records on all employees. Employee records will be kept in a locked storage space and electronically in a secure site, and only accessed by the Manager, Human Resources and/or the Compliance Officer for purposes of completing an audit or retrieving HR relevant information. Employees have access to review their personnel file in the presence the Human Resources representative upon official request. Each employee record shall contain (minimally and as appropriate): Application form and/or Resume Reference results for two (2) references Emergency contact information State and Federal withholding statements signed and dated (as applicable) Employee orientation checklist Copies of credentials/licenses, or primary verification from credentialing website (if applicable) Performance and Competency evaluations, as appropriate (Probationary and Annual) Conflict of Interest Statement Confidentiality Agreement Job Description Documented Receipt of Personnel Policies Statement of Wages/Compensation and Benefits, as applicable Other documents to be maintained as confidential, or waived to be included if not required: Hepatitis B: Accepting Vaccine or Declining Vaccine (Direct Care Staff) TB test results as required per policy (Direct Care Staff) Health Insurance enrollment or decline (if applicable) Background Check results (Criminal, Sex Offender and OIG Exclusion, as applicable) *Federal immigration form (I9) Tennessee Abuse Registry, Tennessee Felony Registry, Tennessee Sexual Offender Registry Employee records will be maintained for a minimum of seven (7) years after resignation or termination. Employees are required to make personal information updates as needed in the employee self-service payroll system to include; name, address, emergency contact and tax withholding information. 24 Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

187 Employee records will be made available for inspection by Federal, State Regulatory Agencies and Accreditation Agencies as required. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 11/13/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Manager, Human Resources 05/03/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 2

188 EXECUTIVE LEADER STANDARD OPERATING PROCEDURE POLICY NUMBER PS-79 ACHC DRX 1-4A CPPA 1.2g PANTHERx Specialty Pharmacy Policy Owner Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date: 4/6/2015 Scope To explain the daily leadership of PANTHERx Specialty Pharmacy Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times Policy/Procedure PANTHERx Chief Executive Officer is responsible for executive relationships, strategy, and oversight of the Executive Leadership Team. The Chief Executive Officer will guide PANTHERx in a manner which complies with all federal, state, and local laws. The Chief Executive Officer is also ultimately responsible for the company s compliance to all Medicare, Medicaid and other payer groups in its daily operations. Specifically, the Chief Executive Officer will: Direct the organization s ongoing functions Fill the Executive Leadership Team roles with dedicated and qualified employees Maintain ongoing liaison functions among all members of the Executive Leadership Team, professional staff, and ancillary staff Ensure adequate staff training and evaluations are completed Ensure the accuracy of public information materials and activities Implement an effective budgeting and accounting system Govern activities as they pertain to Mission, Vision, and Values The application and/or resume of the Chief Executive Officer (only if other than an owner of the corporation) will verify that the individual holding this position meets the minimum education and experience requirements as defined by the specific company job description and all applicable state and federal laws and regulations. PANTHERx will provide information regarding any changes in the Chief Executive Officer position to Accrediting Organizations and other required Governmental agencies, as applicable, within 30 days of the change. If the Chief Executive Officer of PANTHERx is absent, (temporarily or permanently) the General Manager will fulfill his/her duties until his/her return or until another individual is selected to fulfill the duties of this position. The job description of the General Manager will document the duties that this individual will assume while replacing the Chief Executive Officer. Evidence of orientation to these duties will be documented. In the case where the replacement is a co-owner of PANTHERx Specialty Pharmacy, a separate job description is not required. The VP of Quality and Education will serve as PANTHERx s Compliance Officer PANTHERx Specialty, LLC 1

189 Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

190 FINANCIAL BUDGETING, RETENTION, AND ACCOUNTING STANDARD OPERATING PROCEDURE POLICY NUMBER PS-80 ACHC DRX 3-1A, 3-2A CPPA 1.6a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards of financial budgeting, retention, and accounting. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure ACCOUNTING: PANTHERx Specialty Pharmacy will utilize standard principles of accounting and sound business practice in its fiscal management. PANTHERx utilizes: Checkbook, cash receipts journals and a general ledger to track revenues and expenses. An accounting system will track all revenue, expenses and reconcile individual payor accounts following payments by insurances or other means. A signed delivery ticket or positive carrier delivery notice will document proof of customer receipt of goods/services and will serve as the source document for all claims to all carriers. All receipts shall be posted to the customer s account and deposited directly into the bank account as received. A review of the open accounts receivable will identify any adjustments/write-offs that are required on customer accounts. Patients will be invoiced monthly for any outstanding balances on their accounts. It is the policy of PANTHERx to process any credit balances as soon as they are identified and return overpayments immediately to customers or other insurance carriers. Primary and secondary claims will be transmitted/sent (either electronically or by paper claim) as created. All co-insurances, deductibles, co-pays and insurance denials balances that can be forwarded to the customer as a private responsibility will be done on an on-going basis. Private balances over 90 days will be considered delinquent and may be sent to a collection agency for action to collect or written off pursuant to company credit policy. PANTHERx does not extend credit. PANTHERx will alert customer as soon as any changes in reimbursement from third party payers change. RETENTION and REVIEW OF FINANCIAL RECORDS: PANTHERx will maintain all financial records for the current fiscal year plus five (5) years into the future, to comply with IRS, Medicare and banking requirements. The Management Team will perform a quarterly review of current year financials. Financial records of PANTHERx will be reviewed on an annual basis by an outside accounting firm. BUDGETING: PANTHERx Governing Body, in conjunction with individuals in charge of the day to day operations of the company, will prepare an annual budget projecting revenues and expenses for the next fiscal year in the 4th quarter of the current year PANTHERx Specialty, LLC 1

191 The budget will be used as a tool to determine whether or not the company is expected to be profitable. Budgeted revenue and expenses will be reviewed and updated on an annual basis. Standard principles of accounting will be utilized. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

192 IN-SERVICE POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-81 ACHC DRX4-8A CPPA 3.8b, 1.5k, 3.8a PANTHERx Specialty Pharmacy Policy Owner: Douglas Gebhard, Vice President, Quality & Education Effective Date: 4/6/2015 Scope To explain the standards of company In Services and applicable programs. Policy/Procedure PANTHERx Specialty Pharmacy offers on-going in-service programs to all employees relative to the services it offers. The following topics will be in-serviced annually Infection Control / Universal Precautions Safety testing on equipment used in work environment Fraud, waste and abuse Ethical Issues (including cultural) Sexual Harassment (work place / customer) Emergency/Disaster Training / Fire Safety Handling of complaints/grievances (employee/customer) Workplace and Customer Home Safety Supplier Standards Customer Rights and Responsibilities HIPAA and patient privacy Cultural Diversity Communication Barriers OSHA (Right to Know Laws) In-services may be presented via video, lecture or self-study, journals, internet either directly or via outside sources for each position based on requirements of position. A list of required employee training topics will be posted. The Compliance Officer will assure that all required training is completed. All in-service attendance will be documented and maintained by the Compliance Officer. Professional staff will complete appropriate in-service hours to comply with licensure. Non-professional staff will complete appropriate in-service hours based on list of topics required based on job responsibilities. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action 2017 PANTHERx Specialty, LLC 1

193 Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

194 INFECTION CONTROL STANDARD OPERATING PROCEDURE POLICY NUMBER PS-82 ACHC DRX 7-1A PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards of infection control. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy conforms to acceptable standards of infection control related to home care equipment and clinical respiratory services (applicable as provided) issued by the Centers for Disease Control (CDC), the Health Department and OSHA (as applicable). The Compliance Officer will be responsible for the implementation of infection control activities and staff training. This policy covers: All staff, full or part-time, or volunteers having direct physical contact with customers or dirty equipment. All staff are expected to comply with defined hand washing techniques and the CDC s recommended Universal Precautions Infection Control training will be completed as part of new employee orientation. All employees will be required to attend an in-service on blood borne pathogens and infection control on a yearly basis. In-service training will include the following topics: general infection control measures appropriate for service(s) provided hand washing universal precautions / personal protective equipment appropriate cleaning/disinfecting procedures (if applicable) infection surveillance, monitoring and reporting of employees and customers disposal and transportation of regulated waste, if applicable precautions to protect immune-compromised customers employee health conditions limiting their activities assessment and utilization of data obtained about infections and the infection control program equipment-handling procedures, if applicable (hand-washing, unpacking and storage of) needle stick prevention and safety (if applicable) Employee infections If an employee contracts an infectious disease considered to be serious in nature and/or is transmittable to others, they will be re-assigned from direct customer contact and staff contact for as long as they remain infectious. TB Exposure Control Plan (as applicable regarding direct care staff): The TB Exposure Control Plan for PANTHERx includes a current organizational assessment of the community and company TB incidence/prevalence rate as required by CDC guidelines PANTHERx Specialty, LLC 1

195 1. The Manager, Human Resources, will review the plan on an annual basis and update as necessary to reflect modification(s) of tasks/procedures necessary that may result in occupational exposure. A copy of the plan (if applicable) will be available to all direct care staff during their shift. 2. If an employee has a common infection (such as a cold or respiratory infection) they are required to engage the following precautions: minimize or avoid customer contact use proper hand washing techniques use a mask around customers if necessary avoid contact with customers or other staff who may be immunosuppressed cover mouth and nose with a tissue when coughing or sneezing dispose of used tissues staff who have skin lesions/sores must wear gloves or other protective barriers while handling equipment or other office machinery 3. If employee is positive for HIV or HBV, they are required to engage in the following precautions: use proper hand washing techniques avoid customers who have communicable diseases dispose of soiled tissues, bandages, soiled gloves, and other personal items that have contact with bodily fluids in a closed and secured bag and dispose in a waste receptacle 4. PANTHERx will inform all prospective employees the level of potential exposure to blood, body fluids or dirty equipment of the job they are applying. If individual accepts job offered, appropriate training in personal protection will be in-serviced. 5. PANTHERx defines exposure levels as: Level 1 Duties do not expose employee to blood, bodily fluids or dirty equipment Level 2 Duties have a remote/minimal exposure potential to blood, bodily fluids or dirty equipment. Duties are not a mandatory part of the job. Level 3 Duties involve potential exposure to blood, body fluids and dirty equipment. 6. PANTHERx instructs all employees during orientation to utilize universal precautions in the event they are unexpectedly exposed to blood, bodily fluids, or dirty equipment from any aspect of their position. 7. Standards of infection control practice references: CDC (Centers for Disease Control) State Practice Acts Association for Professionals in Infection Control (APIC) American Nurses Association (ANA) Hand Washing PANTHERx will instruct all employees to follow the following hand washing procedure: 1. Employees will wash hands with plain soap and water; or an antimicrobial soap and water if: Hands are visibly soiled (dirty) Hands are visibly contaminated with blood or body fluids Before eating After using the restroom 2. How to wash hands with soap and water: Wet hands first with warm water (not HOT water) Apply soap to hands Rub hands together for at least seconds Cover all surfaces of the hands and fingers, wrists and exposed forearms Rinse hands with water and dry thoroughly with dry towel/paper towel Use paper towel to turn off water faucet 2017 PANTHERx Specialty, LLC 2

196 INFECTIOUS DISEASE EFFECTIVENESS REPORTING 1. PANTHERx will maintain a log of all infectious diseases incidences of staff and/or customers. 2. The Infection Disease Log will be reviewed at Quarterly Quality meetings on a quarterly basis and a summary report completed by the Quality Committee Chairperson. Follow up action will take place if warranted to eliminate internal company causes of any infection. Follow up action will be logged on the Infection Control Log 3. PANTHERx will report all communicable diseases, if required, to the local and/or state health department If/when they are discovered. 4. A representative listing of diseases which are typically considered to be reportable (not completely inclusive of all): AIDS Anthrax Botulism Chickenpox Chlamydia Cholera Influenza Lyme s Disease Malaria Measles (Rubeola) Meningitis (Aseptic) Meningitis (Bacterial) Mumps Pertussis (Whooping Cough) Plague Poliomyelitis Rabies Rubella (German Measles) Salmonella Infection Smallpox Syphilis Tetanus Trichinosis Tuberculosis Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director of Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

197 RESHIP POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-83 URAC Pharm Ops 4, 6 ACHC DRX 5-11A, 5-11B PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 11/7/2014 Scope To explain the method of dealing with delayed or lost medication shipments Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Purpose Reshipping medication for orders that are delayed or have not been received Policy 1. All shipped packages are monitored and tracked daily to ensure delivery to a patient. 2. When a patient has not received their medication within a reasonable amount of time and they are running low on medication, PANTHERx Specialty Pharmacy will make every effort to provide the member with a replacement or temporary supply until the original shipment arrives. Procedure Wrong Address and Lost in Mail 1. A patient calls in and indicates they have not received a medication. 2. The Patient Care Coordinator (PCC) completes the reship request, asking the appropriate questions and using the available tracking methods to determine if the package was: a. Sent to an incorrect address b. Tracked package via FedEx or appropriate tracking system. 3. This request is forwarded to the pharmacy manager for review. 4. If it is determined that an order was shipped incorrectly due to an organizational error (i.e. wrong address coding, or not sent to alternative address as requested when order was placed) then the order will automatically be replaced with no billing to the patient or the client. 5. However, if we cannot determine why the order is delayed, the patient has less than 4 days of medication or the item has not been delivered by the expected delivery date, then the following will occur... a. PANTHERx Specialty Pharmacy will request an override from the claim processor along with the appropriate copay. b. The patient is given the option to keep both shipments and pay both copays or to refuse the second order and the claim will be reversed and the copay credited when the package is received back by PANTHERx Specialty Pharmacy. c. If the patient opens both packages they will be responsible for both copays. d. Some plans will not allow for an override. If the member is out of medication a courtesy replacement order will be sent to the patient. This is at PANTHERx Specialty Pharmacy s cost. The patients account will be noted so monitoring can be done in case of fraudulent activity PANTHERx Specialty, LLC 1

198 6. Most often what has occurred is that the order was delayed or misrouted via FedEx and it is truly the exception that one never arrives. PANTHERx Specialty Pharmacy Director of Pharmacy will help to monitor orders over $1,000 to help ensure timely delivery. 7. If PANTHERx Specialty Pharmacy determines through monitoring that a shipment will be delayed, PANTHERx Specialty Pharmacy will notify the patient and/or the physician s office to alert them of the delay and to determine if any action is necessary. Damaged and Miscounts If a member receives a damaged medication or does not receive the correct amount of medication (i.e. shorted, received 89 out of the 90 pills shipped), PANTHERx Specialty Pharmacy will send out additional medication. 1. A member calls in and indicates they have received a damaged medication. a. The Patient Care Coordinator (PCC) completes the reship form, asking the appropriate questions to determine how much of the medication was damaged. b. The reship request is forwarded to the pharmacy manager for review. c. If it is determined that the damage is through shipping (i.e. broken pills, etc.), the damaged supply will be replaced with no billing to the patient or the client. d. If it is determined the damage was due to patient error, (i.e. leaving insulin out in the heat for over 24 hours) an attempt will be made to receive some sort of compensation from the client/manufacturer. The patient will not be charged. e. If the damaged quantity is over half the amount of the medication or we have reason to believe the medication cannot be used by the patient, PANTHERx Specialty Pharmacy will send a postage paid envelope or do a driver pick up to retrieve the medication. 2. A member calls in and indicates they were shorted medication. a. The Patient Care Coordinator (PCC) will log comments with the prescription number, drug name, quantity shorted, and shipment number noted. If the customer needs the medication immediately a reship request, is forwarded to the pharmacy manager for review. b. If the amount missing is over half the medication, the pharmacy will count on-hand stock to determine the validity of the request. c. If it is determined we did short the medication, or the amount of missing medication is negligible, we will replace the missing supply with no billing to the patient or the client. d. If it is determined no error was made, the Pharmacist-In-Charge or Patient Care Coordinator (PCC) will contact the member. Prescription Error and Packing/Manifest Error When PANTHERx Specialty Pharmacy sends an incorrect medication to a member, we will correct that error by sending out the correct medication and counseling the member concerning the error. 1. A member calls in and indicates they have received an incorrect medication. a. The Patient Care Coordinator (PCC) completes the reship request, asking the appropriate questions to determine if the medication was: i. Incorrect due to a prescription error ii. Incorrect due to a packing/manifest error b. The Patient Care Coordinator (PCC) will then transfer the member to a pharmacist for counseling and complete the reship request that is forwarded to the pharmacy manager for review. c. If it is determined that the error is a prescription error, the Pharmacist- In-Charge will inactivate the incorrect prescription. The claim for the incorrect prescription will be reversed and the new order will be processed through the insurance. A postage paid envelope will be sent to the patient to retrieve the incorrect medication or send a driver to retrieve the medication. d. If it is determined the error is a packing/manifest error, and the member did not receive his or her own medication, then the order will automatically be replaced with no billing to the patient or the client. A postage paid envelope will be sent to the member or a driver pick up scheduled to retrieve the incorrect medication. e. The Pharmacist-In-Charge will contact the patient whose medication went to the wrong member to confirm if he or she did not receive his or her own package. f. If the patient did not receive his or her own medication, then the order will automatically be replaced with no billing to the patient or the client PANTHERx Specialty, LLC 2

199 g. If it is determined no error was made, either the Pharmacist-In-Charge or Patient Care Advocate (PCA) will contact the member. h. HIPAA Breach reports and notifications will be made as outlined in P&P. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 11/07/ Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 3

200 ALTERNATIVE LEADER POLICY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-84 ACHC DRX 1-4A CPPA 1.2g PANTHERx Specialty Pharmacy Policy Owner: Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date: 4/6/2015 Scope To explain the standards of the Alternate Leader Policy. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure The General Manager is responsible for day to day operations and services and is directly accountable to the CEO. He/She will guide the operation of PANTHERx in a manner which complies with all federal, state and local laws. The General Manager is also responsible for the company s compliance to all Medicare, Medicaid, and other payer groups in its day to day operation. Specifically, the General Manager will: Coordinate and direct the organization s ongoing functions Employ dedicated and qualified employees Maintain ongoing liaison functions among all members of the governing body, professional personnel, and ancillary staff Ensure adequate staff education and evaluations are completed Ensure the accuracy of public information materials and activities Implement an effective budgeting and accounting system The application and/or resume of the General Manager (if other than the owner) will verify that the individual holding this position meets the minimum education and experience requirements as defined by the specific company job description and all applicable state and federal laws and regulations. PANTHERx will provide information regarding any changes in the General Manager position to ACHC and other required Governmental agencies, as applicable, within 30 days of the change. If the General Manager is absent, (temporarily or permanently) The VP of Business Operations will fulfill his/her duties until his/her return or until another individual is selected to fulfill the duties of this position. The job description of the VP of Business Operations will document the duties that this individual will assume while replacing the General Manager. Evidence of orientation to these duties will be documented. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action 2017 PANTHERx Specialty, LLC 1

201 Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/06/ Rob Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

202 CULTURAL & COMMUNCATION BARRIERS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-85 ACHC DRX 2-8A, 2-8B CPPA 3.5a PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 4/6/15 Scope To explain the standards of cultural and communications barriers Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx will strive for all communications between PANTHERx and customer and referral sources to be accomplished in a language that can be understood by both. 1. When communication barriers exist, PANTHERx will take steps to communicate information to the customer or referral source through a family member, other care-giver, translators or other communication aids available. Hearing Impaired - Use of written/fax copy, or TDD Limited English or English as Second Language Use of Language Line interpreter service with an interpreter in the required language at Services are available 24/7. Visual Impairment All documents will be read out loud or provided in large print format 2. PANTHERx will request a return demonstration to ensure that the customer or delegate understands instructions based on the product/supply provided. 3. PANTHERx will provide all written and verbal information in English. 4. Staff is expected to show respect for each referral source s and customer s cultural background and religious beliefs. Staff will be educated upon initial hire and annually on various cultural backgrounds and religious beliefs and their impact of the customer s lifestyle, habits, health views, healing, terminal illness and dying. 5. Staff is expected to put aside their own beliefs and show support for referral sources and customers through any/all of these events which the staff member may become part of during the provision of services to the customer. 6. Staff is provided annual education and resources to increase their cultural awareness of customers served by the company. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge 2017 PANTHERx Specialty, LLC 1

203 Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

204 LEGAL AUTHORITY STANDARD OPERATING PROCEDURE POLICY NUMBER PS-86 ACHC DRX 1-1A CPPA 1.1g PANTHERx Specialty Pharmacy Policy Owner Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date: 4/6/2015 Scope To explain the standards of legal authority. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy, LLC is a business in good standing and will maintain all documents regarding its legal authority as granted by the Pennsylvania Secretary of State. PANTHERx Specialty Pharmacy will complete and submit all necessary reports as required by federal, state, or local regulations. Licenses and permits required by federal, state, or local regulations will be maintained and posted in an obvious place within the public area of the company for viewing by any interested party. A copy of Articles of Incorporation, Bylaws, and all applicable amendments will be kept on file and made available as necessary. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

205 LICENSES & PERMITS STANDARD OPERATING PROCEDURE POLICY NUMBER PS-87 ACHC DRX 1-1B CPPA 1.1a, 1.1g PANTHERx Specialty Pharmacy Policy Owner Jonathan Ogurchak, Director, Clinical Programs & Pharmacy Operations Effective Date: 4/6/15 Scope To explain the standards and management of licensure and permits Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure 1. Licensure/permits will be reviewed monthly for accuracy, expiration, and compliance. 2. Appropriate paperwork will be submitted for expiring and/or changing licensure/permits in advance in order to ensure continued compliance with all State and Federal regulations. 3. Once a new license/permit is received, it will be scanned and saved to the appropriate folder on the PANTHERx shared S drive which is accessible to all colleagues. 4. The new license/permit is displayed (if applicable) in the appropriate location in the pharmacy along with other current licensure. 5. The non-current license/permit is removed and retained in the appropriate file for future reference. 6. PANTHERx Specialty Pharmacy will display all licenses and/or permits required in the operations of the services in an area of public view. Resident State Board Permit/License Non-resident Board Permit/License, if applicable DEA Registration State Controlled Substance License, if applicable Clinical Staff(s) Licenses/Certificates, if applicable Device Dispensing Permit, if applicable Clinical Laboratory Improvement Amendments (CLIA) Certificate, if applicable Biohazard generator permit or appropriate contract as required Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 4/6/ Pantherx Specialty, LLC 1

206 Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 4/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ Pantherx Specialty, LLC 2

207 NOTICE OF ORGANIZATIONAL CHANGES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-88 ACHC DRX 1-1A PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards for notice of organizational changes. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx will inform all federal, state and local regulatory and accreditation agencies of any of the following changes within 30 days of the effective date of the change, as applicable. Ownership Group Company officers (CFO, COO, CEO) Ownership or controlling interest Address, physical location or addition of locations Pharmacist-in-Charge changes In the event that a request of information is received from a regulatory or accrediting body; the Governing Body of PANTHERx will comply appropriately within 30 days of request. In the event that operations are ceased, PANTHERx will inform all federal, state and local regulatory and accreditation agencies in writing within 10 days and will remove any accrediting seals from electronic or physical display. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

208 ORGANIZATIONAL CHART STANDARD OPERATING PROCEDURE POLICY NUMBER PS-89 ACHC DRX 1-5A CPPA 1.2a, 1.5c PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards of the organizational chart and company structure. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure A copy of the current organizational chart will be posted in an obvious location for staff reference. Each employee will receive a copy of the current Organizational Chart upon hire and orientation and is expected to know the chain of command within PANTHERx Specialty Pharmacy. PANTHERx will maintain adequate clinicians and non-clinicians to service all our patients. The staffing model will be reviewed quarterly by the General Manager, in coordination with Vice Presidents and Directors. The Organizational Chart will be comprised of necessary number of employees to ensure we are meeting quality standards for accreditation bodies as well as any contracts which PANTHERx may hold. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 1

209 OWNERSHIP & MANAGEMENT STANDARD OPERATING PROCEDURE POLICY NUMBER PS-90 ACHC DRX 1-11A PANTHERx Specialty Pharmacy Policy Owner: Timothy Davis, General Manager, PANTHERx Specialty Pharmacy Effective Date: 4/6/2015 Scope To explain the standards of maintenance & disclosure of information surrounding the ownership and management. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx is in compliance with disclosure of ownership and management information. PANTHERx will disclose the following information to Accrediting Organizations and other appropriate state or federal agencies at the time of initial application and at the time of any change in ownership or management within 30 days of the change: 1. Name and address of all persons with an ownership or control interest of 5% or greater 2. Name and address of each person who is an officer, a director, an agent or a managing employee of the organization 3. Name and address of the corporation, association, or other company that is responsible for the management of the organization 4. Name and address of the chief executive officer and the chairman of the board of directors of that corporation, association, or other company responsible for the management of the organization. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 5/12/ PANTHERx Specialty, LLC 1

210 PHARMACY SERVICES UTILITIES MANAGEMENT PLAN STANDARD OPERATING PROCEDURE POLICY NUMBER PS-91 ACHC DRX 7-5B CPPA 1.15c, 1.13a PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards of the pharmacy services utilities management plan Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure Utilities Management 1. PANTHERx Specialty Pharmacy will maintain a back-up system, powered by a generator, for all crucial systems in the event of electrical power or utility failure to include: Heating and cooling in the office, warehouse or Pharmacy Area Refrigeration Water Supply Telephone, electronic, other communication devices, electrical and computer systems Routine checks and maintenance of utility systems In the event that maintenance is required of this generator, the Designee of Business Operations will schedule maintenance and keep on file a log of all services performed. 2. Functional Test of back-up systems Completed every 6 months with outcome logged Any batteries that fail functional test will be replaced immediately 3. FDA / OIG or other Regulatory Inspection PANTHERx Specialty Pharmacy will not prohibit entry to their facility for inspections by the FDA or OIG or other Regulatory Agencies Staff are instructed to ask for credentials and immediately notify General Manager or Pharmacist in Charge (PIC) of their presence on site Facilities Management 1. PANTHERx Specialty Pharmacy will contract with a reputable pest control service whom will service the interior pharmacy area on a regularly scheduled basis. Pest control service will be performed on a quarterly basis. Staff will advise management if they ever suspect any pest infestation issues, of any kind, and Designee of Business Operations will request an immediate appointment with pest control to resolve the issue as quickly as possible. Designee of Business Operations will maintain records of all pest control activities, as required. Fire Safety 1. PANTHERx Specialty Pharmacy prohibits smoking in all buildings and company owned vehicles. 2. No smoking signs will be posted in the pharmacy area PANTHERx Specialty, LLC 1

211 3. Smoke alarms and fire extinguishers will be utilized in all buildings and maintained for compliance with the National Fire Protection Agency and local fire and safety codes 4. Compliance with fire safety inspections as required 5. All fire exits and escape routes in each room/hallway and warehouse/storage area will be posted in conspicuous areas 6. Main escape routes will be marked by a lighted sign with back-up battery 7. Fire safety in-service will be completed on an annual basis for all staff and attendance and documented in employee record and outcome reported to all employees 8. A fire drill is conducted (minimally) on an annual basis. Outcome and responses to the fire drill are evaluated and communicated to all staff. Documentation of fire drill will be filed. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 01/31/ Jonathan Ogurchak, PharmD, MBA VP, Business Operations 06/13/ PANTHERx Specialty, LLC 2

212 POSITION DESCRIPTION STANDARD OPERATING PROCEDURE POLICY NUMBER PS-92 ACHC DRX4-2E CPPA 1.5b PANTHERx Specialty Pharmacy Policy Owner: Emily Bowman, Manager, Human Resources Effective Date: 4/6/2015 Scope To explain the standards of position descriptions. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy offers a detailed description of each staff position. Each employee will receive a copy of the job description for the position to which they apply, along with associated salary and benefits during the interview process. Upon acceptance of a job offer, each employee will sign a copy of their job description which will be kept on file in their personnel chart. Elements of a position description include: Position title Position responsibilities/duties Reporting structure Supervisory responsibilities (if applicable) Minimum qualifications, experience, education and/or training Physical and environmental requirements A statement of reasonable accommodations Position descriptions are reviewed annually and updated as needed as evidenced by a signed copy in employee record. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet. Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge. Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Emily Bowman Manager, Human Resources 06/23/ Summit Park Dr, Pittsburgh, PA 2017 PANTHERx Specialty, LLC 1

213 SUPERVISION OF DIRECT CARE STAFF STANDARD OPERATING PROCEDURE POLICY NUMBER PS-94 ACHC DRX 4-7A CPPA 3.8a, 3.8b PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 4/6/2015 Scope To explain the standards of the supervision of direct care staff. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure The General Manager of PANTHERx is the overall supervisor of all employees. Other employees may have a supervisory role as delegated by the Governing Body or General Manager as represented on the Organizational Chart. Supervisors will always be available to assist employees with questions, concerns with other employees or customers or referral sources and the resolution. The supervisor monitors the day to day activities of those employees who they have been assigned to supervise. A list of all supervisors and employees telephone/cell # will be posted in an obvious place for use by all staff to contact a supervisor / management team member in case of emergency. The supervisor list will be updated as necessary. All direct care employees will be observed and evaluated while performing their position duties, at least annually, by a qualified employee. This evaluation will be documented in employee record. Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ PANTHERx Specialty, LLC 1

214 Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

215 USUAL & CUSTOMARY CHARGES STANDARD OPERATING PROCEDURE POLICY NUMBER PS-95 ACHC DRX 3-2A, 3-4A, 3-4B PANTHERx Specialty Pharmacy Policy Owner: Jonathan Ogurchak, Vice President, Business Operations Effective Date: 4/6/2015 Scope To explain the standards of the usual and customary changes. Guidelines PANTHERx Specialty Pharmacy employees are expected to understand and adhere to this standard operating procedure at all times. Policy/Procedure PANTHERx Specialty Pharmacy will make available its usual and customary charges to its referral sources, customers and any other person or regulatory organization upon request. 1. A written copy of charges for serviced/products provided are available upon request. 2. At the time of service, each customer will receive the following information in relation to charges and reimbursement of products/services: Description of services/products to be provided Expected coverage from primary payment source Whether assignment will be accepted or not and why or why not Hardship Policy for private secondary balances Credit Policy Private balance responsibility Customers are notified of any changes in payment (reimbursement) information no later than 30 days after the company becomes aware of such change Medicare and Medicaid customers are informed when assignment is accepted 3. For all other questions, the customer will be instructed to call our billing department. 4. PANTHERx expects to be paid, in full, for all services/products provided. 5. PANTHERx does not utilize a sliding fee scale. 6. Usual & Customary Charges for products dispensed, expected allowable/reimbursement from insurance carriers and potential/expected customer financial responsible will be provided on a monthly invoice. 7. Appropriate employees are oriented regarding conveying charges to customers, public and referral sources; and updated on an annual basis with documented training. 8. Customers/Family/Caregiver will sign off receipt of above information. 9. Customers who do not have a secondary insurance source and who state they are unable to afford co-pays, co-insurance or deductibles will be required to complete a Financial Hardship Form which will be reviewed by the General Manager and a determination made as to whether they meet the parameters for a total 2017 PANTHERx Specialty, LLC 1

216 Training adjustment of their secondary balances. Those who do not meet the parameters may be offered a monthly payment amount toward their total outstanding balance. This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/06/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 04/12/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2

217 STRENSIQ (asfotase alfa) PACKOUT STANDARD OPERATING PROCEDURE POLICY NUMBER PS-100 URAC PHARM Ops 7 ACHC DRX 1-8A PANTHERx Specialty Pharmacy Policy Owner: Austin Russian, Director, Pharmacy Operations Effective Date: 4/29/2015 Scope To explain the required packout design for Strensiq (asfotase alfa) for both hot and cold time periods. Policy/Procedure PANTHERx Specialty Pharmacy (PANTHERx) must use the following to pack all shipments of Strensiq: All shipments of Strensiq must be shipped in one of the two approved Cold Chain Technologies coolers. For the continental United States, shipments leaving PANTHERx Specialty Pharmacy between Monday-Thursday, the KoolTemp GTS 6L Excel cooler that is qualified, for both Summer and Winter cycles, at 2-8C will be used. The KoolTemp GTS Excel 6L Shipping System will maintain product temperatures between +2 C to +8 C for a minimum of hours for both Summer and Winter simulated temperatures. For Strensiq shipments going anywhere other than the continental United States or shipments that are leaving PANTHERx Specialty Pharmacy on Friday, the KoolTemp GTS 7L Extreme cooler that is qualified, for both Summer and Winter cycles, at 2-8C will be used. The KoolTemp GTS 7L Extreme Shipping System will maintain product temperatures between +2 C to +8 C for a minimum of 93.8 hours for both Summer and Winter simulated temperatures. Below is the approved pack-out design that must be followed by the packing employee: 2017 PANTHERx Specialty, LLC 1

218 Training This policy will be posted on the PANTHERx Specialty Pharmacy Corporate Intranet Violation/Disciplinary Action Associates who violate this policy are subject to disciplinary action up to and including discharge Approvals/Change History Last Edited by: Title Date Version Robert Snyder, PharmD, MBA Director, Pharmacy Operations 04/29/ Robert Snyder, PharmD, MBA Director, Strategic Development 08/27/ Robert Snyder, PharmD, MBA Director, Specialty Pharmacy Development 02/03/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/01/ Douglas Gebhard, PharmD, MBA VP, Quality & Education 06/27/ PANTHERx Specialty, LLC 2