Automated World Health
Local Coverage Determination (LCD) for Fulvestrant (Faslodex®) (L28844)
Contractor Information
Contractor Name
First Coast Service Options, Inc. opens in new window
Contractor Number 09101
Contractor Type MAC - Part A
LCD Information
Document Information
LCD ID Number L28844
LCD Title
Fulvestrant (Faslodex®)
Contractor's Determination Number AJ9395
Primary Geographic Jurisdiction opens in new window Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.
Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.
Original Determination Effective Date
For services performed on or after 02/16/2009 Original Determination Ending Date
Revision Effective Date
For services performed on or after 01/25/2011 Revision Ending Date
CMS National Coverage Policy
Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.
Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 1, Section 30-30.1
CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50
CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10, 20 and 40 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, Section 20.9-20.96 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 100.2.9
CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3 Social Security Act, Section 1861 (t)(2)(B)
Indications and Limitations of Coverage and/or Medical Necessity Fulvestrant (Faslodex®)-J9395
Fulvestrant (Faslodex®) is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol. Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant downregulates the ER protein in human breast cancer cells.
Fulvestrant (Faslodex®) is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Medicare will consider Fulvestrant (Faslodex ®) medically reasonable and necessary for the Food and Drug Administration (FDA) approved uses, as well as for the treatment of the following off-labeled indication:
• For the treatment of male breast cancer
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
013x Hospital Outpatient
021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient
085x Critical Access Hospital
Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
0636 Pharmacy - Drugs Requiring Detailed Coding
CPT/HCPCS Codes
J9395 INJECTION, FULVESTRANT, 25 MG
ICD-9 Codes that Support Medical Necessity
174.0 - 174.9 opens in new window
175.0 - 175.9 opens in new window
MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
Diagnoses that Support Medical Necessity
See ICD-9 Codes that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.
XX000 Not Applicable
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD. Back to Top
General Information
Documentations Requirements
Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used. This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy. This documentation is usually found in the history and physical or in the office/progress notes.
If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.
For patients receiving Fulvestrant, the record must clearly indicate the medical need for the use of this drug. The record must validate that the patient is postmenopausal, has hormone receptor positive metastatic breast cancer and has disease progression following antiestrogen therapy. This documentation is usually found in the history and physical or in the office/progress notes.
Documentation in the medical record must support fulvestrant was given for an indication specified in this Local Coverage Determination (LCD). The amount of drug, route & timing of administration, and any reaction of the patient should be documented in the medical record. In general, a facility should bill what is administered to the patient with attention to the code descriptor and quantity billed (see coding guidelines if applicable). In the event that only one patient needs a portion of the contents in the single-use vial, then the remainder can be discarded. In such a situation, the entire contents of the vial can be billed. Under no circumstances can multiple patients be billed for the entire contents of a single vial when the each patient received a portion of the drug from the same vial. With appropriate procedures, it is safe to re-enter a medication vial labeled as single use. CMS issued a procedure, developed with the approval of the Centers for Disease Control, for safe re-entry into “single-use” vials. Medicare expects this procedure to be used whenever feasible for efficient use of medications and minimal drug wastage. The hospital pharmacy record should have documentation on drugs discarded from single-use vials
that are subsequently billed to a Medicare patient.
Appendices
Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.
Dosage and Administration
Faslodex 500mg should be administered intramuscularly (IM) into the buttocks slowly as two 5ml injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter.
Sources of Information and Basis for Decision
Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.
Fulvestrant (Faslodex®) package insert (2010) AstraZeneca Pharmaceuticals LP, Wilmington, DE
Fulvestrant (Faslodex®) package insert (2002) AstraZeneca Pharmaceuticals LP, Wilmington, DE. This document was utilized to determine the indications and limitations of coverage.
National Comprehensive Cancer Network (2007). Breast Cancer. Clinical Practice Guidelines in Oncology – V.2.2007.
Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch
U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, April 2007.
Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.
Start Date of Comment Period
End Date of Comment Period
Start Date of Notice Period 03/01/2011
Revision History Number 1
Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A
Start Date of Notice Period:03/01/2011 Revision Effective Date: 01/25/2011
LCR A2011-027
February 2011 Bulletin
Explanation of Revision: Reconsideration request to update dosage information t per the current FDA approved label. Revisions will be effective for dates of service on or after 9/9/2010 for claims processed on or after 01/25/2011.
Revision Number:Original
Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009
LCR A2009-
December 2008 Bulletin
This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).
For Florida (00090) this LCD (L28844) replaces LCD L25129 as the policy in notice. This document (L28844) is effective on 02/16/2009.
8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed
8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed
8/1/2010 - The description for Revenue code 0636 was changed
Reason for Change
Related Documents
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All Versions
Updated on 01/26/2011 with effective dates 01/25/2011 - N/A Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 11/29/2008 with effective dates 02/16/2009 - N/A Read the LCD Disclaimer opens in new window