Local Coverage Article Billing and Coding

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

A58756

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Article Information

General Information

Article ID
A58756
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
07/03/2022
Revision Effective Date
10/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
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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 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, §60.1.2 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 L39040.

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 A57880.

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.

Coding Information

CPT/HCPCS Codes

Group 1

(25 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
81202 Apc gene known fam variants
81215 Brca1 gene known famil vrnt
81217 Brca2 gene known famil vrnt
81293 Mlh1 gene known variants
81296 Msh2 gene known variants
81299 Msh6 gene known variants
81308 Palb2 gene known famil vrnt
81318 Pms2 known familial variants
81322 Pten gene known fam variant
81353 Tp53 gene known famil vrnt
81403 Mopath procedure level 4
81404 Mopath procedure level 5
81405 Mopath procedure level 6
81406 Mopath procedure level 7
81432 Hrdtry brst ca-rlatd dsordrs
81433 Hrdtry brst ca-rlatd dsordrs
81435 Hereditary colon ca dsordrs
81436 Hereditary colon ca dsordrs
81437 Heredtry nurondcrn tum dsrdr
81438 Heredtry nurondcrn tum dsrdr
81479 Unlisted molecular pathology
0101U Hered colon ca do 15 genes
0102U Hered brst ca rltd do 17 gen
0103U Hered ova ca pnl 24 genes
0129U Hered brst ca rltd do panel

Group 2

(21 Codes)
Group 2 Paragraph

These code(s) are non-covered

Group 2 Codes
CodeDescription
81163 Brca1&2 gene full seq alys
81164 Brca1&2 gen ful dup/del alys
81165 Brca1 gene full seq alys
81166 Brca1 gene full dup/del alys
81167 Brca2 gene full dup/del alys
81201 Apc gene full sequence
81203 Apc gene dup/delet variants
81212 Brca1&2 185&5385&6174 vrnt
81216 Brca2 gene full seq alys
81292 Mlh1 gene full seq
81294 Mlh1 gene dup/delete variant
81295 Msh2 gene full seq
81297 Msh2 gene dup/delete variant
81298 Msh6 gene full seq
81300 Msh6 gene dup/delete variant
81307 Palb2 gene full gene seq
81317 Pms2 gene full seq analysis
81319 Pms2 gene dup/delet variants
81321 Pten gene full sequence
81323 Pten gene dup/delet variant
81351 Tp53 gene full gene sequence

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(219 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
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
C24.0 Malignant neoplasm of extrahepatic bile duct
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
C48.1 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
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
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
D05.11 Intraductal carcinoma in situ of right breast
D05.12 Intraductal carcinoma in situ of left breast
K63.5 Polyp of colon
Q85.81 PTEN 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
Z85.53 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
Z86.010 Personal history of colonic polyps

ICD-10-CM Codes that DO NOT Support Medical Necessity

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
10/01/2022 R3

Posted 09/29/2022: 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.

07/03/2022 R2

Posted 09/01/2022-Under CPT/HCPCS Codes Group 2: Codes deleted 81162. The addition of this code in Revision 1 was done in error. This revision is retroactive effective for dates of services on or after 7/03/2022.

07/03/2022 R1

Posted 07/28/2022. Added CPT codes 81322, 81403, 81404, 81405, 81406 & removed CPT code 81321 from CPT/HCPC’s Group 1 codes. Under CPT/HCPCS Codes Group 2 Paragraph added verbiage “These code(s) are not covered. Under CPT/HCPCS Codes Group 2 Codes added 81162-81167, 81201, 81203, 81212, 81216, 81292, 81294, 81295, 81297, 81298, 81300, 81307, 81317, 81319, 81321, 81323, 81351.

Associated Documents

Related National Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
09/20/2022 10/01/2022 - N/A Currently in Effect You are here
08/23/2022 07/03/2022 - 09/30/2022 Superseded View
07/20/2022 07/03/2022 - N/A Superseded View
05/10/2022 07/03/2022 - N/A Superseded View

Keywords

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