Coding and Billing Guide for VARUBI Injectable Emulsion-IV and Tablets-Oral

Transcription

1 Coding and Billing Guide for VARUBI Injectable Emulsion-IV and Tablets-Oral Please click here for full Prescribing Information and see Indication and Important Safety Information for VARUBI on page 3. J code for VARUBI oral: J8670 Effective January 1, 2017

2 Introduction This guide is designed to help healthcare providers and office staff with coding and billing questions, information, and processes for coverage for VARUBI injectable emulsion-iv and tablets-oral. In this guide, you will find: VARUBI Injectable Emulsion-IV TOGETHER with TESARO Information Coding and Billing Overview Glossary of Terms VARUBI Tablets-Oral Sample Forms Frequently Asked Questions How to Use the Coding and Billing Guide The sections of this guide are listed across the bottom of each page, to help you move easily from section to section. The arrows on the right and left at the top allow you to go to the next or previous page. 1 For questions about VARUBI access and reimbursement, please visit TOGETHERwithTESARO.com, us at information@tesaroprp.com, or call a TOGETHER with TESARO Case Manager at TESARO ( ), Monday-Friday (8 am to 8 pm ET). The information contained in this guide is intended to provide a general understanding of the coding and billing process and is not intended to assist healthcare providers in obtaining reimbursement for any specific claim. This information is for informational purposes only and does not represent legal or billing advice. The content here is based on information as of October 2017 and may be subject to change. 2 Introduction

3 Indication and Important Safety Information Indication VARUBI, in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy Contraindication VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes Warnings and Precautions Interaction with CYP2D6 substrates VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication). Consider interactions with CYP2D6 substrates before starting treatment with VARUBI Adverse Reactions In patients receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were neutropenia (9% VARUBI vs 8% control) and hiccups (5% vs 4%) In patients receiving moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were decreased appetite (9% VARUBI vs 7% control), neutropenia (7% vs 6%), and dizziness (6% vs 4%) IV administration of VARUBI was associated with infusion-related symptoms in 2.6% of patients (eg, sensation of warmth, abdominal pain, dizziness, and paresthesia) Other Drug Interactions Strong CYP3A4 inducers: Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (eg, rifampin) as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI BCRP and P-gp substrates with a narrow therapeutic index: Oral VARUBI is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (eg, methotrexate, topotecan, or irinotecan) and P-gp substrates (eg digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor for adverse reactions related to the concomitant drug if use with VARUBI cannot be avoided. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations Warfarin: Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR 3 Introduction

4 VARUBI (rolapitant) Injectable Emulsion-IV Indication 1 VARUBI, in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy Contraindication VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes How Supplied 1 Ready-to-use single-dose vial requires no mixing or reconstitution No refrigeration required; store at 20 C to 25 C (68 F to 77 F) Free of polysorbate 80 Important Safety Information Warnings and Precautions Interaction with CYP2D6 substrates Instructions for Administration 1 VARUBI injectable emulsion is supplied as a single-dose vial for intravenous administration. The emulsion is homogeneous (no shaking required) and translucent white in appearance. Inspect VARUBI injectable emulsion for particulate matter and discoloration prior to administration; discard if present. Do not use if contamination is suspected. Administer the dose by inserting an intravenous set (vented) through the septum of the vial. Once the stopper is punctured, use immediately. Infuse 92.5 ml from the vial over 30 minutes. Do not dilute VARUBI injectable emulsion. Maintain aseptic technique while handling VARUBI injectable emulsion. VARUBI injectable emulsion is compatible with the following other intravenous fluids through a Y-site connection: Sodium Chloride (0.9%) Injection, USP Dextrose (5%) Injection, USP Dextrose (5%) in Lactated Ringer s Injection, USP Lactated Ringer s Injection, USP VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication). Consider interactions with CYP2D6 substrates before starting treatment with VARUBI Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page 3. Reference: 1. VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI IV

5 VARUBI (rolapitant) Injectable Emulsion-IV VARUBI IV Dosing Regimen 1 Day 1 Day 2 Day 3 Day 4 VARUBI Dexamethasone 5-HT 3 RA IV: mg/92.5 ml (1.8 mg/ml) infused over 30 min Administer within 2 h prior to chemotherapy at 2-week intervals 20 mg; 30 min prior to chemotherapy See the PI for the coadministered 5-HT 3 RA for appropriate dosing information None For HEC only; 8 mg twice daily For MEC only; see the PI for the coadministered 5-HT 3 RA for appropriate dosing information HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy; RA=receptor antagonist. Important Safety Information (cont'd) Adverse Reactions In patients receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were neutropenia (9% VARUBI vs 8% control) and hiccups (5% vs 4%) In patients receiving moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were decreased appetite (9% VARUBI vs 7% control), neutropenia (7% vs 6%), and dizziness (6% vs 4%) IV administration of VARUBI was associated with infusion-related symptoms in 2.6% of patients (eg, sensation of warmth, abdominal pain, dizziness, and paresthesia) Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page 3. Reference: 1. VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI IV

6 VARUBI (rolapitant) Injectable Emulsion-IV Distribution VARUBI IV is available through the following specialty distributors: ASD Healthcare McKesson Plasma & Biologics McKesson Specialty Oncology Supply Cardinal Health Specialty Pharmaceutical Distribution VARUBI IV is not available through traditional retail pharmacies or payer-affiliated specialty pharmacies. Important Safety Information (cont'd) Other Drug Interactions Strong CYP3A4 inducers: Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (eg, rifampin) as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI BCRP and P-gp substrates with a narrow therapeutic index: Oral VARUBI is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (eg, methotrexate, topotecan, or irinotecan) and P-gp substrates (eg digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor for adverse reactions related to the concomitant drug if use with VARUBI cannot be avoided. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations Warfarin: Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page 3. 6 VARUBI IV

7 VARUBI (rolapitant) Injectable Emulsion-IV National Drug Codes (NDCs) VARUBI IV NDC numbers are listed below. Please note that converting the 10-digit NDC to an 11-digit NDC requires the use of a leading zero in the product code or middle section of the NDC. 1 VARUBI Package Size NDC 2 Form 10-digit 11-digit CMS 1500 CMS 1450/UB-04 VARUBI IV single-dose vial is mg/92.5 ml (1.8 mg/ml) For Intravenous Use Only One single-use vial Item 19 or shaded areas above Items 24A and 24D Form Locator 44 or 80 or Electronic Comment Field REMINDER When filling out the CMS 1500 form, it's important to include the drug name, NDC, and dose given in Item 19. It is important to confirm with each patient's health plan, as the information required may vary. References: 1. National drug code database background information. US Food & Drug Administration website. Accessed May 25, VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI IV

8 VARUBI (rolapitant) Injectable Emulsion-IV ICD-10-CM Diagnosis Codes It is important to check with the health plan to verify coding or special billing requirements. ICD-10-CM diagnosis codes that may be reasonably related to a diagnosis within the VARUBI IV approved label are listed below. Other codes may be appropriate. See the following page for additional codes that may be necessary to specify that VARUBI IV use is for the prevention of nausea and vomiting associated with chemotherapy. ICD-10-CM 1 Description CMS 1500 Form CMS 1450/UB-04 R11.2 Nausea with vomiting, unspecified R11.0 Nausea R11.10 Vomiting, unspecified Item 21 Form Locator 67 R11.11 Vomiting without nausea R11.12 Projectile vomiting Reference: 1. ICD 10 category R11 (nausea and vomiting). ICD-10 Coded website. Accessed May 8, VARUBI IV

9 VARUBI (rolapitant) Injectable Emulsion-IV ICD-10-CM Supplementary Classification Codes Be sure to use the correct coding when submitting claims for items and services. Confirm coding or special billing requirements with the health plan. Examples of ICD-10-CM supplementary classification codes potentially related to the use of VARUBI IV are listed below. Other codes may be appropriate. ICD-10-CM 1 Description CMS 1500 Form CMS 1450/UB-04 T45.1X5 Z41.9 Z51.11* Adverse effect of antineoplastic and immunosuppressive drugs Encounter for other procedures for purposes other than remedying health state Encounter for antineoplastic chemotherapy Item 21 Form Locator 67 * Required when given within 48 hours of moderately or highly emetogenic chemotherapy. Reference: 1. ICD-10-CM official guidelines for coding and reporting FY Centers for Medicare & Medicaid Services website. CM-Guidelines.pdf. Accessed May 8, VARUBI IV

10 VARUBI (rolapitant) Injectable Emulsion-IV Healthcare Common Procedure Coding System (HCPCS) Codes Depending on the health plan s coverage policy, IV antiemetics may be billed under the medical or pharmacy benefit. CPT-4 codes are used to identify services and procedures given incident to physician services. Level I Codes CPT-4 code * (to be used with a primary code) Description Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug). Additional sequential infusion of a new drug/substance, up to 1 hour. Report only once per sequential infusion of the same infusate mix. Please see footnote below for additional information. Form CMS 1500 CMS 1450/UB-04 Item 24D Form Locator Pharmacy, no detailed coding AHA revenue codes IV therapy N/A Form Locator 42 and Drugs requiring detailed coding * CPT Code is to be reported in conjunction with 96365, 96374, 96409, or to identify the infusion of a new drug/substance provided as a secondary or subsequent service after a different initial service is administered through the same IV access. Report only once per sequential infusion of same infusate mix. References: 1. Medicine/hydration, therapeutic, prophylactic, diagnostic injections and infusions, and chemotherapy. In: American Medical Association. CPT (Current Procedural Technology) 2016 Professional Edition. Chicago, IL: American Medical Association; 2015: Section 3: revenue codes inpatient. Missouri Department of Social Services website. hosp03.pdf. Accessed May 8, VARUBI IV

11 VARUBI (rolapitant) Injectable Emulsion-IV HCPCS Codes (cont d) If the health plan s coverage policy dictates that VARUBI IV should be billed under the medical benefit, an HCPCS Level II code will need to be submitted. Level II Codes Description Dates of Service CMS 1500 Form CMS 1450/UB-04 VARUBI IV J3490 1,* C Unclassified drugs Unclassified drugs or biologicals As of October 25, 2017 Item 24D N/A Form Locator 44 or Electronic Comment Field *In the outpatient setting until a permanent J code is assigned by CMS. The earliest date expected is 1/1/2019. When using HCPCS code J3490, report one unit of VARUBI IV. REMINDER When filling out the CMS 1500 form, it's important to include the drug name, NDC, and dose given in Item 19. It is important to confirm with each patient's health plan, as the information required may vary. References: 1. J3490 CPT code Medicare reimbursement for unclassified NDC numbers drugs. MedicalBillingCodings.org website. MedicareReimbursement-BillingGuidelines.html. Accessed May 8, MLN matters. MM5718. Centers for Medicare & Medicaid Services website. Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM5718.pdf. Accessed December 1, VARUBI IV

12 VARUBI (rolapitant) Injectable Emulsion-IV Chemotherapy Diagnosis Code In addition to the diagnosis code corresponding to the patient s cancer diagnosis, concomitant use of dexamethasone and a 5-HT 3 RA are generally required for coverage and should be included if administered. VARUBI IV is generally administered to patients receiving one or more emetogenic chemotherapy agents. 1,2 Please see the Sample Forms section for sample CMS 1500 and 1450 claim forms. References: 1. Drugs and biologicals (chap 17). In: Medicare claims processing manual. Centers for Medicare & Medicaid Services website. Manuals/downloads/clm104c17.pdf. Accessed May 8, Pub Medicare national coverage determinations. Centers for Medicare & Medicaid Services website. Regulations-and-Guidance/Guidance/Transmittals/downloads/R165NCD.pdf. Accessed May 8, VARUBI IV

13 VARUBI (rolapitant) Injectable Emulsion-IV Commercial Health Plans Commercial health plans may provide coverage for VARUBI IV under the pharmacy or medical benefit. While commercial health plans may provide coverage under either of these benefits, the medical benefit will be utilized for the majority of plans. Please contact the health plan for further clarity. Specific coverage requirements and restrictions depend on a given patient s benefits and may vary by plan type and site of service Medicare Medicare Part B In most cases, VARUBI IV will be covered under Part B. 1-3 Medicare Administrative Contractors (MACs) 4 MACs are multistate regional contractors responsible for administering both Medicare Part A and Medicare Part B claims. MACs are the central point of contact for providers of healthcare services. MACs are the primary operational contact between the Medicare fee-for-service (FFS) program and the healthcare providers enrolled in the program. To find your Medicare Part B or DME MAC jurisdiction, visit the CMS website. References: 1. Drugs and biologicals (chap 17). In: Medicare claims processing manual. Centers for Medicare & Medicaid Services website. Manuals/downloads/clm104c17.pdf. Accessed May 8, Medicare drug coverage under Medicare part a, part b, part c, & part d. Centers for Medicare & Medicaid Services website. cms.gov/outreach-and-education/outreach/partnerships/downloads/11315-p.pdf. Revised April Accessed May 8, MLN matters. SE0910. Centers for Medicare & Medicaid Services website. Accessed May 8, What is a MAC? Centers for Medicare & Medicaid Services website. Accessed May 8, VARUBI IV

14 VARUBI (rolapitant) Injectable Emulsion-IV Medicaid VARUBI IV may be available under state Medicaid programs. Each state Medicaid program has its own eligibility standards, so coverage will vary from state to state. It s important to understand how your patient s Medicaid coverage works by contacting the Medicaid program or accessing the specific coverage information. For example, there may be variation between Medicaid fee-for-service (FFS) programs payment formulas for in-office administration of VARUBI. Some Medicaid plans require prior authorization. Contact information for each state s Medicaid program may be found at the CMS website. To help you determine if VARUBI will be covered for your patient, see TOGETHER with TESARO! 14 VARUBI IV

15 VARUBI (rolapitant) Tablets-Oral Indication 1 VARUBI, in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy Contraindication VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes How Supplied 1 Supplied as a single-dose wallet card containing two 90-mg tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions are permitted between 15ºC to 30ºC (59ºF to 86 F) [See USP Controlled Room Temperature] Important Safety Information Warnings and Precautions Interaction with CYP2D6 substrates VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 VARUBI is supplied as a single-dose wallet card containing two 90-mg tablets. substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication). Consider interactions with CYP2D6 substrates before starting treatment with VARUBI Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page 3. Reference: 1. VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI Oral

16 VARUBI (rolapitant) Tablets-Oral VARUBI Oral Dosing Regimen 1 Day 1 Day 2 Day 3 Day 4 VARUBI Dexamethasone 5-HT 3 RA Oral: 180 mg Administer within 2 h prior to chemotherapy at 2-week intervals 20 mg; 30 min prior to chemotherapy See the PI for the coadministered 5-HT 3 RA for appropriate dosing information None For HEC only; 8 mg twice daily For MEC only; see the PI for the coadministered 5-HT 3 RA for appropriate dosing information HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy; RA=receptor antagonist. Important Safety Information (cont'd) Adverse Reactions In patients receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were neutropenia (9% VARUBI vs 8% control) and hiccups (5% vs 4%) In patients receiving moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide in cycle 1, the most common adverse reactions reported at a frequency of 5% and greater than control were decreased appetite (9% VARUBI vs 7% control), neutropenia (7% vs 6%), and dizziness (6% vs 4%) IV administration of VARUBI was associated with infusion-related symptoms in 2.6% of patients (eg, sensation of warmth, abdominal pain, dizziness, and paresthesia) Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page 3. Reference: 1. VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI Oral

17 VARUBI (rolapitant) Tablets-Oral Distribution VARUBI oral is available through the following specialty distributors: ASD Healthcare McKesson Plasma & Biologics McKesson Specialty Oncology Supply Cardinal Health Specialty Pharmaceutical Distribution VARUBI oral is also available through Biologics, Inc., an oncology specialty pharmacy. VARUBI oral is not available through traditional retail pharmacies or payer-affiliated specialty pharmacies. Important Safety Information (cont'd) Other Drug Interactions Strong CYP3A4 inducers: Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (eg, rifampin) as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI BCRP and P-gp substrates with a narrow therapeutic index: Oral VARUBI is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (eg, methotrexate, topotecan, or irinotecan) and P-gp substrates (eg digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor for adverse reactions related to the concomitant drug if use with VARUBI cannot be avoided. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations Warfarin: Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR Please click here for full Prescribing Information and see Indication and additional Important Safety Information for VARUBI on page VARUBI Oral

18 VARUBI (rolapitant) Tablets-Oral National Drug Codes (NDCs) VARUBI oral NDC numbers are listed below. Please note that converting the 10-digit NDC to an 11-digit NDC requires the use of a leading zero in the product code or middle section of the NDC. 1 VARUBI Package Size NDC 2 Form 10-digit 11-digit CMS 1500 CMS 1450/UB-04 VARUBI oral single-dose package (two tablets as one set of twinned blisters), 90-mg per tablet Item 19 Form Locator 44 or 80 or Electronic Comment Field REMINDER When filling out the CMS 1500 form, it's important to include the drug name, NDC, and dose given in Item 19. It is important to confirm with each patient's health plan, as the information required may vary. References: 1. National drug code database background information. US Food & Drug Administration website. Accessed May 25, VARUBI [package insert]. Waltham, MA: Tesaro, Inc; VARUBI Oral

19 VARUBI (rolapitant) Tablets-Oral ICD-10-CM Diagnosis Codes It is important to check with the health plan to verify coding or special billing requirements. ICD-10-CM diagnosis codes that may be reasonably related to a diagnosis within the VARUBI oral approved label are listed below. Other codes may be appropriate. See the following slide for additional codes that may be necessary to specify that VARUBI oral use is for the prevention of nausea and vomiting associated with chemotherapy. ICD-10-CM 1 Description CMS 1500 Form CMS 1450/UB-04 R11.2 Nausea with vomiting, unspecified R11.0 Nausea R11.10 Vomiting, unspecified Item 21 Form Locator 67 R11.11 Vomiting without nausea R11.12 Projectile vomiting Reference: 1. ICD 10 category R11 (nausea and vomiting). ICD-10 Coded website. Accessed May 8, VARUBI Oral

20 VARUBI (rolapitant) Tablets-Oral ICD-10-CM Supplementary Classification Codes Be sure to use the correct coding when submitting claims for items and services. Confirm coding or special billing requirements with the health plan. Examples of ICD-10-CM supplementary classification codes potentially related to the use of VARUBI oral are listed below. Other codes may be appropriate. ICD-10-CM 1 Description CMS 1500 Form CMS 1450/UB-04 T45.1X5 Adverse effect of antineoplastic and immunosuppressive drugs Z41.9 Z51.11* Encounter for other procedures for purposes other than remedying health state Encounter for antineoplastic chemotherapy Item 21 Form Locator 67 * Required when given within 48 hours of moderately or highly emetogenic chemotherapy. Reference: 1. ICD-10-CM official guidelines for coding and reporting FY Centers for Medicare & Medicaid Services website. CM-Guidelines.pdf. Accessed May 8, VARUBI Oral

21 VARUBI (rolapitant) Tablets-Oral HCPCS Codes If the health plan s coverage policy dictates that VARUBI oral should be billed under the medical benefit, an HCPCS Level II code will need to be submitted. Level II Codes Description Dates of Service CMS 1500 Form CMS 1450/UB-04 VARUBI oral J Rolapitant, 1 mg* As of January 1, 2017 Item 24D Form Locator 44 * When filling in the Level II HCPCS code, remember that because J8670 is per 1 mg, it does not represent the entire dose. The unit of measure is 1 mg and one dose of VARUBI oral is 180 units (1 mg x 180-mg dose = one dose of VARUBI oral). Note: The use of Q9981 when billing VARUBI oral under Medicare Part B was discontinued for dates of service after December 31, Reference: 1. Data on file. TESARO, Inc. 2. Application summaries for drugs, biologicals, and radiopharmaceuticals, May 17, Centers for Medicare & Medicaid Services website. Medicare/Coding/MedHCPCSGenInfo/Downloads/ HCPCS-Application-Summary-.pdf. Accessed May 8, VARUBI Oral

22 VARUBI (rolapitant) Tablets-Oral Chemotherapy Diagnosis Code In addition to the diagnosis code corresponding to the patient s cancer diagnosis, concomitant use of dexamethasone and a 5-HT 3 RA are generally required for coverage and should be included if administered. VARUBI oral is generally administered to patients receiving one or more emetogenic chemotherapy agents. 1,2 References: 1. Drugs and biologicals (chap 17). In: Medicare claims processing manual. Centers for Medicare & Medicaid Services website. Manuals/downloads/clm104c17.pdf. Accessed May 8, Pub Medicare national coverage determinations. Centers for Medicare & Medicaid Services website. Regulations-and-Guidance/Guidance/Transmittals/downloads/R165NCD.pdf. Accessed May 8, VARUBI Oral

23 VARUBI (rolapitant) Tablets-Oral Commercial Health Plans Commercial health plans may provide coverage for VARUBI oral under the pharmacy or medical benefit. Specific coverage requirements and restrictions depend on a given patient s benefits and may vary by plan type and site of service The reimbursement rate may vary depending on the agreement between the plan and the healthcare provider and whether VARUBI is covered as a medical or pharmacy benefit Medicare Medicare Part B 1 VARUBI oral is covered under Medicare Part B only when certain conditions are met, including VARUBI is used as part of an all-oral, three-drug regimen as full replacement for the drugs intravenous equivalents for patients receiving moderately or highly emetogenic chemotherapy The three-drug regimen must be administered immediately before, at, or within 48 hours after the time of administration of the chemotherapy This coverage policy applies only to the oral forms of the three drug regimen as full replacement for their intravenous equivalents. All other indications or combinations for the use of VARUBI oral are non-covered under Medicare Part B, but may be considered under Medicare Part D. Medicare Administrative Contractors (MACs) 2 MACs are multistate regional contractors responsible for administering both Medicare Part A and Medicare Part B claims. MACs are the central point of contact for providers of healthcare services. MACs are the primary operational contact between the Medicare fee-for-service (FFS) program and the healthcare providers enrolled in the program. To find your Medicare Part B or DME MAC jurisdiction, visit the CMS website. Medicare Part D VARUBI oral is most commonly covered under Medicare Part D. References: 1. Pub Medicare national coverage determinations. Centers for Medicare & Medicaid Services website. downloads/r165ncd.pdf. Accessed May 8, What is a MAC? Centers for Medicare & Medicaid Services website. Administrative-Contractors/What-is-a-MAC.html. Accessed May 8, VARUBI Oral

24 VARUBI (rolapitant) Tablets-Oral Medicaid VARUBI oral may be available under state Medicaid programs. Each state Medicaid program has its own eligibility standards, so coverage and reimbursement will vary from state to state. It s important to understand how your patient s Medicaid coverage works by contacting the Medicaid program or accessing the specific coverage and reimbursement information. For example, there may be variation between Medicaid fee-for-service (FFS) programs payment formulas for in-office administration of VARUBI. Some Medicaid plans require prior authorization. Contact information for each state s Medicaid program may be found at the CMS website. To help you determine if VARUBI will be covered for your patient, see TOGETHER with TESARO! 24 VARUBI Oral

25 TOGETHER with TESARO Patient Resource Program TOGETHER with TESARO is a patient resource program dedicated to supporting people living with cancer and the healthcare providers who serve them. The program offers a suite of solutions to address medication access and affordability. Our expert case management team facilitates a seamless process to ensure that you and your patients get the individualized support needed. We provide guidance to achieve solutions, so you can focus on what s important your patients and their well-being. We know that you have a lot on your to-do list, and we want to help make patient access and affordability issues as easy as possible. TOGETHER with TESARO provides a full suite of solutions, including the following: VARUBI (rolapitant) tablets-oral Benefits Investigation Prior Authorization Facilitation and Appeals Support First Dose Program Commercial Co-pay Assistance Program Referrals to Independent Co-pay Foundations VARUBI (rolapitant) injectable emulsion-iv Benefits Investigation Prior Authorization/Precertification Facilitation and Appeals Support Commercial Co-pay Assistance Program Referrals to Independent Co-pay Foundations Patient Assistance Program Patient Assistance Program Visit TOGETHERwithTESARO.com to Enroll your patient online Download an enrollment form Find your dedicated Case Manager Learn more about our access and affordability solutions To speak with a TOGETHER with TESARO Case Manager, please call TESARO ( ), Monday-Friday (8 am to 8 pm ET) us at information@tesaroprp.com 25 TOGETHER with TESARO

26 Sample Forms Sample CMS 1450 Claim Form (Hospital Outpatient): VARUBI Injectable Emulsion-IV and Chemotherapy-Induced Nausea and Vomiting (CINV) Drug Note: Sample form and callouts are specific to a hypothetical patient's health plan and are not to be used as a reference. Providers should contact a representative at their patient's health plan to confirm required coding in individual situations. PRODUCT CODE (FORM LOCATOR 44) Plan accepts HCPCS code J3490 (Unclassified drug) SERVICE UNITS (FORM LOCATOR 46) Plan requires the number of NDC units used in Form Locator 46 (When using HCPCS code J3490, report one unit of VARUBI IV) 0636 VARUBI (rolapitant) IV Therapeutic infusion, additional Injection, dexamethasone, 1 mg Inj, ondansetron hydrochloride, per 1 mg Therapeutic Infusion J J1100 J MMDDYY MMDDYY MMDDYY MMDDYY MMDDYY XXXXX XXXXX XXXXX XXXXX XXXXX REVENUE CODE (FORM LOCATOR 42) AND DESCRIPTIONS (FORM LOCATOR 43) Use revenue code 0636 (drugs requiring detailed coding) for J3490 and VARUBI IV Related administration procedure - Use most appropriate revenue code for cost center where services were performed PROCEDURE CODE (FORM LOCATOR 44) Use CPT code representing procedures performed, such as: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure) PRODUCT INFO (FORM LOCATOR 80) Plan will accept Not-Otherwise-Classified (NOC) code J3490 to report the use of VARUBI IV, but requires additional information to include: name of drug (both brand and generic), National Drug Code (NDC) number, strength of drug administered, and dose HIPAA 5010 requirements necessitate the field also contain information on any other injectable drug to include NDC number, drug name, and cost, so the field will need to also accommodate the particulars of the chemotherapy drug DIAGNOSIS CODES (FORM LOCATOR 67) Enter appropriate ICD-10-CM diagnosis code(s) corresponding to patient's diagnosis, such as: For CINV, use ICD-10 R11.2 Nausea with vomiting; unspecified C R11.2 VARUBI, rolapitant injectable emulsion, NDC , dose mg, injection, cost $$ Note that the reporting field for electronic claims (SV202-2) is limited to 80 characters; however, some payers may allow utilization of Loop 2300 NTE 01 and 02 if additional space is needed. Check with the payer for additional guidance 26 Sample Forms

27 Sample Forms Sample CMS 1450 Claim Form (Hospital Outpatient): Chemotherapy With VARUBI Injectable Emulsion-IV Note: Sample form and callouts are specific to a hypothetical patient's health plan and are not to be used as a reference. Providers should contact a representative at their patient's health plan to confirm required coding in individual situations. PRODUCT CODE (FORM LOCATOR 44) Plan accepts HCPCS code J3490 (Unclassified drug) SERVICE UNITS (FORM LOCATOR 46) Plan requires the number of NDC units used in Form Locator 46 (When using HCPCS code J3490, report one unit of VARUBI IV) 0636 VARUBI (rolapitant) IV Therapeutic infusion, additional Injection, dexamethasone, 1 mg Inj, ondansetron hydrochloride, per 1 mg Therapeutic Infusion Chemotherapy administration Dexamethasone J J9171 J J1100 MMDDYY MMDDYY MMDDYY MMDDYY MMDDYY MMDDYY MMDDYY XXXXX XXXXX XXXXX XXXXX XXXXX XXXXX XXXXX DIAGNOSIS CODES (FORM LOCATOR 67) Enter appropriate ICD-10-CM diagnosis code(s) corresponding to patient's diagnosis, such as: ICD-10-CM code examples: C Malignant neoplasm of upper-inner quadrant of right female breast For CINV, use ICD-10 R11.2 Nausea with vomiting; unspecified REVENUE CODE (FORM LOCATOR 42) AND DESCRIPTIONS (FORM LOCATOR 43) Use revenue code 0636 (drugs requiring detailed coding) for J3490 Related administration procedure - Use most appropriate revenue code for cost center where services were performed C R11.2 VARUBI, rolapitant injectable emulsion, NDC , dose mg, injection, cost $$ PROCEDURE CODE (FORM LOCATOR 44) Use CPT code representing procedures performed, such as: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure) PRODUCT INFO (FORM LOCATOR 80) Plan will accept Not-Otherwise-Classified (NOC) code J3490 to report the use of VARUBI IV, but requires additional information to include: name of drug (both brand and generic), National Drug Code (NDC) number, strength of drug administered, and dose HIPAA 5010 requirements necessitate the field also contain information on any other injectable drug to include NDC number, drug name, and cost, so the field will need to also accommodate the particulars of the chemotherapy drug Note that the reporting field for electronic claims (SV202-2) is limited to 80 characters; however, some payers may allow utilization of Loop 2300 NTE 01 and 02 if addirtional space is needed. Check with the payer for additional guidance 27 Sample Forms

28 Sample Forms Sample CMS 1500 Claim Form (Physician Office): VARUBI Injectable Emulsion-IV and CINV Drug Note: Sample form and callouts are specific to a hypothetical patient's health plan and are not to be used as a reference. Providers should contact a representative at their patient's health plan to confirm required coding in individual situations. PROCEDURE CODE (ITEM 44) Use CPT code representing procedures performed, such as: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure) PRODUCT CODE (ITEM 24D) Plan accepts HCPCS code J3490 (Unclassified drug) PRODUCT INFO (ITEM 19) Plan will accept Not-Otherwise-Classified (NOC) code J3490 to report the use of VARUBI IV, but requires additional information to include: name of drug (both brand and generic), National Drug Code (NDC) number, strength of drug administered, and dose HIPAA 5010 requirements necessitate the field also contain information on any other injectable drug to include NDC number, drug name, and cost, so the field will need to also accommodate the particulars of the chemotherapy drug Note that the reporting field for electronic claims (SV202-2) is limited to 80 characters; however, some payers may allow utilization of Loop 2300 NTE 01 VARUBI, rolapitant injectable emulsion, NDC , dose mg, injection, cost $$ R11.2 XX XX XX XX XX XX 11 J3490 A 1 XX XX XX XX XX XX A 1 DIAGNOSIS CODE (ITEM 21) Enter appropriate ICD-10-CM diagnosis code(s) corresponding to patient's diagnosis For CINV, use ICD-10 R11.2 Nausea with vomiting; unspecified DIAGNOSIS CODE POINTER (ITEM 24E) Specify diagnosis, from Item 21, relating to each CPT/HCPCS code listed in Item 24D XX XX XX XX XX XX 11 J9171 A 1 XX XX XX XX XX XX A 1 XX XX XX XX XX XX 11 J1626 A 1 SERVICE UNITS (ITEM 24G) Plan requires the number of NDC units used in Item 24G (When using HCPCS code J3490, report one unit of VARUBI IV) 28 Sample Forms

29 Sample Forms Sample CMS 1500 Claim Form (Physician Office): Chemotherapy With VARUBI Injectable Emulsion-IV Note: Sample form and callouts are specific to a hypothetical patient's health plan and are not to be used as a reference. Providers should contact a representative at their patient's health plan to confirm required coding in individual situations. PRODUCT INFO (ITEM 19) Plan will accept Not-Otherwise-Classified (NOC) code J3490 to report the use of VARUBI IV, but requires additional information to include: name of drug (both brand and generic), National Drug Code (NDC) number, strength of drug administered, and dose HIPAA 5010 requirements necessitate the field also contain information on any other injectable drug to include NDC number, drug name, and cost, so the field will need to also accommodate the particulars of the chemotherapy drug Note that the reporting field for electronic claims (SV202-2) is limited to 80 characters; however, some payers may allow utilization of Loop 2300 NTE 01 PRODUCT CODE (ITEM 24D) Plan accepts HCPCS code J3490 (Unclassified drug) PROCEDURE CODE (ITEM 24D) Use CPT code representing procedures performed, such as: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure) VARUBI, rolapitant injectable emulsion, NDC , dose mg, injection, cost $$ C XX XX XX XX XX XX 11 J3490 B 1 XX XX XX XX XX XX 11 J9171 A 1 XX XX XX XX XX XX A 1 XX XX XX XX XX XX B 1 XX XX XX XX XX XX B 1 XX XX XX XX XX XX 11 J1626 B 1 DIAGNOSIS CODE (ITEM 21) Enter appropriate ICD-10-CM diagnosis code(s) corresponding to patient's diagnosis, such as: ICD-10-CM code examples: C Malignant neoplasm of upper-inner quadrant of right female breast For CINV, use ICD-10 R11.2 Nausea with vomiting; unspecified DIAGNOSIS CODE POINTER (ITEM 24E) Specify diagnosis, from Item 21, relating to each CPT/HCPCS code listed in Item 24D SERVICE UNITS (ITEM 24G) Plan requires the number of NDC units used in Item 24G (When using HCPCS code J3490, report one unit of VARUBI IV) 29 Sample Forms

30 Coding and Billing Overview Overview Once you have administered VARUBI to your patient, your office may submit a claim to the patient s health plan. Depending on your patient s benefits, your office may submit a claim for the drug, or for the drug and the IV administration services, if VARUBI injectable emulsion-iv was administered. National Drug Codes (NDCs) NDCs help healthcare providers and health plans identify specific product package sizes. Some health plans require healthcare providers to use an 11-digit NDC when reporting a drug on a claim form. Converting the 10-digit NDC for VARUBI to an 11-digit NDC requires the use of a leading zero in the product code or middle section of the NDC. 1 (See examples for VARUBI IV and oral on pages 7 and 18, respectively.) ICD-10-CM Diagnosis Codes Use the current ICD-10-CM codes to report a patient s diagnosis on claim submissions. Be sure to use the correct coding when submitting a claim for the item or service. 2 Depending on the site of care (ie, healthcare provider office or hospital), different forms and codes will be used. ICD-10-CM Supplementary Classification Codes Circumstances and conditions affecting the disease may be reported using supplementary ICD-10-CM codes. An ICD-10-CM code from the main chapter of ICD-10-CM indicating the nature of the condition should be provided in addition to the supplementary ICD-10-CM code or codes, as the case may be. ICD=International Classification of Diseases. References: 1. National drug code database background information. US Food & Drug Administration website. Accessed May 25, ICD-10-CM official guidelines for coding and reporting FY Centers for Medicare & Medicaid Services website. Accessed May 8, Coding and Billing Overview

31 Coding and Billing Overview Healthcare Common Procedure Coding System (HCPCS) Codes HCPCS is a set of healthcare procedure codes based on the American Medical Association s Current Procedural Terminology (CPT). Coders use HCPCS codes to represent medical procedures to Medicare, Medicaid, and several other third-party payers. 1 The code set is divided into three levels. Level I is identical to CPT, though technically those codes, when used to bill Medicare or Medicaid, are HCPCS codes. Level I CPT codes consist of five numbers. 1 For some drugs, health plans require healthcare providers to indicate quantity of product administered on the claim form using units from the HCPCS code. Depending on the health plan s coverage policy, IV antiemetics may be billed under the medical or pharmacy benefit. CPT-4 codes are used to identify services and procedures given incident to physician services. CMS issues permanent HCPCS J codes on January 1 (provided the product received FDA approval by March 31 of the previous year and code application has been accepted by CMS). The permanent J code will replace the temporary J code issued when the drug was new. 1 Level II HCPCS codes are established and published by CMS. Level II codes consist of a letter followed by four numbers, often referred to as the J code. 1 Use Level II codes on form CMS 1500 and CMS 1450 (UB-04) to identify the product administered or used. If the health plan s coverage policy dictates that VARUBI IV should be billed under the medical benefit, an HCPCS Level II code will need to be submitted. American Hospital Association (AHA) AHA revenue codes capture facility cost data by department, which the facility uses for cost-reporting purposes. Some health plans request that providers report revenue codes on claim forms. CMS=Centers for Medicare & Medicaid Services. Reference: 1. Healthcare common procedure coding system. Centers for Medicare & Medicaid Services website. Procedures pdf. Accessed May 8, Coding and Billing Overview

32 Coding and Billing Overview To process a claim, it is important to: m Ensure all patient information (name, address, insurance ID) is accurate m Verify the name of the healthcare provider and National Provider Identifier (NPI) m Use the most appropriate ICD-10-CM diagnosis and CPT-4 procedure codes associated with each patient s diagnosis and care m Use the correct HCPCS codes and modifiers where and when appropriate m Specify the setting or place of service (POS) where the service was provided (ie, provider office or hospital outpatient setting) m Ensure patient medical records contain documentation that support the diagnosis and procedure codes submitted on the claim m Complete all fields accurately and provide information upon request See the TOGETHER with TESARO section of this guide for more information about how we can support you and your patients. 32 Coding and Billing Overview

33 Frequently Asked Questions Q. Should I bill VARUBI under the medical or pharmacy benefit? A. A patient's healthcare insurance coverage will determine whether VARUBI is billed under the medical or pharmacy benefit. Please note that VARUBI injectable emulsion-iv and tablets-oral are typically covered and processed differently from one another due to differing modes of administration. This can even differ by the same health plan. For that reason, it is important to conduct a benefits investigation to identify if a patient is covered for VARUBI and whether it is covered as a medical or pharmacy benefit. TOGETHER with TESARO can provide a benefits investigation to you and your patient at no cost. Once you obtain patient consent and enroll your patient in TOGETHER with TESARO, your Case Manager can look into your patient s specific coverage and benefits details and provide you with the results report. For other questions, visit TOGETHERwithTESARO.com, us at information@tesaroprp.com, or call a TOGETHER with TESARO Case Manager at TESARO ( ), Monday-Friday (8 am to 8 pm ET). Q. If VARUBI should be billed under the medical benefit, how do I submit a claim? A. Healthcare providers should use form CMS 1500 (healthcare provider office); be sure to include the appropriate CPT-4 code and the appropriate revenue code. Some health plans require the use of a specialty pharmacy to supply VARUBI. This could be through either a medical or pharmacy benefit of the health plan. If VARUBI is supplied by a specialty pharmacy, the healthcare provider may not bill for the drug itself, only the administration is billable. Contact TOGETHER with TESARO, our patient resource program, for coverage support and financial assistance. 33 Frequently Asked Questions