|
CPT
codes, descriptions and other data only are copyright 2008 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.
|
|
This
article defines coding and coverage for temsirolimus
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. Effective for
dates of service on or after 11/25/2008, American Hospital Formulary
Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium
and/or Thomson Micromedex DrugDex®
compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. 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:
Temsirolimus (Torisel™)
was approved for marketing by the FDA, for treatment of advanced renal cell
carcinoma, on May 30, 2007.
Temsirolimus 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
- Hemoblobin less than
the lower limit of normal.
Coding Guidelines:
General
Guidelines for claims submitted to Carriers or Intermediaries or Part A
or Part B MAC:
When the primary tumor is still present, ICD-9-CM code 189.0 should be used
as the primary diagnosis. Effective for dates of service on or after
10/01/2008, the site of metastasis should be coded as the secondary
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 or Part B MAC:
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. Effective for dates of service on or after 01/01/2009, HCPCS code J9330 should be reported.
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 or Part A MAC:
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. HCPCS
code C9239 has been deleted 12/31/2008. Effective for dates of service on
or after 01/01/2009, HCPCS code J9330 should be reported.
|