RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: Trastuzumab – Trastuzumab Biologics

A56660

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A56660
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Trastuzumab – Trastuzumab Biologics
Article Type
Billing and Coding
Original Effective Date
10/03/2018
Revision Effective Date
10/01/2021
Revision Ending Date
09/26/2024
Retirement Date
09/26/2024

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CMS National Coverage Policy

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L34026 (Trastuzumab – Trastuzumab Biologics). Please refer to the LCD for reasonable and necessary requirements.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Compliance with the provisions in LCD L34026 Trastuzumab – Trastuzumab Biologics may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Documentation Requirements

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.

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.

Dosage and Administration

For specific dosage and administration, please refer to the FDA approved drug label for recommended dosages for specific FDA indications. This can be accessed at https://labels.fda.gov/.

Response To Comments

Number Comment Response
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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(110 Codes)
Group 1 Paragraph

It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

The following ICD-10-CM codes support medical necessity and provide coverage for HCPCS codes:  J9316, J9355, J9356, J9358, Q5112, Q5113, Q5114, Q5116 and Q5117.

Group 1 Codes
Code Description
C15.3 Malignant neoplasm of upper third of esophagus
C15.4 Malignant neoplasm of middle third of esophagus
C15.5 Malignant neoplasm of lower third of esophagus
C15.8 Malignant neoplasm of overlapping sites of esophagus
C15.9 Malignant neoplasm of esophagus, unspecified
C16.0 Malignant neoplasm of cardia
C16.1 Malignant neoplasm of fundus of stomach
C16.2 Malignant neoplasm of body of stomach
C16.3 Malignant neoplasm of pyloric antrum
C16.4 Malignant neoplasm of pylorus
C16.5 Malignant neoplasm of lesser curvature of stomach, unspecified
C16.6 Malignant neoplasm of greater curvature of stomach, unspecified
C16.8 Malignant neoplasm of overlapping sites of stomach
C16.9 Malignant neoplasm of stomach, unspecified
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.019 Malignant neoplasm of nipple and areola, unspecified female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.029 Malignant neoplasm of nipple and areola, unspecified male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.119 Malignant neoplasm of central portion of unspecified female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.129 Malignant neoplasm of central portion of unspecified male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.619 Malignant neoplasm of axillary tail of unspecified female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.629 Malignant neoplasm of axillary tail of unspecified male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.829 Malignant neoplasm of overlapping sites of unspecified male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C50.929 Malignant neoplasm of unspecified site of unspecified male breast
C77.0 Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck
C77.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.3 Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.5 Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.1 Secondary malignant neoplasm of mediastinum
C78.2 Secondary malignant neoplasm of pleura
C78.30 Secondary malignant neoplasm of unspecified respiratory organ
C78.39 Secondary malignant neoplasm of other respiratory organs
C78.4 Secondary malignant neoplasm of small intestine
C78.5 Secondary malignant neoplasm of large intestine and rectum
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C78.80 Secondary malignant neoplasm of unspecified digestive organ
C78.89 Secondary malignant neoplasm of other digestive organs
C79.00 Secondary malignant neoplasm of unspecified kidney and renal pelvis
C79.01 Secondary malignant neoplasm of right kidney and renal pelvis
C79.02 Secondary malignant neoplasm of left kidney and renal pelvis
C79.10 Secondary malignant neoplasm of unspecified urinary organs
C79.11 Secondary malignant neoplasm of bladder
C79.19 Secondary malignant neoplasm of other urinary organs
C79.2 Secondary malignant neoplasm of skin
C79.32 Secondary malignant neoplasm of cerebral meninges
C79.40 Secondary malignant neoplasm of unspecified part of nervous system
C79.49 Secondary malignant neoplasm of other parts of nervous system
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow
C79.60 Secondary malignant neoplasm of unspecified ovary
C79.61 Secondary malignant neoplasm of right ovary
C79.62 Secondary malignant neoplasm of left ovary
C79.63 Secondary malignant neoplasm of bilateral ovaries
C79.70 Secondary malignant neoplasm of unspecified adrenal gland
C79.71 Secondary malignant neoplasm of right adrenal gland
C79.72 Secondary malignant neoplasm of left adrenal gland
C79.82 Secondary malignant neoplasm of genital organs
C79.89 Secondary malignant neoplasm of other specified sites
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

(1 Code)
Group 1 Paragraph

All those not listed under the “ICD-10 Codes that Support Medical Necessity” section of this article.

Group 1 Codes
Code Description
XX000 Not Applicable
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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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N/A

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 article, 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 article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
09/26/2024 R9

This article is being retired effective for dates of service on and after 09/26/2024 in response to the LCD and analysis and the decision to retire the related LCD.

10/01/2021 R8

Article revised and published on 10/14/2021 effective for dates of service on and after 10/01/2021 to reflect the Annual ICD-10-CM Code Updates. The following ICD-10-CM code has been added to the article: C79.63 in Group 1 Codes. Minor formatting changes have been made.

01/01/2021 R7

Based on the annual CPT/HCPCS code update, this article was revised to add code J9316 to the CPT/HCPCS Codes: Group 1 codes section and the ICD-10 codes: Group 1 paragraph. Minor format changes were made throughout the article. Effective date for this revision is 01/01/2021.

07/01/2020 R6

Revision Number: 4
Publication: July 2020 Connection
LCR A/B2020-054

Explanation of Revision: Based on the July 2020 Quarterly Update, the “CPT/HCPCS Codes/Group 1 Paragraph:/Part A and Part B/Group 1 Codes:” sections of the Billing and Coding article were revised to remove HCPCS code C9399 and add HCPCS codes J9358, Q5113 and Q5116. Also, the “CPT/HCPCS Codes/Group 2 Paragraph:/Part B/Group 2 Codes:” sections of the Billing and Coding article were revised to remove HCPCS code J9999, Q5112, Q5113 and Q5116 (HCPCS codes Q5112, Q5113 and Q5116 are now listed under Part A and Part B/Group 1 Codes:). In addition, the “ICD-10 Codes that Support Medical Necessity/Group 1 Paragraph:” section of the Billing and Coding article was revised to remove HCPCS codes C9399 and J9999 and add HCPCS code J9358. The following revision is not related to the July 2020 Quarterly Update: HCPCS code Q5114 was also removed from the “CPT/HCPCS Codes/Group 2 Codes:” section of the Billing and Coding article as it is appropriately listed in the CPT/HCPCS Codes/Group 1 Codes:” section of the Billing and Coding article.

The revision related to removing HCPCS codes C9399 and J9999 and adding HCPCS code J9358 is effective for dates of service on or after 07/01/20. The revision related to HCPCS code Q5112 is effective for claims processed on or after 07/30/20, for dates of service 04/15/20-09/30/20. The revision related to HCPCS code Q5113 is effective for claims processed on or after 07/06/20, for dates of service on or after 03/16/20. The revision related to HCPCS code Q5116 is effective for claims processed on or after 07/06/20, for dates of service on or after 02/23/20. The revision related to HCPCS code Q5114 is effective for claims processed on or after 01/06/20, for dates of service on or after 11/29/19.

02/26/2020 R5

Revision Number: 3
Publication: March 2020 Connection
LCR A/B2020-010

Explanation of Revision: Based on the FDA approval of Enhertu (fam-trastuzumab deruxtecan- nxki), HCPCS code C9399 was added to the “CPT/HCPCS Codes/Group 1 Paragraph:/Codes:” section of this billing and coding article for Part A and Part B. Also, HCPCS code J9999 was added to the “CPT/HCPCS Codes/Group 2 Paragraph:/Codes:” section of this billing and coding article for Part B. In addition, HCPCS codes C9399 and J9999 were added to the “ICD-10 Codes that Support Medical Necessity/Group 1 Paragraph:” section of this billing and coding article. The effective date of this revision is for claims processed on or after 02/26/2020, for dates of service on or after 12/20/2019.

01/06/2020 R4

Revision Number: 2
Publication: January 2020 Connection
LCR A/B2020-003

Explanation of Revision: Based on CR 11605, the status indicator for HCPCS code Q5114 changed from “E2” to “K”. Therefore, it was added to the “CPT/HCPCS Codes/ Group 1 Codes:” section of the Billing and Coding article. The effective date of this revision is for claims processed on or after 01/06/2020, for dates of service on or after 11/29/2019.

10/01/2019 R3

Moved HCPCS code Q5117 from the “CPT/HCPCS Codes/Group 1 Paragraph:” section of the Billing and Coding article to the “CPT/HCPCS Codes/Group 1 Codes:” section of the Billing and Coding article.

Moved HCPCS code Q5116 from the “CPT/HCPCS Codes/Group 2 Paragraph:” section of the Billing and Coding article to the “CPT/HCPCS Codes/Group 2 Codes:” section of the Billing and Coding article.

10/01/2019 R2

Based on CR 11402, CR 11412, CR 11422, CR 11451 and CR 11457 (October 2019 Quarterly Updates) the Billing and Coding Article was revised. Added HCPCS code Q5116 to the “CPT/HCPCS Codes/Part B Group 2 Codes:” and added HCPCS code Q5117 to the “CPT/HCPCS Codes/Part A and Part B Group 1 Codes:” sections of the Billing and Coding Article. Also, HCPCS codes Q5116 and Q5117 were added to the “ICD-10 Codes that Support Medical Necessity/ Group 1 Paragraph:” section of the Billing and Coding Article. The effective date of this revision is based on date of service.

07/01/2019 R1

Moved HCPCS code J9356 from the “CPT/HCPCS Codes/Group 1 Paragraph:” section of the Billing and Coding Article to the “CPT/HCPCS Codes/Group 1 Codes:” section of the Billing and Coding Article.

Moved HCPCS codes Q5112, Q5113, and Q5114 from the “CPT/HCPCS Codes/Group 2 Paragraph:” section of the Billing and Coding Article to the “CPT/HCPCS Codes/Group 2 Codes:” section of the Billing and Coding Article.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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SAD Process URL 2
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Updated On Effective Dates Status
09/26/2024 10/01/2021 - 09/26/2024 Retired You are here
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