Local Coverage Determination (LCD)

MolDX: Molecular Diagnostic Tests (MDT)

L36021

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Contractor Information

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 05/04/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/05/2015
Notice Period End Date
09/21/2015
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

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

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 DateRevision History NumberRevision History ExplanationReasons for Change
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 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
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 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
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
N/A
Related Local Coverage Documents
Articles
A54186 - (MCD Archive Site)
A54187 - (MCD Archive Site)
A54193 - (MCD Archive Site)
A54201 - (MCD Archive Site)
A54292 - (MCD Archive Site)
A54296 - (MCD Archive Site)
A56307 - (MCD Archive Site)
A55716 - Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)
A54243 - Billing and Coding: MolDX: CHD7 Gene Analysis Guidelines
A54241 - Billing and Coding: MolDX: 4q25-AF Risk Genotype Guidelines
A54242 - Billing and Coding: MolDX: 9p21 Genotype Test
A54185 - Billing and Coding: MolDX: Afirma™ Assay by Veracyte Update
A54244 - Billing and Coding: MolDX: ApoE Genotype
A54253 - Billing and Coding: MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing
A54254 - Billing and Coding: MolDX: ATP7B Gene Tests
A54255 - Billing and Coding: MolDX: BCKDHB Gene Test
A54188 - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID®
A54256 - Billing and Coding: MolDX: BLM Gene Analysis
A54257 - Billing and Coding: MolDX: BluePrint® Test
A54189 - Billing and Coding: MolDX: cobas® EGFR Mutation Test Guidelines
A54262 - Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests
A54263 - Billing and Coding: MolDX: FANCC Genetic Testing
A54191 - Billing and Coding: MolDX: FDA-Approved BRAF Tests
A54192 - Billing and Coding: MolDX: FDA-Approved EGFR Tests
A54688 - Billing and Coding: MolDX: FDA-Approved KRAS Tests
A54264 - Billing and Coding: MolDX: Fragile X
A54265 - Billing and Coding: MolDX: GBA Genetic Testing
A54266 - Billing and Coding: MolDX: HAX1 Gene Sequencing
A54267 - Billing and Coding: MolDX: HBB Gene Tests
A54268 - Billing and Coding: MolDX: HEXA Gene Analysis
A54269 - Billing and Coding: MolDX: HTTLPR Gene Testing
A54270 - Billing and Coding: MolDX: IKBKAP Genetic Testing
A54271 - Billing and Coding: MolDX: Immunohistochemistry (IHC) Indications for Breast Pathology
A54272 - Billing and Coding: MolDX: KIF6 Genotype
A54273 - Billing and Coding: MolDX: know error®
A54274 - Billing and Coding: MolDX: L1CAM Gene Sequencing Guidelines
A54275 - Billing and Coding: MolDX: LPA-Aspirin Genotype
A54276 - Billing and Coding: MolDX: LPA-Intron 25 Genotype
A54194 - Billing and Coding: MolDX: MammaPrint
A54277 - Billing and Coding: MolDX: MCOLN1 Genetic Testing Guidelines
A54278 - Billing and Coding: MolDX: MECP2 Genetic Testing
A56106 - Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors
A54288 - Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests Guidelines
A54209 - Billing and Coding: MolDX: MMACHC Test
A56973 - Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)
A54290 - Billing and Coding: MolDX: myPap™
A54291 - Billing and Coding: MolDX: NSD1 Gene Tests
A54195 - Billing and Coding: MolDX: Oncotype DX® Breast Cancer Assay
A54196 - Billing and Coding: MolDX: Oncotype DX® Colon Cancer Assay Update
A54293 - Billing and Coding: MolDX: PAX6 Gene Sequencing Guidelines
A54295 - Billing and Coding: MolDX: PIK3CA Gene Tests
A54197 - Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update
A54297 - Billing and Coding: MolDX: PTCH1 Gene Testing
A54198 - Billing and Coding: MolDX: ResponseDX Tissue of Origin®
A54299 - Billing and Coding: MolDX: RPS19 Gene Tests
A54300 - Billing and Coding: MolDx: SEPT9 Gene Test
A54285 - Billing and Coding: MolDX: SMPD1 Genetic Testing
A54284 - Billing and Coding: MolDX: STAT3 Gene Testing
A54283 - Billing and Coding: MolDX: SULT4A1 Genetic Testing
A54901 - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer
A54282 - Billing and Coding: MolDX: TERC Gene Tests
A54199 - Billing and Coding: MolDX: Therascreen® EGFR RGQ PCR Kit Guidelines
A54200 - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines
A55851 - Billing and Coding: MolDX: ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer
A54281 - Billing and Coding: MolDX: TP53 Gene Test
A54279 - Billing and Coding: MolDx: VEGFR2 Tests
A54830 - Billing and Coding: Short Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268)
A54584 - Response to Comments: Molecular Diagnostic Tests(MDTs) L36021
LCDs
DL36021 - (MCD Archive Site)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
05/01/2023 05/04/2023 - N/A Currently in Effect You are here
08/09/2022 08/18/2022 - 05/03/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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