SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer

A58734

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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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Article Information

General Information

Source Article ID
N/A
Article ID
A58734
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer
Article Type
Billing and Coding
Original Effective Date
08/21/2022
Revision Effective Date
08/01/2024
Revision Ending Date
09/30/2024
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 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 © 2023 American Dental Association. All rights reserved.

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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.

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 Manual, 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: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L39017.

To report a 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
  • Select the appropriate ICD-10-CM code

Regarding single-gene and panel testing of genes-Refer to Billing and Coding: MolDX: Testing of Multiple Genes A57910.

Tier 1 and/or Tier 2 individual biomarker CPT® codes should not be used for a single gene or any combination of genes when testing is performed as part of a NGS or other multiplexing technology panel.

Response To Comments

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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

(263 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
C16.0 Malignant neoplasm of cardia
C16.1 Malignant neoplasm of fundus of stomach
C16.2 Malignant neoplasm of body of stomach
C16.3 Malignant neoplasm of pyloric antrum
C16.4 Malignant neoplasm of pylorus
C16.5 Malignant neoplasm of lesser curvature of stomach, unspecified
C16.6 Malignant neoplasm of greater curvature of stomach, unspecified
C16.8 Malignant neoplasm of overlapping sites of stomach
C16.9 Malignant neoplasm of stomach, unspecified
C17.0 Malignant neoplasm of duodenum
C17.1 Malignant neoplasm of jejunum
C17.2 Malignant neoplasm of ileum
C17.3 Meckel's diverticulum, malignant
C17.8 Malignant neoplasm of overlapping sites of small intestine
C17.9 Malignant neoplasm of small intestine, unspecified
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.0 Malignant neoplasm of anus, unspecified
C21.1 Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C22.0 Liver cell carcinoma
C22.1 Intrahepatic bile duct carcinoma
C22.2 Hepatoblastoma
C22.3 Angiosarcoma of liver
C22.4 Other sarcomas of liver
C22.7 Other specified carcinomas of liver
C22.8 Malignant neoplasm of liver, primary, unspecified as to type
C22.9 Malignant neoplasm of liver, not specified as primary or secondary
C23 Malignant neoplasm of gallbladder
C24.0 Malignant neoplasm of extrahepatic bile duct
C24.1 Malignant neoplasm of ampulla of Vater
C24.8 Malignant neoplasm of overlapping sites of biliary tract
C24.9 Malignant neoplasm of biliary tract, unspecified
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.3 Malignant neoplasm of pancreatic duct
C25.4 Malignant neoplasm of endocrine pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C43.0 Malignant melanoma of lip
C43.10 Malignant melanoma of unspecified eyelid, including canthus
C43.111 Malignant melanoma of right upper eyelid, including canthus
C43.112 Malignant melanoma of right lower eyelid, including canthus
C43.121 Malignant melanoma of left upper eyelid, including canthus
C43.122 Malignant melanoma of left lower eyelid, including canthus
C43.20 Malignant melanoma of unspecified ear and external auricular canal
C43.21 Malignant melanoma of right ear and external auricular canal
C43.22 Malignant melanoma of left ear and external auricular canal
C43.30 Malignant melanoma of unspecified part of face
C43.31 Malignant melanoma of nose
C43.39 Malignant melanoma of other parts of face
C43.4 Malignant melanoma of scalp and neck
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C43.60 Malignant melanoma of unspecified upper limb, including shoulder
C43.61 Malignant melanoma of right upper limb, including shoulder
C43.62 Malignant melanoma of left upper limb, including shoulder
C43.70 Malignant melanoma of unspecified lower limb, including hip
C43.71 Malignant melanoma of right lower limb, including hip
C43.72 Malignant melanoma of left lower limb, including hip
C43.8 Malignant melanoma of overlapping sites of skin
C45.1 Mesothelioma of peritoneum
C48.0 Malignant neoplasm of retroperitoneum
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.2 Malignant neoplasm of peritoneum, unspecified
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C49.A0 Gastrointestinal stromal tumor, unspecified site
C49.A1 Gastrointestinal stromal tumor of esophagus
C49.A2 Gastrointestinal stromal tumor of stomach
C49.A3 Gastrointestinal stromal tumor of small intestine
C49.A4 Gastrointestinal stromal tumor of large intestine
C49.A5 Gastrointestinal stromal tumor of rectum
C49.A9 Gastrointestinal stromal tumor of other sites
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.019 Malignant neoplasm of nipple and areola, unspecified female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.029 Malignant neoplasm of nipple and areola, unspecified male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.119 Malignant neoplasm of central portion of unspecified female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.129 Malignant neoplasm of central portion of unspecified male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.619 Malignant neoplasm of axillary tail of unspecified female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.629 Malignant neoplasm of axillary tail of unspecified male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.829 Malignant neoplasm of overlapping sites of unspecified male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C50.929 Malignant neoplasm of unspecified site of unspecified male breast
C53.8 Malignant neoplasm of overlapping sites of cervix uteri
C54.0 Malignant neoplasm of isthmus uteri
C54.1 Malignant neoplasm of endometrium
C54.2 Malignant neoplasm of myometrium
C54.3 Malignant neoplasm of fundus uteri
C54.8 Malignant neoplasm of overlapping sites of corpus uteri
C54.9 Malignant neoplasm of corpus uteri, unspecified
C55 Malignant neoplasm of uterus, part unspecified
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.00 Malignant neoplasm of unspecified fallopian tube
C57.01 Malignant neoplasm of right fallopian tube
C57.02 Malignant neoplasm of left fallopian tube
C57.10 Malignant neoplasm of unspecified broad ligament
C57.11 Malignant neoplasm of right broad ligament
C57.12 Malignant neoplasm of left broad ligament
C57.20 Malignant neoplasm of unspecified round ligament
C57.21 Malignant neoplasm of right round ligament
C57.22 Malignant neoplasm of left round ligament
C57.3 Malignant neoplasm of parametrium
C57.4 Malignant neoplasm of uterine adnexa, unspecified
C61 Malignant neoplasm of prostate
C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.2 Malignant neoplasm of left kidney, except renal pelvis
C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis
C65.1 Malignant neoplasm of right renal pelvis
C65.2 Malignant neoplasm of left renal pelvis
C65.9 Malignant neoplasm of unspecified renal pelvis
C66.1 Malignant neoplasm of right ureter
C66.2 Malignant neoplasm of left ureter
C66.9 Malignant neoplasm of unspecified ureter
C67.0 Malignant neoplasm of trigone of bladder
C67.1 Malignant neoplasm of dome of bladder
C67.2 Malignant neoplasm of lateral wall of bladder
C67.3 Malignant neoplasm of anterior wall of bladder
C67.4 Malignant neoplasm of posterior wall of bladder
C67.5 Malignant neoplasm of bladder neck
C67.6 Malignant neoplasm of ureteric orifice
C67.7 Malignant neoplasm of urachus
C67.8 Malignant neoplasm of overlapping sites of bladder
C67.9 Malignant neoplasm of bladder, unspecified
C68.8 Malignant neoplasm of overlapping sites of urinary organs
C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles
C71.1 Malignant neoplasm of frontal lobe
C71.2 Malignant neoplasm of temporal lobe
C71.3 Malignant neoplasm of parietal lobe
C71.4 Malignant neoplasm of occipital lobe
C71.5 Malignant neoplasm of cerebral ventricle
C71.6 Malignant neoplasm of cerebellum
C71.7 Malignant neoplasm of brain stem
C71.8 Malignant neoplasm of overlapping sites of brain
C71.9 Malignant neoplasm of brain, unspecified
C73 Malignant neoplasm of thyroid gland
C75.0 Malignant neoplasm of parathyroid gland
C75.1 Malignant neoplasm of pituitary gland
C75.2 Malignant neoplasm of craniopharyngeal duct
C75.3 Malignant neoplasm of pineal gland
C75.4 Malignant neoplasm of carotid body
C75.5 Malignant neoplasm of aortic body and other paraganglia
C75.8 Malignant neoplasm with pluriglandular involvement, unspecified
C75.9 Malignant neoplasm of endocrine gland, unspecified
C79.11 Secondary malignant neoplasm of bladder
D00.2 Carcinoma in situ of stomach
D01.0 Carcinoma in situ of colon
D01.1 Carcinoma in situ of rectosigmoid junction
D01.2 Carcinoma in situ of rectum
D01.40 Carcinoma in situ of unspecified part of intestine
D01.49 Carcinoma in situ of other parts of intestine
D01.5 Carcinoma in situ of liver, gallbladder and bile ducts
D01.7 Carcinoma in situ of other specified digestive organs
D05.00 Lobular carcinoma in situ of unspecified breast
D05.01 Lobular carcinoma in situ of right breast
D05.02 Lobular carcinoma in situ of left breast
D05.10 Intraductal carcinoma in situ of unspecified breast
D05.11 Intraductal carcinoma in situ of right breast
D05.12 Intraductal carcinoma in situ of left breast
D05.80 Other specified type of carcinoma in situ of unspecified breast
D05.81 Other specified type of carcinoma in situ of right breast
D05.82 Other specified type of carcinoma in situ of left breast
D05.90 Unspecified type of carcinoma in situ of unspecified breast
D05.91 Unspecified type of carcinoma in situ of right breast
D05.92 Unspecified type of carcinoma in situ of left breast
D06.0 Carcinoma in situ of endocervix
D06.1 Carcinoma in situ of exocervix
D07.0 Carcinoma in situ of endometrium
D07.5 Carcinoma in situ of prostate
D09.3 Carcinoma in situ of thyroid and other endocrine glands
D09.8 Carcinoma in situ of other specified sites
D13.91 Familial adenomatous polyposis
Q85.81 PTEN hamartoma tumor syndrome
Q85.82 Other Cowden syndrome
Q85.83 Von Hippel-Lindau syndrome
Z85.00 Personal history of malignant neoplasm of unspecified digestive organ
Z85.030 Personal history of malignant carcinoid tumor of large intestine
Z85.038 Personal history of other malignant neoplasm of large intestine
Z85.040 Personal history of malignant carcinoid tumor of rectum
Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus
Z85.060 Personal history of malignant carcinoid tumor of small intestine
Z85.068 Personal history of other malignant neoplasm of small intestine
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.3 Personal history of malignant neoplasm of breast
Z85.42 Personal history of malignant neoplasm of other parts of uterus
Z85.43 Personal history of malignant neoplasm of ovary
Z85.44 Personal history of malignant neoplasm of other female genital organs
Z85.46 Personal history of malignant neoplasm of prostate
Z85.51 Personal history of malignant neoplasm of bladder
Z85.53 Personal history of malignant neoplasm of renal pelvis
Z85.54 Personal history of malignant neoplasm of ureter
Z85.59 Personal history of malignant neoplasm of other urinary tract organ
Z85.820 Personal history of malignant melanoma of skin
Z85.821 Personal history of Merkel cell carcinoma
Z85.828 Personal history of other malignant neoplasm of skin
Z85.841 Personal history of malignant neoplasm of brain
Z85.850 Personal history of malignant neoplasm of thyroid
Z85.858 Personal history of malignant neoplasm of other endocrine glands
Z86.000 Personal history of in-situ neoplasm of breast
Z86.001 Personal history of in-situ neoplasm of cervix uteri
Z86.002 Personal history of in-situ neoplasm of other and unspecified genital organs
Z86.004 Personal history of in-situ neoplasm of other and unspecified digestive organs
Z86.010 Personal history of colonic polyps
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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ICD-10-PCS Codes

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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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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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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
08/01/2024 R6

Revision Effective: 08/01/2024

Revision Explanation: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted K63.5. Added C23, C24.1, C24.8, C48.0, C53.8, C67.0, C67.1, C67.2, C67.3, C67.4, C67.5, C67.6, C67.7, C67.8, C67.9, C79.11, D00.2, D01.0, D01.1, D01.2, D01.40, D01.49, D01.5, D01.7, D05.00, D05.01, D05.02, D05.10, D05.80, D05.81, D05.82, D05.90, D05.91, D05.92, D06.0, D06.1, D07.0, D07.5, D09.3, D09.8, Z85.51, Z86.001, Z86.002, and Z86.004.

11/22/2023 R5

Revision Effective: 11/22/2023

Revision Explanation: Updated LCD Reference Article section.

10/01/2023 R4

Revision Effective Date: 10/01/2023

Revision Explanation: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes the description was revised for Q85.81 and added D13.91. This revision is due to the Annual ICD-10-CM Update and will become effective on 10/1/2023.

Under CMS National Coverage Policy updated section heading. 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. 

Updated article text to reflect current jurisdiction's article details for Billing and Coding: MolDX: Testing of Multiple Genes. 

03/30/2023 R3

Revision Effective Date: 03/30/2023

Revision Explanation: Annual review, no changes 

10/01/2022 R2

Revision Effective Date: 10/01/2022

Revision Explanation: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added Q85.81, Q85.82, and Q85.83. This revision is due to the Annual ICD-10-CM Update and will become effective on 10/1/2022. 

08/21/2022 R1

Revision Effective Date: 08/21/2022

Revision Explanation: Under CPT/HCPCS Codes Group 2: Codes deleted 81162. The addition of this code in Revision 1 was done in error.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 2
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Updated On Effective Dates Status
09/14/2024 10/01/2024 - N/A Currently in Effect View
07/30/2024 08/01/2024 - 09/30/2024 Superseded You are here
11/14/2023 11/22/2023 - 07/31/2024 Superseded View
08/14/2023 10/01/2023 - 11/21/2023 Superseded View
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Keywords

  • NGS