FUTURE LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis

A60217

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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
A60217
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis
Article Type
Billing and Coding
Original Effective Date
08/10/2026
Revision Effective Date
N/A
Revision Ending Date
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Retirement Date
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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Internet-Only Manuals, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

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: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis L40197.

Please submit the following claim information:

• Select appropriate CPT® or PLA code
• Only 1 test may be billed per patient per 12 months
• 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:

o Loop 2400 or SV101-7 for the 5010A1 837P
o 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:

o Line SV202-7 for 837I electronic claim
o Block 80 for the UB04 claim form

• Select the appropriate ICD-10-CM codes

o Must include at least one code from Group 1 and at least one code from Group 2

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.

Specific tests that have been evaluated for compliance with coverage criteria set in policy (and are thus covered or not covered) can be found in the DEX® registry located at www.dexzcodes.com.

Response To Comments

Number Comment Response
1
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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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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

(7 Codes)
Group 1 Paragraph

Codes that establish evidence of liver dysfunction

Group 1 Codes
Code Description
K74.00 Hepatic fibrosis, unspecified
K74.01 Hepatic fibrosis, early fibrosis
K74.02 Hepatic fibrosis, advanced fibrosis
K75.81 Nonalcoholic steatohepatitis (NASH)
K76.0 Fatty (change of) liver, not elsewhere classified
R74.01 Elevation of levels of liver transaminase levels
R94.5 Abnormal results of liver function studies

Group 2

(108 Codes)
Group 2 Paragraph

Codes that establish evidence of cardiometabolic risk factors

Group 2 Codes
Code Description
E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)
E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma
E11.10 Type 2 diabetes mellitus with ketoacidosis without coma
E11.11 Type 2 diabetes mellitus with ketoacidosis with coma
E11.21 Type 2 diabetes mellitus with diabetic nephropathy
E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease
E11.29 Type 2 diabetes mellitus with other diabetic kidney complication
E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.319 Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3219 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3291 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye
E11.3292 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye
E11.3293 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E11.3299 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye
E11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3319 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3391 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye
E11.3392 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye
E11.3393 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral
E11.3399 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye
E11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3419 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E11.3491 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye
E11.3492 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye
E11.3493 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral
E11.3499 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye
E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E11.3519 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
E11.3521 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye
E11.3522 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye
E11.3523 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral
E11.3529 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye
E11.3531 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye
E11.3532 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye
E11.3533 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral
E11.3539 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye
E11.3541 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye
E11.3542 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye
E11.3543 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral
E11.3549 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye
E11.3551 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye
E11.3552 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye
E11.3553 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral
E11.3559 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye
E11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye
E11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye
E11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral
E11.3599 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye
E11.36 Type 2 diabetes mellitus with diabetic cataract
E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye
E11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye
E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral
E11.37X9 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye
E11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complication
E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified
E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy
E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy
E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy
E11.44 Type 2 diabetes mellitus with diabetic amyotrophy
E11.49 Type 2 diabetes mellitus with other diabetic neurological complication
E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E11.59 Type 2 diabetes mellitus with other circulatory complications
E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy
E11.618 Type 2 diabetes mellitus with other diabetic arthropathy
E11.620 Type 2 diabetes mellitus with diabetic dermatitis
E11.621 Type 2 diabetes mellitus with foot ulcer
E11.622 Type 2 diabetes mellitus with other skin ulcer
E11.628 Type 2 diabetes mellitus with other skin complications
E11.630 Type 2 diabetes mellitus with periodontal disease
E11.638 Type 2 diabetes mellitus with other oral complications
E11.641 Type 2 diabetes mellitus with hypoglycemia with coma
E11.649 Type 2 diabetes mellitus with hypoglycemia without coma
E11.65 Type 2 diabetes mellitus with hyperglycemia
E11.69 Type 2 diabetes mellitus with other specified complication
E11.8 Type 2 diabetes mellitus with unspecified complications
E11.9 Type 2 diabetes mellitus without complications
E66.3 Overweight
E66.811 Obesity, class 1
E66.812 Obesity, class 2
E66.813 Obesity, class 3
E66.89 Other obesity not elsewhere classified
E66.9 Obesity, unspecified
E78.00 Pure hypercholesterolemia, unspecified
E78.010 Homozygous familial hypercholesterolemia [HoFH]
E78.011 Heterozygous familial hypercholesterolemia [HeFH]
E78.019 Familial hypercholesterolemia, unspecified
E78.2 Mixed hyperlipidemia
E78.5 Hyperlipidemia, unspecified
I10 Essential (primary) hypertension
I1A.0 Resistant hypertension
R73.01 Impaired fasting glucose
R73.02 Impaired glucose tolerance (oral)
R73.03 Prediabetes
R73.09 Other abnormal glucose
R73.9 Hyperglycemia, unspecified
Z79.4 Long term (current) use of insulin
Z79.84 Long term (current) use of oral hypoglycemic drugs
Z79.85 Long-term (current) use of injectable non-insulin antidiabetic drugs
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

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Group 1 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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N/A

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
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Updated On Effective Dates Status
06/19/2026 08/10/2026 - N/A Future Effective You are here

Keywords

  • MASLD
  • MASH
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Metabolic Dysfunction-Associated Steatohepatitis