05/04/2023
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R33
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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.
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- Provider Education/Guidance
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08/18/2022
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R32
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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.
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09/23/2021
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R31
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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.
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12/19/2019
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R30
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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.
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12/19/2019
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R29
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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.
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- Provider Education/Guidance
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11/28/2019
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R28
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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.
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10/31/2019
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R27
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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.
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- Provider Education/Guidance
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09/19/2019
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R26
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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.
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- Revisions Due To Code Removal
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09/19/2019
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R25
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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.
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- Revisions Due To Code Removal
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09/05/2019
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R24
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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.
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10/01/2018
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R23
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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.
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- Other (removing attachment)
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10/01/2018
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R22
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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.
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- Revisions Due To CPT/HCPCS Code Changes
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06/21/2018
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R21
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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.
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06/21/2018
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R20
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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
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- Revisions Due To CPT/HCPCS Code Changes
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04/05/2018
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R19
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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
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- Revisions Due To CPT/HCPCS Code Changes
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01/01/2018
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R18
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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
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- Revisions Due To CPT/HCPCS Code Changes
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12/13/2017
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R17
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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
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- Other (Retired attached article)
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10/02/2017
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R16
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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.
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- Revisions Due To CPT/HCPCS Code Changes
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01/01/2017
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R15
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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.
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01/01/2017
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R14
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Revision#: R14 Revision Effective: 01/01/2017 Revision Explanation: The Corus CAD article was retired.
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01/01/2017
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R13
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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
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- Revisions Due To CPT/HCPCS Code Changes
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12/08/2016
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R12
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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.
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- Provider Education/Guidance
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12/01/2016
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R11
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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.
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- Other (Removed MolDX from title of article)
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04/21/2016
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R10
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Revision#: R10 Revision Effective: N/A Revision Explanation: Annual review no changes made.
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04/21/2016
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R9
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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.
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04/21/2016
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R8
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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.
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- Other (MolDX annual update)
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01/07/2016
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R7
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Revision#: R7 Revision Effective: 01/01/2016 Revision Explanation: Uploaded new non-covered list
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- Other (non-Covered Test List)
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01/07/2016
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R6
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Revision#: R6 Revision Effective: 01/01/2016 Revision Explanation: Updated Approved Gene Test article with new tests and 2016 CPT code changes
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- Revisions Due To CPT/HCPCS Code Changes
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01/07/2016
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R5
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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.
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- Provider Education/Guidance
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10/01/2015
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R4
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Revision#: R4 Revision Effective: 10/01/2015 Revision Explanation: Added Prosigna to second table in the Approved Gene testing article.
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- Provider Education/Guidance
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10/01/2015
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R3
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Revision#: R3 Revision Effective: N/A Revision Explanation: Annual review no changes made.
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10/01/2015
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R2
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R2 Revision Effective: 10/01/2015 Revision Explanation: Changed MoPath to MolDx on all attached articles.
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- Other (Article name changed from MoPath to MolDX)
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10/01/2015
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R1
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R1 Revision Effective: 10/01/2015 Revision Explanation: Added new article for FDA Vysis test and updated the Allomap article.
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- Provider Education/Guidance
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