URL for source document:

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36256&ver=51&bc=0
LCD Title

MolDX: Molecular Diagnostic Tests (MDT)

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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.

Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of
malformed body member."

Title XVIII of the Social Security Act, §1862(a)(1)(D), Investigational or Experimental.

45 CFR §162.1002 (a)(5), Medical data code sets

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

Coverage Guidance

1
Coverage Indications, Limitations, and/or Medical Necessity

This coverage policy provides the following information:

• defines tests required to register for a unique identifier

• defines tests required to submit a complete technical assessment (TA) for coverage determination

• defines the payment rules applied to covered tests that are not reported with specific codes from a code set recognized in 45 CFR §162.1002(a)(5), and termed "HIPAA compliant code sets" throughout the remainder of this LCD.

• lists specific covered tests that have completed the registration and TA process and meet Medicare’s reasonable and necessary criteria for coverage.

Tests evaluated through the application process and/or technical assessment will be reviewed to answer the following questions:

• Is the test performed in the absence of clinical signs and symptoms of disease?

• Will the test results provide the clinician with information that will improve patient outcomes and/or change physician care and treatment of the patient?

• Will the test results confirm a diagnosis or known information?

• Is the test performed to determine risk for developing a disease or condition?

• Will risk assessment change management of the patient?

• Is there a diagnosis specific indication to perform the test?

• Is the test performed to measure the quality of a process or for Quality Control/Quality Assurance (QC/QA), i.e., a test to ensure a tissue specimen matches the patient?

Molecular Diagnostic Test (MDT) Policy Specific Definitions

MDT: Any test that involves the detection or identification of nucleic acid(s) deoxyribonucleic acid/ribonucleic acid (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or
may not include multiple components. A MDT may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation.

Laboratory developed test (LDT): Any test developed by a laboratory developed without Food and Drug Administration (FDA) approval or clearance.

Applicable Tests/Assays

2
In addition to the MDT definition, this coverage policy applies to all tests that meet at least one of the following descriptions:

• All non-FDA approved/cleared laboratory developed tests (LDT)

• All modified FDA-approved/cleared kits/tests/assays

• All tests/assays billed with more than one code from a HIPAA compliant code set to identify the service, including combinations of method-based, serology-based, and anatomic pathology codes

• All tests that meet the first three bullets and are billed with a Not Otherwise Classified (NOC) code

Unique Test Identifier Requirement

Because the available language in the current HIPAA compliant code sets used to describe the pathology and laboratory categories and the tests included in those categories are not specific to the actual test results provided, all MDT services must
include an identifier as additional claim documentation. Test providers must receive an identifier specific to the applicable test and submit the test assigned identifier with the claim for reimbursement. The assigned identifier will provide a
crosswalk between the test’s associated detail information on file and the submitted claim detail line(s) required to adjudicate each test’s claim. The unique identifier limits the need to submit the required additional information about the test on
each claim.

Technology Assessments (TA)

Molecular Diagnostic Services Program (MolDX®) will review all new test/assay clinical information to determine if a test meets Medicare’s reasonable and necessary requirement. Labs must submit a comprehensive dossier on each new
test/assay prior to claim submission. MolDX® will only cover and reimburse tests that demonstrate analytical and clinical validity, and clinical utility at a level that meets the Medicare reasonable and necessary requirement.

Payment Rules

MolDX® will reimburse:

• approved tests covered for dates of service consistent with the effective date of the coverage determination.

Covered Tests

Please refer to the Noridian website for covered tests' specific coding and billing information.

Other tests/assays may be addressed by separate Noridian policy. In addition, the CPT codes listed under Group 1 are addressed in the MolDX® program. If a test is not linked below under Related Local Coverage Documents, it
may be addressed under separate Noridian policy, or it has not been approved for coverage as it has either not been vetted by the MolDX® contractor or has been found to be considered statutorily excluded.

For additional MolDX® Program information, go to the Noridian Medicare home page at noridianmedicare.com and select MolDX® under the Policies Tab.

3
MolDX® expects laboratory providers to follow test indications published by the developer.

Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

General Information

Associated Information

N/A

Sources of Information

Current Procedural Terminology® (CPT) American Medical Association. American Medical Association Press, ISBN9781603592178, 2011.

Bibliography

NA

Revision History Information

Revision
Revision History
History Date Number Revision History Explanation Reasons for Change
05/04/2023 R15 Under CMS National Coverage Policy deleted regulation Pub 100-08 PIM, Ch. 13, Sec 13.1.3, Program Integrity Manual, and added CMS
Internet-Only Manual, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in LCDs. • Provider Education/Guidance
Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout
the LCD.
11/01/2019 R14 The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
• Other (The LCD is revised to remove CPT/HCPCS
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision codes in the Keyword Section of the LCD.
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. •)
11/01/2019 R13 Under CMS National Coverage Policy added regulation 45 CFR §162.1002 (a)(5).
• Provider Education/Guidance
Under Coverage Indications, Limitations and/or Medical Necessity changed the third bullet to read, “defines the payment rules applied to
covered tests that are not reported with specific codes from a code set recognized in 45 CFR §162.1002 (a)(5), and termed “HIPAA compliant
code sets” throughout the remainder of this LCD”.

Under Applicable Tests/Assays subheading changed verbiage under the third bullet to read, “All tests/assays billed with more than one code

4
 from a HIPAA compliant code set to identify the service, including combinations of method-based, serology-based, and anatomic pathology
codes”.

Under Unique Test Identifier Requirement subheading changed verbiage in the first two sentences to read, “Because the available language in
the current HIPAA compliant code sets used to describe the pathology and laboratory categories and the tests included in those categories are
not specific to the actual test results provided, all MDT services must include an identifier as additional claim documentation. Test providers
must receive an identifier specific to the applicable test and submit the test assigned identifier with the claim for reimbursement” and deleted the
verbiage, “Laboratory providers who bill MDT services must register test services on the DEX Diagnostics Exchange”.

Under Covered Tests subheading deleted the verbiage, “To obtain a unique identifier for a test and, to submit information for a technical
assessment go to DEX Diagnostics Exchange https://app.dexzcodes.com/login”.

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.
11/01/2019 R12 11/01/2019: This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual.
There has been no change in coverage with this LCD revision. • Provider Education/Guidance

Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57627 article.

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.
11/01/2019 R11 As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.
• Revisions Due To Code Removal
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.
11/01/2019 R10 As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.
• Creation of Uniform LCDs With Other MAC
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision Jurisdiction
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. • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R9 01/23/2019 - Either the short and/or long code description was changed for the following code(s). Please Note: Depending on which descriptor
was used, there may not be any changes to the code display in this document: • Creation of Uniform LCDs With Other MAC
Jurisdiction
0008U descriptor was changed in Group 1 • Revisions Due To CPT/HCPCS Code Changes

0011M descriptor was changed in Group 1

01/01/2019 R8 The following paragraph under Covered Tests has been clarified:
• Other (Clarification of paragraph requested by the
Other tests/assays may be addressed by separate Noridian policy. In addition the CPT codes listed under Group 1 are addressed in the MolDX contractor.)
MolDX program. If a test is not linked below under Related Local Coverage Documents, it may be addressed under separate Noridian
policy or it has not been approved for coverage as it has either not been vetted by the MolDx contractor or has been found to be
considered statutorily excluded.
01/01/2019 R7 Corrected typographical error in R7 revision history: CPT codes 71178, 71179, 71180 should be 81178, 81179 and 81180.
• Typographical Error
01/01/2019 R6 The following updates were made as a result of the 2019 Annual HCPCS code update:
• Creation of Uniform LCDs With Other MAC
Deleted codes:0001M, 81211, 81213, 81214 Jurisdiction
• Revisions Due To CPT/HCPCS Code Changes
Codes added to existing ranges: 81163, 81164, 81165, 81166, 81167, 81171, 81172, 81173, 81174, 81177, 71178, 71179, 71180, 81181, 81182,
81183, 81184, 81185, 81186, 81187, 81188, 81189, 81190, 81204, 81233, 81234, 81236, 81237, 81239, 81237, 81239, 81271, 81274, 81284,
81285, 81286, 81289, 81305 ,81306, 81312, 80320, 81329, 81333, 81336, 81337, 81343, 81344,81345, 81443, 81518,81596

5
 Codes with descriptor changes: 0006U, 0012M, 0031U, 0032U, 81109, 81162, 81212, 81215, 81216, 81217, 81244, 81287, 81327, 81334
06/21/2018 R5 Removed: 88399, 89398, 87999, 88199, 88299
• Creation of Uniform LCDs With Other MAC
Added: 0001U, 0002U, 0003U, 0005U, 0006U, 0007U, 0008U, 0009U, 0010U, 0011U, 0012U, 0013U, 0014U, 0016U, 0017U, 0018U, 0019U, Jurisdiction
0020U, 0021U, 0022U, 0023U, 0024U, 0025U, 0026U, 0027U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0035U, 0036U, 0037U, • Revisions Due To CPT/HCPCS Code Changes
0038U, 0039U, 0040U, 0041U, 0042U, 0043U, 0044U, 0011M, 0012M, 0013M, 81105-81112, 81120-81121, 86152-86153, 88120-88121.
01/01/2018 R4 Removed G0452, 88380, 88381 because they no longer require a DEX Z code identifier. Revised the link for technical assessment information.
• Creation of Uniform LCDs With Other MAC
03/29/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. Jurisdiction
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.

01/01/2018 R3 The following changes were made as a result of the Annual 2018 CPT/HCPCS code update:
• Creation of Uniform LCDs With Other MAC
81175, 81176, 81230, 81231, 81232, 81238, 81247, 81248, 81249, 81258, 81259, 81269, 81283, 81328, 81334, 81335, 81346, 81361, 81362, Jurisdiction
81363, 81364, 81448, 81520, 81521, 81541 and 81551 were added to code range 81161 - 81599 in Group 1. • Revisions Due To CPT/HCPCS Code Changes

CPT codes are current as of the AMA CPT® 2018 Professional Edition, ISBN 978-1-62202-600-5, ISSN 0276-8283.

12/5/2017 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.

01/01/2017 R2 2017 CPT Code Changes:

• Revisions Due To CPT/HCPCS Code Changes
The following CPT/HCPCS codes were added to these code ranges:

81327 was added to code range 81161 - 81599 in Group 1

81413 was added to code range 81161 - 81599 in Group 1

81414 was added to code range 81161 - 81599 in Group 1

81422 was added to code range 81161 - 81599 in Group 1

81439 was added to code range 81161 - 81599 in Group 1

81539 was added to code range 81161 - 81599 in Group 1

Description was changed for the following CPT/HCPCS codes:

81402 descriptor was changed in Group 1, 81407 descriptor was changed in Group 1

CPT/HCPCS codes were deleted:

0010M, 81280, 81281 and 81282 was deleted from Group 1.

04/21/2016 R1 Replaced Palmetto GBA reference with MolDX, Under "Unique Test Identifier Requirement" - removed instruction
• Creation of Uniform LCDs With Other MAC

6
 to register services via Z-Code Identifier Application and Palmetto GBA Test Identifier (PTI) Application. Under "Payment Rules" - removed Jurisdiction
suspension of claims that omit Z-Code IDs. Under "Covered Tests" - updated the point of contact for McKesson and MolDX.) JFA LCD
L36255 is retired and JFA contract numbers are added to the JFB LCD so that JFA and JFB have the same MCD LCD number.
Associated Documents

Attachments

N/A

Related Local Coverage Documents

Articles

A55712 - Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)

A54358 - Billing and Coding: MolDX: Afirma™ Assay by Veracyte

A54388 - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID®

A54420 - Billing and Coding: MolDX: FDA-Approved BRAF Tests

A54424 - Billing and Coding: MolDX: FDA-Approved EGFR Tests

A54500 - Billing and Coding: MolDX: FDA-Approved KRAS Tests

A55295 - Billing and Coding: MolDX: Germline testing for use of PARP inhibitors

A54447 - Billing and Coding: MolDX: MammaPrint

A56104 - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors

A57527 - Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)

A54482 - Billing and Coding: MolDX: Oncotype DX® Breast Cancer Assay

A54486 - Billing and Coding: MolDX: Oncotype DX® Colon Cancer

A54496 - Billing and Coding: MolDx: ResponseDX Tissue of Origin®

A54554 - Response to Comments: MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Public Versions

Updated On Effective Dates Status

05/03/2023 05/04/2023 - N/A Currently in Effect You are here

7
URL for source document:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=55712&ver=17

Article Title

Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

8
The Abbott RealTime IDH1 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for treatment with
TIBSOVO® (ivosidenib).

TIBSOVO® (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an
FDA-approved test.

Abbott RealTime IDH1 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 7/20/2018.

The Abbott RealTime IDH2 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for treatment with
enasidenib (IDHIFA®).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

Abbott RealTime IDH2 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 8/1/2017.

Select the CPT 81120 for claims on or after 7/20/2018.

To report an Abbott RealTime IDH2 service, please submit the following claim information:

• Select the CPT code 81121 for claims on or after 1/1/2018.

• Enter 1 unit of service (UOS)
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM code

Note: This MolDX coverage determination and coding guideline ONLY applies to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on www.PalmettoGBA.com/medicare , must be submitted and a determination assessed prior to claims submission.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

9
 Code Description
81120 IDH1 (ISOCITRATE DEHYDROGENASE 1 [NADP+], SOLUBLE) (EG, GLIOMA), COMMON VARIANTS (EG, R132H, R132C)
81121 IDH2 (ISOCITRATE DEHYDROGENASE 2 [NADP+], MITOCHONDRIAL) (EG, GLIOMA), COMMON VARIANTS (EG, R140W, R172M)
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(2 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

10
Additional ICD-10 Information

N/a

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
06/01/2023 R5 Under CMS National Coverage Policy added regulations, Title XVIII of the Social Security Act, §1833(e), CMS Internet-Only Manuals, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15,
§80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories, CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory
Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance, and CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting
ICD Diagnosis and Procedure Codes.
11/01/2019 R4 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into
related Billing and Coding Articles.

Under Article Title changed title from "MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML) Coding and Billing Guidelines" to "MolDX: Abbott RealTime IDH1
and IDH2 testing for Acute Myeloid Leukemia (AML)".
11/01/2019 R3 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
07/20/2018 R2 Added Abbott RealTime IDH1 (81120) coverage information to the article, effective 7/20/18.
01/01/2018 R1 Article is revised to replace 81403 with 81121, effective 1/1/2018.
Associated Documents

Related Local Coverage Documents

11
LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

06/21/2023 06/01/2023 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54358&ver=22

Article Title

Billing and Coding: MolDX: Afirma™ Assay by Veracyte

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

12
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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

N/A

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

The MolDX Team has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 10/01/2015, MolDX will
reimburse Afirma services for patients with the following conditions (patient must have 1 and 2):

1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:

• Nodule growth over time

• Family history of thyroid cancer
• Hoarseness, difficulty swallowing or breathing
• History of exposure to ionizing radiationHard nodule compared with rest of gland consistency
• Presence of cervical adenopathy

2. Have an indeterminate follicular pathology on fine needle aspiration

MolDX expects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with support documentation.

To report an Afirma service, submit the following claim information:

• Select the appropriate CPT® code.

• Select the appropriate ICD-10-CM diagnosis
• Enter the DEX Z-Code™ identifier in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the DEX Z-Code™ identifier in the comment/narrative field for the following Part A claim field/types:
•
• Line SV202-7 for 837I electronic claim

13
 • Block 80 for the UB04 claim form

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81546 ONCOLOGY (THYROID), MRNA, GENE EXPRESSION ANALYSIS OF 10,196 GENES, UTILIZING FINE NEEDLE ASPIRATE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (EG, BENIGN OR SUSPICIOUS)
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(11 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
D34 Benign neoplasm of thyroid gland
D44.0 Neoplasm of uncertain behavior of thyroid gland
D44.9 Neoplasm of uncertain behavior of unspecified endocrine gland
E01.0 Iodine-deficiency related diffuse (endemic) goiter
E01.1 Iodine-deficiency related multinodular (endemic) goiter
E01.2 Iodine-deficiency related (endemic) goiter, unspecified
E04.0 Nontoxic diffuse goiter
E04.1 Nontoxic single thyroid nodule
E04.2 Nontoxic multinodular goiter
E04.8 Other specified nontoxic goiter
E04.9 Nontoxic goiter, unspecified

14
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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
018x Hospital - Swing Beds
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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
01/01/2021 R6 Under Article Text: Added bullet to read “Select the appropriate CPT® code”
01/01/2021 R5 81545 was deleted and 81546 was added to Group I Codes. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 01/01/2021.
11/01/2019 R4 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
09/20/2018 R3 Reimbursement and coverage is clarified to require a condition from 1. and 2. Effective 09/20/2018.

15
01/05/2018 R2 Article is updated to add Part A claim filing information.

Article number A54357 for Jurisdiction F Part A (JFA) was retired on January 5, 2018, and combined into Jurisdiction F Part B (JFB) article number A54358. JFA and JFB contract numbers will
have the same final MCD article number and remain an Active article. Coverage will remain the same.

01/01/2016 R1 Article is revised to replace 81479 with 81545 effective 01/01/2016.

Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

02/16/2021 01/01/2021 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54388&ver=24

16
Article Title

Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID®

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

To bill for Cancer TYPE ID, please provide the following claim information:

• Enter “1” in the Days/Unit field

• Enter DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
•

17
 • Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
•
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM code.

Note: MolDX expects this test to ONLY be ordered by the treating physician.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81540 ONCOLOGY (TUMOR OF UNKNOWN ORIGIN), MRNA, GENE EXPRESSION PROFILING BY REAL-TIME RT-PCR OF 92 GENES (87 CONTENT AND 5 HOUSEKEEPING) TO CLASSIFY TUMOR INTO MAIN
CANCER TYPE AND SUBTYPE, UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A PROBABILITY OF A PREDICTED MAIN CANCER TYPE AND SUBTYPE
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(256 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description

18
C02.1 Malignant neoplasm of border of tongue
C08.9 Malignant neoplasm of major salivary gland, unspecified
C09.9 Malignant neoplasm of tonsil, unspecified
C11.8 Malignant neoplasm of overlapping sites of nasopharynx
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
C15.9 Malignant neoplasm of esophagus, unspecified
C16.0 Malignant neoplasm of cardia
C16.2 Malignant neoplasm of body of stomach
C16.8 Malignant neoplasm of overlapping sites of stomach
C16.9 Malignant neoplasm of stomach, unspecified
C17.9 Malignant neoplasm of small intestine, unspecified
C18.0 Malignant neoplasm of cecum
C18.2 Malignant neoplasm of ascending colon
C18.4 Malignant neoplasm of transverse colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C22.0 Liver cell carcinoma
C22.1 Intrahepatic bile duct carcinoma
C22.7 Other specified carcinomas of liver
C22.8 Malignant neoplasm of liver, primary, unspecified as to type
C22.9 Malignant neoplasm of liver, not specified as primary or secondary
C23 Malignant neoplasm of gallbladder
C24.8 Malignant neoplasm of overlapping sites of biliary tract
C24.9 Malignant neoplasm of biliary tract, unspecified
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C26.9 Malignant neoplasm of ill-defined sites within the digestive system
C31.9 Malignant neoplasm of accessory sinus, unspecified
C32.0 Malignant neoplasm of glottis
C32.8 Malignant neoplasm of overlapping sites of larynx
C33 Malignant neoplasm of trachea
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.2 Malignant neoplasm of middle lobe, bronchus or lung
C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung
C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

19
C37 Malignant neoplasm of thymus
C38.3 Malignant neoplasm of mediastinum, part unspecified
C38.4 Malignant neoplasm of pleura
C40.01 Malignant neoplasm of scapula and long bones of right upper limb
C40.02 Malignant neoplasm of scapula and long bones of left upper limb
C41.2 Malignant neoplasm of vertebral column
C41.3 Malignant neoplasm of ribs, sternum and clavicle
C41.9 Malignant neoplasm of bone and articular cartilage, unspecified
C43.39 Malignant melanoma of other parts of face
C43.4 Malignant melanoma of scalp and neck
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C43.60 Malignant melanoma of unspecified upper limb, including shoulder
C43.61 Malignant melanoma of right upper limb, including shoulder
C43.62 Malignant melanoma of left upper limb, including shoulder
C43.9 Malignant melanoma of skin, unspecified
C4A.71 Merkel cell carcinoma of right lower limb, including hip
C4A.9 Merkel cell carcinoma, unspecified
C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal
C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal
C44.329 Squamous cell carcinoma of skin of other parts of face
C44.399 Other specified malignant neoplasm of skin of other parts of face
C44.42 Squamous cell carcinoma of skin of scalp and neck
C44.49 Other specified malignant neoplasm of skin of scalp and neck
C44.501 Unspecified malignant neoplasm of skin of breast
C44.509 Unspecified malignant neoplasm of skin of other part of trunk
C44.521 Squamous cell carcinoma of skin of breast
C44.529 Squamous cell carcinoma of skin of other part of trunk
C44.599 Other specified malignant neoplasm of skin of other part of trunk
C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder
C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder
C44.709 Unspecified malignant neoplasm of skin of left lower limb, including hip
C44.90 Unspecified malignant neoplasm of skin, unspecified
C44.92 Squamous cell carcinoma of skin, unspecified
C45.7 Mesothelioma of other sites
C45.9 Mesothelioma, unspecified
C47.0 Malignant neoplasm of peripheral nerves of head, face and neck
C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified
C48.0 Malignant neoplasm of retroperitoneum
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.2 Malignant neoplasm of peritoneum, unspecified
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck
C49.12 Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder
C49.5 Malignant neoplasm of connective and soft tissue of pelvis
C49.9 Malignant neoplasm of connective and soft tissue, unspecified
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast

20
C50.412 Malignant neoplasm of upper-outer quadrant of left 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female 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
C50.911 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
C53.0 Malignant neoplasm of endocervix
C53.8 Malignant neoplasm of overlapping sites of cervix uteri
C53.9 Malignant neoplasm of cervix uteri, unspecified
C54.1 Malignant neoplasm of endometrium
C54.3 Malignant neoplasm of fundus uteri
C54.9 Malignant neoplasm of corpus uteri, unspecified
C55 Malignant neoplasm of uterus, part unspecified
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.00 Malignant neoplasm of unspecified fallopian tube
C57.8 Malignant neoplasm of overlapping sites of female genital organs
C57.9 Malignant neoplasm of female genital organ, unspecified
C61 Malignant neoplasm of prostate
C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.2 Malignant neoplasm of left kidney, except renal pelvis
C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis
C65.1 Malignant neoplasm of right renal pelvis
C65.2 Malignant neoplasm of left renal pelvis
C66.1 Malignant neoplasm of right ureter
C66.2 Malignant neoplasm of left ureter
C67.1 Malignant neoplasm of dome of bladder
C67.2 Malignant neoplasm of lateral wall of bladder
C67.4 Malignant neoplasm of posterior wall of bladder
C67.5 Malignant neoplasm of bladder neck
C67.8 Malignant neoplasm of overlapping sites of bladder
C67.9 Malignant neoplasm of bladder, unspecified
C68.9 Malignant neoplasm of urinary organ, unspecified
C71.1 Malignant neoplasm of frontal lobe
C71.9 Malignant neoplasm of brain, unspecified
C73 Malignant neoplasm of thyroid gland
C74.90 Malignant neoplasm of unspecified part of unspecified adrenal gland
C74.92 Malignant neoplasm of unspecified part of left adrenal gland
C75.1 Malignant neoplasm of pituitary gland
C7A.00 Malignant carcinoid tumor of unspecified site
C7A.019 Malignant carcinoid tumor of the small intestine, unspecified portion
C7A.090 Malignant carcinoid tumor of the bronchus and lung

21
C7A.1 Malignant poorly differentiated neuroendocrine tumors
C7A.8 Other malignant neuroendocrine tumors
C7B.02 Secondary carcinoid tumors of liver
C7B.03 Secondary carcinoid tumors of bone
C7B.8 Other secondary neuroendocrine tumors
C76.0 Malignant neoplasm of head, face and neck
C76.2 Malignant neoplasm of abdomen
C76.3 Malignant neoplasm of pelvis
C76.51 Malignant neoplasm of right lower limb
C76.52 Malignant neoplasm of left lower limb
C76.8 Malignant neoplasm of other specified ill-defined sites
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
C78.4 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
C79.01 Secondary malignant neoplasm of right kidney and renal pelvis
C79.02 Secondary malignant neoplasm of left kidney and renal pelvis
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
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
C79.81 Secondary malignant neoplasm of breast
C79.82 Secondary malignant neoplasm of genital organs
C79.89 Secondary malignant neoplasm of other specified sites
C79.9 Secondary malignant neoplasm of unspecified site
C80.0 Disseminated malignant neoplasm, unspecified
C80.1 Malignant (primary) neoplasm, unspecified
C81.90 Hodgkin lymphoma, unspecified, unspecified site
C82.00 Follicular lymphoma grade I, unspecified site
C82.57 Diffuse follicle center lymphoma, spleen
C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites

22
C83.10 Mantle cell lymphoma, unspecified site
C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen
C84.Z7 Other mature T/NK-cell lymphomas, spleen
C84.97 Mature T/NK-cell lymphomas, unspecified, spleen
C85.14 Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb
C85.17 Unspecified B-cell lymphoma, spleen
C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen
C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site
C85.87 Other specified types of non-Hodgkin lymphoma, spleen
C85.88 Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites
C85.97 Non-Hodgkin lymphoma, unspecified, spleen
C86.1 Hepatosplenic T-cell lymphoma
C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
D37.6 Neoplasm of uncertain behavior of liver, gallbladder and bile ducts
D37.8 Neoplasm of uncertain behavior of other specified digestive organs
D37.9 Neoplasm of uncertain behavior of digestive organ, unspecified
D38.1 Neoplasm of uncertain behavior of trachea, bronchus and lung
D38.3 Neoplasm of uncertain behavior of mediastinum
D41.01 Neoplasm of uncertain behavior of right kidney
D48.0 Neoplasm of uncertain behavior of bone and articular cartilage
D48.1 Neoplasm of uncertain behavior of connective and other soft tissue
D48.3 Neoplasm of uncertain behavior of retroperitoneum
D48.4 Neoplasm of uncertain behavior of peritoneum
D48.5 Neoplasm of uncertain behavior of skin
D48.61 Neoplasm of uncertain behavior of right breast
D48.62 Neoplasm of uncertain behavior of left breast
D49.0 Neoplasm of unspecified behavior of digestive system
D49.1 Neoplasm of unspecified behavior of respiratory system
D49.2 Neoplasm of unspecified behavior of bone, soft tissue, and skin
D49.3 Neoplasm of unspecified behavior of breast
D49.4 Neoplasm of unspecified behavior of bladder
D49.511 Neoplasm of unspecified behavior of right kidney
D49.512 Neoplasm of unspecified behavior of left kidney
D49.59 Neoplasm of unspecified behavior of other genitourinary organ
D49.6 Neoplasm of unspecified behavior of brain
D49.7 Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system
D49.89 Neoplasm of unspecified behavior of other specified sites
D49.9 Neoplasm of unspecified behavior of unspecified site
J91.0 Malignant pleural effusion
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

23
Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
06/01/2023 R8 Under CMS National Coverage Policy added regulations, Title XVIII of the Social Security Act, §1833(e), CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15,
§80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories, CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory
Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance, and CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting
ICD Diagnosis and Procedure Codes.
10/01/2021 R7 Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3 and C79.63. This revision is due to the Annual ICD-10 update and will become effective on 10/1/2021.
11/01/2019 R6 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.

24
05/09/2019 R5 Removed the first two bullets containing 81479 and 81540. 81540 is listed in the coding section; 81479 deleted.

Removed the following ICD-10 codes: C18.1, C22.2, C22.3, C22.4, D01.5, D01.7, D01.9, D02.21, D02.22, D03.51, D03.52, D03.59.

Added the following ICD-10 codes: C02.1, C08.9, C09.9, C11.8, C15.3, C15.4, C15.5, C15.9, C16.0, C16.2, C16.8, C16.9, C17.9, C18.0, C18.2, C18.4, C18.4, C18.7, C18.8, C22.1, C23, C24.8,
C24.9, C25.0, C25.1, C26.9, C31.9, C32.0, C32.8, C34.00, C34.10, C34.30, C34.80, C34.90, C37, C38.3, C38.4, C40.01, C40.02, C41.2, C41.3, C41.9, C43.39, C43.4, C43.60, C43.61, C43.62,
C43.9, C44.222, C44.229, C44.329, C44.399, C44.42, C44.49, C44.501, C44.509, C44.521, C44.529, C44.599, C44.622, C44.629, C44.709, C44.90, C44.92, C45.7, C48.1, C48.2, C48.8, C49.12,
C49.5, C4A.71, C4A.9, C50.111, C50.112, C50.211, C50.212, C50.311, C50.312, C50.421, C50.422, C50.611, C50.612, C50.819, C50.919, C50.921, C50.922, C50.929, C53.0, C53.8, C53.9,
C54.1, C54.3, C54.9, C55, C56.9, C57.00, C57.8, C57.9, C64.9, C65.1, C65.2, C66.1, C66.2, C67.1, C67.2, C67.4, C67.8, C68.9, C71.1, C71.9, C73, C74.90, C74.92, C75.1, C76.2, C76.3, C76.51,
C76.52, C76.8, C78.00, C78.1, C78.2, C78.4, C78.80, C78.89, C79.60, C79.70, C79.71, C79.72, C79.81, C79.82, C79.9, C7A.00, C7A.019, C7A.090, C7A.1, C7A.8, C7B.02, C7B.03, C7B.8,
C81.90, C82.00, C83.09, C83.10, C83.31, C85.14, C85.80, C85.88, C88.4, D37.6, D37.8, D37.9, D38.1, D38.3, D41.01, D48.0, D48.1, D48.3, D48.4, D48.5, D48.61, D48.62.
12/08/2016 R4 ICD-10 code D49.59 is added to the LCD effective 10/01/2016. The current revision effective date of 12/08/2016 is unchanged as the MCD will not allow a retroactive revision effective date prior to
12/08/2016.
12/08/2016 R3 Replaced assigned ID with DEX Z-Code™ identifier, added instruction for Part A claim submission.
10/01/2016 R2 The following revisions were made due to annual ICD-10 updates effective 10/1/16: D49.511 and D49.512 were added and D49.5 was deleted. The JFA article (A54387) is retired and Part A
contract numbers are added to the Part B article. Z-Code Identifier references were replaced with unique identifier.
01/01/2016 R1 Replaced 81479 with 81540 effective 01/01/2016.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

05/18/2023 06/01/2023 - N/A Currently in Effect You are here

25
URL for source document:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54420&ver=24

Article Title

Billing and Coding: MolDX: FDA-Approved BRAF Tests

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

Two tests have met the FDA criteria for BRAF genetic testing:

1. Effective 09/07/2012

cobas® 4800 BRAF V600 to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf ™(vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has
spread in the body.

26
2. Effective 5/29/13

ThxID™ BRAF V600/K to detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients
whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].

To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, submit the following claim information:

• CPT code 81210

• Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM diagnosis.

NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on the DEX™
Diagnostics Exchange: https://app.dexzcodes.com/login .

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81210 BRAF (B-RAF PROTO-ONCOGENE, SERINE/THREONINE KINASE) (EG, COLON CANCER, MELANOMA), GENE ANALYSIS, V600 VARIANT(S)
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(56 Codes)

27
Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.0 Malignant neoplasm of anus, unspecified
C21.1 Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C43.0 Malignant melanoma of lip
C43.111 Malignant melanoma of right upper eyelid, including canthus
C43.112 Malignant melanoma of right lower eyelid, including canthus
C43.121 Malignant melanoma of left upper eyelid, including canthus
C43.122 Malignant melanoma of left lower eyelid, including canthus
C43.21 Malignant melanoma of right ear and external auricular canal
C43.22 Malignant melanoma of left ear and external auricular canal
C43.31 Malignant melanoma of nose
C43.39 Malignant melanoma of other parts of face
C43.4 Malignant melanoma of scalp and neck
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C43.61 Malignant melanoma of right upper limb, including shoulder
C43.62 Malignant melanoma of left upper limb, including shoulder
C43.71 Malignant melanoma of right lower limb, including hip
C43.72 Malignant melanoma of left lower limb, including hip
C43.8 Malignant melanoma of overlapping sites of skin
C43.9 Malignant melanoma of skin, unspecified
C79.2 Secondary malignant neoplasm of skin
C91.40 Hairy cell leukemia not having achieved remission
C91.42 Hairy cell leukemia, in relapse
D03.0 Melanoma in situ of lip
D03.111 Melanoma in situ of right upper eyelid, including canthus
D03.112 Melanoma in situ of right lower eyelid, including canthus
D03.121 Melanoma in situ of left upper eyelid, including canthus
D03.122 Melanoma in situ of left lower eyelid, including canthus
D03.21 Melanoma in situ of right ear and external auricular canal
D03.22 Melanoma in situ of left ear and external auricular canal
D03.39 Melanoma in situ of other parts of face
D03.4 Melanoma in situ of scalp and neck

28
D03.51 Melanoma in situ of anal skin
D03.52 Melanoma in situ of breast (skin) (soft tissue)
D03.59 Melanoma in situ of other part of trunk
D03.61 Melanoma in situ of right upper limb, including shoulder
D03.62 Melanoma in situ of left upper limb, including shoulder
D03.71 Melanoma in situ of right lower limb, including hip
D03.72 Melanoma in situ of left lower limb, including hip
D03.8 Melanoma in situ of other sites
D03.9 Melanoma in situ, unspecified
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

29
Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
07/27/2023 R7 Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C91.40 and C91.42.
10/13/2022 R6 Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C18.0, C18.1,C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20, C21.0, C21.1, C21.2, C21.8
03/03/2022 R5 Under CMS National Coverage Policy added regulation, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the
claim. Under Article Text, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information. “ This
revision is effective on 03/03/2022.
11/01/2019 R4 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into
related Billing and Coding Articles.

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81210.

CPT® was inserted throughout the article where applicable

11/01/2019 R3 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
10/01/2018 R2 Article is revised to add the following ICD-10 codes per the 2019 Annual Update: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122.

The following codes are deleted:C43.11, C43.12, D03.11, D03.12.

12/14/2017 R1 Article is updated for consistency with the MolDX Contractor: to remove modifier 22 instructions; added Part A claim filing instructions and correct reference to and website address for DEX™
Diagnostics Exchange.

Article number A54419 for Jurisdiction F Part A (JFA) was retired on January 29, 2018, and combined into Jurisdiction F Part B (JFB) article number A54420. JFA and JFB contract numbers will
have the same final MCD article number.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

30
Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

08/02/2023 07/27/2023 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54424&ver=15

Article Title

Billing and Coding: MolDX: FDA-Approved EGFR Tests

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

31
its affiliates.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

Two tests have met the FDA criteria for EGFR genetic testing:

1. Effective 6/01/16

cobas EGFR Mutation Test is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected
using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.

The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table below in accordance with the approved therapeutic product labeling:

Drug FFPET Plasma

TARCEVA®(erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858R
TAGRISSO™ (osimertinib) T790M

Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for
these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

2. Effective 7/12/13

therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue to help select patients with NSCLC for whom GILOTRIF™ (afatinib), an EGFR
tyrosine kinase inhibitor (TKI), is indicated.

To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information:

• CPT® code: 81235

• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• ICD-10-CM codes

NOTE: MolDX will apply NPI to ID editing on FDA approved EGFR kits. All labs that submit claims for an EGFR kit MUST register the test and confirm the UNMODIFIED use of the kit.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Coding Information

32
CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81235 EGFR (EPIDERMAL GROWTH FACTOR RECEPTOR) (EG, NON-SMALL CELL LUNG CANCER) GENE ANALYSIS, COMMON VARIANTS (EG, EXON 19 LREA DELETION, L858R, T790M, G719A, G719S, L861Q)
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(9 Codes)

Group 1 Paragraph

81235

Group 1 Codes

Code Description
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.2 Malignant neoplasm of middle lobe, bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

33
N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

34
 Revision History Revision History
Date Number Revision History Explanation
03/03/2022 R4 Under CMS National Coverage Policy added regulation, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the
claim. Under Article Text number 2, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information.”

This revision is effective on 03/03/2022.

11/01/2019 R3 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into
related Billing and Coding Articles.

Under Article Text created another bullet for verbiage, "Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim
field/types".

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81235. Formatting, punctuation and typographical errors were corrected throughout the Article. CPT® was inserted throughout the article
where applicable.
11/01/2019 R2 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
12/14/2017 R1 Article is updated for consistency with the MolDX Contractor: The entire section for cobas EGFR Mutation Test was revised, including effective date; modifier 22 instruction was removed; added Part
A claim filing instructions and correct reference to and website address for DEX™ Diagnostics Exchange.

Article number A54423 for Jurisdiction F Part A (JFA) was retired on January 24, 2018, and combined into Jurisdiction F Part B (JFB) article number A54424. JFA and JFB contract numbers will
have the same final MCD article number.

Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

35
Public Versions

Updated On Effective Dates Status

02/28/2022 03/03/2022 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54500&ver=17

Article Title

Billing and Coding: MolDX: FDA-Approved KRAS Tests

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

36
The following coding and billing guidance is to be used with its associated Local coverage determination.

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:

1. Effective 7/6/2012

therascreen® KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux® (cetuximab).

2. Effective 5/7/2015

cobas® KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab).

To report an FDA approved or laboratory developed test (LDT) KRAS, codon 12 and 13 test kit service, please submit the following claim information:

• Enter CPT® 81275

• Enter the appropriate DEX Z-Code™ Identifier in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code™ Identifier in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for the 837I electronic claim
• Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM diagnosis.

NOTE: MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kit MUST register the test and confirm the UNMODIFIED use of the kit.
Tests may be registered on the DEX™ Diagnostics Exchange: https://app.dexzcodes.com/login .

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81275 KRAS (KIRSTEN RAT SARCOMA VIRAL ONCOGENE HOMOLOG) (EG, CARCINOMA) GENE ANALYSIS; VARIANTS IN EXON 2 (EG, CODONS 12 AND 13)
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

37
Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(37 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
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
C78.01 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
C78.39 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
C79.01 Secondary malignant neoplasm of right kidney and renal pelvis
C79.02 Secondary malignant neoplasm of left kidney and renal pelvis
C79.11 Secondary malignant neoplasm of bladder
C79.19 Secondary malignant neoplasm of other urinary organs
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.32 Secondary malignant neoplasm of cerebral meninges
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
C79.61 Secondary malignant neoplasm of right ovary
C79.62 Secondary malignant neoplasm of left ovary
C79.63 Secondary malignant neoplasm of bilateral ovaries
C79.71 Secondary malignant neoplasm of right adrenal gland
C79.72 Secondary malignant neoplasm of left adrenal gland
C79.81 Secondary malignant neoplasm of breast
C79.82 Secondary malignant neoplasm of genital organs
C79.89 Secondary malignant neoplasm of other specified sites

38
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

39
Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
03/03/2022 R6 Under CMS National Coverage Policy added regulation, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the
claim. Under Article Text, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) KRAS, codon 12 and 13 test kit service, please submit the following claim
information.” This revision is effective on 03/03/2022.
10/01/2021 R5 Under Article Text corrected hyperlink for DEX webpage. Acronyms were defined and inserted where appropriate throughout the article. Formatting was corrected throughout the article. This revision
is effective 10/1/2021.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C79.63. This revision is due to the Annual ICD-10 update and will become effective on 10/1/2021.
11/01/2019 R4 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into
related Billing and Coding Articles.

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81275.

CPT® was inserted throughout the article where applicable.

11/01/2019 R3 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
12/14/2017 R2 Article is updated to remove modifier 22 instruction, add Part A claim filing instructions and correct reference to and website address for DEX™ Diagnostics Exchange.

Article number A54501 for Jurisdiction F Part A (JFA) was retired on January 24, 2018, and combined into Jurisdiction F Part B (JFB) article number A54500. JFA and JFB contract numbers will
have the same final MCD article number.

01/01/2016 R1 Article is revised to change the title from "MolDX: therascreen® KRAS PCR Kit Billing/Coding Guidelines" to "MolDX: FDA-Approved KRAS" Tests and the following diagnoses were removed to
be consistent with the MolDX Contractor coverage article: C78.00, C78.30, C79.00, C79.10, C79.40, C79.60, C79.70 and C79.9.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

40
N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

02/28/2022 03/03/2022 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=55295&ver=25

Article Title

Billing and Coding: MolDX: Germline testing for use of PARP inhibitors

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act (SSA) §1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

41
Article Guidance

Article Text

The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Results of tests that assess for deleterious variants in homologous recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in patients who are being considered for treatment with PARP inhibitors in accordance with
published guidelines and approved therapeutic product labeling. These genes are often tested as part of routine management of these cancer patients as part of services that interrogate a panel of genes as described in LCD L38974. In rare
circumstances limited testing for only a select group of genes may be tested to ensure compliance with FDA indicated drug usage, wherein additional genes outlined in guidelines such as the NCCN are not necessary because the patient does not
meet testing criteria for larger panels.

According to criteria defined by L38974, billing for these services can occur in the following situation:

• The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use AND
• The patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing AND
• The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38974 requiring more comprehensive testing.

To report a service, please submit the following claim information:

• Select appropriate CPT® code

• One (1) unit of service
• Enter DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• Select at least one ICD-10-CM diagnosis code.

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)

Group 1 Paragraph

CPT® codes that are also referenced in other articles.

Group 1 Codes

Code Description
81162 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND FULL
DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

42
N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(64 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.3 Malignant neoplasm of pancreatic duct
C25.4 Malignant neoplasm of endocrine pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C48.0 Malignant neoplasm of retroperitoneum
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.2 Malignant neoplasm of peritoneum, unspecified
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left 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
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast

43
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.01 Malignant neoplasm of right fallopian tube
C57.02 Malignant neoplasm of left fallopian tube
C61 Malignant neoplasm of prostate
C79.61 Secondary malignant neoplasm of right ovary
C79.62 Secondary malignant neoplasm of left ovary
C79.63 Secondary malignant neoplasm of bilateral ovaries
C79.9 Secondary malignant neoplasm of unspecified site
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.3 Personal history of malignant neoplasm of breast
Z85.43 Personal history of malignant neoplasm of ovary
Z85.44 Personal history of malignant neoplasm of other female genital organs
Z85.46 Personal history of malignant neoplasm of prostate
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

44
N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
07/28/2022 R9 Under Article Text revised typographical error: The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more
comprehensive testing from L38966 to L38974.
07/28/2022 R8 Under Article Title revised to Germline testing for use of PARP inhibitors.

Under Article Text deleted second paragraph and revised the verbiage in the third paragraph. Added new verbiage following the third paragraph. Deleted Table 1, fourth, fifth, and sixth paragraphs.
Revised seventh paragraph first sentence to read, “To report service, please submit the following claim information”. Revised the seventh paragraph first bullet to read, “Select appropriate
CPT® code”. Deleted the eighth and ninth paragraphs.

Under CPT/HCPCS Codes Group 1: Codes added 81479.

01/06/2022 R7 Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C25.9, C48.2, C50.911, C50.912, C50.921, C50.922, C56.9, and C79.9. The deletion of these codes with Revision 15 was
done in error and is retroactive effective for dates of service on or after 4/29/2021.
10/01/2021 R6 Effective 04.29.021: Under CMS National Coverage Policy added regulation Title XVIII of the Social Security Act (SSA) §1833(e), prohibits Medicare payment for any claim lacking the necessary
documentation to process the claim. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C25.9, C48.2, C50.911, C50.912, C50.921, C50.922, C56.9, and C79.9.

Typographical errors were corrected throughout the article.

Effective 10.01.2021: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3 and C79.63. This revision is due to the Annual ICD-10 Update.
07/17/2020 R5 Under Article Title replaced the trademark symbol with a registered symbol. Under Article Text removed the verbiage “Lynparza™ (olaparib), as a treatment for women with advanced ovarian cancer

45
 or women or men with metastatic breast cancer, and the companion diagnostic BRACAnalysis CDx™, the laboratory test to detect mutated BRCA genes” and revised the first paragraph to state “The
United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer,
pancreatic cancer, and prostate cancer”. Added the verbiage “BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the
protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and
small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex
PCR” to the second paragraph. Added the verbiage “Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table
1 in accordance with the approved therapeutic product labeling” to the third paragraph. Added Table 1: Companion diagnostic indications. Added the verbiage “This assay is for professional use
only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108” to the fourth paragraph. Added the verbiage “This
article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for this test” to the fifth paragraph. Removed the verbiage
“Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, blocks enzymes involved in repairing damaged DNA and is intended for women with heavily pretreated ovarian cancer or HER2-negative
metastatic breast cancer associated with defective BRCA genes. BRACAnalysis CDx™ detects the presence of BRCA1 and BRCA2 gene mutations. According to the FDA, results of the test are used as
an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza® (olaparib)” and
revised the sixth paragraph to state “BRACAnalysis CDx® is only covered for individuals diagnosed with ovarian cancer, breast cancer, pancreatic cancer, or prostate cancer and who have not been
previously tested for BRCA mutations”. Removed the word “Lynparza” and added the word “PARPi” to the second sentence in the eighth paragraph. Removed the verbiage “or other hereditary
cancer syndromes” and added the verbiage “pancreatic, or prostate cancer” to the first bullet in the ninth paragraph. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added
ICD-10 codes C25.0, C25.1, C25.2, C25.3, C25.4, C25.7, C25.8, C25.9, C61, Z85.07, and Z85.46. BRACAnalysis CDx® was inserted throughout the article where applicable. CPT® was inserted
throughout the article where applicable. Typographical errors were corrected throughout the article.
11/01/2019 R4 relating LCD to Article
11/01/2019 R3 This article was converted to a billing and coding type article. There is no change in coverage.
02/21/2019 R2 Revised the first paragraph to include men in the treatment for metastatic breast cancer and included non-coverage indications.

Effective 1/1/2019, 81479 is replaced with CPT code 81162.

07/05/2018 R1 Revised opening paragraphs and added the following ICD-10 codes:

C48.0, C48.1, C48.2, C48.8, C50.011, C50.012, C50.021, C50.022, C50.111, C50.112, C50.121, C50.122, C50.211, C50.212, C50.221, C50.222, C50.311, C50.312, C50.321, C50.322, C50.411,
C50.412, C50.421, C50.422, C50.511, C50.512, C50.521, C50.522, C50.611, C50.612, C50.621, C50.622, C50.811, C50.812, C50.821, C50.822, C50.911, C50.912, C50.921, C50.922, C57.01,
C57.02, Z85.3, Z85.43, Z85.44.

Removed ICD-10 C79.60

Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

46
CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

06/29/2023 07/28/2022 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54447&ver=21

Article Title

Billing and Coding: MolDX: MammaPrint

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

47
N/A

Article Guidance

Article Text

MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.

The test can be performed using either a FDA-cleared in vitro microarray assay or a next generation sequencing (NGS)-based assay. Each assay has been assigned a unique Z-code identifier in the DEX Registry.

MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has
demonstrated technically equivalent performance to the predicate microarray test.

To bill for MammaPrint® services, submit the following claim information:

• Enter “1” in the Days/Unit field

• For CPT® non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information. For dates of service on or after 01/01/2022, use CPT® code 81523 for the test if performed by
NGS.
• Enter the DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form

Only one test- NGS or microarray may be performed on a given date of service for a given patient.

Note: Noridian expects this test may be performed upon occasion twice per patient lifetime for bilateral disease. Should a patient experience an additional occurrence, coverage may be considered with supporting documentation through the
appeal process.

Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81479 Unlisted molecular pathology
81521 Onc breast mrna 70 genes
81523 Onc brst mrna 70 cnt 31 gene

48
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(36 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left 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
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left 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
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast

49
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
Z17.0 Estrogen receptor positive status [ER+]
Z17.1 Estrogen receptor negative status [ER-]
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

50
Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
01/01/2022 R7 Under Article Text deleted the first paragraph. The second paragraph was revised to read, “MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue
samples to assess a patient’s risk for distant metastasis” and a new third paragraph was added. The second bullet point was revised to add the verbiage, “For dates of service on or after 01/01/2022, use
CPT code 81523 for the test if performed by NGS”. A new paragraph was added after verbiage regarding instructions on how to submit claims information. This revision is effective for dates of service
on or after 1/1/2022.

Under CPT/HCPCS Codes Group 1: Codes added 81523. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on 1/1/2022.
10/08/2021 R6 10/08/2021: Under Article Text revised the first sentence to read, “MammaPrint®, a next-generation sequencing (NGS)-based diagnostic test that uses gene expression profiling to analyze the gene
activity of the identified tumor, has been assigned a unique identifier” and revised the third sentence to read, “MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient
MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has demonstrated technically equivalent performance
to the predicate microarray test”.

Under CPT/HCPCS Codes Group 1: Codes added 81479. Mammaprint® was inserted throughout the article where applicable.

10/01/2015: Under Does the CPT 30% Coding Rule Apply: changed to yes. Retroactive back to the creation of the policy.
11/01/2019 R5 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
01/01/2018 R4 Added the following: "MammaPrint™ is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of FFPE breast cancer tissue samples to assess a
patients' risk for distant metastasis.

MammaPrint was prospectively validated in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status."
01/01/2018 R3 Removed the FDA decision summary.
01/01/2018 R2 Added the FDA decision summary providing the intended use information.
01/01/2018 R1 The following updates were made per the 2018 annual HCPCS update:

Added: 81521

Deleted: 81479, 84999

Added Part A billing instructions.

Article number A54446 for Jurisdiction F Part A (JFA) was retired on 01/01/2018 and combined into Jurisdiction F Part B (JFB) article number A54447. JFA and JFB contract numbers will have the
same final MCD article number. Coverage remains the same.

Associated Documents

Related Local Coverage Documents

51
LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

01/25/2022 01/01/2022 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56104&ver=10

Article Title

Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

52
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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

N/A

Article Guidance

Article Text

In May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and
classical Hodgkin’s lymphoma.

This contractor will allow one of the following:

• dMMR by immunohistochemistry (IHC), or

• MSI by PCR, or
• Multi-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genes

Testing by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patient’s tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1,
MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and
appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).

To report a dMMR service, please submit the following claim information:

• CPT code 88342 – One (1) unit of service

• CPT code 88341 – Three (3) units of service

To report a MSI service, please submit the following claim information:

• CPT code 81301 – One (1) unit of service

To report by NGS, please submit the following claim information:

• CPT code 81479 – One (1) unit of service

53
Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
88341 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH ADDITIONAL SINGLE ANTIBODY STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY
PROCEDURE)
88342 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; INITIAL SINGLE ANTIBODY STAIN PROCEDURE
Group 2

(1 Code)

Group 2 Paragraph

CPT® codes that are also referenced in other articles.

Group 2 Codes

Code Description
81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26),
INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

54
N/A

Group 1 Codes

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

55
N/A

Revision History Information

Revision
Revision History
History Date Number Revision History Explanation
11/01/2019 R3 Corrected typographical error under Article Title.
11/01/2019 R2 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual.

Under Article Title changed title from “MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker Coding and Billing Guidelines for Patients with Unresectable or
Metastatic Solid Tumors” to “Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid
Tumors”.

Under Article Text deleted statement, “ICD10 – appropriate for the tumor type and location”.

Under CPT/HCPCS Codes Group 1: Codes deleted CPT® code 81301.

Under CPT/HCPCS Codes Group 2: Paragraph added verbiage, “CPT® codes that are also referenced in other articles”.

Under CPT/HCPCS Group 2: Codes added CPT® code 81301. CPT® was inserted throughout the article where applicable.
11/01/2019 R1 As required by CR 10901 article is converted to a formal billing and coding type article.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

56
 Updated On Effective Dates Status
07/24/2023 11/01/2019 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=57527&ver=48

Article Title

Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

Title XVIII of the Social Security Act (SSA) §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1 Clinical Laboratory Services

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2. Travel Allowance

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

57
Article Text

The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Diagnostic Tests (MDT) L36256.

To report a Molecular Diagnostic Test service, please submit the following claim information:

• Select appropriate CPT® code

• Enter 1 unit of service (UOS)
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:\
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form

Coding Information

CPT/HCPCS Codes

Group 1

(500 Codes)

Group 1 Paragraph

The codes listed below fall within scope of the associated policy but do not automatically imply coverage.

Group 1 Codes

Code Description
81105 Hpa-1 genotyping
81106 Hpa-2 genotyping
81107 Hpa-3 genotyping
81108 Hpa-4 genotyping
81109 Hpa-5 genotyping
81110 Hpa-6 genotyping
81111 Hpa-9 genotyping
81112 Hpa-15 genotyping
81120 Idh1 common variants
81121 Idh2 common variants
81161 Dmd dup/delet analysis
81162 Brca1&2 gen full seq dup/del
81163 Brca1&2 gene full seq alys
81164 Brca1&2 gen ful dup/del alys
81165 Brca1 gene full seq alys
81166 Brca1 gene full dup/del alys
81167 Brca2 gene full dup/del alys
81168 Ccnd1/igh translocation alys
81170 Abl1 gene
81171 Aff2 gene detc abnor alleles
81172 Aff2 gene charac alleles
81173 Ar gene full gene sequence

58
81174 Ar gene known famil variant
81175 Asxl1 full gene sequence
81176 Asxl1 gene target seq alys
81177 Atn1 gene detc abnor alleles
81178 Atxn1 gene detc abnor allele
81179 Atxn2 gene detc abnor allele
81180 Atxn3 gene detc abnor allele
81181 Atxn7 gene detc abnor allele
81182 Atxn8os gen detc abnor allel
81183 Atxn10 gene detc abnor allel
81184 Cacna1a gen detc abnor allel
81185 Cacna1a gene full gene seq
81186 Cacna1a gen known famil vrnt
81187 Cnbp gene detc abnor allele
81188 Cstb gene detc abnor allele
81189 Cstb gene full gene sequence
81190 Cstb gene known famil vrnt
81191 Ntrk1 translocation analysis
81192 Ntrk2 translocation analysis
81193 Ntrk3 translocation analysis
81194 Ntrk translocation analysis
81200 Aspa gene
81201 Apc gene full sequence
81202 Apc gene known fam variants
81203 Apc gene dup/delet variants
81204 Ar gene charac alleles
81205 Bckdhb gene
81206 Bcr/abl1 gene major bp
81207 Bcr/abl1 gene minor bp
81208 Bcr/abl1 gene other bp
81209 Blm gene
81210 Braf gene
81212 Brca1&2 185&5385&6174 vrnt
81215 Brca1 gene known famil vrnt
81216 Brca2 gene full seq alys
81217 Brca2 gene known famil vrnt
81218 Cebpa gene full sequence
81219 Calr gene com variants
81220 Cftr gene com variants
81221 Cftr gene known fam variants
81222 Cftr gene dup/delet variants
81223 Cftr gene full sequence
81224 Cftr gene intron poly t
81225 Cyp2c19 gene com variants
81226 Cyp2d6 gene com variants
81227 Cyp2c9 gene com variants
81228 Cytog alys chrml abnr cgh
81229 Cytog alys chrml abnr snpcgh
81230 Cyp3a4 gene common variants
81231 Cyp3a5 gene common variants
81232 Dpyd gene common variants
81233 Btk gene common variants
81234 Dmpk gene detc abnor allele
81235 Egfr gene com variants

59
81236 Ezh2 gene full gene sequence
81237 Ezh2 gene common variants
81238 F9 full gene sequence
81239 Dmpk gene charac alleles
81240 F2 gene
81241 F5 gene
81242 Fancc gene
81243 Fmr1 gene detection
81244 Fmr1 gene charac alleles
81245 Flt3 gene
81246 Flt3 gene analysis
81247 G6pd gene alys cmn variant
81248 G6pd known familial variant
81249 G6pd full gene sequence
81250 G6pc gene
81251 Gba gene
81252 Gjb2 gene full sequence
81253 Gjb2 gene known fam variants
81254 Gjb6 gene com variants
81255 Hexa gene
81256 Hfe gene
81257 Hba1/hba2 gene
81258 Hba1/hba2 gene fam vrnt
81259 Hba1/hba2 full gene sequence
81260 Ikbkap gene
81261 Igh gene rearrange amp meth
81262 Igh gene rearrang dir probe
81263 Igh vari regional mutation
81264 Igk rearrangeabn clonal pop
81265 Str markers specimen anal
81266 Str markers spec anal addl
81267 Chimerism anal no cell selec
81268 Chimerism anal w/cell select
81269 Hba1/hba2 gene dup/del vrnts
81270 Jak2 gene
81271 Htt gene detc abnor alleles
81272 Kit gene targeted seq analys
81273 Kit gene analys d816 variant
81274 Htt gene charac alleles
81275 Kras gene variants exon 2
81276 Kras gene addl variants
81277 Cytogenomic neo microra alys
81278 Igh@/bcl2 translocation alys
81279 Jak2 gene trgt sequence alys
81283 Ifnl3 gene
81284 Fxn gene detc abnor alleles
81285 Fxn gene charac alleles
81286 Fxn gene full gene sequence
81287 Mgmt gene prmtr mthyltn alys
81288 Mlh1 gene
81289 Fxn gene known famil variant
81290 Mcoln1 gene
81291 Mthfr gene
81292 Mlh1 gene full seq

60
81293 Mlh1 gene known variants
81294 Mlh1 gene dup/delete variant
81295 Msh2 gene full seq
81296 Msh2 gene known variants
81297 Msh2 gene dup/delete variant
81298 Msh6 gene full seq
81299 Msh6 gene known variants
81300 Msh6 gene dup/delete variant
81301 Microsatellite instability
81302 Mecp2 gene full seq
81303 Mecp2 gene known variant
81304 Mecp2 gene dup/delet variant
81305 Myd88 gene p.leu265pro vrnt
81306 Nudt15 gene common variants
81307 Palb2 gene full gene seq
81308 Palb2 gene known famil vrnt
81309 Pik3ca gene trgt seq alys
81310 Npm1 gene
81311 Nras gene variants exon 2&3
81312 Pabpn1 gene detc abnor allel
81313 Pca3/klk3 antigen
81314 Pdgfra gene
81315 Pml/raralpha com breakpoints
81316 Pml/raralpha 1 breakpoint
81317 Pms2 gene full seq analysis
81318 Pms2 known familial variants
81319 Pms2 gene dup/delet variants
81320 Plcg2 gene common variants
81321 Pten gene full sequence
81322 Pten gene known fam variant
81323 Pten gene dup/delet variant
81324 Pmp22 gene dup/delet
81325 Pmp22 gene full sequence
81326 Pmp22 gene known fam variant
81327 Sept9 gen prmtr mthyltn alys
81328 Slco1b1 gene com variants
81329 Smn1 gene dos/deletion alys
81330 Smpd1 gene common variants
81331 Snrpn/ube3a gene
81332 Serpina1 gene
81333 Tgfbi gene common variants
81334 Runx1 gene targeted seq alys
81335 Tpmt gene com variants
81336 Smn1 gene full gene sequence
81337 Smn1 gen nown famil seq vrnt
81338 Mpl gene common variants
81339 Mpl gene seq alys exon 10
81340 Trb@ gene rearrange amplify
81341 Trb@ gene rearrange dirprobe
81342 Trg gene rearrangement anal
81343 Ppp2r2b gen detc abnor allel
81344 Tbp gene detc abnor alleles
81345 Tert gene targeted seq alys
81346 Tyms gene com variants

61
81347 Sf3b1 gene common variants
81348 Srsf2 gene common variants
81349 Cytog alys chrml abnr lw-ps
81350 Ugt1a1 gene common variants
81351 Tp53 gene full gene sequence
81352 Tp53 gene trgt sequence alys
81353 Tp53 gene known famil vrnt
81355 Vkorc1 gene
81357 U2af1 gene common variants
81360 Zrsr2 gene common variants
81361 Hbb gene com variants
81362 Hbb gene known fam variant
81363 Hbb gene dup/del variants
81364 Hbb full gene sequence
81374 Hla i typing 1 antigen lr
81377 Hla ii type 1 ag equiv lr
81381 Hla i typing 1 allele hr
81383 Hla ii typing 1 allele hr
81400 Mopath procedure level 1
81401 Mopath procedure level 2
81402 Mopath procedure level 3
81403 Mopath procedure level 4
81404 Mopath procedure level 5
81405 Mopath procedure level 6
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81408 Mopath procedure level 9
81410 Aortic dysfunction/dilation
81411 Aortic dysfunction/dilation
81412 Ashkenazi jewish assoc dis
81413 Car ion chnnlpath inc 10 gns
81414 Car ion chnnlpath inc 2 gns
81415 Exome sequence analysis
81416 Exome sequence analysis
81417 Exome re-evaluation
81418 Rx metab gen seq alys pnl 6
81419 Epilepsy gen seq alys panel
81420 Fetal chrmoml aneuploidy
81422 Fetal chrmoml microdeltj
81425 Genome sequence analysis
81426 Genome sequence analysis
81427 Genome re-evaluation
81430 Hearing loss sequence analys
81431 Hearing loss dup/del analys
81432 Hrdtry brst ca-rlatd dsordrs
81433 Hrdtry brst ca-rlatd dsordrs
81434 Hereditary retinal disorders
81435 Hereditary colon ca dsordrs
81436 Hereditary colon ca dsordrs
81437 Heredtry nurondcrn tum dsrdr
81438 Heredtry nurondcrn tum dsrdr
81439 Hrdtry cardmypy gene panel
81440 Mitochondrial gene
81441 Ibmfs seq alys pnl 30 genes

62
81442 Noonan spectrum disorders
81443 Genetic tstg severe inh cond
81445 Tgsap so neo 5-50dna/dna&rna
81448 Hrdtry perph neurphy panel
81449 Tgsap so neo 5-50 rna alys
81450 Tgsap hl neo 5-50dna/dna&rna
81451 Tgsap hl neo 5-50 rna alys
81455 Tgsap so/hl 51/> dna/dna&rna
81456 Tgsap so/hl 51/> rna alys
81460 Whole mitochondrial genome
81465 Whole mitochondrial genome
81470 X-linked intellectual dblt
81471 X-linked intellectual dblt
81479 Unlisted molecular pathology
81493 Cor artery disease mrna
81504 Oncology tissue of origin
81507 Fetal aneuploidy trisom risk
81518 Onc brst mrna 11 genes
81519 Oncology breast mrna
81520 Onc breast mrna 58 genes
81521 Onc breast mrna 70 genes
81522 Onc breast mrna 12 genes
81523 Onc brst mrna 70 cnt 31 gene
81525 Oncology colon mrna
81528 Oncology colorectal scr
81529 Onc cutan mlnma mrna 31 gene
81540 Oncology tum unknown origin
81541 Onc prostate mrna 46 genes
81542 Onc prostate mrna 22 cnt gen
81546 Onc thyr mrna 10,196 gen alg
81551 Onc prostate 3 genes
81552 Onc uveal mlnma mrna 15 gene
81554 Pulm ds ipf mrna 190 gen alg
81595 Cardiology hrt trnspl mrna
0004M Scoliosis dna alys
0006M Onc hep gene risk classifier
0007M Onc gastro 51 gene nomogram
0011M Onc prst8 ca mrna 12 gen alg
0012M Onc mrna 5 gen rsk urthl ca
0013M Onc mrna 5 gen recr urthl ca
0016M Onc bladder mrna 219 gen alg
0017M Onc dlbcl mrna 20 genes alg
0001U Rbc dna hea 35 ag 11 bld grp
0005U Onco prst8 3 gene ur alg
0016U Onc hmtlmf neo rna bcr/abl1
0017U Onc hmtlmf neo jak2 mut dna
0018U Onc thyr 10 microrna seq alg
0019U Onc rna tiss predict alg
0022U Tgsap nsm lung neo dna&rna23
0023U Onc aml dna detcj/nondetcj
0026U Onc thyr dna&mrna 112 genes
0027U Jak2 gene trgt seq alys
0029U Rx metab advrs trgt seq alys
0030U Rx metab warf trgt seq alys

63
0031U Cyp1a2 gene
0032U Comt gene
0033U Htr2a htr2c genes
0034U Tpmt nudt15 genes
0036U Xome tum & nml spec seq alys
0037U Trgt gen seq dna 324 genes
0040U Bcr/abl1 gene major bp quan
0045U Onc brst dux carc is 12 gene
0046U Flt3 gene itd variants quan
0047U Onc prst8 mrna 17 gene alg
0048U Onc sld org neo dna 468 gene
0049U Npm1 gene analysis quan
0050U Trgt gen seq dna 194 genes
0055U Card hrt trnspl 96 dna seq
0060U Twn zyg gen seq alys chrms2
0069U Onc clrct microrna mir-31-3p
0070U Cyp2d6 gen com&slct rar vrnt
0071U Cyp2d6 full gene sequence
0072U Cyp2d6 gen cyp2d6-2d7 hybrid
0073U Cyp2d6 gen cyp2d7-2d6 hybrid
0074U Cyp2d6 nonduplicated gene
0075U Cyp2d6 5' gene dup/mlt
0076U Cyp2d6 3' gene dup/mlt
0078U Pain mgt opi use gnotyp pnl
0079U Cmprtv dna alys mlt snps
0084U Rbc dna gnotyp 10 bld groups
0087U Crd hrt trnspl mrna 1283 gen
0088U Trnsplj kdn algrft rej 1494
0089U Onc mlnma prame & linc00518
0090U Onc cutan mlnma mrna 23 gene
0091U Onc clrct scr whl bld alg
0094U Genome rapid sequence alys
0101U Hered colon ca do 15 genes
0102U Hered brst ca rltd do 17 gen
0103U Hered ova ca pnl 24 genes
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U Hered brst ca rltd do panel
0130U Hered colon ca do mrna pnl
0131U Hered brst ca rltd do pnl 13
0132U Hered ova ca rltd do pnl 17
0133U Hered prst8 ca rltd do 11
0134U Hered pan ca mrna pnl 18 gen
0135U Hered gyn ca mrna pnl 12 gen
0136U Atm mrna seq alys
0137U Palb2 mrna seq alys
0138U Brca1 brca2 mrna seq alys
0153U Onc breast mrna 101 genes
0154U Onc urthl ca rna fgfr3 gene
0155U Onc brst ca dna pik3ca gene
0156U Copy number sequence alys

64
0157U Apc mrna seq alys
0158U Mlh1 mrna seq alys
0159U Msh2 mrna seq alys
0160U Msh6 mrna seq alys
0161U Pms2 mrna seq alys
0162U Hered colon ca trgt mrna pnl
0169U Nudt15&tpmt gene com vrnt
0170U Neuro asd rna next gen seq
0171U Trgt gen seq alys pnl dna 23
0172U Onc sld tum alys brca1 brca2
0173U Psyc gen alys panel 14 genes
0175U Psyc gen alys panel 15 genes
0177U Onc brst ca dna pik3ca 11
0179U Onc nonsm cll lng ca alys 23
0180U Abo gnotyp abo 7 exons
0181U Co gnotyp aqp1 exon 1
0182U Crom gnotyp cd55 exons 1-10
0183U Di gnotyp slc4a1 exon 19
0184U Do gnotyp art4 exon 2
0185U Fut1 gnotyp fut1 exon 4
0186U Fut2 gnotyp fut2 exon 2
0187U Fy gnotyp ackr1 exons 1-2
0188U Ge gnotyp gypc exons 1-4
0189U Gypa gnotyp ntrns 1 5 exon 2
0190U Gypb gnotyp ntrns 1 5 seux 3
0191U In gnotyp cd44 exons 2 3 6
0192U Jk gnotyp slc14a1 exon 9
0193U Jr gnotyp abcg2 exons 2-26
0194U Kel gnotyp kel exon 8
0195U Klf1 targeted sequencing
0196U Lu gnotyp bcam exon 3
0197U Lw gnotyp icam4 exon 1
0198U Rhd&rhce gntyp rhd1-10&rhce5
0199U Sc gnotyp ermap exons 4 12
0200U Xk gnotyp xk exons 1-3
0201U Yt gnotyp ache exon 2
0203U Ai ibd mrna xprsn prfl 17
0204U Onc thyr mrna xprsn alys 593
0205U Oph amd alys 3 gene variants
0209U Cytog const alys interrog
0211U Onc pan-tum dna&rna gnrj seq
0212U Rare ds gen dna alys proband
0213U Rare ds gen dna alys ea comp
0214U Rare ds xom dna alys proband
0215U Rare ds xom dna alys ea comp
0216U Neuro inh ataxia dna 12 com
0217U Neuro inh ataxia dna 51 gene
0218U Neuro musc dys dmd seq alys
0221U Abo gnotyp next gnrj seq abo
0222U Rhd&rhce gntyp next gnrj seq
0228U Onc prst8 ma molec prfl alg
0229U Bcat1&ikzf1 prmtr mthyln aly
0230U Ar full sequence analysis
0231U Cacna1a full gene analysis

65
0232U Cstb full gene analysis
0233U Fxn gene analysis
0234U Mecp2 full gene analysis
0235U Pten full gene analysis
0236U Smn1&smn2 full gene analysis
0237U Car ion chnlpthy gen seq pnl
0238U Onc lnch syn gen dna seq aly
0239U Trgt gen seq alys pnl 311+
0242U Trgt gen seq alys pnl 55-74
0244U Onc solid orgn dna 257 genes
0245U Onc thyr mut alys 10 gen&37
0246U Rbc dna gnotyp 16 bld groups
0250U Onc sld org neo dna 505 gene
0258U Ai psor mrna 50-100 gen alg
0260U Rare ds id opt genome mapg
0262U Onc sld tum rt-pcr 7 gen
0264U Rare ds id opt genome mapg
0265U Rar do whl gn&mtcdrl dna als
0266U Unxpl cnst hrtbl do gn xprsn
0267U Rare do id opt gen mapg&seq
0268U Hem ahus gen seq alys 15 gen
0269U Hem aut dm cgen trmbctpna 14
0270U Hem cgen coagj do 20 genes
0271U Hem cgen neutropenia 23 gen
0272U Hem genetic bld do 51 genes
0273U Hem gen hyprfibrnlysis 8 gen
0274U Hem gen pltlt do 43 genes
0276U Hem inh thrombocytopenia 42
0277U Hem gen pltlt funcj do 31
0278U Hem gen thrombosis 12 genes
0282U Rbc dna gntyp 12 bld grp gen
0285U Onc rsps radj cll fr dna tox
0286U Cep72 nudt15&tpmt gene alys
0287U Onc thyr dna&mrna 112 genes
0288U Onc lung mrna quan pcr 11&3
0289U Neuro alzheimer mrna 24 gen
0290U Pain mgmt mrna gen xprsn 36
0291U Psyc mood do mrna 144 genes
0292U Psyc strs do mrna 72 genes
0293U Psyc suicidal idea mrna 54
0294U Lngvty&mrtlty rsk mrna 18gen
0296U Onc orl&/orop ca 20 mlc feat
0297U Onc pan tum whl gen seq dna
0298U Onc pan tum whl trns seq rna
0299U Onc pan tum whl gen opt mapg
0300U Onc pan tum whl gen seq&opt
0306U Onc mrd nxt-gnrj alys 1st
0307U Onc mrd nxt-gnrj alys sbsq
0313U Onc pncrs dna&mrna seq 74
0314U Onc cutan mlnma mrna 35 gene
0315U Onc cutan sq cll ca mrna 40
0318U Ped whl gen mthyltn alys 50+
0319U Neph rna pretrnspl perph bld
0320U Neph rna psttrnspl perph bld

66
0323U Iadna cns pthgn next gen seq
0326U Trgt gen seq alys pnl 83+
0327U Ftl aneuploidy trsmy dna seq
0329U Onc neo xome&trns seq alys
0330U Iadna vag pthgn panel 27 org
0331U Onc hl neo opt gen mapping
0332U Onc pan tum gen prflg 8 dna
0333U Onc lvr surveilanc hcc cfdna
0334U Onc sld orgn tgsa dna 84/+
0335U Rare ds whl gen seq feta
0336U Rare ds whl gen seq bld/slv
0339U Onc prst8 mrna hoxc6 & dlx1
0340U Onc pan ca alys mrd plasma
0341U Ftl aneup dna seq cmpr alys
0343U Onc prst8 xom aly 442 sncrna
0345U Psyc genom alys pnl 15 gen
0347U Rx metab/pcx dna 16 gen alys
0348U Rx metab/pcx dna 25 gen alys
0349U Rx metab/pcx dna 27gen rx ia
0350U Rx metab/pcx dna 27 gen alys
0355U Apol1 risk variants
0356U Onc orop 17 dna ddpcr alg
0362U Onc pap thyr ca rna 82&10
0363U Onc urthl mrna 5 gen alg
0364U Onc hl neo gen seq alys alg
0368U Onc clrct ca mut&mthyltn mrk
0369U Iadna gi pthgn 31 org&21 arg
0370U Iadna surg wnd pthgn 34&21
0371U Iadna gu pthgn semiq dna16&1
0372U Nfct ds gu pthgn arg detcj
0373U Iadna rsp tr nfct 17 8 13&16
0374U Iadna gu pthgn 21 org&21arg
0378U Rfc1 repeat xpnsj vrnt alys
0379U Tgsap sl or neo dna523&rna55
0380U Rx metb advrs trgt sq aly 20
0386U Gi barrett esoph mthyltn aly
0388U Onc nonsm cll lng ca 37 gen
0389U Ped fbrl kd ifi27&mcemp1 rna
0391U Onc sld tum dna&rna 437 gen
0392U Rx metab gen-rx ia 16 genes
0395U Onc lng multiomics plsm alg
0396U Ob preimpltj tst 300000 dna
0397U Onc nonsm cll lng ca 109
0398U Gi baret esph dna mthyln aly
0400U Ob xpnd car scr 145 genes
0401U Crd c hrt ds 9 gen 12 vrnts
Group 2

(24 Codes)

Group 2 Paragraph

Codes 81599 and 87999 require a Z-Code for DNA/RNA based testing. The remaining molecular microbiology tests, a Z-Code is only required for non-FDA approved/cleared services/tests.

67
Group 2 Codes

Code Description
81513 Nfct ds bv rna vag flu alg
81514 Nfct ds bv&vaginitis dna alg
81599 Unlisted maaa
87154 Cul typ id bld pthgn 6+ trgt
87483 Cns dna amp probe type 12-25
87505 Nfct agent detection gi
87506 Iadna-dna/rna probe tq 6-11
87507 Iadna-dna/rna probe tq 12-25
87631 Resp virus 3-5 targets
87632 Resp virus 6-11 targets
87633 Resp virus 12-25 targets
87636 Sarscov2 & inf a&b amp prb
87637 Sarscov2&inf a&b&rsv amp prb
87800 Detect agnt mult dna direc
87801 Detect agnt mult dna ampli
87999 Unlisted microbiology px
0115U Respir iadna 18 viral&2 bact
0202U Nfct ds 22 trgt sars-cov-2
0223U Nfct ds 22 trgt sars-cov-2
0225U Nfct ds dna&rna 21 sarscov2
0240U Nfct ds vir resp rna 3 trgt
0241U Nfct ds vir resp rna 4 trgt
0352U Nfct ds bv&vaginitis amp prb
0353U Iadna chlmyd&gonorr amp prb
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
XX000 Not Applicable
ICD-10-CM Codes that DO NOT Support Medical Necessity

68
Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

69
N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
07/01/2023 R13 Under CMS National Coverage Policy updated section heading. This revision is effective on 7/1/2023.

Under CPT/HCPCS Codes Group 1: Codes added 0388U, 0389U, 0391U, 0392U, 0395U, 0396U, 0397U, 0398U, 0400U, and 0401U. This revision is due to the 2023 Q3 CPT/HCPCS Code Update
and is effective on 7/1/2023.
04/01/2023 R12 Under CPT/HCPCS Codes Group 1: Codes added 0364U, 0368U, 0369U, 0370U, 0371U, 0372U, 0373U, 0374U, 0378U, 0379U, 0380U, and 0386U. The description was revised for 0022U. This
revision is due to the 2023 Q2 CPT/HCPCS Code Update and is effective on April 1, 2023.
01/01/2023 R11 Under CPT/HCPCs Codes Group I: Added 0334U, 0343U and 0345U effective 10.01.2022 as indicated in Revision 10.

Under Revision 10 Group 2 coding update: Typographical error. 0115U was to Group 2 CPT coding not 0015U.
01/01/2023 R10 Under CPT/HCPCS Codes Group 1: Codes added 0318U. This revision is due to the Q2 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 4/01/2022.

Under CPT/HCPCS Codes Group 1: Codes added 0327U. This revision is due to the Q3 2022 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 07/01, 2022.

Under CPT/HCPCS Codes Group 1: Codes added 0332U, 0333U, 0334U, 0335U, 0336U, 0339U, 0340U, 0341U, 0343U, 0345U, 0347U, 0348U, 0349U, 0350U, deleted 0012U, 0013U,0014U,0056U,
and the description was revised for 0229U, 0262U, 0276U, 0296U, 0319U. Under CPT/HCPCS Codes Group 2: Codes added 0352U, 0353U. This revision is due to the Q4 2022 CPT/HCPCS Code
Update and is effective for dates of service on or after 10/01/2022.

Under CPT/HCPCS Codes Group 2: Paragraph revised the first and second sentence. Under CPT/HCPCS Codes Group 2: Codes added 81513, 81514, 87154, 87483, 87505, 87506, 87507, 87631,
87632, 87633, 87636, 87637, 0015U, 0202U, 0223U, 0225U, 0240U, 0241U. This revision is retroactive effective for dates of service on or after 04/17/2022.
01/01/2023 R9 Under CPT/HCPCS Codes Group 1: Codes added 81418, 81441, 81449, 81451, 81456, 0355U, 0356U, 0362U, and 0363U. The description was revised for 81330, 81445, 81450, 81455, 0017M, and
0069U. Under CPT/HCPCS Codes Group 2: Codes the description was revised for 87999. This revision is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is effective on January 1, 2023.
07/01/2022 R8 Under CPT/HCPCS Codes Group#1: Codes the description was revised for 0016M, 0229U, and 0306U. Under CPT/HCPCS Codes Group 1: Codes added 0323U, 0326U, 0329U, 0330U, 0331U. This
revision is due to the Q3 2022 CPT/HCPCS Code Update and is effective on July 1, 2022
05/17/2022 R7 Under CPT/HCPCS Codes Group1: Codes added 0306U, 0307U, 0313U, 0314U, 0315U, 0319U, 0320U and revised the description for 0022U.

This revision is due to the Q2 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2022.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage, “However, for molecular microbiology tests using codes 87800 and 87801, a Z-code is only required for non-FDA-approved/cleared
services/tests.”

Under CPT/HCPCS Codes Group 2: added codes 87800 and 87801.

This revision is effective on 05/17/2022.

04/17/2022 R6 Under CPT/HCPCS Codes Group1: Codes deleted 81599.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage, “The following CPT codes require a Z-code if the testing is molecular (DNA/RNA) based.”

Under CPT/HCPCS Codes Group 2: added codes 81599 AND 87999.

This revision is effective on 04/17/2022

01/01/2022 R5 Under CPT/HCPCS Codes Group 1: Paragraph added the verbiage “The codes listed below fall within scope of the associated policy but do not automatically imply coverage. This revision is effective
January 1, 2022.

Under CPT/HCPCS Codes Group 1: Codes added 0285U, 0286U, 0287U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0296U, 0297U, 0298U, 0299U, 0300U, 81349, and 81523. Deleted
0208U. The description was revised for 0016M, 0017M, 0090U,0154U, 0155U, 0177U, 0180U, 0193U, 0200U, 0205U, 0216U, 0221U, 0244U, 0258U, 0262U, 0265U, 0266U, 0276U, 81194, 81228,
and 81229. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on January 1, 2022.

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may

70
 not exactly match the MolDX PGBA revision history. However, these revisions do not change coverage or guidance.

10.01.2021: Under CPT/HCPCS Codes Group 1: Codes added 0258U, 0260U, 0262U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U,
0282U and deleted 0168U. This revision is due to the Q4 2021 CPT®/HCPCS Code Update and is effective for dates of service on or after 10/1/2021.

07.01.2021: Under CPT/HCPCS Codes Group 1: Codes added 0016M. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after
1/1/2021. Under CPT/HCPCS Codes Group 1: Codes added 0250U. This revision is due to the Q3 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 7/1/2021.

12/09/2021 - The following CPT/HCPCS codes were deleted: 0208U was deleted from Group 1
04/01/2021 R4 Under CPT/HCPCS Group 1: Codes added 0017M and deleted 0105U. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after
1/1/2021.

Under CPT/HCPCS Group 1: Codes added 0242U, 0244U, 0245U, and 0246U. This revision is due to the Q2 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2021.
01/01/2021 R3 Under CPT/HCPCS Codes Group 1: Codes added 81374, 81377, 81381, 81383, 0069U, 0133U, 0168U, 0169U, 0170U, 0171U, 0172U, 0173U, 0175U, 0177U, 0179U, 0180U, 0181U, 0182U,
0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0198U, 0199U, 0200U 0201U, 0203U, 0204U, 0205U, 0208U, 0209U, 0211U,
0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0218U, 0221U, and 0222U and deleted 81490, 81500, 81503, 81506, 81508, 81509, 81510, 81511, 81512, 81535, 81536, 81538, 81539, 81545, 84999,
85999, 86152, 86153, 86849, 87999, 0003U, 0009U, 0021U, 0024U, 0039U, 0053U, 0054U, 0058U, 0059U, 0062U, 0067U, 0068U, 0080U, 0083U, 0092U, 0107U, and 0108U.

Under CPT/HCPCS Codes Group 1: Codes added 81168, 81191, 81192, 81193, 81194, 81278, 81279, 81338, 81339, 81347, 81348, 81351, 81352, 81353, 81357, 81360, 81419, 81529, 81546, 81554,
0228U, 0229U, 0230U, 0231U, 0232U, 0233U, 0234U, 0235U, 0236U, 0237U, 0238U, 0239U.

Under CPT/HCPCS Codes Group 2: Codes moved 81401, 81403, 81406, 81407, 81412 to CPT/HCPCS Codes Group 1: Codes.

This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021.

This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021.

01/01/2020 R2 Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 87999, 0045U-0050U, 0053U-0060U, 0062U, 0067U, 0068U, 0070U-0076U, 0078U-0080U, 0083U, 0105U, 0107U, 0108U, 0111U,
0113U, 0114U, 0118U, 0120U, 0129U-0132U, and 0134U-0138U. CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U,
0041U-0044U, 0086U, 0093U, 0095U-0100U were deleted. CPT code range 0084U-0103U was revised to add/delete applicable codes above. This addition and deletion is due to coding that is
applicable to the MolDX program.

Under CPT/HCPCS Codes Group 1: Codes CPT® code range 81161-81400 was revised to 81161-81364 including the addition of 81277, 81307, 81308, 81309, 81522, 81542, 81552, and added code
range 0153U-0162U. CPT® codes 0009M and 0085U were deleted. The code descriptions were revised for CPT® codes 81350, 0101U, 0102U, and 0103U. This revision is due to the Annual
CPT®/HCPCS Code Update and becomes effective on 1/1/2020.

Typographical errors were corrected in CMS National Coverage Policy.

11/01/2019 R1 11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual.

Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related MolDX: Molecular Diagnostic Tests (MDT) L36256 LCD and placed in this
article.

Under CPT/HCPCS Codes Group 1: Codes deleted CPT® codes 81401, 81403, 81406, 81407, and 81412.

Under CPT/HCPCS Codes Group 2: Paragraph added verbiage CPT® codes that are also referenced in other articles.

Under CPT/HCPCS Codes Group 2: Codes added CPT® codes 81401, 81403, 81406, 81407, and 81412.

The above revisions will become effective on 11/01/19.

Under CPT/HCPCS Codes Group 1: Codes: CPT code 0104U was deleted.

Under CPT/HCPCS Codes Group 1: Codes: CPT codes 0008U and 81404 descriptions were changed.

71
 Under CPT/HCPCS Codes Group 2: Codes: CPT code 81407 description was changed.

These revisions are due to the Q4 CPT®/HCPCS Code Updates and are retroactive effective for dates of service on or after 11/1/19.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

06/30/2023 07/01/2023 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54482&ver=11

Article Title

Billing and Coding: MolDX: Oncotype DX® Breast Cancer Assay

Article Type

Billing and Coding

72
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

N/A

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

NOTE: The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS Scoreare different tests and should NOT be submitted with the same Z-Code Identifier. Because this article ONLY addresses Oncotype DX Breast, the diagnosis codes
for breast carcinoma in situ have been removed.

Oncotype DX® Breast was developed for patients with the following findings:

• estrogen-receptor positive, node-negative carcinoma of the breast

• estrogen-receptor positive micrometastases of carcinoma of the breast, and
• estrogen-receptor positive breast carcinoma with 1-3 positive nodes.

To bill an Oncotype Breast service, please provide the following claim information:

• Enter “1” in the Days/Unit field

• Select the appropriate ICD-10-CM code
• Enter Z-Code™ Identifier in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P

73
 • Item 19 for paper claim
• Enter Z-Code™ Identifier in the comment/narrative field for the following Part A claim field/types:
•
• Line SV202-7 for 837I electronic claim
• Block 80 for the UBo4 claim form

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81519 ONCOLOGY (BREAST), MRNA, GENE EXPRESSION PROFILING BY REAL-TIME RT-PCR OF 21 GENES, UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS
RECURRENCE SCORE
CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(55 Codes)

Group 1 Paragraph

Select the appropriate ICD-10-CM code:

Group 1 Codes

Code Description
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

74
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
Z17.0 Estrogen receptor positive status [ER+]
ICD-10-CM Codes that DO NOT Support Medical Necessity

N/A

Additional ICD-10 Information

N/A

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

75
indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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.

N/A

Other Coding Information

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
11/01/2019 R3 As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage.
01/01/2016 R2 Added NOTE emphasizing this article applies only to the Oncotype DX Breast Cancer Assay and the following ICD-10 codes are removed to be consistent with the MolDX Contractor: D05.00,
D05.01, D05.02, D05.10, D05.11, D05.12, D05.80, D05.81, D05.82, D05.90, D05.91 and D05.92. This revision was added to the MCD but was never approved.

Added Part A claim filing information.

Part A article number A54481 is retired and combined into this Part B article.

01/01/2016 R1 Added the following diagnoses to be consistent with the MolDX Contractor: D05.00, D05.10, D05.80 and D05.90.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

76
Other URLs

N/A

Public Versions

Updated On Effective Dates Status

10/16/2019 11/01/2019 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54486&ver=8

Article Title

Billing and Coding: MolDX: Oncotype DX® Colon Cancer

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

N/A

Article Guidance

77
Article Text

The Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence risk for patients with Stage II colon cancer, has been assigned a unique identifier.

To bill an Oncotype DX Colon service, please provide the following claim information:

• Enter 1 unit of service (UOS)

• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
♦ Loop 2400 or SV101-7 for the 5010A1 837P
♦ Item 19 for paper claims
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
♦ Line SV202-7 for 837I electronic claim
♦ Block 80 for UB04 claim form
• Select the appropriate ICD-10-CM code

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
81525 ONCOLOGY (COLON), MRNA, GENE EXPRESSION PROFILING BY REAL-TIME RT-PCR OF 12 GENES (7 CONTENT AND 5 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE,
ALGORITHM REPORTED AS A RECURRENCE SCORE
CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(13 Codes)

78
Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.1 Malignant neoplasm of anal canal
ICD-10-CM Codes that DO NOT Support Medical Necessity

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

Other Coding Information

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
11/01/2019 R2 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage. Added Part A claim filing information. Article number A54485 for
Jurisdiction F Part A (JFA) was retired on Enter effective date and combined into Jurisdiction F Part B (JFB) Article number A54486. JFA and JFB contract numbers will have the same final MCD
Article number and remain an Active Article. Coverage will remain the same.
01/01/2016 R1 Article is revised to replace 81479 with 81525 effective 01/01/2016.

79
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

10/16/2019 11/01/2019 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54496&ver=14

Article Title

Billing and Coding: MolDx: ResponseDX Tissue of Origin®

Article Type

Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

80
CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

N/A

Article Guidance

Article Text

Tissue of Origin®, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier. To bill for Tissue of
Origin services, please provide the following claim information:

• CPT® code 81504 - Oncology (tissue of origin)

• Enter “1” in the Days/Unit field
• Select the appropriate ICD-10-CM diagnosis.
• Enter DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form

Note: Noridian expects this test to ONLY be ordered by the treating physician.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)

Group 1 Paragraph

81
N/A

Group 1 Codes

Code Description
81504 Oncology tissue of origin
CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(115 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description
C18.1 Malignant neoplasm of appendix
C18.9 Malignant neoplasm of colon, unspecified
C22.0 Liver cell carcinoma
C22.2 Hepatoblastoma
C22.3 Angiosarcoma of liver
C22.4 Other sarcomas of liver
C22.7 Other specified carcinomas of liver
C22.8 Malignant neoplasm of liver, primary, unspecified as to type
C22.9 Malignant neoplasm of liver, not specified as primary or secondary
C25.2 Malignant neoplasm of tail of pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C33 Malignant neoplasm of trachea
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

82
C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C45.9 Mesothelioma, unspecified
C47.0 Malignant neoplasm of peripheral nerves of head, face and neck
C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified
C48.0 Malignant neoplasm of retroperitoneum
C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck
C49.9 Malignant neoplasm of connective and soft tissue, unspecified
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female 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
C50.811 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
C50.911 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
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C61 Malignant neoplasm of prostate
C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.2 Malignant neoplasm of left kidney, except renal pelvis
C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis
C67.5 Malignant neoplasm of bladder neck
C67.9 Malignant neoplasm of bladder, unspecified
C76.0 Malignant neoplasm of head, face and neck
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
C78.5 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
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
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone

83
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
C79.89 Secondary malignant neoplasm of other specified sites
C79.9 Secondary malignant neoplasm of unspecified site
C80.0 Disseminated malignant neoplasm, unspecified
C80.1 Malignant (primary) neoplasm, unspecified
C82.57 Diffuse follicle center lymphoma, spleen
C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen
C84.97 Mature T/NK-cell lymphomas, unspecified, spleen
C85.17 Unspecified B-cell lymphoma, spleen
C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen
C85.87 Other specified types of non-Hodgkin lymphoma, spleen
C85.97 Non-Hodgkin lymphoma, unspecified, spleen
C86.1 Hepatosplenic T-cell lymphoma
D01.5 Carcinoma in situ of liver, gallbladder and bile ducts
D01.7 Carcinoma in situ of other specified digestive organs
D01.9 Carcinoma in situ of digestive organ, unspecified
D02.20 Carcinoma in situ of unspecified bronchus and lung
D02.21 Carcinoma in situ of right bronchus and lung
D02.22 Carcinoma in situ of left bronchus and lung
D03.51 Melanoma in situ of anal skin
D03.52 Melanoma in situ of breast (skin) (soft tissue)
D03.59 Melanoma in situ of other part of trunk
D49.0 Neoplasm of unspecified behavior of digestive system
D49.1 Neoplasm of unspecified behavior of respiratory system
D49.2 Neoplasm of unspecified behavior of bone, soft tissue, and skin
D49.3 Neoplasm of unspecified behavior of breast
D49.4 Neoplasm of unspecified behavior of bladder
D49.511 Neoplasm of unspecified behavior of right kidney
D49.512 Neoplasm of unspecified behavior of left kidney
D49.6 Neoplasm of unspecified behavior of brain
D49.7 Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system
D49.89 Neoplasm of unspecified behavior of other specified sites
D49.9 Neoplasm of unspecified behavior of unspecified site
J91.0 Malignant pleural effusion
ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

84
Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History Revision History

Date Number Revision History Explanation
10/01/2021 R4 Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3 and C79.63. This revision is due to the Annual ICD-10 update and will become effective on 10/1/21. Under Article
Text: Addition of first bullet regarding CPT® code 81504 - Oncology (tissue of origin).
11/01/2019 R3 As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.
10/01/2016 R2 Article is revised to change "identifier" to "DEX Z-Code identifier" and add Part A claim filing instructions.
10/01/2016 R1 The following revisions were made due to annual ICD-10 updates effective 10/1/16: D49.511 and D49.512 were added and D49.5 was deleted. The Part A article (A54495) is retired and Part A
contract numbers are added to the Part B article. Z-Code Identifier references were replaced with unique identifier.
Associated Documents

85
Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

07/24/2023 10/01/2021 - N/A Currently in Effect You are here

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54554&ver=3

Article Title

Response to Comments: MolDX: Molecular Diagnostic Tests (MDT)

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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

86
dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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.

Article Guidance

Article Text

Noridian’s Response to Provider Recommendations (for comment period ending 03/30/2015):

Response To Comments

Number Comment Response

1 MolDX program and expansion to other MACs creates beneficiary access concerns. Commenter states that the Inconsistent coverage policies from one MAC to another create beneficiary access concerns. Medicare supports
actions taken by some Medicare contractors follow neither the letter nor the spirit of the law which requires that consistent policies for consistent access. All policies have been developed and comply with Medicare requirements.
coverage decisions be transparent and based on medical evidence. This commenter expressed concern that Based on similar concerns raised by this same commenter, CMS has reviewed the molecular diagnostic policies
Medicare assumes that tests performed primarily in pediatric populations would never have other uses in adults developed to date, and found all have complied completely with both the spirits and the letter of the law. The
that would be covered by Medicare, particularly younger disabled beneficiaries. The commenter states that this Medicare benefit applies to the aged (>65 years) and the disabled. For the unusual situations where genetic testing for
adverse impact can be magnified in that Medicaid and private payers emulate Medicare coverage genes predominately used in perinatal, pediatric or adolescent assessment is medically indicated for a disabled or
determinations. aged person, the provider can appeal this decision with submission of medical records supporting the medical
necessity for testing and how the results change medical management in cases that would be exceptions to the core
policy. Medicaid and private payers are responsible for determining their own coverage decisions. Medicare
contractors establish coverage within the reasonable and necessary criteria of the Medicare program and they do not
make coverage or payment determinations for other entities.
2 MolDX circumvents LCD process and does not allow input in coverage process. The commenter states “the The commenter provides no specific LCDs or articles that have not complied with the LCD process. In fact, this
program lacks the transparency that the LCD process creates in determining coverage policy. The MolDX commenter has responded to every MolDX, laboratory and pathology LCD put forth by the CMS MolDX Contractor
program by way of the Technical Assessment (TA) process is making local coverage determinations for each and/or Noridian. The current policy does not address “reasonable and necessary” criteria for a specific test. This
TA request and posting the decision on-line on the Program webpage. This does not follow the LCD process of policy defines the process by which this contractor (Noridian, and previously the CMS MolDX Contractor ) makes a
presenting coverage for a medical procedure as a draft decision to the public, the medical community, and the coverage determination. Specifically, it requires that 1) all molecular testing within the contractor’s jurisdiction will
CAC, and providing a Comment and Notice Period as required. The use of an internal technical assessment require a unique identifier to uniquely identify every molecular tests, and 2) that all new tests coming to market must
process by the MolDX program does not replace the established requirements that define the LCD and the LCD submit documents for a technical assessment (TA). The commenter indicates that the policy refers to the website for
process.” The commenter goes on to state “This is in contrast to the Article format, which is associated with a specific coding and billing information which is correct and expressly forbidden from being in the text of the policy.
LCD and provides additional educational information about the LCD and the coding guidelines. The coding
guidelines could include definitions of codes, lists of items that may be billed under a particular code and
minimum requirements that providers must meet in order to bill using a certain code. It could also include a
product classification list that would inform providers about which specific products meet the requirements of a
specific code.”
3 The action proposed in this policy represents a withdrawal of coverage for Molecular Pathology Testing. The Historically, when a lab developed an assay, it marketed to providers who ordered the test and the labs submitted a
commenter wants molecular testing to be covered unless there is evidence the testing is NOT safe and effective. claim. The MDT policy is a restatement that tests must meet “reasonable and necessary” criteria for coverage. This
The commenter also wants Noridian to retract its position that all molecular testing will not be covered, or cover is not new information to providers but what is new is that the enforcement (submission of data to support reasonable
on a case-by-case basis until the TA is completed. and necessary) is being applied. There is no coverage of new tests until a TA is submitted and reviewed. Testing that
is “safe and effective” can be likened to an assay having analytical and clinical validity. CMS requires that a test
must be “reasonable and necessary” as demonstrated by the test’s clinical utility in that it improves patient outcomes
or changes physician management decisions that improve patient outcomes. Noridian will not retract its position, nor

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 cover new tests on a cases-by-case basis until the TA is completed. Once the TA is completed and the test approved,
Noridian will, upon request, allow coverage from the effective date established by the CMS MolDX Contractor. The
commenter is incorrect with their statement that the CMS MolDX Contractor covers these tests on a case-by-case
basis until the TA is complete.
4 Unique Test Identifier Requirement Difficulty identifying tests performed from the claim form; the commenter Tier 1 codes add a level of specificity, but not enough to discern and apply coverage. Unique identifiers allow the
believes Tier 1 codes are sufficient. Commenters expressed concern regarding the need for the unique identifier. necessary specificity to establish edits to provide the differential reimbursement.
5 Unique Test Identifier Requirement Need to verify AV/CV of test performed; the commenter states that “CLIA CLIA does not require AV or CV review of each new test introduced into a lab’s test menu. A CLIA inspection is a
established quality standards for laboratories to ensure the accuracy, reliability and timeliness of patient test general overview of the lab – not the individual characteristics of a given test. CLIA looks at QC, proficiency testing,
results regardless of where the test is performed. Analytical validity is already addressed by CLIA regulations, SOPs, educational qualifications of employees, criteria of the lab director, space, expired reagents, etc. Furthermore,
which require laboratories to demonstrate analytical validity and regular proficiency testing.” CLIA allows a lab to perform testing for upwards of 2 years prior to a lab inspection. Nothing within a CLIA
certification would provide evidence of clinical utility that establishes the ‘reasonable and necessary’ expectation of
any specific test performed by that lab.
6 Unique Test Identifier Requirement Ensure claims are not being paid on asymptomatic persons – commenter A unique identifier does help address the problem by providing additional information that can be applied via claim
agrees that this is an importance issue but disagrees that a unique identifier helps address the problem. system editing rules.
7 Need to address Clinical Utility of a test; this should not be done by an outside organization; CU should go The LCD process is being used as prescribed and specifically it is used to summarize the review of all evidence that
through the LCD process; accused the CMS MolDX Contractor of not adhering to the process. was conducted in formulating the policy as it pertains to the reasonable and necessary standard of which part of that
is the test’s ‘clinical utility’ as presented by the developer lab. This review is posted for public and specific CAC
membership comment as required. As we are doing here, any comments are addressed as part of that process. If the
commenter(s) provides significant and actionable additional information that should have been considered in the
formation of the policy, a policy revision would be noted.
8 Performing 3 or more test creates “new test” to be reviewed for medical necessity. There is no language in the MDT draft LCD policy that 3 tests performed in a series (reflex testing – next test
depends on the result of the previous test) is considered a new test that requires AV/CV/CU.
9 Will the test results provide the clinician with information that will improve patient outcomes and/ or change These tests may in fact have been covered, either by policy or lack thereof, prior to the development of the MolDX
physician care and treatment of the patient?” and “Will risk assessment change management of the patient?” It program. Contractors routinely review claims and other data (i.e. technology changes, clinical publications,
is unclear in the draft policy whether a test must meet all or only some of the listed bullet points to qualify for professional association guideline updates) to determine impacts to existing policies and coverage. They can and will
coverage or whether these are simply listed considerations in arriving at coverage decisions. Regardless, we review the existing coverage criteria to determine if changes to that coverage are needed based on new evidence. This
have significant concerns about the proposed coverage of some of these tests. We are not aware that the can include new or revised LCD development that would follow the LCD process should the change result in a
following tests listed have met the above stated standards in prospectively randomized appropriate clinical trials limitation/restriction of any existing coverage. Commenters wishing to address the coverage of these tests can do so
published in peer reviewed medical journals which would allow physicians to reasonably answer affirmatively by following the LCD reconsideration process, available on all Medicare contractor websites.
the above two questions. We suggest therefore that for the listed tests below, they prima facie do not meet the
statutory requirement for coverage as “reasonable and necessary”. If these tests have indeed in your judgement
met this standard, we would ask for the publication references justifying such appropriate clinical use of the
following listed tests which are proposed to be covered: a) Afirma b) Allomap c) Avise PG d) ConfirmMdx
Epigenetic e) Progensa PCA3 f) Tissue of Origin g) Vectra DA h) Vysis.
Associated Documents

Related Local Coverage Documents

LCDs

L36256 - MolDX: Molecular Diagnostic Tests (MDT)

Related National Coverage Documents

N/A

Public Versions

Updated On Effective Dates Status

07/21/2015 10/01/2015 - N/A Currently in Effect You are here

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