LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)

A57526

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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General Information

Source Article ID
N/A
Article ID
A57526
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)
Article Type
Billing and Coding
Original Effective Date
11/01/2019
Revision Effective Date
10/01/2024
Revision Ending Date
N/A
Retirement Date
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CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA) §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1 Clinical Laboratory Services

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2. Travel Allowance

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Diagnostic Tests (MDT) L35160.

To report a Molecular Diagnostic Test service, please submit the following claim information:

  • Select appropriate CPT® code
  • Enter 1 unit of service (UOS)
  • Enter the appropriate DEX Z-Code® identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the appropriate DEX Z-Code® identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form

NOTE: When entering the DEX Z- Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.

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Coding Information

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ICD-10-CM Codes that Support Medical Necessity

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(1 Code)
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Group 1 Codes
Code Description
XX000 Not Applicable
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

Group 1

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2024 R20

Under CPT/HCPCS Codes Group 1: Codes deleted 0078U and 0396U. The description was revised for 0403U. Added 0476U, 0477U, 0478U, 0480U, 0481U, 0485U, 0486U, 0487U, 0488U, 0489U, 0490U, 0491U, 0492U, 0493U, 0494U, 0495U, 0496U, 0497U, 0498U, 0499U, 0500U, 0501U, 0504U, 0505U, 0506U, 0507U, 0508U, 0509U, 0510U, 0511U, and 0516U. This revision is due to the 2024 Q4 CPT/HCPCS Code Update and is effective 10/1/2024.

Under CPT/HCPCS Codes Group 1: Codes added 0152U. This is due to the 2020 Annual CPT/HCPCS Code Update and is effective 1/1/2020.

Under CPT/HCPCS Codes Group 1: Codes added 0321U. This is due to the 2022 Q2 CPT/HCPCS Code Update and is effective 4/1/2022.

07/01/2024 R19

Under CPT/HCPCS Codes Group 1: Codes deleted 0204U. Added 0020M, 0452U, 0453U, 0454U, 0456U, 0460U, 0461U, 0463U, 0464U, 0465U, 0466U, 0467U, 0469U, 0470U, 0471U, 0473U, 0474U, and 0475U. Under CPT/HCPCS Codes Group 2: Codes deleted 0353U. Added 0455U. 

This revision is due to the 2024 Q3 CPT/HCPCS Code Update and is effective 7/1/2024.

04/01/2024 R18

Under CPT/HCPCS Codes Group 1: Codes deleted 0416U. Added 0439U, 0440U, 0444U, 0448U, and 0449U. This revision is due to the 2024 Q2 CPT/HCPCS Code Update and is effective 4/1/2024.

Under CPT/HCPCS Codes Group 1: Codes added 0112U. This revision is effective 4/1/2024.

01/01/2024 R17

Under CPT/HCPCS Codes Group 1: Codes deleted 0228U. This revision is effective 1/1/2024.

01/01/2024 R16

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0356U, 81171, 81172, 81243, 81244, 81445, 81449, 81450, 81451, 81455, and 81456. Added 81457, 81458, 81459, 81462, 81463, 81464, 0420U, 0421U, 0422U, 0423U, 0424U, 0425U, 0426U, 0428U, 0433U, 0434U, 0437U, and 0438U. This revision is due to the 2024 Annual/Q1 CPT/HCPCS Code Update and is effective 1/1/2024.

Under Article Text added “NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line”. Under CPT/HCPCS Group 1: Codes added 81599, 0253U, and 0254U. Under CPT/HCPCS Group 2: Paragraph revised first sentence to read “For DNA/RNA based testing that use CPT® code 87999 a Z-code is required for claims submission”. Under CPT/HCPCS Group 2: Codes deleted 81599. This revision is effective 1/1/2024.

Updated CPT/HCPCS Codes Group 2 Paragraph "For DNA/RNA based testing that use CPT® code 87999 a Z-code is required for claims submission. Any remaining molecular microbiology tests that are non-FDA approved/cleared services/tests also require a Z-code for claims submission." Noridian has modified certain language in the articles to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history. However, these revisions do not change coverage or guidance.

10/01/2023 R15

Updated to indicate this article is an LCD Reference Article.

10/01/2023 R14

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0258U, 0269U, 0271U, 0272U, 0274U, 0277U, 0278U, and 0362U. Added 0403U, 0405U, 0409U, 0410U, 0411U, 0413U, 0416U, 0417U, and 0419U. Deleted 0386U and 0397U. Under CPT/HCPCS Codes Group 2: Codes added 0402U. This revision is due to the 2023 Q4 CPT/HCPCS Code Update and is effective on 10/1/2023.

Under Article Text revised the 3rd and 6th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”. This revision is effective on 10/1/2023.

07/01/2023 R13

Under CMS National Coverage Policy updated section heading. This revision is effective on 7/1/2023.

Under CPT/HCPCS Codes Group 1: Codes added 0388U, 0389U, 0391U, 0392U, 0395U, 0396U, 0397U, 0398U, 0400U, and 0401U. This revision is due to the 2023 Q3 CPT/HCPCS Code Update and is effective on 7/1/2023.

04/01/2023 R12

Under CPT/HCPCS Codes Group 1: Codes added 0364U, 0368U, 0369U, 0370U, 0371U, 0372U, 0373U, 0374U, 0378U, 0379U, 0380U, and 0386U. The description was revised for 0022U. This revision is due to the 2023 Q2 CPT/HCPCS Code Update and is effective on April 1, 2023.

01/01/2023 R11

Under CPT/HCPCs Codes Group I: Added 0334U, 0343U and 0345U effective 10.01.2022 as indicated in Revision 10. 

Under Revision 10 Group 2 coding update:  Typographical error. 0115U was to Group 2 CPT coding not 0015U. 

01/01/2023 R10

Under CPT/HCPCS Codes Group 1: Codes added 0318U. This revision is due to the Q2 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 4/01/2022.

Under CPT/HCPCS Codes Group 1: Codes added 0327U. This revision is due to the Q3 2022 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 07/01/2022.

Under CPT/HCPCS Codes Group 1: Codes added 0332U, 0333U, 0334U, 0335U, 0336U, 0339U, 0340U, 0341U, 0343U, 0345U, 0347U, 0348U, 0349U, 0350U, deleted 0012U, 0013U,0014U,0056U, and the description was revised for 0229U, 0262U, 0276U, 0296U, 0319U. Under CPT/HCPCS Codes Group 2: Codes added 0352U, 0353U. This revision is due to the Q4 2022 CPT/HCPCS Code Update and is effective for dates of service on or after 10/01/2022.

Under CPT/HCPCS Codes Group 2: Paragraph revised the first and second sentence. Under CPT/HCPCS Codes Group 2: Codes added 81513, 81514, 87154, 87483, 87505, 87506, 87507, 87631, 87632, 87633, 87636, 87637, 0015U, 0202U, 0223U, 0225U, 0240U, 0241U. This revision is retroactive effective for dates of service on or after 04/17/2022.

01/01/2023 R9

Under CPT/HCPCS Codes Group 1: Codes added 81418, 81441, 81449, 81451, 81456, 0355U, 0356U, 0362U, and 0363U. The description was revised for 81330, 81445, 81450, 81455, 0017M, and 0069U. Under CPT/HCPCS Codes Group 2: Codes the description was revised for 87999. This revision is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is effective on January 1, 2023.

07/01/2022 R8

Under CPT/HCPCS Codes Group#1: Codes the description was revised for 0016M, 0229U, and 0306U. Under CPT/HCPCS Codes Group 1: Codes added 0323U, 0326U, 0329U, 0330U, 0331U. This revision is due to the Q3 2022 CPT/HCPCS Code Update and is effective on July 1, 2022

05/17/2022 R7

Under CPT/HCPCS Codes Group1: Codes added 0306U, 0307U, 0313U, 0314U, 0315U, 0319U, 0320U and revised the description for 0022U.

This revision is due to the Q2 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2022.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage, “However, for molecular microbiology tests using codes 87800 and 87801, a Z-code is only required for non-FDA-approved/cleared services/tests.”

Under CPT/HCPCS Codes Group 2: added codes 87800 and 87801.
This revision is effective on 05/17/2022.

04/17/2022 R6

Under CPT/HCPCS Codes Group1: Codes deleted 81599.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage, “The following CPT codes require a Z-code if the testing is molecular (DNA/RNA) based.”

Under CPT/HCPCS Codes Group 2: added codes 81599 AND 87999.

This revision is effective on 04/17/2022. 

01/01/2022 R5

Under CPT/HCPCS Codes Group 1: Paragraph added the verbiage “The codes listed below fall within scope of the associated policy but do not automatically imply coverage. This revision is effective January 1, 2022.

Under CPT/HCPCS Codes Group 1: Codes added 0285U, 0286U, 0287U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0296U, 0297U, 0298U, 0299U, 0300U, 81349, and 81523. Deleted 0208U. The description was revised for 0016M, 0017M, 0090U,0154U, 0155U, 0177U, 0180U, 0193U, 0200U, 0205U, 0216U, 0221U, 0244U, 0258U, 0262U, 0265U, 0266U, 0276U, 81194, 81228, and 81229. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on January 1, 2022.

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history. However, these revisions do not change coverage or guidance.

10/01/2021Under CPT/HCPCS Codes Group 1: Codes added 0258U, 0260U, 0262U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U, 0282U and deleted 0168U. This revision is due to the Q4 2021 CPT®/HCPCS Code Update and is effective for dates of service on or after 10/1/2021.

07.01.2021: Under CPT/HCPCS Codes Group 1: Codes added 0016M. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021. Under CPT/HCPCS Codes Group 1: Codes added 0250U. This revision is due to the Q3 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 7/1/2021.

12/09/2021 - The following CPT/HCPCS codes were deleted: 0208U was deleted from Group 1

04/01/2021 R4

Under CPT/HCPCS Group 1: Codes added 0017M and deleted 0105U. This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021.

Under CPT/HCPCS Group 1: Codes added 0242U, 0244U, 0245U, and 0246U. This revision is due to the Q2 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2021.

01/01/2021 R3

Under CPT/HCPCS Codes Group 1: Codes added 81374, 81377, 81381, 81383, 0069U, 0133U, 0168U, 0169U, 0170U, 0171U, 0172U, 0173U, 0175U, 0177U, 0179U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0198U, 0199U, 0200U 0201U, 0203U, 0204U, 0205U, 0208U, 0209U, 0211U, 0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0218U, 0221U, and 0222U and deleted 81490, 81500, 81503, 81506, 81508, 81509, 81510, 81511, 81512, 81535, 81536, 81538, 81539, 81545, 84999, 85999, 86152, 86153, 86849, 87999, 0003U, 0009U, 0021U, 0024U, 0039U, 0053U, 0054U, 0058U, 0059U, 0062U, 0067U, 0068U, 0080U, 0083U, 0092U, 0107U, and 0108U. 

Under CPT/HCPCS Codes Group 1: Codes added 81168, 81191, 81192, 81193, 81194, 81278, 81279, 81338, 81339, 81347, 81348, 81351, 81352, 81353, 81357, 81360, 81419, 81529, 81546, 81554, 0228U, 0229U, 0230U, 0231U, 0232U, 0233U, 0234U, 0235U, 0236U, 0237U, 0238U, 0239U. 

Under CPT/HCPCS Codes Group 2: Codes moved 81401, 81403, 81406, 81407, 81412 to CPT/HCPCS Codes Group 1: Codes.  

This revision is due to coding that is applicable to the MolDX program and is retroactive effective for dates of service on or after 1/1/2021.

This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021.

01/01/2020 R2

Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 87999, 0045U-0050U, 0053U-0060U, 0062U, 0067U, 0068U, 0070U-0076U, 0078U-0080U, 0083U, 0105U, 0107U, 0108U, 0111U, 0113U, 0114U, 0118U, 0120U, 0129U-0132U, and 0134U-0138U. CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U were deleted. CPT code range 0084U-0103U was revised to add/delete applicable codes above. This addition and deletion is due to coding that is applicable to the MolDX program.

Under CPT/HCPCS Codes Group 1: Codes CPT® code range 81161-81400 was revised to 81161-81364 including the addition of 81277, 81307, 81308, 81309, 81522, 81542, 81552, and added code range 0153U-0162U. CPT® codes 0009M and 0085U were deleted. The code descriptions were revised for CPT® codes 81350, 0101U, 0102U, and 0103U. This revision is due to the Annual CPT®/HCPCS Code Update and becomes effective on 1/1/2020.

Typographical errors were corrected in CMS National Coverage Policy.

11/01/2019 R1

11/01/2019: This article 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 and incorporate into related Billing and Coding Articles. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related MolDX: Molecular Diagnostic Tests (MDT) L35160 LCD and placed in this article.

Under CPT/HCPCS Codes Group 1: Codes deleted CPT® codes 81401, 81403, 81406, 81407, and 81412. Under CPT/HCPCS Codes Group 2: Paragraph added verbiage CPT® codes that are also referenced in other articles. Under CPT/HCPCS Codes Group 2: Codes added CPT® codes 81401, 81403, 81406, 81407, and 81412.

The above revisions will become effective on 11/01/19.

Under CPT/HCPCS Codes Group 1: Codes: CPT code 0104U was deleted. Under CPT/HCPCS Codes Group 1: Codes: CPT codes 0008U and 81404 descriptions were changed. Under CPT/HCPCS Codes Group 2: Codes: CPT code 81407 description was changed. These revisions are due to the Q4 CPT®/HCPCS Code Updates and are retroactive effective for dates of service on or after 11/1/19.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L35160 - MolDX: Molecular Diagnostic Tests (MDT)
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