BILLING AND CODING GUIDE

Transcription

1 BILLING AND CODING GUIDE The following information 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 are updated frequently. Individual coding decisions should be based upon diagnosis and treatment of individual patients. While we have 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. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Please consult with your legal counsel or reimbursement specialist for any reimbursement or billing questions. For more information, please call the Lilly PatientOne program at

2 2 LARTRUVO DOSING AND ADMINISTRATION INDICATION LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. LARTRUVO IS ADMINISTERED IN COMBINATION WITH DOXORUBICIN LARTRUVO is supplied as 500 mg/50 ml and 190 mg/19 ml (10 mg/ml), single-dose vials LARTRUVO DOSING AND ADMINISTRATION Recommended Dose and Schedule For the first 8 cycles, LARTRUVO is administered with doxorubicin, which is given on Day 1 of each cycle following the LARTRUVO infusion. Administer LARTRUVO until disease progression or unacceptable toxicity. Do not administer LARTRUVO as an intravenous push or bolus. Treatment Dosage Interval Infusion Time LARTRUVO 15 mg/kg IV Days 1 and 8 of 21-day cycle 60 minutes Doxorubicin* 75 mg/m 2 IV Day 1 of each 21-day cycle for the first 8 cycles <60 minutes * In the registration trial, all patients received dexrazoxane, a cardioprotectant, prior to doxorubicin in Cycles 5 to 8. See dexrazoxane prescribing information for dosing and administration. See doxorubicin prescribing information for additional information on dosing and administration. SELECT IMPORTANT SAFETY INFORMATION Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade 3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.

3 3 LARTRUVO DOSING AND ADMINISTRATION, CONTINUED PREMEDICATION Premedicate with diphenhydramine (25 mg to 50 mg intravenously) and dexamethasone (10 mg to 20 mg intravenously) prior to LARTRUVO on Day 1 of Cycle 1 DOSING MODIFICATIONS FOR LARTRUVO EVENT INFUSION-RELATED REACTIONS NEUTROPENIA DOSING MODIFICATION FOR TOXICITIES Permanently discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions (IRR) Interrupt infusion of LARTRUVO for Grade 1 or 2 IRRs. After resolution, resume LARTRUVO infusion at 50% of the initial infusion rate For neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week, discontinue administration of LARTRUVO until the absolute neutrophil count is 1,000/microliter or greater and then permanently reduce the dose to 12 mg/kg SELECT IMPORTANT SAFETY INFORMATION Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose. Most Common Adverse Reactions The most commonly reported adverse reactions (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%).

4 4 LARTRUVO BILLING AND CODING INFORMATION All coding and documentation requirements for drugs should be confirmed with each payer. This is not a comprehensive list. Additional codes may be used for soft tissue sarcomas. Please refer to the plan for a determination of benefits. DIAGNOSIS CODES ICD-10 Code Description C47.0 Malignant neoplasm of peripheral nerves of head, face, and neck C47.1 Malignant neoplasm of peripheral nerves of upper limb, including shoulder C47.10 Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder C47.11 Malignant neoplasm of peripheral nerves of right upper limb, including shoulder C47.12 Malignant neoplasm of peripheral nerves of left upper limb, including shoulder C47.2 Malignant neoplasm of peripheral nerves of lower limb, including hip C47.20 Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip C47.21 Malignant neoplasm of peripheral nerves of right lower limb, including hip C47.22 Malignant neoplasm of peripheral nerves of left lower limb, including hip C47.3 Malignant neoplasm of peripheral nerves of thorax C47.4 Malignant neoplasm of peripheral nerves of abdomen C47.5 Malignant neoplasm of peripheral nerves of pelvis C47.6 Malignant neoplasm of peripheral nerves of trunk, unspecified C47.8 Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified C48.0 Malignant neoplasm of retroperitoneum and peritoneum C48.1 Malignant neoplasm of specified parts of peritoneum C48.2 Malignant neoplasm of peritoneum, unspecified C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum C49.0 Malignant neoplasm of connective and soft tissue of head, face, and neck C49.1 Malignant neoplasm of connective and soft tissue of upper limb, including shoulder C49.10 Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder C49.11 Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder C49.12 Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder ICD=International Classification of Diseases. SELECT IMPORTANT SAFETY INFORMATION Most Common Lab Abnormalities The most common laboratory abnormalities (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%), thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aptt (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%).

5 5 LARTRUVO BILLING AND CODING INFORMATION, CONTINUED All coding and documentation requirements for drugs should be confirmed with each payer. This is not a comprehensive list. Additional codes may be used for soft tissue sarcomas. Please refer to the plan for a determination of benefits. DIAGNOSIS CODES, CONTINUED ICD-10 Code Description C49.2 Malignant neoplasm of connective and soft tissue of lower limb, including hip C49.20 Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip C49.21 Malignant neoplasm of connective and soft tissue of right lower limb, including hip C49.22 Malignant neoplasm of connective and soft tissue of left lower limb, including hip C49.3 Malignant neoplasm of connective and soft tissue of thorax C49.4 Malignant neoplasm of connective and soft tissue of abdomen C49.5 Malignant neoplasm of connective and soft tissue of pelvis C49.6 Malignant neoplasm of connective and soft tissue of trunk, unspecified C49.8 Malignant neoplasm of overlapping sites of connective and soft tissue C49.9 Malignant neoplasm of connective and soft tissue, unspecified C53.0 Malignant neoplasm of endocervix C54.0 Malignant neoplasm of isthmus uteri C54.1 Malignant neoplasm of endometrium C54.2 Malignant neoplasm of myometrium C54.3 Malignant neoplasm of fundus uteri C54.8 Malignant neoplasm of overlapping sites of corpus uteri C54.9 Malignant neoplasm of corpus uteri, unspecified C55 Malignant neoplasm of uterus, part unspecified C78.00 Secondary malignant neoplasm of unspecified lung C78.01 Secondary malignant neoplasm of right lung C78.02 Secondary malignant neoplasm of left lung Z80.49 Family history of malignant neoplasm of other genital organs Z Personal history of malignant neoplasm of soft tissue SELECT IMPORTANT SAFETY INFORMATION Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade 3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.

6 6 LARTRUVO BILLING AND CODING INFORMATION, CONTINUED All coding and documentation requirements for drugs should be confirmed with each payer. HCPCS CODES Code J9285 Description Injection, olaratumab, 10 mg C94858* Injection, olaratumab, 10 mg HCPCS=Healthcare Common Procedure Coding System. For dates of service prior to January 1, 2017, use the appropriate unspecified HCPCS C-code (C9399) to bill for LARTRUVO. *Effective April 1, 2017, LARTRUVO - specific C-Code The JW modifier may be required by some payers to report drug wastage. Effective January 1, 2018, the following J-code can be used for administrative and billing purposes specific to Lartruvo (olaratumab) J9285, INJECTION, OLARATUMAB, 10 MG (10 mg of LARTRUVO = 1 unit). DRUG ADMINISTRATION CPT CODES CPT Code Description Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug NDC FOR LARTRUVO Vial Size NDC 500 mg/50 ml single-dose vial * 190 mg/19 ml single-dose vial * Vials not actual size. * FDA standard NDC has been zero-filled to ensure creation of an 11-digit code that meets HIPAA standards. The zero-fill location is indicated in bold. CPT=Current Procedural Terminology; NDC=National Drug Code; HIPAA=Health Insurance Portability and Accountability Act. SELECT IMPORTANT SAFETY INFORMATION Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.

7 7 SAMPLE CLAIM FORM CMS-1450 (UB-04) (HOSPITAL OUTPATIENT) All coding and documentation requirements for drugs should be confirmed with each payer. FL 42 & 43: REVENUE CODES AND DESCRIPTION Enter the revenue codes that correspond to HCPCS or CPT codes outlined in FL 44 (eg, corresponding revenue codes for Codes J9285. Payers may vary on revenue code requirements for each procedure/ service performed. FL 44: PRODUCT AND PROCEDURE CODING Enter the HCPCS drug code and CPT code for the administration of LARTRUVO. HCPCS: J9285 Injection, olaratumab, 10 mg C9485 Injection, olaratumab, 10 mg C9399: Unclassified drugs or biologics J9999: Not otherwise classified, antineoplastic drugs J3490: Unclassified drugs J3590: Unclassified biologics CPT: 96413: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug SAMPLE Please see additional CMS-1450 claim form information on page 8.

8 8 SAMPLE CLAIM FORM CMS-1450 (UB-04) (HOSPITAL OUTPATIENT), CONTINUED All coding and documentation requirements for drugs should be confirmed with each payer. FL 46: SERVICE UNITS Specify the appropriate number of service units as designated by individual payers. Check to confirm the unit of use established by other payers, as there may be variation. FL 66: DIAGNOSIS CODES Enter the appropriate ICD diagnosis code(s) that correspond(s) to the type and location of the disease with which the patient has been diagnosed (codes C49.0-C49.9). FL 80: REMARKS To support the review and payment of the claim, include additional information as required by respective payers. This may include NDC, total dosage, and date LARTRUVO was administered. SAMPLE

9 9 SAMPLE CLAIM FORM CMS-1500 (PHYSICIAN OFFICE) All coding and documentation requirements for drugs should be confirmed with each payer. BOX 19: ADDITIONAL CLAIM INFORMATION Box 19 of the CMS-1500 claim form (or its electronic equivalent) is frequently utilized to obtain information regarding the use of drugs. The information will vary, but may include some or all of these items: Drug name Route of administration NDC Amount of drug wasted Total dose administered BOX 21: DIAGNOSIS OR NATURE OF ILLNESS OR INJURY Enter the appropriate diagnosis code on lines A-L to identify the patient s diagnosis/condition and the applicable ICD indicator to identify which ICD code version is being reported (eg, C49.10-C49.12; C C49.22; C49.3-C49.9). Use the highest level of specificity. BOX 24A: DATE(S) OF SERVICE When required by payers to provide the NDC, enter the code in the shaded areas of item number 24. SAMPLE Please see additional CMS-1500 claim form information on page 10.

10 10 SAMPLE CLAIM FORM CMS-1500 (PHYSICIAN OFFICE), CONTINUED All coding and documentation requirements for drugs should be confirmed with each payer. BOX 24D: PROCEDURES, SERVICES, OR SUPPLIES Enter the HCPCS or CPT code and modifier(s) from the appropriate code set. HCPCS: J9285 Injection, olaratumab, 10 mg C9485 Injection, olaratumab, 10 mg J9999: Not otherwise classified, antineoplastic drugs J3490: Unclassified drugs J3590: Unclassified biologics CPT: 96413: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug BOX 24E: DIAGNOSIS POINTER Enter the diagnosis code reference letter, as shown in Box 21, to relate the date of service and the procedures performed to the primary diagnosis. Enter only one reference letter per line item. BOX 24G: DAYS OR UNITS Specify the appropriate number of service units as designated by individual payers. Check to confirm the unit of use established by each payer, as there may be variation. SAMPLE

11 11 Lilly PatientOne: Support and Reimbursement Find easy-to-use forms and reimbursement information to help support your patient s treatment journey. Lilly PatientOne is committed to helping eligible patients access support programs for Lilly Oncology products they are prescribed. We aim to address both financial and coverage issues for qualified uninsured, underinsured, and insured patients. Lilly PatientOne strives to offer resources, ranging from benefits investigations to financial assistance and appeals information, that provide reliable and individualized treatment support for eligible patients. Co-pay Program Lilly PatientOne Co-pay Program patients pay no more than $25 per dose to assist eligible patients with co-pay and coinsurance costs for prescribed Lilly Oncology products where available* No income eligibility requirement Provides an annual maximum patient benefit of $25,000 Insurance Expertise Coding and billing information Payment methodologies and allowables Payer policy information Reimbursement Assistance Eligibility determination Benefits investigation Prior authorization assistance Denied claims appeals information Lilly Cares Foundation The Lilly Cares Foundation, Inc, a separate nonprofit organization, provides free Lilly medications to qualifying patients. For more information about Lilly Cares, please visit LillyCares.com or call For more information, visit LillyPatientOne.com. * This offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program. For more information about Lilly PatientOne, call PatOne ( ), Monday Friday, 9 am 7 pm ET, or visit LillyPatientOne.com. Follow Lilly on these social media platforms.

12 12 IMPORTANT SAFETY INFORMATION FOR LARTRUVO WARNINGS AND PRECAUTIONS Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade 3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR. Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose. MOST COMMON ADVERSE REACTIONS/LAB ABNORMALITIES The most commonly reported adverse reactions (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%). The most common laboratory abnormalities (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%) and thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aptt (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%). USE IN SPECIFIC POPULATIONS Lactation: Because of the potential risk for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LARTRUVO and for at least 3 months following the last dose. Please see full Prescribing Information for LARTRUVO. OR HCP ISI 19OCT2016 PP-OR-US /2017 Lilly USA, LLC All rights reserved. LARTRUVO TM is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. CPT is a registered trademark of the American Medical Association.