This document is NOT FOR PROMOTIONAL USE. Do not copy, distribute, or share with physicians, staff, or patients. FOR INTERNAL USE ONLY.

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1 SIMPONI ARIA Infusion Suite Module Summary Page 1 of 5 The trademark, SIMPONI ARIA, has received provisional acceptance from the FDA. SIMPONI ARIA is an investigational agent currently under review by the FDA for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). SIMPONI ARIA is not yet FDA approved. The information in this learning module is for your background information only. This document is NOT FOR PROMOTIONAL USE. Do not copy, distribute, or share with physicians, staff, or patients. FOR INTERNAL USE ONLY. Outpatient Infusion Suite Settings Infusions are administered in three types of infusion suite settings. Setting A private physician s practice Outpatient hospital Freestanding infusion center Description The practice may have dedicated space within the building for an infusion suite, or the practice may use space that serves multiple purposes by moving mobile infusion equipment in and out of the space The infusion suite is located within or adjacent to a hospital The infusion suite may be affiliated with a hospital or it may operate independently, but it is not located within a hospital or physician practice Infusion suites need the following equipment, supplies, and medications to operate. Category Equipment Supplies Medications Optional Items Blood pressure monitor Infusion chairs IV poles for hanging bags of liquids to be infused Infusion cart for storing and moving supplies Infusion pump Refrigerator that is temperature controlled or with a thermometer Antiseptic swabs Catheter Crash kit Diluents such as bags of normal saline for infusion Dressings (e.g., gauze, tape) Extensions Filters Gloves IV tubing Portable oxygen tank Ports Start needles Sterile water Tourniquets Medications to be infused Pre-meds (acetaminophen, diphenhydramine) Corticosteroids Antihistamines Backup generator Entertainment such as TV, magazines, books, ipads

2 SIMPONI ARIA Infusion Suite Module Summary Page 2 of 5 AccessOne and SimponiOne Services AccessOne support for physician s offices is initiated through the following process. When a physician first prescribes SIMPONI ARIA, the office submits a Benefit Investigation Form, or BIF, to AccessOne The patient signs a Patient Authorization, or PA, Form to give AccessOne permission to contact his or her health plan to look into benefits AccessOne assigns a Care Coordinator to the patient, and the Care Coordinator initiates the benefits investigation process AccessOne can support providers with the following services when SIMPONI ARIA is prescribed: Research the patient s coverage and provide an AccessOne Coverage Report The Coverage Report lists any prior authorization requirements, the number of infusions covered, acquisition requirements or preferences (e.g., specialty pharmacy, buy-and-bill), and the patient s outof-pocket costs for SIMPONI ARIA Support the prior authorization process AccessOne can: Provide blank forms Forward the plan s medical policy Track the status of a request Confirm the approval of a PA request AccessOne cannot: Complete forms Advise customers on information to include on forms SimponiOne can help eligible patients who are prescribed SIMPONI ARIA with the SimponiOne Rebate Program. Upon approval, this program will: Help with out-of-pocket costs, including deductible, co-payment, and co-insurance Be available only to patients covered by commercial plans Require the patient to pay out-of-pocket costs at the time of the appointment Require the patient to send a copy of the infusion explanation of benefits (EOB) to SimponiOne Send the patient a rebate MasterCard that can only be used at the practice where infusions are administered

3 SIMPONI ARIA Infusion Suite Module Summary Page 3 of 5 Acquiring Infusion Products There are two main methods for physician practices to acquire infusion products. Buy-and-Bill Process: Practice orders the specialty product from a distributor The product arrives The product is checked against order The product is properly stored The practice pays for the product The product is administered to the patient The practice bills the health plan for the service of administering the infusion and for the product itself Specialty Pharmacy (SP) Process: Practice orders the specialty product from the SP The product arrives labeled with the patient's name The product is checked against order The product is properly stored The product is administered to the patient The practice bills the health plan for the service of administering the infusion, but does not bill for the product itself (the SP bills the health plan for the product itself) Patient Coverage and Costs for Infused Products Patient cost sharing may vary depending on whether the agent is covered under the medical benefit, the pharmacy benefit, or both. Commercial Benefit Usually Covers Medicare Parallel Medical Physician care and hospital care HCP-administered agents Pharmacy Outpatient prescription drugs Self-administered agents Part B Part D Each commercial plan makes its own decision on how to cover each type of drug, so coverage varies from plan to plan. Typically, health plans cover HCP-administered agents under the medical benefit and self-administered specialty drugs under the pharmacy benefit. As a result, patients may have different cost sharing for selfadministered versus HCP-administered drugs. Before Administering an Infusion Physician practices may take the following steps before administering SIMPONI ARIA to a patient: 1. Confirm the patient's coverage by submitting a Benefit Information Form (BIF) to AccessOne 2. Choose a site for administration based on the patient's health plan's reimbursement requirements and preference 3. If an in-office site is chosen, confirm that the appropriate equipment, supplies, and processes are in place 4. Submit a prior authorization request to the patient s health plan, if required 5. Confirm prior authorization approval 6. Upon approval, encourage the patient to apply for rebate assistance through the SimponiOne Rebate Program if he or she is eligible 7. Schedule the infusion appointment 8. Order SIMPONI ARIA from either a specialty distributer or a specialty pharmacy, depending on the plan s requirements or the practice s preference

4 SIMPONI ARIA Infusion Suite Module Summary Page 4 of 5 9. Receive SIMPONI ARIA and check it against the order 10. Store the SIMPONI ARIA in a refrigerator if refrigeration is required 11. SIMPONI ARIA must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF) and protected from light. Administering Infusions Infusion nurses may take the following steps to administer SIMPONI ARIA to a patient: Prepare the patient Review the patient s completed patient assessment form Take vital signs and record results Temperature Blood pressure Pulse Respiration - Describe what the patient should expect during the infusion - Give the patient the medication guide and a glass of water to drink Prepare the infusion Record the patient s baseline assessment and vital signs Obtain supplies Verify prescription Calculate and/or double check the patient's dose Get medication to be infused from the refrigerator Scrub and put on gloves Connect and prime an IV set to the saline bag Prepare medication according to the manufacturer s prescribing information Remove caps from the medication and clean with alcohol wipes Draw the medication from the vial into a syringe Inject the medication from the syringe into an IV bag Connect and prime an IV set to medication bag Remove and dispose of the needle Bring saline and medication bags into infusion suite Initiate the infusion Hang both bags on IV pole Prepare IV site and insert an IV catheter with a start needle Connect the IV tubing to IV catheter Hook up saline to infusion line Do not infuse SIMPONI ARIA concomitantly in the same intravenous line with other agents Run the saline to ensure the line is flowing smoothly Begin the infusion with the saline solution to keep the vein open Administer the infusion Once saline is flowing, piggyback the SIMPONI ARIA into the IV port closest to the patient in the primary infusion line Shut off the primary infusion line (saline)

5 SIMPONI ARIA Infusion Suite Module Summary Page 5 of 5 Run the medication line Set the flow rate Infuse the diluted solution over 30 minutes Ask the patient how she or he is feeling Offer entertainment Monitor the patient When the infusion is complete, withdraw the line Evaluate the patient for signs of infusion reactions and adverse events Provide post-infusion care Once again, review possible side effects with the patient Remind the patient to call the office if side effects are experienced Schedule the next appointment with the patient Do not store any unused portion of the infusion solution for reuse The infusion nurse follows the same pre-infusion, administration, and post-infusion care steps for every infusion for every patient. This routine helps ensure the drug is administered properly. Submitting Claims for Infused Medications The practice submits the claim to the patient s health plan after the infusion has been administered. What s listed on the claim? Claims for drugs acquired using the buy-and-bill method list: The drug A J-code is recorded for the drug If a permanent J-code has not been assigned to the drug, use the miscellaneous J-code The service of administering the drug Claims for drugs acquired using the Specialty Pharmacy method list: The service of administering the drug Reimbursement: Patient Cost Sharing Payment for the infusion is collected from two sources: the patient and the payer Commercial coverage There is a wide range of out-of-pocket medication costs for infused agents because each plan has different benefits About half of commercially-insured patients who have coverage under the medical benefit do not have any cost sharing Coinsurance is more common than copays for drugs covered under the medical benefit Medicare coverage Medicare Part B covers infused drugs Medicare pays 80% and the patient is responsible for the remaining 20% The vast majority of Medicare patients have supplemental coverage (e.g., a Medigap plan or Medicaid) that pays the 20% coinsurance so the patient has no out-of-pocket costs for infused drugs