RETIRED Local Coverage Determination (LCD)

Trastuzumab – Trastuzumab Biologics

L34026

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

LCD Information

Document Information

LCD ID
L34026

LCD Title
Trastuzumab – Trastuzumab Biologics

Proposed LCD in Comment Period
N/A

Source Proposed LCD
N/A

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 10/01/2019

Revision Ending Date
09/26/2024

Retirement Date
09/26/2024

Notice Period Start Date
N/A

Notice Period End Date
N/A

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.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Trastuzumab – Trastuzumab Biologics. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Trastuzumab – Trastuzumab Biologics and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

CMS IOM Publication 100-02, Medicare Benefit Policy Manual
- Chapter 1, Sections 30-30.1 Drugs and Biologicals
- Chapter 15, Section 50.4.1 – 50.4.3 Approved Use of Drug
CMS IOM Publication 100-04, Medicare Claims Processing Manual
- Chapter 12, Section 30.5 Payment for codes for Chemotherapy Administration and Nonchemotherapy Injections and infusions
- Chapter 17, Sections 10 Payment Rules for Drugs and Biologicals, 20 Payment Allowance Limit for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis, and 40 Discarded Drugs and Biologicals
- Chapter 23, Sections 20.9 - 20.96 National Correct Coding Initiative (NCCI)
CMS IOM Publication 100-08, Medicare Program Integrity Manual
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Trastuzumab – Trastuzumab Biologics

Trastuzumab is a monoclonal antibody, one of a group of drugs designed to attack specific cancer cells. Trastuzumab’s targets are cancer cells that overexpress an oncogene called HER2 or HER2/neu, which occurs in high numbers in about 25 to 30 percent of breast cancers. According to the National Comprehensive Cancer Network (NCCN), breast cancers can be categorized as being HER2 positive or HER2 negative. HER2-positive breast cancer is faster growing and considered more aggressive. Studies indicate that the drug trastuzumab (Herceptin) is effective in treatment of HER2-positive early stage breast cancer and HER2-positive metastatic breast cancer. Trastuzumab is not effective in the treatment of HER2-negative breast cancers.

There are two methods of testing for HER2 tumor status in women with breast cancer: immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). HER2 test results are interpreted as follows:

HER2 positive status is IHC 3+ or FISH positive
HER2 negative status is IHC 0, 1+ or FISH negative
A borderline IHC result of 2+ should be followed by performing a FISH test.
A borderline FISH result of an average HER2 gene/chromosome 17 ratio of 1.8 to 2.2 (or an average of greater than 4 to less than 6 HER2 gene copies/cell) should be followed by one of the following:
- Counting additional cells in the tissue sample
- Retesting with FISH
- Performing an IHC test

Results from both tests are used in the clinical setting, and the results of the tests influence treatment choices for women with breast cancer. The pathology laboratory where the HER2 testing is done should be accredited to perform such testing. It should have quality control procedures in place to ensure that the test is done correctly, and a quality assurance plan to validate (i.e., determine the accuracy of) the HER2 test results.

Covered Indications

Trastuzumab – Trastuzumab Biologics

Trastuzumab and its biologics are covered for Food and Drug Administration (FDA) approved labeled indications. Please see the FDA drug label for the FDA approved indications and dosages. This can be accessed at https://labels.fda.gov/.

Trastuzumab and its biologics will be considered medically necessary when provided for its FDA approved uses, as well as for the treatment of any of the following off-labeled indications:

For metastatic and non-metastatic breast cancer, trastuzumab and its biologics may be considered medically reasonable and necessary when incorporated into the adjuvant therapy in the following recommended uses by the NCCN Drugs and Biologics Compendium:

Preoperative chemotherapy in combination with paclitaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen with trastuzumab for patients with human epidermal growth factor receptor 2 (HER2)-positive stage IIA, IIB, or T3, N1, M0 disease who desire breast preservation and fulfill criteria for breast-conserving surgery except for tumor size or for patients with locally advanced disease (stage IIIA, IIIB, or IIIC).
Adjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-positive, stage I, IIA, IIB, or T3, N1, M0 disease (ductal, lobular, mixed, or metaplastic histologies) that is node-positive, node-negative with tumor 0.5 cm or greater in hormone receptor-negative patients, or node-negative with tumor 0.6 to 1 cm, grade 2 or 3, or with unfavorable features or tumor greater than 1 cm in hormone receptor-positive patients, or for patients with locally advanced disease (stages IIIA, IIIB, or IIIC).
- concurrently with paclitaxel following AC (doxorubicin and cyclophosphamide) regimen as preferred regimen
- in TCH (docetaxel, carboplatin, and trastuzumab) regimen as preferred regimen
- in combination with docetaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen
- following chemotherapy
- in combination with docetaxel following AC regimen
Used in combination with aromatase inhibition for the treatment of recurrent or stage IV estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive disease in postmenopausal women* who have received no prior endocrine therapy within one year.
*Men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis.
Preferred regimen for patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer that is hormone receptor-negative or hormone receptor-positive and endocrine refractory and not characterized by bone or soft tissue involvement only or asymptomatic visceral disease as:
- first-line chemotherapy in combination with docetaxel, vinorelbine, or capecitabine or with paclitaxel with or without carboplatin
- treatment for trastuzumab-exposed HER2-positive disease in combination with lapatinib without cytotoxic therapy, with docetaxel, vinorelbine, or capecitabine, or with paclitaxel with or without carboplatin

The timing of therapy combination with other agents or regimen, dosage, and duration of therapy should be based on NCCN guidelines and the package insert.

Limitations

For limitations of use of trastuzumab and its biologics, please see the FDA drug label. This can be accessed at: https://labels.fda.gov/

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

ICD-10-CM Codes that DO NOT Support Medical Necessity

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Trastuzumab – Trastuzumab Biologics (A56660) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Trastuzumab – Trastuzumab Biologics (A56660) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number(s) – L29030, L29297, L29482

Clinical Pharmacology, Trastuzumab, 12/22/2009.

U.S. Food and Drug Administration, Department of Health and Human Services, Drugs @ FDA, October 2010.

U.S. Food and Drug Administration (FDA). Product information KANJINTI^TM (trastuzumab-anns). 2019. Accessed September 06, 2019.

U.S. Food and Drug Administration (FDA). Product information TRAZIMERA^TM (trastuzumab-qyyp). 2019. Accessed September 06, 2019.

Bibliography

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers.
Herceptin® (trastuzumab) for injection, for intravenous use, U.S. Food and Drug Administration (FDA) label. (2017).
National Comprehensive Cancer Network (2010). Invasive Breast Cancer. Clinical Practice Guidelines in Oncology – V.2.2010.
National Comprehensive Cancer Network (2017). Esophageal and Esophagogastric Junction Cancers. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) – Version 1.2017.
National Comprehensive Cancer Network (2017). Gastric Cancer. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) – Version 1.2017.
National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (2010).
Thomson Micromedex . USP DI Drug Information for the Health Care Professional. (2007).

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
09/26/2024	R4	This LCD is being retired effective for dates of service on and after 09/26/2024 in response to the analysis and the decision to retire the LCD.	LCD Being Retired
10/01/2019	R3	Revision Number: 3 Publication: September 2019 Connection LCR A/B 2019-059 Explanation of Revision: Based on CR11402, CR 11412, CR11422, CR11451 and CR11457 (October 2019 Quarterly Updates) the “Sources of Information” section of the LCD was updated to include U.S. Food and Drug Administration (FDA) product information for KANJINTI^TM(trastuzumab-anns) and TRAZIMERA^TM (trastuzumab-qyyp). The effective date of this revision is based on date of service. 10/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.	Other (Revisions based on CRs 11402, 11412, 11422, 11451, 11457)
07/01/2019	R2	Revision Number: 2 Publication: June 2019 Connection LCR A/B2019-035 Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. Also, the FDA language has been removed from the LCD and instead the FDA citation related to this language is referenced to the FDA approved product labels. The effective date of this LCD revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018. Additionally, based on change requests (CRs) 11293, 11296, 11298, 11318, and 11328, the “CPT/HCPCS Codes” section of the newly created billing and coding article was updated to change the descriptor for HCPCS code J9355, add new HCPCS codes J9356, Q5112, Q5113 and Q5114 to the "Group 1 Paragraph:" section of the billing and coding article A56660. Furthermore, the LCD title was changed to “Trastuzumab –Trastuzumab Biologics” (Herceptin was removed from the title). The effective date of this LCD revision is for dates of service on or after July 1, 2019. 07/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.	Revisions Due To CPT/HCPCS Code Changes Other (Other revisions based on CR 10901.)
07/14/2017	R1	Revision History Number: R1 Revision Number: 1 Publication: July 2017 Connection LCR A/B2017-029 Explanation of revision: Based on an LCD reconsideration request, the LCD was revised to add ICD-10-CM diagnosis codes C16.1-C16.9 to the “ICD-10 Codes that Support Medical Necessity” section of the LCD. In addition, the LCD was revised, in the “Utilization Guidelines” section of the LCD under “Dosage and Administration” to remove the 440 mg per vial supply and replace it with current FDA label dosage forms and strengths; 150 mg single-dose vial and 420 mg multiple-dose vial. The effective date of this revision is based on date of service. 07/14/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.	Reconsideration Request

Associated Documents

Attachments
N/A

Updated On	Effective Dates	Status
09/26/2024	10/01/2019 - 09/26/2024	Retired	You are here
10/02/2019	10/01/2019 - N/A	Superseded	View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

Trastuzumab
metastatic disease
Ontruzant
Herzuma
Ogivri

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Trastuzumab – Trastuzumab Biologics

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Note History

Contractor Information

LCD Information

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Issue

CMS National Coverage Policy

Coverage Guidance

Proposed Process Information

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Additional ICD-10 Information

General Information

Revision History Information

Associated Documents

Keywords

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