Local Coverage Determination (LCD)

MolDX: Molecular Diagnostic Tests (MDT)

L36021

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	MAC - Part A	15101 - MAC A	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part B	15102 - MAC B	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part A	15201 - MAC A	J - 15	Ohio
CGS Administrators, LLC	MAC - Part B	15202 - MAC B	J - 15	Ohio

LCD Information

Document Information

LCD ID
L36021

LCD Title
MolDX: Molecular Diagnostic Tests (MDT)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL36021

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

Revision Effective Date
For services performed on or after 08/22/2024

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
08/05/2015

Notice Period End Date
09/21/2015

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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

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

Issue

Issue Description

Annual review, no changes needed at this time.

CMS National Coverage Policy

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

Pub 100-08 PIM, Ch. 13, Sec 13.1.3, Program Integrity Manual, “LCDs consist of only “reasonable and necessary” information.

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

Coverage Indications, Limitations, and/or Medical Necessity

As of September 16, 2013 CGS Administrators accepts all coverage determinations made by Palmetto GBA through the MolDX Program, which are discussed in the details of this policy.

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
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)

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.

LDT: Any test developed by a laboratory developed without FDA approval or clearance.

Applicable Tests/Assays

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 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 an NOC code

Unique Test Identifier Requirement

Because the available language in the manuals 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 apply for 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 MolDX^® website www.palmettogba.com/MolDX for covered and excluded tests' specific coding and billing information.

For additional MolDX^® Program information, go to the Medicare home page www.PalmettoGBA.com/MolDX.

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

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

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

Additional ICD-10 Information

General Information

Associated Information
N/A

Sources of Information

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

Bibliography

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
08/22/2024	R34	R34 Revision Effective: 08/22/2024 Revision Explanation: Annual review, no changes.	Other (Annual Review)
05/04/2023	R33	R33 Revision Effective: 05/04/2023 Revision Explanation: 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. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD. 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.	Provider Education/Guidance
08/18/2022	R32	R32 Revision Effective: 08/18/2022 Revision Explanation: Annual review, no changes were made. 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.	Other (Annual Review)
09/23/2021	R31	R31 Revision Effective:10/23/2021 Revision Explanation: Annual review no changes were made. 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.	Other (Annual review)
12/19/2019	R30	R30 Revision Effective: n/a Revision Explanation: Annual review no changes were made. 11/30/2020: 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.	Other (Annual Review)
12/19/2019	R29	R29 Revision Effective:12/19/2019 Revision Explanation: There has been no change in coverage with this LCD revision. Under *CMS National Coverage Policy* added regulation 45 CFR §162.1002 (a)(5). 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 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”. 12/11/2019-At this time 21^stCentury 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.	Provider Education/Guidance
11/28/2019	R28	R28 Revision Effective: 11/28/2019 Revision Explanation: Annual review no changes made. 11/21/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other (Annual review)
10/31/2019	R27	R27 Revision Effective:10/31/2019 Revision Effective:This LCD 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. There has been no change in coverage with this LCD revision. 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) article. At this time 21^stCentury 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.	Provider Education/Guidance
09/19/2019	R26	R26 Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes. 09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To Code Removal
09/19/2019	R25	R25 Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. 09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To Code Removal
09/05/2019	R24	Revision#: R24 Revision Effective: 09/05/2019 Revision Explanation: Removed all coding from the policy and placed into a related billing and coding article based on CR 10901. Added MolDX to the title. 08/28/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other (Code Migration)
10/01/2018	R23	Revision#: R23 Revision Effective: N/A Revision Explanation: Removing the attachment for non covered tests as this is outdated and handled through the test registration process. 11/26/2018: 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.	Other (removing attachment)
10/01/2018	R22	Revision#: R22 Revision Effective: 10/01/2018 Revision Explanation: 2018 4th quarter CPT/HCPCS Updates: Either the short and/or long code description was changed for the following code(s): 0001M descriptor was changed in Group 1. The following CPT/HCPCS codes were deleted: 0020U was deleted from Group 1, 0028U was deleted from Group 1. These revisions are effective 10/01/2018. 11/26/2018: 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.	Revisions Due To CPT/HCPCS Code Changes
06/21/2018	R21	Revision#: R21 Revision Effective: N/A Revision Explanation: Annual review no changes made. 10/30/2018: 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.	Other (Annual Review)
06/21/2018	R20	Revision#: 20 Revision Effective: 06/21/2018 Revision Explanation: Deleted 88399, 89398, 87999, 88199, and 88299 as these code are no linger under scope of MolDX. Added codes 0001U-0014U, 0016U-0044U, 0011M-0013M, 81105-81112, 81120-81121, 86152-86153, and 88120-88121 as these were left off in error. 06/21/2018-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	Revisions Due To CPT/HCPCS Code Changes
04/05/2018	R19	Revision#: R19 Revision Effective: 04/05/2018 Revision Explanation: Deleted 88380, 88381, and G0452 from group 1 under CPT code section as they no longer require a Z-Code identifier this is effective 01/01/2018. update dex web address and added CGS-MolDX topic page information to be reviewed for additional information. 04/04/2018-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	Revisions Due To CPT/HCPCS Code Changes
01/01/2018	R18	Revision#: R18 Revision Effective: 01/01/2018 Revision Explanation: Mammaprint article updated code to 81521 from 81479 due to HCPCS annual update. 12/13/2017-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	Revisions Due To CPT/HCPCS Code Changes
12/13/2017	R17	Revision#: R17 Revision Effective: 12/13/2017 Revision Explanation: Retired A53799 Approved Gene Testing article. a new article will be done to replace this one. 12/13/2017-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	Other (Retired attached article)
10/02/2017	R16	Revision#: R16 Revision Effective: 10/01/2017 Revision Explanation: Updated McKesson references to show DEX Diagnostics and updated website. Descriptor change for 81405 in group1. 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.	Revisions Due To CPT/HCPCS Code Changes
01/01/2017	R15	Revision#: R15 Revision Effective: N/A Revision Explanation: Annual review no changes made. 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.	Other (Annual review)
01/01/2017	R14	Revision#: R14 Revision Effective: 01/01/2017 Revision Explanation: The Corus CAD article was retired.	Other (Retired article)
01/01/2017	R13	Revision#: R13 Revision Effective: 01/01/2017 Revision Explanation: 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 was deleted from Group 1 81280 was deleted from Group 1 81281 was deleted from Group 1 81282 was deleted from Group 1	Revisions Due To CPT/HCPCS Code Changes
12/08/2016	R12	Revision#: R12 Revision Effective: 12/08/2016 Revision Explanation: Updated A54187 Avise PG Assay article added a group 2 list specific to indicate methotrexate use, removed the group 1 list from text, added Z79.899 an dZ92.25. Removed unspecified codes M05.40, M05.419,M05.429, M05.439, M05.449,M05.459, M05.469, M05.479,M05.50, M05.519, M05.529,M05.539, M05.549, M05.559,M05.569, M05.579, M05.59 from group one list of ICD-10 codes.	Provider Education/Guidance
12/01/2016	R11	Revision#: R11 Revision Effective: 12/01/2016 Revision Explanation: Removed MolDX from title of FDA approved ALK Companion Diagnostic Tests Coding and Billing Article A54598.	Other (Removed MolDX from title of article)
04/21/2016	R10	Revision#: R10 Revision Effective: N/A Revision Explanation: Annual review no changes made.	Other (Annual Review)
04/21/2016	R9	Revision#: R9 Revision Effective: 04/21/2016 Revision Explanation: Added 0009M and 0010M as they were left off in error. Also removed the last sentence under the Technical Assessment heading.	Typographical Error
04/21/2016	R8	Revision#: R8 Revision Effective: 04/21/2016 Revision Explanation: Replaced CGS and MolDX reference and updated pointed of contact for McKesson. The suspension of claims without Z-Code identifier has been removed along with instructions to register via Z-code identifier application and MolDX contractor test identifier application.	Other (MolDX annual update)
01/07/2016	R7	Revision#: R7 Revision Effective: 01/01/2016 Revision Explanation: Uploaded new non-covered list	Other (non-Covered Test List)
01/07/2016	R6	Revision#: R6 Revision Effective: 01/01/2016 Revision Explanation: Updated Approved Gene Test article with new tests and 2016 CPT code changes	Revisions Due To CPT/HCPCS Code Changes
01/07/2016	R5	Revision#: R5 Revision Effective: 01/07/2016 Revision Explanation: Articles A54259 - MolDX: Chimerism Testing Billing and Coding Guidelines and A54287 - MolDX: Short Tandem Repeat (STR) Markers Coding and Billing Guidelines retired and replaced with new article for STR and Chimerism combined.	Provider Education/Guidance
10/01/2015	R4	Revision#: R4 Revision Effective: 10/01/2015 Revision Explanation: Added Prosigna to second table in the Approved Gene testing article.	Provider Education/Guidance
10/01/2015	R3	Revision#: R3 Revision Effective: N/A Revision Explanation: Annual review no changes made.	Other (Annual review)
10/01/2015	R2	R2 Revision Effective: 10/01/2015 Revision Explanation: Changed MoPath to MolDx on all attached articles.	Other (Article name changed from MoPath to MolDX)
10/01/2015	R1	R1 Revision Effective: 10/01/2015 Revision Explanation: Added new article for FDA Vysis test and updated the Allomap article.	Provider Education/Guidance

Associated Documents

Attachments
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Updated On	Effective Dates	Status
08/14/2024	08/22/2024 - N/A	Currently in Effect	You are here
05/01/2023	05/04/2023 - 08/21/2024	Superseded	View
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MolDX: Molecular Diagnostic Tests (MDT)

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