| REIMBURSEMENT INFORMATION F.A.Q. | |
WHEN WAS TOTECT® FDA APPROVED? | | (Back to Top) | HOW MAY WE OBTAIN TOTECT®? | TOTECT may be obtained from one of the following authorized distributors: ASD Healthcare (800) 746-6273 Cardinal Health Specialty Pharmaceutical Distribution (866) 677-4844 Oncology Supply by calling (800) 633-7555 McKesson Specialty Care (800) 482-6700 US Oncology (888) 987-6679
| (Back to Top) | WE PURCHASE DRUGS FROM ANOTHER DISTRIBUTOR; IS TOTECT® AVAILABLE FROM THEM? | Please check with your distributor to determine availability and price. TOTECT is available directly from ASD Healthcare (800) 746-6273), Cardinal Health Specialty Pharmaceutical Distribution (866) 677-4844; Oncology Supply (800) 633-7555; McKesson Specialty Care (800) 482-6700; and US Oncology (888) 987 6679.
| (Back to Top) | WHAT IS THE SHELF LIFE OF TOTECT®? | | (Back to Top) | Will TopoTarget Replace the Totect® Kit we purchased if the shelf-life expires before we need to use it? | If purchasing a Totect emergency treatment kit at $14,750, product life is guaranteed for up to 72 months (six years). When TOTECT is purchased at $14,750, TopoTarget will provide replacement kits of any complete unused expired TOTECT Kits for up to 72 months from the date of purchase of the original kit. Details of the replacement policy can be found at http://www.totect.com/PDF/Replacement_Kit_Policy_10_08_08.pdf Replacement kit procedures may be found at http://www.totect.com/rprocedures.htm TOTECT now also has a new lower-priced purchase option that does not include a replacement policy. Under this purchasing option, a TOTECT emergency treatment kit is available for $6,500 with a 16-month product-life guarantee. This means that if an unused kit reaches its expiration date within 16 months of the date you buy it, you are eligible to receive one replacement kit at no additional charge to you.
| (Back to Top) | FOR WHAT PURPOSE IS TOTECT® PRESCRIBED? | TOTECT is indicated for the treatment of extravasation resulting from IV anthracycline chemotherapy (daunorubicin, doxorubicin, idarubicin, and epirubicin). TOTECT is the only product that has clearly demonstrated effectiveness in the treatment of biopsy-verified cases of anthracycline extravasations, and initiating the regimen is time sensitive. It is the only approved therapy for this indication. In addition to the proven effectiveness of TOTECT in reducing tissue damage from anthracycline extravasation, such as physical impairment, it may reduce the need for delaying chemotherapy, thus improving the chance of successful chemotherapy.
| (Back to Top) | HOW DO WE CODE FOR TOTECT®? | HCPCS code J1190 (injection, dexrazoxane hydrochloride, per 250 mg) is the appropriate billing code for Totect when filing claims to payers who require HCPCS coding. Some payers, including certain state Medicaid plans, may require NDC numbers instead of (or in addition to) HCPCS codes. For billing purposes, the NDC number for TOTECT is 38423-0110-01.
| (Back to Top) | WHAT IS THE NDC NUMBER FOR TOTECT®? | The NDC number for TOTECT is 38423-110-01. For billing purposes, the NDC number for TOTECT is 38423-0110-01. TOTECT is packaged as an emergency treatment kit for single patient use. Each kit contains 10 vials of TOTECT (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent, which provides a complete three day treatment. Some payers, including certain state Medicaid plans, may require NDC numbers instead of (or in addition to) HCPCS codes.
| (Back to Top) | HOW IS TOTECT® SUPPLIED? | TOTECT is packaged as an emergency treatment kit for single patient use. Each kit contains 10 vials of TOTECT (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent, which provides a complete three day treatment. Each kit contains twenty 50 mL Type I glass vials. Ten vials contain dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. The other 10 vials contain diluent (0.167M Sodium Lactate Injection, USP). Each vial of dexrazoxane for injection is closed with an aluminum flip-off cap covered with a dark red overcap. Each vial of diluent is closed with an aluminum flip-off cap covered with a white overcap. Before infusion each vial of TOTECT Powder must be mixed with 50 mL TOTECT diluent. The mixed solution should be further diluted in 1000 mL 0.9% NaCl.
| (Back to Top) | WHAT IS THE MEDICARE FEE SCHEDULE AMOUNT FOR TOTECT®? | Prescribers billing on the CMS-1500 claim form: Medicare reimbursement for drugs is based on a fee schedule. For dates of service between July 1, 2010 and September 30, 2010, the Medicare drug fee schedule allowable for code J1190 is $255.17 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $510.33, or $5,103.30 per 5000 mg For dates of service between April 1, 2010 and June 30, 2010, the Medicare drug fee schedule allowable for code J1190 is $261.24 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $522.48, or $5,224.80 per 5000 mg For dates of service between January 1, 2010 and March 31, 2010, the Medicare drug fee schedule allowable for code J1190 is $374.16 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $748.32, or $7,483.20 per 5000 mg For dates of service between October 1, 2009 and December 31, 2009, the Medicare drug fee schedule allowable for code J1190 is $346.57 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $693.14, or $6931.40 per 5000 mg. For dates of service between July 1, 2009 and September 30, 2009, the Medicare drug fee schedule allowable for code J1190 is $272.91 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $545.82, or $5458.20 per 5000 mg. For dates of service between April 1, 2009 and June 30, 2009, the Medicare drug fee schedule allowable for code J1190 is $ $380.85 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $761.70, or $7617.00 per 5000 mg. For dates of service between January 1, 2009 and March 31, 2009, the Medicare drug fee schedule allowable for code J1190 is $452.56 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $905.12 or $9,051.20 per 5000 mg. For dates of service between October 1, 2008 and December 31, 2008, the Medicare drug fee schedule allowable for code J1190 is $268.86 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $537.72 or $5,377.20 per 5000 mg. For dates of service between July 1, 2008 and September 30, 2008, the Medicare drug fee schedule allowable for code J1190 is $352.34 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $704.68 or $7,046.80 per 5000 mg.
Hospital Outpatient Departments Billing on the UB-04 claim form: Medicare reimbursement for drugs is based on a fee schedule. For dates of service between July 1, 2010 and September 30, 2010, the Medicare drug fee schedule allowable for code J1190 is $250.35 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $500.70, or $5,007 per 5000 mg For dates of service between April 1, 2010 and June 30, 2010, the Medicare drug fee schedule allowable for code J1190 is $256.34 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $512.68, or $5,126.80 per 5000 mg For dates of service between January 1, 2010 and March 31, 2010, the Medicare drug fee schedule allowable for code J1190 is $367.10 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $734.20, or $7,342.00 per 5000 mg For dates of service between October 1, 2009 and December 31, 2009, the Medicare drug fee schedule allowable for code J1190 is $340.03 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $680.06, or $6,800.60 per 5000 mg. For dates of service between July 1, 2009 and September 30, 2009, the Medicare drug fee schedule allowable for code J1190 is expected to be $267.76 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service is $535.52, or $5355.20 per 5000 mg. For dates of service between April 1, 2009 and June 31,2009, the Medicare drug fee schedule allowable for code J1190 is expected to be $373.66 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $747.32 or $7473.20 per 5000 mg. For dates of service between January 1, 2009 and March 31, 2009, the Medicare drug fee schedule allowable for code J1190 is expected to be $444.02 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $888.04 or $8,880.40 per 5000 mg. For dates of service between October 1, 2008 and December 31,2008, the Medicare drug fee schedule allowable for code J1190 is expected to be $266.31 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $532.62 or $5,326.20 per 5000 mg. For dates of service between July 1, 2008 and September 30, 2008, the Medicare drug fee schedule allowable for code J1190 is $349.02 per 250 mg. Thus, the Medicare allowable per 500 mg for these dates of service $698.04 or $6,980.40 per 5000 mg.
| (Back to Top) | HOW MUCH DO COMMERCIAL PAYERS REIMBURSE FOR TOTECT®? | Commercial payers are expected to set fee schedule amounts using the same contractual methods that they use for other drugs. This varies among payers. It could be invoice cost or some other variation based on AWP, WAC or ASP. | (Back to Top) | WHAT HAS BEEN THE EXPERIENCE OF OTHER PRESCRIBERS/HOSPITALS WHO HAVE BILLED FOR TOTECT®? | Coverage and reimbursement can vary by payer and by plan. If there is a specific payer that you would like us to contact to verify benefits on behalf of a patient, we would be happy to assist you. To speak with a reimbursement specialist, call the TOTECT Reimbursement Support Hotline at (877) 456-4017. | (Back to Top) | IF A PAYER DENIES A CLAIM OR PAYS IT INCORRECTLY, WHAT CAN WE DO... DOES TOPOTARGET PROVIDE ASSISTANCE? | If a claim is denied or incorrectly paid, we can assist you in preparing an appeal. To speak with a reimbursement specialist, call the TOTECT Reimbursement Support Hotline at (877) 456-4017. | (Back to Top) | IF A PATIENT CANNOT AFFORD THE CO-PAY, DOES TOPOTARGET PROVIDE ASSISTANCE? | We will provide the patient with referrals to co-pay assistance foundations that may be able to assist with the co-pay. To speak with a reimbursement specialist, call the TOTECT Reimbursement Support Hotline at (877) 456-4017. | (Back to Top) | IF A PATIENT DOES NOT HAVE INSURANCE, DOES TOPOTARGET PROVIDE ASSISTANCE? | We can assist by searching for alternative coverage sources for the patient. If coverage is found, we can help the patient enroll. To speak with a reimbursement specialist, call the TOTECT Reimbursement Support Hotline at (877) 456-4017. If alternative coverage is not found, patients will be considered on a case-by-case basis for eligibility for assistance via the indigent program. Eligibility for the indigent program is based on financial need.
| (Back to Top) | WHAT ARE THE APPROVED INDICATIONS FOR TOTECT®? | Based upon the FDA approved package insert: | (Back to Top) | WHICH ICD-9 DIAGNOSIS CODES SHOULD BE USED TO REPORT THE APPROVED INDICATION? | | (Back to Top) | HOW DO YOU COMPLETE THE CMS-1500 CLAIM FORM (OFFICE SETTING)? | DRUG In Field 24D: Enter HCPCS code J1190 (injection, dexrazoxane hydrochloride, per 250 mg) In Field 24G: Enter the number of 250 mg billing units (NOT THE NUMBER OF VIALS) used to treat the patient on the date of service. For example, if 2000 mg of Totect is administered, then 8 billing units should be reported in Field 24G.
DRUG ADMINISTRATION TOTECT ADMINISTERED ON THE SAME DAY AS OTHER DRUGS: In Field 24D: Enter CPT code 96367 (IV infusion, for therapy, prophylaxis, or diagnosis; additional sequential infusion, up to 1 hour). In Field 24G: Enter the number of hours over which TOTECT was administered. Enter 1 hour if the infusion is longer than 15 minutes and shorter than 91 minutes. Enter 2 hours if the infusion is longer than 90 minutes and shorter than 151 minutes.
TOTECT ADMINISTERED AS THE ONLY DRUG (Days 2 and 3) In Field 24D: Enter CPT code 96365 (IV infusion, for therapy, prophylaxis or diagnosis; initial, up to one hour) If the infusion time exceeds one hour, enter CPT code 96366 (IV infusion, for therapy, prophylaxis or diagnosis; each additional hour) in addition to CPT code 96365. In Field 24G, with 96365: Enter a unit of code of 1 if the infusion is longer than 15 minutes. In Field 24G, with 96366 Enter a unit code of 1 if the infusion is longer than 90 minutes and shorter than 151 minutes.
TOTECT ADMINISTERED IN THE PATIENT’S HOME BY HOME HEALTH CARE DILUENTS IN ALL SITUATIONS | (Back to Top) | HOW DO YOU COMPLETE THE CMS-1450 (UB-04) FOR HOSPITAL OUTPATIENT DEPARTMENT? | DRUG In FL42 (Revenue Code) Enter code 0636 (Drugs requiring detailed coding) OR 250 (Revenue code for general pharmacy (non-Medicare claims) In FL44 (HCPCS) Enter code J1190 (injection, dexrazoxane hydrochloride, per 250 mg) In FL46 (Service Units) Report the number of 250 mg units used to treat the patient (NOT THE NUMBER OF VIALS). For example, if 2000 mg of Totect are administered, then the number reported in FL46 should be 8.
DRUG ADMINISTRATION TOTECT ADMINISTERED ON THE SAME DAY AS OTHER DRUGS: In FL44 (HCPCS): Enter CPT code 96367 (IV infusion, for therapy, prophylaxis, or diagnosis; additional sequential infusion, up to 1 hour). In FL46 (Service Units): Enter the number of hours over which TOTECT was administered. Enter 1 hour if the infusion is longer than fifteen minutes and shorter than 91 minutes. Enter 2 hours if the infusion is longer than 90 minutes and shorter than 151 minutes.
TOTECT ADMINISTERED AS THE ONLY DRUG (Days 2 and 3) In Field 44 (HCPCS): Enter CPT code 96365 (IV infusion, for therapy, prophylaxis or diagnosis; initial, up to one hour)
If the infusion time exceeds one hour, enter CPT code 96366 (IV infusion, for therapy, prophylaxis or diagnosis; each additional hour) in addition to CPT code 96365. In FL46 (Service Units), with 96365: Enter a unit of code of 1 if the infusion is longer than 15 minutes. In FL46 (Service Units) with 96366: Enter a unit code of 1 if the infusion is longer than 90 minutes and shorter than 151 minutes. DILUENTS (in all situations) are not separately billable with therapeutic injections or infusions.
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