Hospital Outpatient Coding and Billing Information Sheet for Neulasta and NEUPOGEN

Transcription

1 Hospital Outpatient Coding and Billing Information Sheet for Neulasta and Neulasta Delivery Kit Neulasta Prefilled Syringe For assistance contact MYNEULASTA ( ) or visit

2 NEULASTA DELIVERY KIT COMPARISON TWO DELIVERY OPTIONS FOR NEULASTA Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 1 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1 Neulasta Delivery Kit, which includes: the same Neulasta with a different delivery option 1 Must be prepared and applied by a healthcare provider on the same day as chemotherapy 1 Designed to deliver a full dose of Neulasta approximately 27 hours after its activation 1 As per the label, a healthcare provider may initiate administration with the On-body Injector for Neulasta (also referred to as the On-body Injector ) on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector delivers pegfilgrastim no less than 24 hours after administration of cytotoxic chemotherapy 1 Apply today, deliver* Neulasta tomorrow 1 Day 1 Day (hours) Healthcare provider activates and applies the On-body Injector to the patient Three minutes after activation, the needle inserts the cannula subcutaneously 2 * The On-body Injector for Neulasta is designed to deliver Neulasta approximately 27 hours after activation. Approximately 27 hours after the On-body Injector is activated and applied to the patient, Neulasta will be delivered subcutaneously over approximately 45 minutes Neulasta delivered via the On-body Injector vs Neulasta delivered via the manual use Neulasta Prefilled Syringe Select Attributes Same Different Active Ingredient 1 Indication 1 Route of Administration 1 Administration Process 1 Deliverable Dose 1 How Supplied 1 WAC 3 J-code 4, * NDC Number 1, * * See next page for coding and billing information sheet for Neulasta. On-body Injector for Neulasta A missed dose could occur due to an On-body Injector for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use, as soon as possible after detection. The On-body Injector is backed by 24/7 telephone support and a full return policy. Call MYNEULASTA at any time for assistance or answers to product-related questions. Special Instructions for the On-body Injector for Neulasta A healthcare provider must fill the On-body Injector with Neulasta (pegfilgrastim) using the co-packaged prefilled syringe and then apply the On-body Injector for Neulasta to the patient s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector for Neulasta. Approximately 27 hours after the On-body Injector for Neulasta is applied to the patient s skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On-body Injector for Neulasta on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector for Neulasta delivers Neulasta no less than 24 hours after the administration of cytotoxic chemotherapy. Neulasta Delivery Kit Neulasta Prefilled Syringe Please see Important Safety Information on pages 8 and

3 HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR THE NEULASTA DELIVERY KIT HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR THE NEULASTA DELIVERY KIT Hospital Outpatient Billing Information Sheet for the Neulasta Delivery Kit Item Revenue Code Coding Information (HCPCS 4 /CPT 5 / ICD-9-CM) Neulasta Delivery Kit Administration of the On-body Injector Diagnosis/ Condition Medicare: 0636, drugs requiring detailed coding Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer Appropriate revenue code for the cost center in which the service is performed N/A J2505, injection, pegfilgrastim, 6 mg Potential CPT code options include CPT (therapeutic, prophylactic, or diagnostic injection [subcutaneous or intramuscular]) OR another code. Please consult payers regarding appropriate coding prior to submitting claims. Appropriate diagnosis code(s) for patient condition: ICD-9-CM code(s) for services performed before October 1, 2015 ICD-10-CM code(s) for services performed on or after October 1, 2015 Please see Important Safety Information on pages 8 and 9. Notes Neulasta is supplied as a 6 mg deliverable dose. 1 Billing requirements may vary by payer; however, it may be important to document the NDC number (in the 11-digit format) on a claim in order to differentiate the Neulasta Delivery Kit 1 : Healthcare providers can initiate administration with the On-body Injector on the same day as the administration of chemotherapy. 1, * Consider using modifier 59 to indicate that the subcutaneous administration via the On-body Injector in the Neulasta Delivery Kit is distinct from chemotherapy administration services on the same day of service. 6 See payer guidelines for specific coding requirements. Allowable diagnosis codes may vary by payer. * As long as Neulasta is not delivered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. The information provided in this Coding and Billing Information document is of a general nature and for informational purposes only and is not intended to be a comprehensive list nor instructive. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. The information provided in this section should in no way be considered a guarantee of coverage or reimbursement for any product or service. For assistance with payer-specific requirements, contact local payer or call MYNEULASTA ( ) The CMS 1450 for Hospital Outpatient the Neulasta Delivery Kit Sample UB-04 (CMS 1450) Form Hospital Outpatient Administration Anytown Hospital 100 NDC Main CODE Street (BOX 43) Anytown, In order to Anystate distinguish the Neulasta Delivery Kit, it may be important to document the NDC number in Box 43 (or corresponding electronic field): Smith, Jane Note: Specific payer requirements may vary. Some payers may require to report the NDC number in the following format the NDC qualifier (eg, N4), followed by the 11-digit NDC number (without hyphens), followed by the NDC unit of measurement qualifier (eg, ML), followed by the quantity corresponding to the unit of measurement. REVENUE CODES (BOX 42) AND DESCRIPTIONS (BOX 43) Medicare: Use revenue code 0636, drugs requiring detailed coding. Other payers: Use revenue code 0250, general pharmacy (or 0636, if required by a given payer). Use most appropriate revenue code for cost center where services were performed (eg, 0510, clinic). DIAGNOSIS CODES (BOX 67) Enter appropriate ICD-9-CM diagnosis code(s) corresponding to patient s diagnosis. Allowable diagnosis codes may vary by payer. XXX.X SERVICE DATE (BOX 45) Report date of service. For example, the date when On-body Injector from the Neulasta Delivery Kit was applied. Note: Specific payer requirements may vary. 123 Main Street, Anytown, Anystate SERVICE UNITS (BOX 46) Report units of service. 1 unit (Neulasta dose is 6 mg, per label) J2505 MMDDYY 1 XXXXX 0510 Clinic MMDDYY 1 XXXXX PRODUCT AND PROCEDURE CODE (BOX 44) (J-Code) J2505, injection, pegfilgrastim, 6 mg. Potential CPT code options include CPT (therapeutic, prophylactic, or diagnostic injection [subcutaneous or intramuscular]) OR another code. Please consult payers regarding appropriate coding prior to submitting claims. Note: Healthcare providers can initiate administration with the On-body Injector on the same day as the administration of chemotherapy*. Consider using modifier 59 to indicate that the subcutaneous administration via the On-body Injector is distinct from chemotherapy administration services on the same day of service. * As long as Neulasta is not delivered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. This sample form is intended as a reference for coding and billing for product and associated services. It is not intended to be a directive, nor does the use of the recommended codes guarantee reimbursement. Physicians and staff may deem other codes or policies more appropriate. Providers should select the coding options that most accurately reflect their internal system guidelines, payer requirements, practice patterns, and the services rendered. Providers are responsible for ensuring the accuracy and validity of all billing and claims for appropriate reimbursement. Neulasta Delivery Kit Neulasta Prefilled Syringe 4 5

4 HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR THE NEULASTA PREFILLED SYRINGE HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR THE NEULASTA PREFILLED SYRINGE Hospital Outpatient Billing Information Sheet for the Neulasta Prefilled Syringe Item Revenue Code Coding Information (HCPCS 4 /CPT 5 / ICD-9-CM) Neulasta Prefilled Syringe for Manual Injection Administration of Neulasta Prefilled Syringe for Manual Injection Diagnosis/ Condition Medicare: 0636, drugs requiring detailed coding Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer Appropriate revenue code for the cost center in which the service is performed N/A J2505, injection, pegfilgrastim, 6 mg 96372, therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular Appropriate diagnosis code(s) for patient condition: ICD-9-CM code(s) for services performed before October 1, 2015 ICD-10-CM code(s) for services performed on or after October 1, 2015 Notes Neulasta is supplied as a 6 mg deliverable dose is the NDC number (in the 11-digit format) for the Neulasta prefilled syringe for manual injection. 1 Allowable diagnosis codes may vary by payer. The information provided in this Coding and Billing Information document is of a general nature and for informational purposes only and is not intended to be a comprehensive list nor instructive. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. The information provided in this section should in no way be considered a guarantee of coverage or reimbursement for any product or service. The CMS 1450 for Hospital Outpatient the Neulasta Prefilled Syringe Sample UB-04 (CMS 1450) Form Hospital Outpatient Administration Anytown Hospital 100 Main Street Anytown, Anystate Smith, Jane 123 Main Street, Anytown, Anystate Drugs/detailed coding J2505 MMDDYY 1 XXXXX 0510 Clinic MMDDYY 1 XXXXX REVENUE CODES (BOX 42) AND DESCRIPTIONS (BOX 43) Medicare: Use revenue code 0636, drugs requiring detailed coding. Other payers: Use revenue code 0250, general pharmacy (or 0636, if required by a given payer). Use most appropriate revenue code for cost center where services were performed (eg, 0510, clinic). DIAGNOSIS CODES (BOX 67) Enter appropriate ICD-9-CM diagnosis code(s) corresponding to patient s diagnosis. Allowable diagnosis codes may vary by payer. SERVICE DATE (BOX 45) Report date of service. For example, the date when Neulasta prefilled syringe for manual injection was administered. SERVICE UNITS (BOX 46) Report units of service. 1 unit (Neulasta dose is 6 mg, per label). PRODUCT AND PROCEDURE CODE (BOX 44) (J-Code) J2505, injection, pegfilgrastim, 6 mg. Use CPT code representing procedure performed, such as 96372, therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular Neulasta Prefilled Syringe XXX.X For assistance with payer-specific requirements, contact local payer or call MYNEULASTA ( ) Please see Important Safety Information on pages 8 and 9. This sample form is intended as a reference for coding and billing for product and associated services. It is not intended to be a directive, nor does the use of the recommended codes guarantee reimbursement. Physicians and staff may deem other codes or policies more appropriate. Providers should select the coding options that most accurately reflect their internal system guidelines, payer requirements, practice patterns, and the services rendered. Providers are responsible for ensuring the accuracy and validity of all billing and claims for appropriate reimbursement. 6 7

5 SPECIAL INSTRUCTIONS FOR THE ON-BODY INJECTOR FOR NEULASTA (PEGFILGRASTIM) NEULASTA (PEGFILGRASTIM) IMPORTANT SAFETY INFORMATION A healthcare provider must fill the On-body Injector with Neulasta using the co-packaged prefilled syringe and then apply the On-body Injector for Neulasta to the patient s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector for Neulasta. Approximately 27 hours after the On-body Injector for Neulasta is applied to the patient s skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On-body Injector for Neulasta on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector for Neulasta delivers Neulasta no less than 24 hours after the administration of cytotoxic chemotherapy. The prefilled syringe co-packaged in the Neulasta Delivery Kit contains additional solution to compensate for liquid loss during delivery through the On-body Injector for Neulasta. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the On-body Injector for Neulasta, the patient may receive less than the recommended dose. Do not use the On-body Injector for Neulasta to deliver any other drug product except the Neulasta prefilled syringe co-packaged with the On-body Injector for Neulasta. The On-body Injector for Neulasta should be applied to intact, non-irritated skin on the arm or abdomen. A missed dose could occur due to an On-body Injector for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection. Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient. Refer to the Healthcare Provider Instructions for Use for the On-body Injector for Neulasta for full administration information. For any On-body Injector for Neulasta problems, call Amgen at or MYNEULASTA ( ). Neulasta is administered by subcutaneous injection. Contraindication Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta. Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta for ARDS. Discontinue Neulasta in patients with ARDS. Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Allergies to Acrylics The On-body Injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. Use in Patients With Sickle Cell Disorders Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim. Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. The most common adverse reactions ( 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity. Please see accompanying Neulasta Prescribing Information. 8 9

6 HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR HOSPITAL OUTPATIENT BILLING INFORMATION SHEET FOR Hospital Outpatient Billing Information Sheet for (filgrastim) is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. 7 Item Revenue Code Coding Information (HCPCS 4 /CPT 5 /ICD-9-CM) Administration Diagnosis/ Condition Medicare: 0636, drugs requiring detailed coding Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer Appropriate revenue code for the cost center in which the service is performed N/A J1442, injection, filgrastim (G-CSF), 1 mcg* 96372, therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular Appropriate diagnosis code(s) for patient condition: ICD-9-CM code(s) for services performed before October 1, 2015 ICD-10-CM code(s) for services performed on or after October 1, 2015 Notes J-code effective for dates of service on or after 1/1/2014 The NDC numbers for, in the 11-digit format, are as follows 7 : mcg vial: mcg prefilled syringe: mcg vial: mcg prefilled syringe: Allowable diagnosis codes may vary by payer. Please contact your local payer or Amgen Assist at 888-4ASSIST who can assist in an insurance verification * J1442 is intended to replace J1440 and J1441 for services rendered to Medicare Part B (fee-for-service) patients on or after 1/1/2014; other payers, including commercial and Medicare Advantage plans, may have other timelines for updating their systems with the new J-code. The CMS 1450 for Hospital Outpatient Sample UB-04 (CMS 1450) Form Hospital Outpatient Administration Anytown Hospital 100 Main Street Anytown, Anystate Smith, Jane 123 Main Street, Anytown, Anystate Drugs/detailed coding J1442 MMDDYY XXX XXXXX 0510 Clinic MMDDYY XXXXX REVENUE CODES (BOX 42) AND DESCRIPTIONS (BOX 43) Medicare: Use revenue code 0636, drugs requiring detailed coding. Other payers: Use revenue code 0250, general pharmacy (or 0636, if required by a given payer). Use most appropriate revenue code for cost center where services were performed (eg, 0510, clinic). DIAGNOSIS CODES (BOX 67) Enter appropriate ICD-9-CM diagnosis code(s) corresponding to patient s diagnosis. Allowable diagnosis codes may vary by payer. SERVICE UNITS (BOX 46) Report units of service. 1 unit for J1442 corresponds to 1 mcg of ; for example, 300 units for the 300 mcg dose. PRODUCT AND PROCEDURE CODES (BOX 44) J1442, injection, filgrastim (G-CSF), 1 mcg. Use CPT code representing procedure performed, such as 96372, therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular. TOTAL CHARGES (BOX 47) Report appropriate charges for product used and related procedures. XXX.X For assistance with payer-specific requirements, contact local payer or Amgen Assist ASSIST Please see Important Safety Information on page 12. This sample form is intended as a reference for coding and billing for product and associated services. It is not intended to be a directive, nor does the use of the recommended codes guarantee reimbursement. Physicians and staff may deem other codes or policies more appropriate. Providers should select the coding options that most accurately reflect their internal system guidelines, payer requirements, practice patterns, and the services rendered. Providers are responsible for ensuring the accuracy and validity of all billing and claims for appropriate reimbursement

7 (FILGRASTIM) IMPORTANT SAFETY INFORMATION Contraindication is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim or pegfilgrastim. Splenic Rupture Splenic rupture, including fatal cases, has been reported following the administration of. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) has been reported in patients receiving. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue in patients with ARDS. Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, have been reported in patients receiving. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue in patients with serious allergic reactions. Sickle Cell Disorders Sickle cell crisis, in some cases fatal, has been reported with the use of in patients with sickle cell trait or sickle cell disease. Glomerulonephritis Glomerulonephritis has occurred in patients receiving. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of. If causality is likely, consider dose-reduction or interruption of. Capillary Leak Syndrome Capillary leak syndrome has been reported after G-CSF administration, including, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include the need for intensive care. Thrombocytopenia Thrombocytopenia has been reported in patients receiving. Monitor platelet counts. Please see accompanying Prescribing Information. Leukocytosis White blood cell counts of 100,000/mm 3 were observed in about 2% of patients with cancer receiving myelosuppressive chemotherapy who received at dosages > 5 mcg/kg/day. It is recommended to monitor CBCs at least twice weekly, and adjust dosing as clinically indicated to help mitigate risk of leukocytosis. Dosages of that increase the absolute neutrophil count (ANC) beyond /mm 3 may not result in any additional clinical benefit. Discontinuation of therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis Cutaneous vasculitis has been reported in patients treated with. In most cases the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with severe chronic neutropenia (SCN) receiving long-term therapy. Hold therapy in patients with cutaneous vasculitis. may be started at a reduced dose when the symptoms resolve and the absolute neutrophil count (ANC) has decreased. Potential Effect on Malignant Cells The granulocyte-colony-stimulating factor (G-CSF) receptor through which filgrastim acts has also been found on tumor cell lines. The possibility that acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded. Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended The safety and efficacy of given simultaneously with cytotoxic chemotherapy have not been established. Do not use in the period 24 hours before or after the administration of cytotoxic chemotherapy. The safety and efficacy of have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of with chemotherapy and radiation therapy. Nuclear Imaging Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results. The most common adverse reactions ( 5% difference in incidence, compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, edema peripheral, hemoglobin decreased, decreased appetite, oropharyngeal pain, and alopecia. References 1. Neulasta (pegfilgrastim) Prescribing Information, Amgen. 2. Neulasta Kit Healthcare Provider Instructions for Use, Amgen. 3. RED BOOK Online. Neulasta. Available at: com/micromedex2/librarian/nd_t/evidencexpert/nd_pr/evidencexpert/cs/da9c68/nd_app/evidencexpert/duplicationshieldsync/c1253a/nd_pg/evidencexpert/nd_b /evidencexpert/nd_p/evidencexpert/pfactionid/redbook.showsearchresults?searchterm=neulasta&searchtype=redbookname&searchtermid=30621&searchcontent=redb OOK&searchFilterAD=filterADActive&searchFilterRepackager=filterExcludeRepackager&searchPattern=%5Eneulasta. Accessed May 26, CMS. Alpha-Numeric HCPCS Drug Table for Available at: Accessed May 26, American Medical Association. Current Procedural Terminology (CPT ) copyright 2014 American Medical Association All rights reserved. 6. CMS. Modifier 59 Article. Available at: /Downloads/modifier59.pdf. Accessed May 26, (filgrastim) Prescribing Information, Amgen. Amgen One Amgen Center Drive Thousand Oaks, CA Amgen Inc. 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