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CPT
codes, descriptions and other data only are copyright 2007 American Medical
Association (or such other date of publication of CPT). All Rights
Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology,
(CDT) (including procedure codes, nomenclature, descriptors and other data
contained therein) is copyright by the American Dental Association.© 2002,
2004 American Dental Association. All rights reserved. Applicable
FARS/DFARS apply.
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This
article defines coding and coverage for temosirlimus
including off-label indications. National Government Services Local
Coverage Determination (LCD) “Coverage of Drugs and Biologicals
for Label and Off-Label Uses” allows coverage for off-label indications
only if the United States Pharmacopeia Drug Information (USP-DI), the
American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such
indications or if National Government Services has published an article or
LCD expanding such coverage. Providers may request approval for additional
off-label indications by submitting this request in writing with supporting
medical literature. The aforementioned National Government Services LCD,
which describes the requirements for such a request, can be accessed on our
contractor Web site at www.NGSMedicare.com or on the Medicare Coverage
Database at www.cms.hhs.gov/mcd.
Indications:
Temosirlimus (Torisel™)
was approved for marketing by the FDA, for treatment of advanced renal cell
carcinoma, on May 30, 2007.
Torisel will be covered as a 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.
Documentation Requirements:
The medical record must document the diagnosis of advanced renal cell
carcinoma and must document renal cell carcinoma and three or more of the
following prognostic factors:
- Treatment to start within one
year of the diagnosis;
- Karnofsky performance
status of 60 or 70;
- Corrected calcium of greater
than 10mg/dl;
- Lactate dehydogenase
> 1.5 times the upper limit of normal;
- More than one
metastatic organ site.
Coding Guidelines:
General Guidelines for claims submitted to Carriers or Intermediaries:
When the primary tumor is still present, ICD-9-CM code 189.0 should be used
as the primary diagnosis.
When the primary tumor has been excised or eliminated, the ICD-9-CM code
representing the site of metastasis should be used as the primary diagnosis
and ICD-9-CM code V10.52 should be used as the secondary diagnosis.
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.
For claims submitted to the carrier:
Claims for temsirolimus, for providers who bill
the carrier, should be reported using HCPCS code J9999 NOC, antineoplastic drug. The narrative “Torisel
25mg” should be entered into item #19 of the CMS-1500 form or its
electronic equivalent.
Temsirolimus should be billed using chemotherapy
administration codes and is payable in the following places of service:
office (11), skilled nursing home for patients in a Part A stay (31) [if
the drug is supplied by the facility, no claims for the drug should be
submitted to the Part B carrier.], nursing facility for patients not in a
Part A stay (32) and independent clinic (49) only when supplied as an
“incident to” service by the physician.
For claims submitted to the Intermediary:
Claims for temsirolimus, for providers who bill
the FI, should be reported using HCPCS code C9399 and revenue code 0636 .
Hospitals should report the National Drug Code (NDC), the quantity of the
drug that was administered (units) and the date the drug was administered
in the CMS-1450 or its electronic equivalent. Effective for dates of
service on or after 01/01/2008 HCPCS code C9239 should be reported.
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