Local Coverage Determination (LCD)

MolDX: Molecular Diagnostic Tests (MDT)

L36807

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36807
Original ICD-9 LCD ID
Not Applicable
LCD Title
MolDX: Molecular Diagnostic Tests (MDT)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36807
Original Effective Date
For services performed on or after 02/16/2017
Revision Effective Date
For services performed on or after 04/27/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
01/01/2017
Notice Period End Date
02/15/2017

CPT codes, descriptions, and other data only are copyright 2023 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 © 2023 American Dental Association. All rights reserved.

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

Review completed 03/15/2023. Formatting, punctuation, and typographical errors were corrected throughout the LCD.

Issue - Explanation of Change Between Proposed LCD and Final LCD

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

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 meets
    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. An 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
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 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.

WPS GHA and the MolDX® Contractor expects laboratory providers to follow test indications published by the developer.

Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

NA

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
04/27/2023 R15

Posted 04/27/2023: 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. Added CPT reference under Sources of Information.

  • Provider Education/Guidance
12/30/2021 R14

12/30/2021-Review completed 10/08/2021. Typo corrected.

  • Other (Review)
01/01/2020 R13

12/26/2019 Removed 0057U effective 6/30/2019 Per CR 11318. Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Guidelines have been removed from this LCD and placed in Billing and Coding MolDX: Molecular Diagnostic Tests (MDT) article linked to this LCD. Review completed 11/21/2019. 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”.

  • Other (Change Request 10901)
01/01/2019 R12

08/01/2019- Removed 0051U, 0052U, 0054U, 0061U, 0064U, 0065U, 0066U, 0068U, 0082U and 0083U from the list of CPT/HCPCS Codes. These codes do not require a DEX Z-Code™ identifier.

 

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R11

04/25/2019-added 0080U-0083U effective 01/01/2019.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R10

03/28/2019- Either the short and/or long code description was changed for the following codes. Please Note: Depending on which descriptor was used, there may not be any changes to the code display in this document:0008U descriptor was changed in Group 1, 0011M descriptor was changed in Group 1, 0068U descriptor was changed in Group 1 This change is due to the CPT/HCPCS 2019 Q1 update and is effective 01/01/2019.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R9

01/01/2019 Code update-Added 81162-81167, 81171-81174, 81177-81190, 81204, 81233, 81234, 81236, 81237, 81239, 81271, 81274, 81284-81286, 81289,81305, 81306, 81312,81320, 81329, 81333,81336, 81337, 81343-81345, 81443, 81518, 062U-0079U. Removed deleted codes 81211, 81213, 81214, 0001M. Long Description change 81120, 81121, 81162, 81170, 81175, 81176, 81201-81203, 81205, 81209, 81212, 81215-81219, 81225-81227, 81235, 81240, 81242, 81244, 81250-81254, 81260, 81263, 81272, 81273, 81276, 81283, 81287, 81291-81297, 81314, 81321-81328, 81330, 81332, 81350, 81361-81364, 81370, 81371, 81374, 81378, 81433, 81434, 81437, 81438, 81506, 81508-81512. Removed G0452-effective 09/28/2017.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2018 R8

11/01/2018- Due to the 04Q18 Code Update & AMA CPT Proprietary Laboratory Analyses (PLA) Codes Long Descriptors document, removed deleted codes 0020U & 0028U effective 10/01/2018.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2018 R7

10/01/2018- Added 00045U-00061U & description change for 0006U (CR 10875) effective 07/01/2018.

  • Revisions Due To CPT/HCPCS Code Changes
08/01/2018 R6

08/01/2018- Removed 87999, 88199, 88299, 88398 & 89399 from the CPT code table. Moved 0024U-0034U from the Group 1 paragraph into the Group 1 Code table.  Annual Review completed 07/02/2018.  Added 0012M, 0013M, 0035U-0044U. Replaced McKesson with DEXTM and updated the website: https://app.dexzcodes.com/login

  • Revisions Due To CPT/HCPCS Code Changes
  • Other (Annual review )
05/15/2018 R5

04/01/2018-Removed 88271-88275 & the following deleted codes 0008M. 0004U & 0015U-effective 01/01/2018. Removed CPT codes 87149, 87150, 87505-87507, 87631-87633 effective 03/01/2018. Added 81105-81112, 81120, 81121, & 0011M effective 05/15/2018. The 01/01/2018 revision hx did not include the addition of 88120 & 88121 effective 02/15/2018. This change was posted on our website.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2018 R4

02/01/2018 Added 88271-88275 & 0018U-0034U.

 

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2018 R3

01/01/2018-Code update added 81175, 81176, 81230-81232, 81238,81247-81249, 81258, 81259, 81269, 81105-81112, 81120, 81121, 81283,81328, 81334, 81335, 81346, 81361-81364, 81448, 81520, 81521 & description change 81257, 81400, 81401, 81403-81406, 81432, 81439. Added 0001M, 87631-87633, 87149-87150 effective 02/15/2018.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R2

 

10/01/2017: Added new codes 0004U & 0005U to the CPT table effective 05/01/2017 (Change Request (CR) 10104 & 10122) & added 0006U -0017U to CPT table; effective 08/01/2017 (CR 10222 & 10236).  Moved 0001U-0003U from paragraph to CPT code table. Annual Review completed 09/08/2017. 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
  • Other (Annual Review)
05/16/2017 R1 04/01/2017-Added CPT codes 86152, 86153, 87505-87507 & 0001U-0003U with 45 day notice-effective 05/16/2017 and removed CPT codes 88380 and 88381-effective 04/01/2017.
  • Revisions Due To CPT/HCPCS Code Changes
N/A

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Attachments
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