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Local Coverage Determination (LCD)

MolDX: Molecular Diagnostic Tests (MDT)

L35025

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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
L35025
Original ICD-9 LCD ID
Not Applicable
LCD Title
MolDX: Molecular Diagnostic Tests (MDT)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 05/04/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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

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

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 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

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.

MolDX® expects laboratory providers to follow test indications published by the developer.
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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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

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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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

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
05/04/2023 R29

Annual review completed. No changes.
  • Other (Annual review complete. No changes)
05/04/2023 R28

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.
  • Provider Education/Guidance
12/12/2019 R27

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. 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”.

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
10/24/2019 R26

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) A56853 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.

  • Provider Education/Guidance
08/15/2019 R25

All coding located in the Coding Information section has been moved into the related Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853 article and removed from the LCD.

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
01/01/2019 R24

Either the short and/or long code description was changed for the following codes: 0008U descriptor was changed in Group 1, 0011M descriptor was changed in Group 1. This change is due to the CPT/HCPCS 2019 Q1 update and is effective 1/1/2019.
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R23

CPT descriptions updated
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R22

2019 CPT/HCPCS Annual Updates.

Under CPT/HCPCS Codes Group1: The following CPT/HCPCS codes were added to these code ranges: 81163, 81164, 81165, 81166, 81167, 81171, 81172, 81173, 81174,81177, 81178, 81179, 81180, 81181, 81182, 81183, 81184, 81185, 81186, 81187, 81188, 81189, 81190, 81204, 81233, 81234, 81236, 81237, 81239, 81271, 81274, 81284, 81285, 81286, 81289, 81305, 81306, 81312, 81320, 81329, 81333, 81336, 81337, 81343, 81344, 81345, 81443, 81518, 81596

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: 0006U, 0012M, 0031U, 0032U, 81109, 81162, 81212, 81215, 81216, 81217, 81244, 81287, 81327, 81334.

The following CPT/HCPCS codes were deleted from Group1: 0001M, 81211, 81213, 81214

We removed bill type 032X, which was selected in error.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2018 R21

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.

 
  • Revisions Due To CPT/HCPCS Code Changes
07/26/2018 R20

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: 0006U descriptor was changed in Group 1. This change was due to the 03Q18 Quarterly CPT/HCPCS Code Update.
  • Revisions Due To CPT/HCPCS Code Changes
06/21/2018 R19

Made revisions to the CPT/HCPCS Codes section. Removed: 88399, 89398, 87999, 88199, 88299 from the LCD. Added: 0001U, 0002U, 0003U, 0005U, 0006U, 0007U, 0008U, 0009U, 0010U, 0011U, 0012U, 0013U, 0014U, 0016U, 0017U, 0018U, 0019U, 0020U, 0021U, 0022U, 0023U, 0024U, 0025U, 0026U, 0027U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0035U, 0036U, 0037U, 0038U, 0039U, 0040U, 0041U, 0042U, 0043U, 0044U, 0011M, 0012M, 0013M, 81105-81112, 81120-81121, 86152-86153, 88120-88121
  • Revisions Due To CPT/HCPCS Code Changes
04/05/2018 R18

The following CPT/HCPCS codes were deleted: 0008M was deleted from Group 1. This deletion was effective 1/25/2018 as part of the 2018 Q1 Update. The DEX web address was updated to: https://app.dexzcodes.com/login. Removed G0452, 88380, 88381 from CPT/HCPCS Group 1 because they do not require Z-Codes. The removal of CPT/HCPCS codes G0452, 88380, 88381 is effective 1/1/2018. 
  • Revisions Due To CPT/HCPCS Code Changes
02/26/2018 R17 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R16 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/01/2018 R15

2018 Annual CPT/HCPCS Updates: Description was changed for the following CPT/HCPCS codes, effective 1/1/2018:

81257 descriptor was changed in Group 1
81405 descriptor was changed in Group 1
81432 descriptor was changed in Group 1
81439 descriptor was changed in Group 1
81519 descriptor was changed in Group 1
  • Revisions Due To CPT/HCPCS Code Changes
10/02/2017 R14

2017 4th quarter CPT/HCPCS Updates: Description was changed for the following CPT/HCPCS codes: 81405 descriptor was changed in Group 1, effective 10/2/2017.

Added Part A contractor numbers.

Replaced McKesson Diagnostics ExchangeTM with DEXTM Diagnostics Exchange and corrected a typo the web address.
  • Revisions Due To CPT/HCPCS Code Changes
04/20/2017 R13

Annual review, no changes.

DATE (08/21/2017): 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 (Annual review, no changes.)
01/01/2017 R12 2017 CPT 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 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
06/20/2016 R11 Typographical error. Under Coverage Guidance Coverage Indications, Limitations and/or Medical Necessity section moved "Technology Assessments (TA) down and removed the following last sentence "Prior to completion of this TA and published coverage determination."
  • Typographical Error
04/21/2016 R10 Annual validation completed. Replaced Palmetto GBA reference with MolDX, Under "Unique Test Identifier Requirement" - removed instruction to register services via Z-Code Identifier Application and Palmetto GBA Test Identifier (PTI) Application. Under "Payment Rules" - removed suspension of claims that omit Z-Code IDs. Under "Covered Tests" - updated the point of contact for McKesson and MolDX.
  • Other (Annual validation completed. Replaced Palmetto GBA reference with MolDX, Under "Unique Test Identifier Requirement" - removed instruction to register services via Z-Code Identifier Application and Palmetto GBA Test Identifier (PTI) Application. Under "Payment Rules" - removed suspension of claims that omit Z-Code IDs. Under "Covered Tests" - updated the point of contact for McKesson and MolDX.)
01/01/2016 R9 2016 CPT code update
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R8 addition of MolDX to LCD title
  • Other (per request of MAC's using MolDX service)
10/01/2015 R7 Completed Annual Validation - 4/15/15
  • Other (Annual Validation)
10/01/2015 R6 To expand and include the MAAA codes.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R5 Added new CPT codes:

81500-81599
0001M
0002M
0003M
0004M
  • New/Updated Technology
10/01/2015 R4 Added the following codes due to CR 8975:

81410
81471
81246
81288
61313
0006M
0007M
0008M
81519

For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
81245 descriptor was changed in Group 1
81402 descriptor was changed in Group 1
81405 descriptor was changed in Group 1
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R3 Added 81161 to HCPCS code list. Removed it from the paragraph section since is has been released in the annual CPT update.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R2 Updated policy to remove covered tests table and direct readers to the MolDX program Web site for covered and excluded tests' billing and coding guidelines.

For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
81405 descriptor was changed in Group 1
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R1 On the Covered Tests table, AlloMap (ZB863) CPT code was changed to 81479.
ZB798 test developer name was changed to Response Genetics and title changed to ResponseDX: Tissue of Origin. ThxID™ BRAF V600E/K Test by bioMerieux, Inc. (ZBO64) was added as a covered test.
  • Revisions Due To CPT/HCPCS Code Changes
N/A

Associated Documents

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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
08/26/2024 05/04/2023 - N/A Currently in Effect You are here
04/26/2023 05/04/2023 - N/A Superseded View
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