SUPERSEDED LCD Reference Article Billing and Coding Article

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

A56973

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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
A56973
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
09/05/2019
Revision Effective Date
11/16/2023
Revision Ending Date
12/31/2023
Retirement Date
N/A

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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, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1, 80.1.1, 80.1.2, 80.1.3, laboratory services must meet applicable requirements of CLIA.

CMS Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Ch. 16, §50.5 Jurisdiction of Laboratory Claims, §60.1 Independent Laboratory Specimen Drawing, §60.2. Travel Allowance.

CMS Internet-Only Manual Publication 100-04 Medicare Claims Processing Manual, Chapter 23 Section 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) L36021.

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
    • Box 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

 

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(1 Code)
Group 1 Paragraph

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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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Group 1 Codes

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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.

Code Description

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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.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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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
11/16/2023 R22

R22

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

10/01/2023 R21

R21

Revision Effective: 10/01/2023

Revision Explanation:  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.

07/01/2023 R20

R20

Revision Effective: 07/01/2023

Revision Explanation: 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 retroactive effective for dates of service on or after effective on April 1, 2023.

07/01/2023 R19

R19

Revision Effective: 07/01/2023

Revision Explanation: 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.

01/01/2023 R18

R18

Revision Effective: 01/01/2023

Revision Explanation: 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.

10/01/2022 R17

R17

Revision Effective: 10/01/2022

Revision Explanation: In revision 16 codes 0334U, 0343U, and 0345U were added to group1 CPT/HCPCS codes but were left off in error. 

In the revision history for group 2 CPT/HCPCS code it was listed that 0015U was added to this grouping, but this was a typo it should have been 0115U.

10/01/2022 R16

R16

Revision Effective: 10/01/2022

Revision Explanation: 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 4/1/2022.

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 July 1, 2022.

Under CPT/HCPCS Codes Group 1: Codes added 0332U, 0333U, 0334U, 0335U, 0336U, 0339U, 0340U, 0341U, 0343U, 0345U, 0347U, 0348U, 0349U, 0350U, 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.

07/01/2022 R15

R15

Revision Effective: 07/01/2022

Revision Explanation: 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 R14

R14

Revision Effective: 05/17/2022

Revision Explanation: 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 Group2: added codes 87800 and 87801.

04/17/2022 R13

R13

Revision Effective: 04/17/2022

Revision Explanation: Under CPT/HCPCS Codes Group1: Codes deleted 81599. 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 R12

R12

Revision Effective: 01/01/2022

Revision Explanation: 

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.

10/01/2021 R11

R11

Revision Effective: 10/01/2021

Revision Explanation: Under 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.

09/23/2021 R10

R10

Revision Effective: 09/23/2021

Revision Explanation: Annual review no changes.

07/01/2021 R9

R9

Revision effective: 07/01/2021

Revision Explanation:

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.

04/01/2021 R8

R8
Revision Effective: 04/01/2021
Revision Explanation:

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 R7

R7
Revision Effective: 01/01/2021
Revision Explanation: 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, 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 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.

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, deleted 81545.

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.

10/01/2020 R6

R6
Revision Effective: 10/01/2020
Revision Explanation: Based on the 4th quarter CPT/HCPCS update 0154U had a description revision.

01/01/2020 R5

R5
Revision Effective: N/A
Revision Explanation: Corrected typographical error of policy number from L35025 to correct policy number L36021.

01/01/2020 R4

R4

Revision Effective: 1/1/2020

Revision Explanation: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. This addition and deletion is due to coding that is applicable to the MolDX program.

Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 81277, 81307, 81308, 81309, 81522, 81542, 81552, and 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.

10/31/2019 R3

R3

Revision Effective: 10/31/2019

Revision Explanation: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) L35025 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 10/24/19.

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 10/1/19.

09/19/2019 R2

R2

Revision Effective: 07/01/2019

Revision Explanation: New PLA codes 0084U-0103U were added during the conversion of moving codes from the policy and placing into a related billing and coding article as they were effective 07/01/2019. this was left off the revision 1 explanation when the article was converted to the billing and coding article template.

09/19/2019 R1

R1

Revision Effective: 09/19/2019

Revision Explanation: Converted article into new Billing and Coding template no other changes made.

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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
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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SAD Process URL 2
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