2016 Billing Guide for REMICADE (infliximab)

2016 Billing Guide for REMICADE (infliximab)

Table of Contents Introduction... 1 Factors That Influence Coverage... 2 REMICADE (infliximab) Quick Reference Guide...3 Coding for REMICADE and Drug Administration Services... 4 Indications and Usage... 4 REMICADE Coding Summary...5 ICD-10-CM Diagnosis Codes... 6 CPT and HCPCS Codes for Drugs and Drug Administration... 7 Physician Office Setting...7 Place of Service Codes...7 Hospital Outpatient Setting... 9 Home Infusion Providers...10 Other Coding Considerations...11 REMICADE Billing Units... 11 Billing With National Drug Codes (NDCs)... 11 Partial Additional Hours of Infusion Time... 13 Modifiers... 13 Distinct Procedural Service... 15 CMS Discarded Drug Policies... 15 Same Day Evaluation and Management Services...16 Payment for REMICADE and Drug Administration Services... 17 Medicare Payment to Physician Offices... 17 Medicare Payment to Hospital Outpatient Departments... 17 Medicare Policy for Other Healthcare Providers...18 Medicaid Payment Policies...18 Commercial Payers...18 Home Infusion Reimbursement...19 Medicare Part D...19 i

References... 20 Appendices Appendix A: Sample Claim Forms... 21 Appendix B: Medical Necessity... 26 Appendix C: Appeals... 26 Appendix D: Working With Specialty Pharmacy...27 Appendix E: Medicare Quality Programs... 28 Appendix F: ICD-10-CM... 29 Appendix G: Resources... 31 Important Safety Information...33 Please see Important Safety Information, full Prescribing Information, and Medication Guide for REMICADE (infliximab). The information in this guide is provided to assist you in understanding the reimbursement process. It is intended to help providers in accurately obtaining reimbursement for healthcare services. It is not intended to increase or maximize reimbursement by any payer. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and updated frequently. While Janssen Biotech, Inc., has made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Please consult with your counselor reimbursement specialist for any reimbursement or billing questions. Similarly, all Current Procedural Terminology (CPT ) & Healthcare Common Procedural Coding System (HCPCS) billing codes are supplied for informational purposes only and represent no statement, promise or guarantee by Janssen Biotech, Inc., that these codes will be appropriate or that reimbursement will be made. CPT 2015 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for the data contained or not contained herein. Current Procedural Terminology (CPT) 2015. American Medical Association. All rights reserved. 01 ii

Introduction Janssen Biotech, Inc., has developed this Billing Guide to help healthcare providers and billing staff understand third-party reimbursement for REMICADE (infliximab). Specifically, this guide presents general information on coverage, coding, reimbursement, and claims submission for REMICADE. In addition, it provides information on how to manage denied claims and information about other reimbursement-related topics that are relevant to the sites of care in which REMICADE is administered. The information contained in this guide is intended to provide a general understanding of the reimbursement process and is not intended to assist providers in obtaining reimbursement for any specific claim. Additional information about coding, billing, and coverage of REMICADE may be obtained through Janssen CarePath for REMICADE, a single source of services designed to simplify access to therapy with REMICADE. You may contact Janssen CarePath at 877-CarePath (877-227-3728) Monday through Friday, 8 AM to 8 PM, ET, or visit the website at: www.janssencarepath.com. 1

Factors That Influence Coverage Most third-party payers (eg, commercial insurers, Medicare, Medicaid) cover REMICADE (infliximab) for its approved U.S. Food and Drug Administration indications (see Indications on page 5 of this guide). However, benefits may vary depending upon a patient s insurer or specific insurance plan (or product ) offered by a payer. When third-party payers review claims for REMICADE, first they will determine if the reported service is covered under their contract or rules. Most payers cover drug infusions as part of their core benefits. Next, payers will look for evidence supporting the medical necessity of therapy. This evidence may include: Information about the patient s medical condition and history A physician s statement or letter of medical necessity Supporting literature (eg, peer-reviewed studies and compendia monographs) Prescribing information Availability of other treatment alternatives Administrative issues may also affect coverage of therapy with REMICADE. For example, payers may consider the following: Does the payer s contract specifically preclude physician offices from billing for infusion services or infused drugs? A small portion of payers have exclusive contracts with designated preferred providers for infusion services. This may include certain clinics or specialty pharmacies that deliver drugs to healthcare providers or other infusion centers. Does the payer cover the therapy only when provided through a specific treatment site? Payers may have site-specific coverage rules that restrict provision of infused therapies. For example, currently Medicare does not cover infusions when they are billed by Medicare-certified ambulatory surgery centers. Medicare and other payers also may restrict coverage for certain infused drugs in the home or hospital outpatient setting. Is the billing provider a participating member of, or in-network provider for, that particular plan? Payers contract with providers to deliver services to the plan s members. Providers are thus participating or within that plan s network, requiring them to abide by the contract charge structure when providing care for that plan s members. Did the patient obtain the appropriate referral or prior authorization if required by their plan? Many plans require that non-emergency services be pre-approved or that a primary care physician make the referral for specialty care. Failing to obtain appropriate referrals or preauthorization can result in non-payment by the plan. 2

REMICADE (infliximab) Quick Reference Guide This section provides general information about the payers and payment mechanisms for the different sites of care in which REMICADE is administered (Table 1) and lists the codes commonly associated with billing for REMICADE and the related drug administration services (Table 2). Table 1: REMICADE Reimbursement Summary by Payer Type and Site of Care Payer Hospital Outpatient Department Physician Office Medicare Part B* Medicaid Commercial Insurance Outpatient Prospective Payment System (OPPS) ASP+6% Covered incident to physician services Local Coverage Determinations (LCD) may apply Variable reimbursement methodology Coverage policies may apply May require preauthorization Variable reimbursement methodology May require use of specialty pharmacy May require preauthorization Physician Fee Schedule (PFS) ASP+6% Covered incident to physician services Local Coverage Determinations (LCD) may apply Variable reimbursement methodology Coverage policies may apply May require preauthorization Variable reimbursement methodology May require use of specialty pharmacy May require preauthorization * Note: While REMICADE is covered under Medicare Part B some Part D formularies also list REMICADE. If the physician and patient conclude that obtaining REMICADE through Part D (at a Part D retail pharmacy provider or a Part D participating specialty pharmacy) is clinically better for the patient, that option is available. Under these circumstances providers may not bill Part B for the drug, only the services for drug administration. Medicare payment rates may be subject to change based on mandated budget cuts or Congressional legislation. Please see Important Safety Information, full Prescribing Information, and Medication Guide for REMICADE. 3

Coding for REMICADE (infliximab) and Drug Administration Services Indications and Usage Crohn s Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients 6 years of age and older with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy. REMICADE is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn s disease. Pediatric Crohn s Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active disease who have had an inadequate response to conventional therapy. Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Pediatric Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active disease who have had an inadequate response to conventional therapy. Rheumatoid Arthritis in combination with methotrexate REMICADE is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease. Ankylosing Spondylitis REMICADE is indicated for reducing signs and symptoms in patients with active disease. Psoriatic Arthritis REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function. Plaque Psoriasis REMICADE is indicated for treatment of adult patients with chronic severe (ie, extensive and /or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. SELECTED IMPORTANT SAFETY INFORMATION Serious and sometimes fatal side effects have been reported with REMICADE (infliximab). Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (eg, TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma (HSTCL), and other malignancies have been reported, including in children and young adult patients. Due to the risk of HSTCL, mostly reported in Crohn s disease and ulcerative colitis, assess the risk/benefit, especially if the patient is male and is receiving azathioprine or 6-mercaptopurine treatment. REMICADE is contraindicated in patients with severe hypersensitivity reactions to REMICADE and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome. Please see related and other Important Safety Information. 4

REMICADE (infliximab) Coding Summary It is important to accurately and fully complete claim forms for the therapy, whether the claim is submitted by physician offices using the CMS-1500 claim form or by hospital outpatient departments using the UB-04 claim form. This section identifies procedure and supply codes that are likely to be most relevant to healthcare provider claims for therapy with REMICADE. Please note that healthcare providers are responsible for selecting appropriate codes for any particular claim based on the patient s condition and the items and services that are furnished. Contact your local payer with regard to local payment and policies. Table 2 summarizes the relevant codes for REMICADE claims. See Appendix A for sample CMS- 1500 and UB-04 REMICADE claims, along with tips for successful claims submission. Table 2: REMICADE Coding Summary Type of Claim Information Diagnosis* Procedures, Services and Supplies Type of Code Code Description Physician Office Location on CMS-1500 Form Hospital Outpatient Department Location on UB-04 Form Crohn s Disease K50.00 Crohn s disease of small intestine w/o complications K50.10 Crohn s disease of large intestine w/o complications K50.80 Crohn s disease of both small and large intestine w/o complications K50.90 Crohn s disease, unspecified, w/o complications Fistula (use in addition to codes for Crohn s Disease) K60.3 Anal fistula K63.2 Fistula of intestine Ulcerative Colitis K51.80 Other ulcerative colitis w/o complications K51.20 Ulcerative (chronic) proctitis w/o complications K51.30 Ulcerative (chronic) rectosigmoiditis w/o complications Item 21 Form Locator 67 ICD-10-CM K51.50 Left-sided colitis w/o complications Diagnosis 1 K51.00 Ulcerative (chronic) pancolitis w/o complications K51.90 Ulcerative colitis, unspecified, w/o complications Rheumatoid Arthritis (RA) M06.00 Rheumatoid arthritis w/o rheumatoid factor, unspecified M05.60 Rheumatoid arthritis of unspecified site with involvement of organs and systems Ankylosing Spondylitis M45.9 Ankylosing spondylitis of unspecified sites in spine Psoriatic Arthritis L40.50 Arthropathic psoriasis, unspecified Plaque Psoriasis L40.8 Other psoriasis 96413 IV infusion, up to 1 hour (chemotherapy) 96415 IV infusion for each additional hour CPT 96365 IV infusion, up to 1 hour (therapeutic) 96366 IV infusion for each additional hour Item 24D Form Locator 44 99211 to 99215,,II Evaluation and management services HCPCS J7050 Infusion, normal saline solution, 250 ml N/A Form Locator 44 0250 Pharmacy, no detailed coding AHA 0258 IV solutions Form Revenue 0260 IV therapy N/A Locator 42 Codes 0636 Pharmacy, with detailed coding (requires HCPCS) and 43 0510 Clinic visit 5

Table 2: REMICADE Coding Summary (cont d) Physician Office Hospital Outpatient Department Type of Claim Information Type of Code Code Description Location on CMS-1500 Form Location on UB-04 Form REMICADE Medicare HCPCS J1745 # Infliximab, 10 mg (1/10th vial) Item 24D Form NDC (11 digit) 57894-0030-01** REMICADE (infliximab vial, 100 mg) Shaded area above Item 24D or Item 24A or Item 19 Locator 44 or Electronic Comment Field * The ICD-10-CM codes listed in this table are general and for example only. Actual clinical diagnosis coding should be done to the highest level of specificity, including complications, lateralization and other considerations, resulting in many more code options. For more information regarding ICD-10-CM coding, please refer to additional materials located throughout this guide. Payer policies for codes used to describe IV therapy may vary. Consult local payers for policies regarding use of 96413 and 96415 or 96365 and 96366. CPT code 99211 is not billable or payable on physician office Medicare claims when used in conjunction with CPT codes 96413, 96415, 96365, or 96366. Code all hospital outpatient clinic visits (99201-99205 and 99211-99215) for Medicare claims with G0463. ll Use of evaluation and management codes require documentation of medically appropriate services performed on the same day as the infusion. Medicare suggests use of revenue code 0636 along with HCPCS J1745 to describe REMICADE on hospital outpatient claim forms. # 10 units = 1 vial of REMICADE, 100 mg. **The NDC is not usually listed as a line item. When required in the shaded area above Item 24A-D, it also usually requires a Unit of Measure identifying the quantity per NDC; the units of measure will likely be 1 unit = one 100-mg vial. Please consult with your local payer for additional guidance. ICD-10-CM Diagnosis Codes 1 As of October 1, 2015, all parties covered by HIPAA, not just providers who bill Medicare or Medicaid, are required to use the International Classification of Diseases, 10th Revision, Clinical Modification (ICD- 10-CM) codes to document patient diagnoses. ICD-10-CM replaces ICD-9-CM and far exceeds previous coding systems in the number of concepts and codes provided, allowing for greater specificity when describing patient conditions. ICD-10-CM uses 3-7 alpha and numeric digits to achieve this level of detail: ALPHA (NOT U) NUMERIC CHARACTERS 3-7 CAN BE ANY COMBINATION OF ALPHA OR NUMERIC 1 st DIGIT 2 nd DIGIT 3 rd DIGIT 4 th DIGIT 5 th DIGIT 6 th DIGIT 7 th DIGIT CATEGORY ETIOLOGY, ANATOMICAL SITE, SEVERITY EXTENSION Source: CMS. Road to 10: The Small Physician Practice s Route to ICD-10, at: http://www.roadto10.org/icd-10-basics; last accessed December 30, 2015. Codes with three characters are included in ICD-10-CM as the heading of a category of codes that may be further subdivided by the use of any or all of the 4th, 5th, and 6th characters. Digits 4-6 provide greater detail of etiology, anatomical site, and severity. For example: K50 Crohn s disease K50.0 Crohn s disease of small intestine K50.01 Crohn s disease of small intestine with complications K50.012 Crohn s disease of small intestine with intestinal obstruction The 7th character may be used to provide data about the characteristic of the encounter (eg, initial, subsequent). It is not necessary to use all seven digits, however coding to the highest level of specificity is a must. 6

ICD-10-CM Diagnosis Codes 1 (continued) There are many sources for mapping ICD-9-CM codes to ICD-10-CM, including https://www.janssencarepath.com/hcp/remicade/reimbursement/icd-10-support. Although the guidelines are helpful, the ultimate responsibility for correct coding lies with the provider of services and must be supported with detailed documentation in the medical record. For more information about ICD-10-CM helpful resources, please see Appendix F. CPT and HCPCS Codes for Drugs and Drug Administration This section discusses appropriate codes for REMICADE (infliximab) and associated drug administration services provided in physician offices and hospital outpatient departments. Physician Office Setting Drug Medicare Administrative Contractors (MACs), many private payers, and most Medicaid agencies require healthcare providers to use Healthcare Common Procedure Coding System (HCPCS) codes to identify infused drugs on claim forms. HCPCS codes have a 5-character alphanumeric format and are used to bill for supplies and services not described by the Current Procedural Terminology (CPT), 4th Edition, coding system. The following HCPCS code may be used to describe REMICADE on claim forms submitted from the physician office setting: J1745 Infliximab 10 mg Although the National Drug Code (NDC) is usually reserved for billing by pharmacies, some private payers and the majority of Medicaid fee-for-service programs require an NDC for billing instead of, or in addition to, an HCPCS code, for physicians and other service providers as well. Although the FDA uses a 10-digit format when registering NDCs, payers usually recognize and often require an 11-digit NDC format on claim forms for billing purposes. It is important to confirm with your payer which NDC format they require. Guidelines for reporting the NDC in the appropriate format, quantity, and unit of measure vary by state and by payer, and should be reviewed prior to submitting a claim. The 10-digit NDC and 11-digit alternative NDC formats used for REMICADE 100 mg are: 10-Digit NDC format: 57894-030-01 11-Digit NDC format (used by most payers): 57894-0030-01 Place of Service Codes 2 The Place of Service (POS) code set provides setting information necessary to appropriately pay professional service claims. The place of service is the location of the provider s face-to-face encounter with the beneficiary. POS codes are required on all claims for professional services (billed on CMS-1500). Under the Physician Fee Schedule (PFS), some procedures have separate rates for professional services when provided in facility and non-facility settings, therefore it is important to accurately designate the POS in order to assure appropriate payment. The physician practice location is considered non-facility (NF), allowing for the practice expenses to be included in the payment under the Physician Fee Schedule (PFS). When professional services are performed in a facility (eg, hospital outpatient department) the practice does not incur the same expense (overhead, staff, equipment and supplies, etc.), thus payment under the PFS is generally lower for facility-based services than for NF. 7

The physician practice setting is indicated with POS code 11. In order to differentiate between on-campus and off-campus provider-based departments CMS recently created a new POS code (POS 19) and revised the POS code description for outpatient hospital (POS 22). Professional services delivered in outpatient hospital settings must now specifically include the off-campus or on-campus POS on the claim form: POS Code POS Location POS Descriptor 11 19 22 Office Off Campus - Outpatient Hospital On Campus - Outpatient Hospital Location, other than a hospital, skilled nursing facility, military treatment facility, community health center, state or local public health clinic, or intermediate care facility, where the health professional routinely provides health examinations, diagnosis, and treatment of illness or injury on an ambulatory basis. A portion of an off-campus hospital provider based department which provides diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services to sick or injured persons who do not require hospitalization or institutionalization. (Effective January 1, 2016) A portion of a hospital s main campus which provides diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services to sick or injured persons who do not require hospitalization or institutionalization. (Effective January 1, 2016) Use of the new/revised codes is required as of January 1, 2016. When billing professional services on the CMS-1500, enter the appropriate POS code in Item 24B, adjacent to each HCPCS code. Claims for covered services rendered in either on-campus or off-campus outpatient hospital settings will be paid at the facility rate. Payment policies that currently apply to POS 22 will continue to apply and will also apply to POS 19. Drug Administration Services 3 Physician services are reported on claim forms using the Current Procedural Terminology (CPT), 4th Edition, coding system. The CPT codes most commonly associated with the administration of REMICADE (infliximab) are: 96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug 96415 Each additional hour (Use 96415 in conjunction with 96413; report 96415 for infusion intervals of greater than 30 minutes beyond 1 hour increments.) According to the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS), these codes also cover certain complex biologic infusions such as monoclonal antibodies, including infliximab. Non-Medicare payer policies regarding the use of 96413 and 96415 may vary. Alternatively, some may require the use of CPT codes: 96365 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 96366 Each additional hour (List separately in addition to code for primary procedure; report 96366 for infusion intervals of greater than 30 minutes beyond 1 hour increments.).lease contact your local payers for specific coding policies and more information on correct billing and claims submission, or call Janssen CarePath for assistance at 877-CarePath (877-227-3728). 8

Hospital Outpatient Setting Drug Medicare Administrative Contractors (MACs), many private payers, and most Medicaid agencies require healthcare providers to use Healthcare Common Procedure Coding System (HCPCS) codes to identify infused drugs on claim forms. HCPCS codes have a 5-character alphanumeric format and are used to bill for supplies and services not described by the Current Procedural Terminology (CPT), 4th Edition, coding system. The following HCPCS code may be used to describe REMICADE (infliximab) on claim forms submitted from the hospital outpatient setting: J1745 Infliximab 10 mg Although the National Drug Code (NDC) is usually reserved for billing by pharmacies, some private payers and the majority of Medicaid fee-for-service programs require an NDC for billing instead of, or in addition to, an HCPCS code, for physicians and other service providers as well. Although the FDA uses a 10-digit format when registering NDCs, payers usually recognize and often require an 11-digit NDC format on claim forms for billing purposes. It is important to confirm with your payer which NDC format they require. Guidelines for reporting the NDC in the appropriate format, quantity, and unit of measure vary by state and by payer, and should be reviewed prior to submitting a claim. The 10-digit NDC and 11-digit alternative NDC formats used for REMICADE 100 mg are: 10-Digit NDC format: 57894-030-01 11-Digit NDC format (used by most payers): 57894-0030-01 Payers policies regarding separate payment for saline used to administer IV drugs vary. Hospitals may need to record costs on claims even though saline is not separately reimbursed (ie, it is bundled into the APC payment for infusion services). If billed on the claim form, the following HCPCS code describes saline used to administer REMICADE : J7050 Infusion, normal saline solution, 250 ml Drug Administration Services 3 Hospital outpatient department services are reported on claim forms using the Current Procedural Terminology (CPT), 4th Edition, coding system. The CPT codes most commonly associated with the administration of REMICADE are: 96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug 96415 Each additional hour (Use 96415 in conjunction with 96413; report 96415 for infusion intervals of greater than 30 minutes beyond 1 hour increments.) According to the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS), these codes also cover certain complex biologic infusions such as monoclonal antibodies, including infliximab. Non-Medicare payer policies regarding the use of 96413 and 96415 may vary. Alternatively, some may require the use of CPT codes: 96365 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 96366 Each additional hour (List separately in addition to code for primary procedure; report 96366 for infusion intervals of greater than 30 minutes beyond 1 hour increments.).lease contact your local payers for specific coding policies and more information on correct billing and claims submission, or call Janssen CarePath for assistance at 877-CarePath (877-227-3728). 9

Revenue Codes Many payers require use of American Hospital Association (AHA) revenue codes to bill for services provided in hospital outpatient departments. Revenue codes consist of a leading zero followed by three other digits and are used on claim forms to assign costs to broad categories of hospital revenue centers. The revenue codes that are commonly used with REMICADE are: 0250 Pharmacy, drugs not requiring detailed coding (used for claims to many non-medicare payers) 0636 Pharmacy, drugs requiring detailed coding with HCPCS code (suggested for Medicare and sometimes required for other payers) When AHA revenue code 0636 is used to identify REMICADE, hospital outpatient departments should also record HCPCS code J1745. Home Infusion Providers The Healthcare Common Procedure Coding System (HCPCS) contains the only Health Insurance Portability and Accountability Act (HIPAA)-approved, comprehensive code set available to submit home infusion and ambulatory infusion suite claims that support the typical per diem contracts present in the marketplace. The S codes are used to report drugs, services, and supplies for which there are no national codes but for which codes are needed by the private sector to implement policies, programs, or claims processing. Some combination of the codes may be appropriate for describing therapy with REMICADE when it is provided by ambulatory infusion service providers. The following chart illustrates the codes that may be relevant. Although these codes are used by some private payers, please note that they are not payable by Medicare or other Federal payers. Table 3: Home Infusion Codes 4 Code Type Code Description PER DIEM SPECIALTY THERAPY SERVICES: HCPCS CODES S9359* HCPCS Home infusion therapy, anti tumor necrosis factor intravenous therapy (eg, infliximab); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem HOME NURSING: CPT CODES 99601* CPT Home infusion/specialty drug administration, per visit (up to 2 hours) 99602* CPT Each additional hour (list separately in addition to code for primary procedure) (use 99602 in conjunction with 99601) J1745* HCPCS Injection, infliximab, 10 mg CODES FOR REMICADE 57894-0030-01 NDC REMICADE (infliximab vial, 100 mg) * If the infusion is performed in an ambulatory infusion suite rather than a patient s home, modifier SS may be appended to the codes. 10

Table 3: Home Infusion Codes 4 (cont d) Code Type Code Description OTHER SUPPLIES J7050* HCPCS Infusion, normal saline solution, 250 cc NDC Sodium chloride 0.9% 250 ml bag A4216* HCPCS Sterile water, sterile saline and/or dextrose, diluent/flush, 10 ml xxxxxxxxx-xx xxxxxxxxx-xx NDC Sterile water, preservative-free injection, 20 ml vial * If the infusion is performed in an ambulatory infusion suite rather than a patient s home, modifier SS may be appended to the codes. The NDC will vary by product manufacturer. Other Coding Considerations When coding and billing for REMICADE (infliximab) and drug administration services, providers may also need to accurately calculate billing units, describe concomitant services or supplies, or account for modification to a service. This section reviews some of those additional considerations. REMICADE Billing Units The HCPCS code for REMICADE is J1745, described as: Injection infliximab, 10 mg. Thus, each 10-mg dose equals one billing unit, or 1/10th of a vial. It is important to understand that when billing for REMICADE, each 100-mg vial of drug represents 10 units of J1745. The following chart illustrates the correlation between vials, milligrams, and billing units. Number of 100-mg vials of infliximab Number of mg Number of billing units based on J1745 (10 mg infliximab per unit) 1 100 10 2 200 20 3 300 30 4 400 40 5 500 50 Billing With National Drug Codes (NDCs) 5 Reporting NDCs is required for Medicaid and Medicare/Medicaid crossover claims to support the Medicaid drug rebate process. NDCs may also be reported to facilitate claims processing and may be required by payers. Accurate NDC reporting must include specific elements: NDC (11-digit format) NDC unit of measure qualifier (eg, UN, ML, GR, etc.) NDC qualifier - N4 NDC units 11

NDC billing information must conform to the HIPAA 5010 standard, thus follow a specific format: 11-DIGIT NDC NDC UNITS N4xxxxxxxxxxxUNx NDC QUALIFIER QUANTITY QUALIFIER The corresponding entry for one vial of REMICADE is: N457894003001UN1. The number of NDC units to be billed is based on the dose: Example: NDC Unit Calculation X Doe, John B. Amount of drug to be billed 3914 Spruce Street Anytown Medicare HCPCS code HCPCS code description 01010 203 555-1234 Number of HCPCS units 30 J1745 300 MG Infliximab injection, 10 mg NDC (11-digit billing format) 57894-0030-01 NDC description AS NDC unit of measure 07 01 45 X REMICADE (infliximab vial, 100 mg) To calculate the NDC units: the amount to be billed is 300 mg the NDC unit of measure is UN (powder for reconstitution) mg must be converted to UN the Dr. Jones NDC description is 100 mg/vial 123 456 7890 divide the amount to be billed (300-mg) by the number in the NDC description (300/100 = 3) Below 555.1 is an example of the CMS 1500 form entry for a 300-mg dose of REMICADE (30 units of J1745 or UN3 1 of the NDC): 2 3a PAT. 4 TYPE 10 BIRTHDATE 11 SEX ADMISSION 12 DATE 13 HR 14 TYPE 15 SRC 16 DHR 17 STAT 18 19 20 X UN 000-00-1234 Doe, John B. 3914 Spruce Street Anytown 01010 203 555-1234 Anytown Hospital Pay-to-name CNTL # XX-XXXX OF BILL b. MED. 160 Main Street Pay-to-address REC. # DOE 1234-97 6 STATEMENT COVERS PERIOD 7 Anytown, Anystate 01010 Pay-to-city/state 5 FED. TAX NO. FROM THROUGH 010001010 8N457894003001UN3 PATIENT NAME a 9 PATIENT ADDRESS a John B. Doe (ID) 3914 Spruce St. b01 31 16 01 31 16 J1745 b A xxxx 30 c d e John B. Doe Anytown, AS 01010 US 07-01-45 M CONDITION CODES 21 22 23 24 25 26 27 28 29 ACDT 30 STATE 31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM THROUGH CODE FROM THROUGH AS a a b b 38 39 VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT a b The corresponding CMS-1450 form entry for a 300-mg dose of REMICADE is: c d 1 2 3 4 5 6 7 12 8 9 42 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49 N457894003001UN3 3 Dr. Jones 4231 Center Road Anytown, AS 01010 123 456 7890 203 987-6543 1 2 3 4 5 6 7 8 9

Partial Additional Hours of Infusion Time 6 CMS has a policy for reporting the add-on infusion codes when less than a full hour of service is provided. CPT code 96415 (for each additional hour ) is to be used for infusion intervals of greater than thirty minutes beyond one hour increments. If the incremental amount of infusion time is 30 minutes or less the time is not to be billed separately. Document infusion start and stop times in the medical record. Some payers may require reporting the actual number of minutes on claims. Modifiers Modifiers provide a means to report or indicate that a service or procedure has been altered by some specific circumstance but not changed in its definition or code. They add more information and help to eliminate the appearance of duplicate billing and unbundling. Appropriately used, modifiers increase coding and reimbursement accuracy. The following table summarizes modifiers that may be applicable to the provision of REMICADE (infliximab) in physician offices and hospital outpatient departments. Table 4: Summary of Code Modifiers 7 Modifier Description Indication and Placement 25 Significant, separately identifiable evaluation and management service by the same physician or other qualified healthcare professional on the same day of the procedure or other service 52 Reduced Services patient requires distinct E/M service in addition to the infusion procedure must be substantiated with relevant documentation append the modifier to the relevant E/M code last additional hour of service is not a full 60 minutes; may require listing actual service minutes local MAC/other payer requirements may vary append the modifier to the infusion code CMS- 1500 Item 24D If required by payer UB-04 Locator Box 44 If required by payer 59 Distinct Procedural Service indicates a procedure or service separate and distinct from another service with which it would usually be considered bundled do not use with E/M codes and use only if a more descriptive modifier is not available may append to an initial drug administration service code when the patient must return for a separately identifiable drug administration service on the same day or has two IV lines per protocol 13

Table 4: Summary of Code Modifiers 7 (cont d) Modifier Description Indication and Placement CMS- 1500 Item 24D UB-04 Locator Box 44 PO Services, procedures, and/or surgeries furnished at offcampus provider-based outpatient departments required beginning January 1, 2016 to be reported with every HCPCS code for all items and services furnished in offcampus provider-based departments of a hospital should not be reported for remote locations or satellite facilities of a hospital, or emergency departments N/A JW Drug amount discarded/not administered to any patient unused drug remains after applicable dose is administered from single-use vial CMS has issued a discarded drug policy; local MAC/other payer requirements may vary append the modifier to the drug code on a line separate from that reporting the administered dose If required by payer If required by payer KX Requirements specified in the medical policy have been met represents awareness of/compliance with payer policies for the use of specific codes payer requirements may vary regarding use with the chemotherapy/complex biologic infusion codes append the modifier to codes as required by the payer If required by payer If required by payer 14

Distinct Procedural Service 8 The -59 modifier is the most widely used modifier. Because it is defined for use in a wide variety of circumstances it has often been implicated for incorrect use and abuse. To better separate the circumstances in which this modifier is likely to apply from those for which it would be inappropriate, CMS has defined four new HCPCS modifiers. The new modifiers selectively identify subsets of Distinct Procedural Services (-59 modifier) and are collectively referred to as the -X {EPSU} modifiers: Modifier Title Description XE XS XP XU Separate Encounter Separate Structure Separate Practitioner Unusual Nonoverlapping Service A service that is distinct because it has occurred during a separate encounter A service that is distinct because it was performed on a separate organ/structure A service that is distinct because it was performed by a different practitioner The use of a service that is distinct because it does not overlap components of the main service Although CMS continues to recognize the -59 modifier, it may selectively require a -X {EPSU} modifier, especially when billing codes are at high risk for incorrect billing. Overall CMS encourages providers to rapidly migrate to these new, more specific modifiers. CMS Discarded Drug Policies 9 When it is necessary to discard the remainder of a single-use vial or other single-use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label. When processing claims for drugs and biologicals local contractors may require the use of the modifier JW to identify unused drugs or biologicals from single-use vials or packages. This modifier, billed on a separate line, will provide payment for the amount of discarded drug or biological. For example, a single-use vial that is labeled to contain 100 units of a drug has 95 units administered to the patient and 5 units discarded. The 95-unit dose is billed on one line, while the discarded 5 units may be billed on another line by using the JW modifier. Both line items would be processed for payment. The JW modifier is only applied to the amount of drug or biological that is discarded. Summary: Payment for discarded amounts of drug or biological applies only to single-use vials or packages. Multi-use vials are not subject to payment for discarded amounts of drug or biological. Medicare contractors may choose to require the JW modifier on claims for discarded drug or biological. Check with your local contractor for their specific requirements. Both the administered and discarded drug amounts should be clearly documented in the medical record. 15

Same Day Evaluation and Management Services 10 It may be necessary to provide evaluation and management (E/M) services on the same day as a drug administration procedure. Depending on the payer, E/M services that are medically necessary, separate and distinct from the infusion procedure (CPT codes 99201-99205 and 99211-99215 in the physician office and HCPCS code G0463 in the hospital outpatient setting), and documented appropriately are generally covered. Please note that CMS has a specific policy regarding use of CPT code 99211 (level 1 medical visit for an established patient) in the physician office. The policy states: For services furnished on or after January 1, 2004, do not allow payment for CPT code 99211, with or without modifier 25, if it is billed with a nonchemotherapy drug infusion code or a chemotherapy administration code. This means that a level 1 medical visit for an established patient (99211) cannot be billed on the same day as an office-based infusion of REMICADE (infliximab). 16

Payment for REMICADE (infliximab) and Drug Administration Services There is a demonstrated history of paid claims for REMICADE for all payers, including Medicare, Medicaid, and commercial plans. Coverage varies by payer, contracts, treatment setting, and individual patient case. There are comprehensive published Medicare coverage policies specific to REMICADE. Copies of coverage policies are available on your regional Medicare Administrative Contractor (MAC) website, and are also available from the Janssen CarePath website under Reimbursement: https:// www.janssencarepath.com/hcp/remicade/reimbursement. The following section discusses Medicare, Medicaid, and private insurer payment policies that will usually apply to REMICADE. Medicare Payment to Physician Offices In 2016, Medicare Part B reimburses for REMICADE administered in Medicare-participating physician offices based on Average Sales Price plus six percent (ASP+6%). After the patient s deductible is met, Medicare pays 80% of these established rates, and the patient or secondary insurance is responsible for the remaining 20%. CMS updates the ASP+6% reimbursement amount on a quarterly basis. Current drug pricing files are accessible from the CMS website at: http://www.cms.gov/medicare/medicare-fee-for-service-part-b- Drugs/McrPartBDrugAvgSalesPrice/index.html. Medicare reimburses physicians for drug administration services and procedures associated with REMICADE according to the Physician Fee Schedule (PFS). The Medicare fee schedule for professional services is based on the resource-based relative value scale (RBRVS) methodology, a system in which considerations are made for physician work, practice expense, and malpractice expense relative to each code, then adjusted for differences in costs by geographic location. For geographic-specific rates for any PFS code, please refer to the Physician Fee Schedule Search, available at: http://www.cms.gov/apps/physician-fee-schedule/overview.aspx. Medicare Payment to Hospital Outpatient Departments In 2016, Medicare Part B reimburses for REMICADE administered in Medicare-participating hospital outpatient departments based on Average Sales Price plus six percent (ASP+6%). After the patient s deductible is met, Medicare pays 80% of these established rates, and the patient or secondary insurance is responsible for the remaining 20%. CMS updates the ASP+6% reimbursement amount on a quarterly basis. Current drug pricing files are accessible from the CMS website at: http://www.cms.gov/medicare/medicare-fee-for-service-part-b- Drugs/McrPartBDrugAvgSalesPrice/index.html. Medicare reimburses hospital outpatient departments for drug administration services and procedures associated with REMICADE (infliximab) according to the Outpatient Prospective Payment System (OPPS). Payment is based on ambulatory payment classifications (APC), a system in which services of similar resource consumption are grouped and paid at the same rate. Adjustments are made for geographic location. Updates are posted quarterly to the OPPS website at: http://www.cms.gov/regulations-and-guidance/regulations-and-policies/quarterlyproviderupdates/ index.html. 17

Medicare Policy for Other Healthcare Providers Medicare coverage policies limit provision of drugs to certain treatment settings. Under current rules, Medicare will not reimburse home health companies, ambulatory surgical centers, or durable medical equipment companies for REMICADE (infliximab). If patients have secondary or supplemental insurance (eg, through a spouse s employer-sponsored plan or post-retirement health benefits), there may be coverage and reimbursement that goes beyond what is provided by Medicare. Also, Medicare does not provide additional payment to rural health clinics for infused drugs like REMICADE. Medicaid Payment Policies Medicaid programs generally provide reimbursement for REMICADE in one or more ambulatory treatment settings, but the Medicaid payment policies may vary because each state administers its own program. Not all Medicaid fee-for-service programs use the same payment formula to reimburse for REMICADE provided in physician offices. Providers can check with the state agency for the current reimbursement method. States will typically use a fee schedule to reimburse for office-based infusion services. Most Medicaid programs require prior authorization for office infusions, and some may have specific coverage policies for infused therapies. Some state Medicaid programs may allow REMICADE to be billed through pharmacies. In a few states, Medicaid programs may require REMICADE to be dispensed to the physician s office then billed through the pharmacy benefit. In these cases, the drug is delivered to the treatment setting and the office or clinic may only bill for the infusion service. In some cases, state Medicaid programs also may permit REMICADE to be provided in the home setting by a qualified home infusion company. Medicaid reimbursement for drugs provided in hospital outpatient departments is most commonly determined by an ASP-based formula and may be influenced by whether the facility is located in an urban or rural area or whether it is a specialty (eg, children s or rehabilitation hospital) or teaching facility. If you need assistance understanding Medicaid policies in your area, Janssen CarePath is available to help you at at 877-CarePath (877-227-3728). In addition, you may contact your local payer. Commercial Payers Private payers will generally provide reimbursement for REMICADE although some may restrict the site of care in which infusion services will be covered. For example, recently some payers have restricted coverage in the hospital outpatient setting (POS 19 and 22) to those cases for which medical necessity for a hospital setting can be established. Some payers may require drug acquisition through a specialty pharmacy, in which case the provider may only bill for the administration service (please refer to Coding for Drugs Purchased From Other Than the Administering Provider, Appendix D). Payment for REMICADE provided in the office setting is commonly based on an ASP-based formula. However, there will be some cases in which the cost of the drug is included in some type of capitated rate. Although such rates are often assumed to cover the cost of the therapy, physician offices and clinics can sometimes obtain separate payment by calling the plan and explaining the medical necessity and specific circumstances. To the degree that providers are offered capitated or risk contracts, they should consider attempting to negotiate a separately payable status for drugs like REMICADE. 18

Private insurance payments for hospital outpatient department services will typically be based on charges, fee schedules, or outpatient per-diem rates. However, this will vary by plan, the contracts between plans and hospitals, and by the specific insurance products offered by any given payer (eg, HMO, PPO, etc.). If you need assistance understanding plan payment policies, contact Janssen CarePath for REMICADE or your local payer. Home Infusion Reimbursement Ambulatory infusion providers are licensed pharmacies that provide a wide range of services ranging from home infusion and nutritional therapies, to care management services and biologics, including REMICADE. Reimbursement for REMICADE provided through a home infusion pharmacy depends strictly on individual private payer and state Medicaid policies. It is especially important to note that Medicare does not currently pay for REMICADE when provided by a home infusion provider although other payers may allow or even require this setting. Drug administration services may be provided in either the patient s place of residence or within an Ambulatory Infusion Suite (AIS) operated by the home infusion provider. Medicare Part D REMICADE is covered under Medicare Part B, however some Part D formularies also list REMICADE.In circumstances where the physician and patient conclude that obtaining REMICADE through Part D (eg, Part D retail pharmacy provider, or Part D participating specialty pharmacy) is clinically preferred for the patient, this option is available. Under these circumstances physicians may not bill Part B for the drug, only the services they supply for drug administration. 19

References 1 American Medical Association. (2015). ICD-10-CM Mappings 2016: Linking ICD-9-CM to All Valid ICD-10-CM Alternatives. Chicago; American Medical Association. (2015). ICD-10-CM: The Complete Official Codebook. Chicago. 2 CMS. Transmittal 3315. August 6, 2015; CMS Place of Service Codes for Professional Claims Database (updated August 6, 2015) at: https://www.cms.gov/medicare/medicare-fee-for-service-payment/ PhysicianFeeSched/Downloads/Website-POS-database.pdf. Last accessed Dec. 31, 2015. 3 American Medical Association. (2015). CPT 2016: Professional Edition. Chicago. 4 National Home Infusion Association. NHIA national coding standard for home infusion claims under HIPAA, version 1.11.01d. 5 CMS. Transmittal 1401. December 21, 2007; CMS. Pub. 100-04 Medicare Claims Processing Manual, Chap. 26, Section 10.4. CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 25, Section 75.5. 6 CMS. Pub. 100-04 Medicare Claims Processing Manual, Chap. 12, Section 30.5(E). 7 American Medical Association. (2015). CPT 2016: Professional Edition. Chicago. American Medical Association. (2015). HCPCS 2016 Level II Professional Edition. Chicago. 8 CMS. Transmittal 1422. August 15, 2014. 9 CMS Pub. 100-04 Medicare Claims Processing Manual, Chapter 17, Section 40. 10 CMS Pub. 100-04 Medicare Claims Processing Manual, Chapter 12, Section 30.5(F). 20

Appendix A: Sample Claim Forms The Form CMS-1500 is the basic form prescribed by CMS for the Medicare and Medicaid programs for claims from suppliers and non-institutional providers that qualify for a waiver from the Administrative Simplification Compliance Act (ASCA) requirement for electronic submission of claims. It has also been adopted by the TRICARE Program. For detailed guidance on completing the CMS-1500 items, please see the Medicare Claims Processing Manual, Pub. 100-04, Chap 26, available at: http://www.cms.gov/regulations-and-guidance/guidance/manuals. The 837P (Professional) is the standard format used by healthcare professionals and suppliers to transmit healthcare claims electronically. The American National Standards Institute (ANSI) Accredited Standards Committee (ASC) X12N 837P (Professional) Version 5010A1 is the current electronic claim version. Data elements in the CMS uniform electronic billing specifications are consistent with the hard copy data set to the extent that one processing system can handle both. For more information on electronic claims, please see the ASC website at: http://www.x12.org/. To view a crosswalk between the electronic and hard copy claim form, please see: http://www.nucc.org/images/stories/pdf/1500_form_map_to_837p_5010_v2-0_112011.pdf. The Form CMS-1450, also known as the UB-04, is a uniform institutional provider bill suitable for use in billing multiple third party payers. It is the basic form prescribed by CMS for the Medicare and Medicaid programs for claims from hospitals, including hospital outpatient departments. Because it serves many payers, a particular payer may not need some data elements. For detailed guidance on completing the CMS-1450 items, please see the Medicare Claims Processing Manual, Pub. 100-04, Chap 25, available at: http://www.cms.gov/regulations-and-guidance/guidance/manuals. Please see Checklist for Clean Claims on page 26. 21

REMICADE (infliximab) 2016 Physician Office Sample Claim Form: CMS-1500 1 2 Item 19 Some payers may ask providers to specify REMICADE (infliximab) dosage and NDC, or insert patient on concomitant methotrexate therapy for RA. Do not abbreviate methotrexate. NOTE: Some payers require alternate product codes (eg, Medicaid claims). Please consult with your local payers or contact Janssen CarePath at 877-CarePath (877-227-3728) to confirm payerspecific coding requirements. Item 21 Indicate diagnosis/diagnoses using appropriate ICD-10-CM codes. Use diagnosis codes to the highest level of specificity for the date of service and enter the diagnoses in priority order. The ICD Indicator identifies the ICD code set being reported. For ICD-10-CM diagnoses enter 0 (zero) as a single digit between the vertical, dotted lines. 3 Item 24D Indicate appropriate CPT and HCPCS codes and modifiers if required. Be sure to enter the correct CPT codes by payer Medicare claims for REMICADE administration will use codes 96413 and 96415. NOTE: Individual payer (eg, private, Medicaid) policies may vary regarding the use of codes 96413 and 96415 or 96365 and 96366. Consult local payers for coding policy. Medicaid coding for REMICADE may vary. Please consult with your local payer or contact Janssen CarePath at 877-CarePath (877-227-3728) to confirm payer requirements. 4 Use of evaluation and management codes requires documentation of medically appropriate services performed on the same day as the infusion. Medicare requires the use of modifier 25 when reporting a significant, separately identifiable E/M service by the same physician, on the same day of the infusion procedure. 5 Item 24E Refer to the diagnosis for this service (see box 21). Enter only one diagnosis pointer per line. 6 Item 24G 10-mg units (10 units of J1745 = a single 100-mg vial of infliximab). 22

X 000-00-1234 Doe, John B. 07 01 45 X Doe, John B. 3914 Spruce Street X 3914 Spruce Street Anytown AS Anytown AS 01010 203 555-1234 01010 203 555-1234 Medicare 1 2 Dr. Jones K50.10 123 456 7890 0 3 5 6 01 02 16 01 02 16 11 96413 A 1 123 456 7890 01 02 16 01 02 16 11 96415 A 1 123 456 7890 01 02 16 01 02 16 11 J1745 A 40 123 456 7890 4 01 02 16 01 02 16 11 99212 25 A 1 123 456 7890 PLEASE PRINT OR TYPE Dr. Jones 4231 Center Road Anytown, AS 01010 123 456 7890 203 987-6543 APPROVED OMB-0938-1197 FORM 1500 (02-12) 23

REMICADE (infliximab) 2016 HOPD Sample Claim Form: UB-04 1 Locator Box 42 List revenue codes in ascending order. 2 Locator Box 43 Describe procedure (eg, IV therapy, clinic visit). 3 Use of E/M codes requires documentation of medically appropriate services performed on the same day as the infusion. Medicare requires that HCPCS code G0463 be used to represent all hospital outpatient clinic visits (formerly coded with CPT codes 99201-99205 and 99211-99215). 4 Locator Box 44 Indicate appropriate CPT and HCPCS codes and modifiers if required. Be sure to enter the correct CPT codes by payer Medicare claims for REMICADE (infliximab) administration will use codes 96413 and 96415. NOTE: Individual payer (eg, private, Medicaid) policies for codes to describe IV therapy may vary. Consult local payers or contact Janssen CarePath at 877-CarePath (877-227-3728) for coding policy regarding use of 96413 and 96415 or 96365 and 96366. NOTE: Effective January 1, 2016, the -PO modifier is required for all items and services provided in an off-campus, provider-based department of a hospital. 5 Locator Box 46 10-mg units (10 units of J1745 = a single 100-mg vial of infliximab). 6 Locator Box 47 Indicate total charges. 7 Locator Box 67 Indicate diagnosis using appropriate ICD-10-CM codes. Use diagnosis codes to the highest level of specificity for the date of service and enter the diagnoses in priority order. 24

1 2 4 6 J7050 01-02-15 01-02-16 96413 01-02-16 96415PO 01-02-16 3 G0463 01-02-16 J1745 01-02-16 5 7 0 K50.10 25

Checklist for Clean Claims To proactively prevent denials and underpayments, it may be helpful to perform a pre-billing review prior to submitting any claim to a payer. The following may be considered: Has insurance been verified? Is this a covered service? Were the specific payer requirements followed? If applicable, is the referral authorized? Is medical necessity documented? Is all of the required information included on the claim? Are the correct codes (diagnosis, CPT, and HCPCS) reported? Are the billed units accurate and consistent with the J code descriptor? If reporting any discarded drug, was it properly documented? If a separate and distinct E/M service was provided, is it identified with modifier 25? Appendix B: Medical Necessity Medical necessity refers to a decision by a health plan that a treatment, test, or procedure is necessary for health or to treat a diagnosed medical problem. Health insurance companies provide coverage only for health-related services that they define or determine to be medically necessary. Medicare National Coverage Determinations (NCDs) and Medicare Administrative Contractors (MACs) Local Coverage Determinations (LCDs) define medical necessity requirements. Within these documents covered diagnoses, documentation requirements, and limitations of coverage for specific services provide guidance for establishing medical necessity. You can check your regional MAC website for coverage policies for REMICADE (infliximab) or go to https://www.janssencarepath.com/hcp/remicade/insurance-coverage/medicare to access state-specific billing and reimbursement guidelines for Medicare Administrative Contractors. This website also contains information on state-specific Commercial Payer and Medicare Part D prior authorization. For a sample template for a letter of medical necessity, please contact Janssen CarePath at 877-CarePath (877-227-3728), Monday through Friday, 8 AM to 8 PM, ET. Appendix C: Appeals The most common reasons for denials or underpayment of claims include: Omission of any information that clarifies medical necessity (eg, relevant diagnosis codes) Inaccurately reporting the billable units of drug; note that REMICADE (infliximab) is reported in 10-mg units Use of incorrect CPT or HCPCS codes Lack of proper and complete documentation Omission of a physician letter/statement of medical necessity Omission of special coding requirements (eg, the NDC number or required modifiers) Failure to follow payer-specific requirements for providing this therapy 26

Different payers provide different appeals rights depending upon the level of appeal for the denied claim (eg, first appeal, second appeal). In the event of a claim denial, be sure to resubmit your claim. Most well-documented follow-up submissions are successful. Additional resources for appealing Medicare claims may be found at: https://www.cms.gov/medicare/appeals-and-grievances/orgmedffsappeals/index.html? redirect=/orgmedffsappeals/. You may also want to encourage your patients to contact their employer s benefits office. Many companies are willing to intervene on behalf of employees when prescribed therapies are challenged. For additional information regarding coding, coverage, and reimbursement policies or claim denials for REMICADE, see: https://www.janssencarepath.com/hcp/remicade/reimbursement. For additional assistance, call Janssen CarePath at 877-CarePath (877-227-3728), Monday through Friday, 8 AM to 8 PM, ET. Appendix D: Working With Specialty Pharmacy Some patients may obtain REMICADE through Medicare Part D or another prescription drug benefit, and thus acquire the drug through a retail or specialty pharmacy. The drug is then brought or sent to the administering site of care. Providers that do not buy and supply the drug may not bill for the drug itself, but only for the services associated with drug administration. Management Tools Providers that obtain drugs outside the buy-and-bill model for both commercial and Medicare patients (ie, via some type of pharmacy delivery option) generally find it helpful to develop systems to help manage this method of drug acquisition and service delivery. Please contact Janssen CarePath at 877-CarePath (877-227-3728) for tools that may assist you with tracking and coordinating drugs acquired through specialty pharmacy channels. Coding for Drugs Purchased From Other Than the Administering Provider If the drug is brought to the provider by the patient or delivered to the provider by a specialty pharmacy, the provider may only bill for the administration service. In order to identify and reimburse for the appropriate administration service, most payers require that the name and dosage of the drug be documented on the claim. Commonly payers require that the drug be reported in 24D and billed with a charge of $0.00.* Billing systems that do not permit a $0.00 charge entry may require entering $0.01. Please check with your software vendor. Because payer policies can vary widely regarding the entry of charges and where the drug detail should be reported on the claim form, please contact the payer to clarify the billing policies for drugs that are provider-administered but not provider-purchased. Janssen CarePath for REMICADE is also available to help research payer-specific policies for documenting non-charged drugs. * Data on file with Janssen Biotech, Inc. 27

Appendix E: Medicare Quality Programs* Medicare quality programs apply to both the hospital outpatient department and the physician practice setting. The programs are designed to reward high quality, efficient performance and support the move from payment for volume to payment for value. Compliance with the requirements may preserve or enhance payments and non-compliance may decrease payments across the relevant Medicare payment systems. The following is a brief overview of programs applicable to the hospital outpatient department and physician practice sites of care. Please refer to the respective websites for additional detail and resources. Hospital Outpatient Departments The Hospital Outpatient Quality Reporting Program (Hospital OQR) is a pay for quality data reporting program implemented by CMS for outpatient hospital services. This program requires hospitals that are paid under the Outpatient Prospective Payment System (OPPS) to report quality measures for care provided in their outpatient settings. There is no upward payment adjustment available with the Hospital OQR. Hospitals that fail to comply are subject to a two (2) percentage point reduction in their annual payment update across the OPPS. For more information and resources, please see the Hospital OQR home page at the CMS website: http://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/hospitalqualityinits/ HospitalOutpatientQualityReportingProgram.html. Physician Practice Settings The Physician Quality Reporting System (PQRS) is intended to promote reporting of quality information by eligible professionals (EPs) practicing in the medical office setting. Under the PQRS EPs are encouraged to report quality measures for covered professional services furnished to Medicare Part B Fee-for-Service (FFS) beneficiaries or incur a payment reduction under the Physician Fee Schedule (PFS). There is no longer an upward payment adjustment available to PQRS participants. Additionally, successful participation in PQRS is fundamental to successful participation in the Physician Value-Based Payment Modifier program (see below). The following website serves as the primary and authoritative source for all publicly available information and CMS-supported educational and implementation support materials for PQRS: http://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/pqrs/index. html?redirect=/pqri/01_overview.asp. The Physician Value-Based Payment Modifier (VM) is designed to support the transformation of Medicare from a passive payer to an active purchaser of higher quality, more efficient health care through the value-based purchasing (VBP) initiative. The VM is designed to provide comparative performance information to eligible professionals and medical practice groups to improve the quality and efficiency of medical care. Both cost and quality data are included in calculating the VM. In 2017, the VM applies to all physicians who bill Medicare for services provided under the PFS, and in 2018, to all EPs. Based on quality and cost performance compared to benchmarks, both upward and downward payment adjustments are possible under the VM program. For a detailed discussion of the VM and access to resources, please see: http://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeedbackprogram/ ValueBasedPaymentModifier.html. * This summary provides an overview of the prominent Medicare quality programs and is not intended to be all-inclusive. Other factors/programs may ultimately impact payment in the hospital outpatient department or physician practice settings. Within some programs, under specific circumstances, hardship exemptions may apply. EPs include physicians, nurse practitioners, physician assistants, and others. Disciplines included as EPs may vary between quality programs. The performance period precedes the payment adjustment period by two years (ie, participation in 2016 impacts payment in 2018). 28

Appendix F: ICD-10-CM The compliance date for implementation of ICD-10-CM was October 1, 2015, for all Health Insurance Portability and Accountability Act (HIPAA)-covered entities. ICD-10-CM replaces International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) Diagnosis Codes in all healthcare settings for diagnosis reporting with dates of service, or dates of discharge for inpatients, that occur on or after October 1, 2015. There is no grace period, however CMS acknowledges that ICD-10 is a significant change and has implemented some provider supports to help the transition:. Coding: for the first 12 months after ICD-10 implementation, Medicare review contractors will not deny PFS claims based solely on the specificity of the ICD-10 diagnosis code, as long as the claims contain a code from the right family. Problem resolution: developed a communication and collaboration center (ICD10@cms.hhs.gov) responsible for identifying and initiating resolution of issues that arise as a result of the ICD-10 transition. Ombudsman: appointed William Rogers, MD, as the ICD-10 Ombudsman MD (ICD10_Ombudsman@cms.hhs.gov) to help receive and triage physician and other provider issues. 1 Approach to ICD-10 To help providers smooth the transition to ICD-10, CMS recommends the following 3-step process: Step 1 For general ICD-10 information, access the many resources on the CMS ICD-10 and Road to 10 web pages (see Resources, below). Step 2 Contact your Medicare Administrative Contractor (MAC) for Medicare claims questions. If you have a Medicaid claim question contact your State Medicaid Agency. If you have a commercial or private health plan claim question, please contact your health plan directly. Step 3 Contact the ICD-10 Ombudsman for questions. The ICD-10 Ombudsman is an impartial advocate with a dedicated team of experts to answer your questions. Send your Ombudsman inquiries to ICD10_Ombudsman@cms.hhs.gov. Responses typically will be sent within 3 business days of receipt. Resources ICD-10 Code Lookup Enter a code or keyword to conduct your search for ICD-10 Codes. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx Road to 10: The Small Physician Practice s Route to ICD-10 The Road to 10 is a no-cost tool intended to familiarize providers with ICD-10; explore the common codes; review clinical documentation and clinical scenarios; provide additional resources associated with specialty practice; and help create an action plan. http://www.roadto10.org ¹ CMS. ICD-10 Letter to Medicare Providers. July 7, 2015, at: https://www.cms.gov/medicare/coding/icd10/downloads/medicareprovidericd-10.pdf; see also the ICD-10 Ombudsman and ICD-10 Coordination Center (ICC) web page, at: https://www.cms.gov/medicare/coding/icd10/ ICD10OmbudsmanandICD10CoordinationCenterICC.html. 29

Appendix F: ICD-10-CM (continued) ICD-10: Resources for Specialties and Selected Health Conditions and Services This guide offers links to webcasts, videos, interactive case studies and other resources, by specialty. Specialty categories include: dermatology, Family Practice and Internal Medicine, Pharmacy and others. https://www.cms.gov/medicare/coding/icd10/downloads/icd10specialtyresourcesguide20151123.pdf Provider ICD-10 Resource Guide & Contact List CMS developed this state-by-state list of contacts for Medicare and Medicaid ICD-10 questions; includes a link to contact the ICD-10 Ombudsman: https://www.cms.gov/medicare/coding/icd10/icd-10-provider-contact-table.pdf ICD-10-CM Official Guidelines for Coding and Reporting FY 2016 These guidelines have been approved by the four organizations that make up the Cooperating Parties for the ICD-10-CM: the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), CMS, and the National Center for Health Statistics (NCHS). The guidelines are a set of rules that have been developed to accompany and complement the official conventions and instructions provided within the ICD-10-CM itself. https://www.cms.gov/medicare/coding/icd10/downloads/2016-icd-10-cm-guidelines.pdf 2016 ICD-10-CM and GEMs This CMS website provides links to 2016 ICD-10-CM coding resources, including the General Equivalence Mappings (GEMs) for 2016. https://www.cms.gov/medicare/coding/icd10/2016-icd-10-cm-and-gems.html ICD-10-CM Coding Basics and Coding for ICD-10-CM: More of the Basics (videos) This MedLearn Matters video series presents an overview of ICD-10-CM and introduction to coding. https://www.youtube.com/watch?v=kcv6afla-sc#t=0m0s https://www.youtube.com/watch?v=s86pxhhog7c ICD-10 Post-Implementation: Coding Basics Revisited In this 33-minute video, Sue Bowman from the American Health Information Management Association (AHIMA) and Nelly Leon-Chisen from the American Hospital Association (AHA) discuss the unique characteristics and features of the new coding system: what is a valid code; guidelines for coding and reporting; coding process and examples: 7th character, unspecified codes, external cause codes, laterality; how to submit coding questions and resources for coders. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership- Email-Archive-Items/2015-12-10-eNews.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descendi ng#icd-10%20post-implementation:%20coding%20basics%20revisited In addition to CMS, many medical and trade associations offer ICD-10 resources: American Academy of Professional Coders (AAPC) https://www.aapc.com/icd-10/ American Health Information Management Association (AHIMA) http://www.ahima.org American Medical Association (AMA) http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/ coding-billing-insurance/hipaahealth-insurance-portability-accountability-act/transaction-code-setstandards/icd10-code-set.page 30

Appendix G: Resources The following resources are available to you and your patients. Janssen CarePath for REMICADE Janssen CarePath provides information and assistance regarding coding, coverage, and claim submissions related to REMICADE (infliximab). In addition, Janssen CarePath can also investigate specialty pharmacy options that may be available to simplify product procurement and billing for healthcare providers. Finally, Janssen CarePath can provide coverage information and support directly to patients. Call 877-CarePath (877-227-3728), Monday through Friday, 8 AM to 8 PM, ET. Services: Benefits investigation to determine patient-specific benefits for REMICADE Alternate coverage research for patients requiring coverage or additional coverage for REMICADE Requirements for the prior authorization process Assistance with the appeal process for administrative denials Infusion site location assistance through www.2infuse.com Personalized care coordination including benefits explanation to your patients Upon patient request: Patient education materials, providing disease-state information and infusion education for all approved indications for REMICADE Patient insurance benefit investigation is provided as a service by The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, The Lash Group, Inc., assists healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider s exclusive determination of medical necessity. This reimbursement support service has no independent value to providers apart from the product and is included within the cost of the product. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, The Lash Group, Inc., and Janssen Biotech, Inc., make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While The Lash Group, Inc., tries to provide correct information, it and Janssen Biotech, Inc., make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall The Lash Group, Inc., or Janssen Biotech, Inc., or its employees or agents be liable for any damages resulting from, or relating to, these services. All providers and other users of this information agree that they accept responsibility for the use of this service. 31

Patient Assistance Programs Foundations offer assistance with out-of-pocket costs for prescription drugs. Patients that are having difficulty paying for their medications, and that have federally funded Medicare, Medicaid, TRICARE, or commercial insurance, may qualify for additional support from foundations. Fund availability can vary from time to time. If initially there is no funding available it may be helpful to periodically check back with these sources. Foundation Services Contact Information HealthWell Foundation Patient Access Network Foundation Patient Advocate Foundation Assistance with cost-sharing premiums deductibles co-payments co-insurance Assistance with cost-sharing co-payments co-insurance support and referral services Co-Pay Relief Program P.O. Box 4133 Gaithersburg, MD 20885 1-800-675-8416 www.healthwellfoundation.org P.O. Box 221858 Charlotte, NC 28222 1-866-316-PANF (7263) www.panfoundation.org 421 Butler Farm Rd. Hampton, VA 23666 1-800-532-5274 www.patientadvocate.org Co-Pay Relief Program 1-866-512-3861 www.copays.org Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is committed to providing access to medicines for uninsured patients who lack the financial resources to pay for them. If your patient needs REMICADE (infliximab), and is uninsured and unable to pay for their medicine, please have them contact a JJPAF program specialist at 1-800-652-6227 (9 AM to 6 PM, ET) or visit the foundation website at http://jjpaf.org to see if they might qualify for assistance. 32

Important Safety Information for REMICADE (infliximab) SERIOUS INFECTIONS Patients treated with REMICADE (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE if a patient develops a serious infection or sepsis. Reported infections include: - Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE. 1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE. - Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. - Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with REMICADE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection. Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE included pneumonia, cellulitis, abscess, and skin ulceration. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE. Approximately half of these cases were lymphomas, including Hodgkin s and non-hodgkin s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE cases have occurred in patients with Crohn s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE, especially in these patient types. (continued) 33

Important Safety Information for REMICADE (infliximab) (continued) MALIGNANCIES (continued) In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE (infliximab), more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNFblocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD). Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS REMICADE is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE if new or worsening CHF symptoms appear. REMICADE should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product. HEPATITIS B REACTIVATION TNF inhibitors, including REMICADE, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE. Discontinue REMICADE in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE and monitor patients closely. HEPATOTOXICITY Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving REMICADE postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, 5 times the upper limit of normal) develop, REMICADE should be discontinued, and a thorough investigation of the abnormality should be undertaken. 34

HEMATOLOGIC EVENTS Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY REMICADE has been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available. NEUROLOGIC EVENTS TNF inhibitors, including REMICADE, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE in patients with these disorders and consider discontinuation if these disorders develop. AUTOIMMUNITY Treatment with REMICADE may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. ADVERSE REACTIONS In clinical trials, the most common REMICADE adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. USE WITH OTHER DRUGS Concomitant use of REMICADE with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection. LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Live vaccines or therapeutic infectious agents should not be given with REMICADE due to the possibility of clinical infections, including disseminated infections. Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE. For more information, please see Important Safety Information, full Prescribing Information, and Medication Guide for REMICADE. Provide the Medication Guide to your patients and encourage discussion. References: 1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients. 039670-150902 35

Please see full Prescribing Information and Medication Guide for REMICADE (infliximab), also available at www.remicade.com. Extensive resources available at JanssenCarePath.com. Janssen Biotech, Inc. Janssen Biotech, Inc. 2016 07/2016 051454-160706