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National
Government Services, Inc.
Medicare Monthly Review Part A and B |
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A
Combined Part A and Part B Newsletter |
MLN Matters. . .Information
for Medicare Providers
(Issued by the Centers for Medicare & Medicaid Services)
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MMR-2007 11B, November 2007
Temsirolimus (Torisel™)
Temsirolimus (Torisel™) was approved for marketing by the Food and Drug Administration (FDA) for treatment of advanced renal cell carcinoma on May 30, 2007.
As indicated in National Government Services Part B (New York and New Jersey) Local Coverage Determinations L7497 and L3614, Coverage Of Drugs For Labeled And Off-Labeled Indications, Torisel will be covered for its FDA-approved indication, as monotherapy for advanced renal cell carcinoma, when administered incident to a physician’s service. Any use of the drug as multi-therapy would be reimbursable only if administered in the context of an approved clinical trial, as provided under Section 310, National Coverage Determinations Manual (Publication 100-3). The approved starting dose is 25mg but may be reduced to 15mg if toxicity occurs, administered once a week.
Claims for temsirolimus should indicate:
- HCPCS code J9999, NOC, antineoplastic drug
- The narrative “Torisel 25mg” should be entered into item #19 of the CMS-1500 form or it’s the electronic equivalent. Claims should be submitted electronically, as required by Medicare.
- Units of service = 1 (regardless of dose)
- The FDA-approved label states that the drug is administered over 30-60 minutes. The correct administration code is CPT 96413, Chemotherapy administration, intravenous infusion, technique; up to one hour, single or initial substance or drug©.
Additional time for administration is not anticipated; therefore, no other administration code should be billed.
| CPT five-digit codes, descriptions, and other data only are copyright 2006 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for data contained or not contained herein. Applicable FARS/DFARS clauses apply. |
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