2016 Billing Guide for REMICADE (infliximab)

Transcription

1 2016 Billing Guide for REMICADE (infliximab)

2 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 Billing With National Drug Codes (NDCs) Partial Additional Hours of Infusion Time Modifiers Distinct Procedural Service CMS Discarded Drug Policies Same Day Evaluation and Management Services...16 Payment for REMICADE and Drug Administration Services Medicare Payment to Physician Offices Medicare Payment to Hospital Outpatient Departments Medicare Policy for Other Healthcare Providers...18 Medicaid Payment Policies...18 Commercial Payers...18 Home Infusion Reimbursement...19 Medicare Part D...19 i

3 References Appendices Appendix A: Sample Claim Forms Appendix B: Medical Necessity Appendix C: Appeals Appendix D: Working With Specialty Pharmacy...27 Appendix E: Medicare Quality Programs Appendix F: ICD-10-CM Appendix G: Resources 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) American Medical Association. All rights reserved. 01 ii

4 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 ( ) Monday through Friday, 8 AM to 8 PM, ET, or visit the website at: 1

5 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

6 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

7 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

8 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 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 IV infusion, up to 1 hour (chemotherapy) IV infusion for each additional hour CPT IV infusion, up to 1 hour (therapeutic) IV infusion for each additional hour Item 24D Form Locator to 99215,,II Evaluation and management services HCPCS J7050 Infusion, normal saline solution, 250 ml N/A Form Locator 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 Clinic visit 5

9 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) ** 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 and or and CPT code is not billable or payable on physician office Medicare claims when used in conjunction with CPT codes 96413, 96415, 96365, or Code all hospital outpatient clinic visits ( and ) 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: last accessed December 30, 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 K 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

10 ICD-10-CM Diagnosis Codes 1 (continued) There are many sources for mapping ICD-9-CM codes to ICD-10-CM, including 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: Digit NDC format (used by most payers): 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

11 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 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, 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: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Each additional hour (Use in conjunction with 96413; report 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 and may vary. Alternatively, some may require the use of CPT codes: Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Each additional hour (List separately in addition to code for primary procedure; report 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 ( ). 8

12 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: Digit NDC format (used by most payers): 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: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Each additional hour (Use in conjunction with 96413; report 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 and may vary. Alternatively, some may require the use of CPT codes: Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Each additional hour (List separately in addition to code for primary procedure; report 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 ( ). 9

13 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 in conjunction with 99601) J1745* HCPCS Injection, infliximab, 10 mg CODES FOR REMICADE 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

14 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) 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

15 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: N UN1. 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 Number of HCPCS units 30 J MG Infliximab injection, 10 mg NDC (11-digit billing format) NDC description AS NDC unit of measure 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 divide the amount to be billed (300-mg) by the number in the NDC description (300/100 = 3) Below 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 X UN Doe, John B Spruce Street Anytown Anytown Hospital Pay-to-name CNTL # XX-XXXX OF BILL b. MED. 160 Main Street Pay-to-address REC. # DOE STATEMENT COVERS PERIOD 7 Anytown, Anystate Pay-to-city/state 5 FED. TAX NO. FROM THROUGH N UN3 PATIENT NAME a 9 PATIENT ADDRESS a John B. Doe (ID) 3914 Spruce St. b J1745 b A xxxx 30 c d e John B. Doe Anytown, AS US M CONDITION CODES 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 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 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49 N UN3 3 Dr. Jones 4231 Center Road Anytown, AS

16 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 (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 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

17 Table 4: Summary of Code Modifiers 7 (cont d) Modifier Description Indication and Placement CMS 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

18 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

19 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 and 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 (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

20 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: 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: 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: 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: 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: index.html. 17

21 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 ( ). 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

22 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

23 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 August 6, 2015; CMS Place of Service Codes for Professional Claims Database (updated August 6, 2015) at: PhysicianFeeSched/Downloads/Website-POS-database.pdf. Last accessed Dec. 31, 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 d. 5 CMS. Transmittal December 21, 2007; CMS. Pub Medicare Claims Processing Manual, Chap. 26, Section CMS Pub Medicare Claims Processing Manual, Chapter 25, Section CMS. Pub 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 August 15, CMS Pub Medicare Claims Processing Manual, Chapter 17, Section CMS Pub Medicare Claims Processing Manual, Chapter 12, Section 30.5(F). 20