SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: Molecular Pathology Procedures

A56199

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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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Source Article ID
N/A
Article ID
A56199
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Molecular Pathology Procedures
Article Type
Billing and Coding
Original Effective Date
01/01/2019
Revision Effective Date
01/01/2024
Revision Ending Date
07/31/2024
Retirement Date
N/A

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Article Guidance

Article Text

This article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Molecular Pathology Procedures.

Specific Coding of Molecular Testing Panels

The submission of claims using individual gene CPT codes, when either 5-50 or >50 gene panels are ordered, is considered incorrect coding. Correct coding requires that when a panel code is ordered, it should be billed, rather than the individual gene codes. CPT code 81445, 81449, 81450, or 81451 should be billed when 5 to 50 genes are ordered. CPT code 81455, or 81456, should be billed when 51 or greater genes are ordered for molecular biomarkers. Please refer to Local Coverage Determination L37810 Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms and the associated Article A56867. When a panel with greater than one or less than five genes is ordered, use the corresponding existing panel CPT code or CPT code 81479 if none exists.

Coding Information

Coding guidance in this article is categorized into four, distinct CPT/HCPCS sections:

· CPT/HCPCS section-Group1-Tier 1 Covered Codes for which limited coverage may be provided for the genetic tests and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed

· CPT/ HCPCS section-Group 2-Tier 1 Codes that require Individual Review for which coverage may be provided for the genetic tests submitted, if documentation supports medical necessity, and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed.

· CPT/HCPCS section-Group 3-Tier 1 Non-covered Codes for which genetic testing is unlikely to impact therapeutic decision-making in the clinical management of the patient and will be denied automatically as not medically necessary.

· CPT/HCPCS section-Group 4- Tier 2/NOC Covered Code/Gene Combinations for which limited coverage may be provided for specific genes listed in the Group 4 paragraph; Tier 2/NOC Individual Review Code/Gene Combinations; Tier 2/NOC Non-covered Code/Gene Combinations.

Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.

The diagnosis code(s) must best describe the patient's condition for which the service was performed.

Modifier 91

Please use Modifier 91 as appropriate, based on the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1. Modifier 91 may be is used "to indicate that a test was performed more than once on the same day for the same patient., only when it is necessary to obtain multiple results in the course of treatment."

Documentation Requirements

Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition (ICD-10-CM code) that warrants the test(s).

Examples of documentation requirements of the ordering physician/nonphysician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).

Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.

Documentation requirements for LDT(s)/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.

Providers are required to code to specificity however, if CPT 81479 (unlisted molecular pathology procedure) is used the documentation must clearly identify the unique molecular pathology procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable. If on review the contractor cannot link a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act, §1833(e). For these tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

Utilization Guidelines

Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a Medicare benefit and are not covered. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly affects the management of the patient.

A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage. 
 

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Coding Information

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

(1 Code)
Group 1 Paragraph

The 91 modifier is used for laboratory tests paid under the clinical laboratory fee schedule, as stated in the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1.

Group 1 Codes
Code Description
91 REPEAT CLINICAL DIAGNOSTIC LABORATORY TEST: IN THE COURSE OF TREATMENT OF THE PATIENT, IT MAY BE NECESSARY TO REPEAT THE SAME LABORATORY TEST ON THE SAME DAY TO OBTAIN SUBSEQUENT (MULTIPLE) TEST RESULTS. UNDER THESE CIRCUMSTANCES, THE LABORATORY TEST PERFORMED CAN BE IDENTIFIED BY ITS USUAL PROCEDURE NUMBER AND THE ADDITION OF THE MODIFIER '-91'. NOTE: THIS MODIFIER MAY NOT BE USED WHEN TESTS ARE RERUN TO CONFIRM INITIAL RESULTS; DUE TO TESTING PROBLEMS WITH SPECIMENS OR EQUIPMENT; OR FOR ANY OTHER REASON WHEN A NORMAL, ONE-TIME, REPORTABLE RESULT IS ALL THAT IS REQUIRED. THIS MODIFIER MAY NOT BE USED WHEN OTHER CODE(S) DESCRIBE A SERIES OF TEST RESULTS (E.G., GLUCOSE TOLERANCE TESTS, EVOCATIVE/SUPPRESSION TESTING). THIS MODIFIER MAY ONLY BE USED FOR LABORATORY TEST(S) PERFORMED MORE THAN ONCE ON THE SAME DAY ON THE SAME PATIENT.
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ICD-10-CM Codes that Support Medical Necessity

Group 1

(78 Codes)
Group 1 Paragraph

CPT codes 81162-81167, 81212, 81215, 81216, 81217 are considered medically necessary for the following ICD-10-CM codes:

Group 1 Codes
Code Description
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
C48.1 Malignant neoplasm of specified parts of peritoneum
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
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
C61 Malignant neoplasm of prostate
D05.11 Intraductal carcinoma in situ of right breast
D05.12 Intraductal carcinoma in situ of left breast
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.3 Personal history of malignant neoplasm of breast
Z85.43 Personal history of malignant neoplasm of ovary
Z85.46 Personal history of malignant neoplasm of prostate
Z86.000 Personal history of in-situ neoplasm of breast

Group 2

(9 Codes)
Group 2 Paragraph

CPT code 81170 is considered medically necessary for the following ICD-10-CM codes

Group 2 Codes
Code Description
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C92.10 - C92.12 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission - Chronic myeloid leukemia, BCR/ABL-positive, in relapse
C92.20 - C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission - Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse

Group 3

(14 Codes)
Group 3 Paragraph

CPT codes 81206, 81207, and 81208 (BCR/ABL) are considered medically necessary for the following ICD-10-CM codes:

Group 3 Codes
Code Description
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C92.10 - C92.12 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission - Chronic myeloid leukemia, BCR/ABL-positive, in relapse
C92.20 - C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission - Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.90 - C92.92 Myeloid leukemia, unspecified, not having achieved remission - Myeloid leukemia, unspecified in relapse
D47.3 Essential (hemorrhagic) thrombocythemia
D72.829 Elevated white blood cell count, unspecified

Group 4

(93 Codes)
Group 4 Paragraph

CPT code 81210 (BRAF) is considered medically necessary for the following ICD-10-CM codes:

Group 4 Codes
Code Description
C17.0 - C17.9 Malignant neoplasm of duodenum - Malignant neoplasm of small intestine, unspecified
C18.0 - C19 Malignant neoplasm of cecum - Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
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
C33 - C34.92 Malignant neoplasm of trachea - Malignant neoplasm of unspecified part of left bronchus or lung
C43.0 - C43.9 Malignant melanoma of lip - Malignant melanoma of skin, unspecified
C78.4 Secondary malignant neoplasm of small intestine
C78.5 Secondary malignant neoplasm of large intestine and rectum
C91.40 - C91.42 Hairy cell leukemia not having achieved remission - Hairy cell leukemia, in relapse
D03.0 - D03.9 Melanoma in situ of lip - Melanoma in situ, unspecified
Z85.038 Personal history of other malignant neoplasm of large intestine
Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus
Z85.820 Personal history of malignant melanoma of skin

Group 5

(28 Codes)
Group 5 Paragraph

CPT Code 81218 (CEBPA) is considered medically necessary for the following ICD-10-CM codes:

Group 5 Codes
Code Description
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 6

(3 Codes)
Group 6 Paragraph

CPT codes 81315 and 81316 PML/RARALPHA are considered medically necessary for the following ICD-10-CM codes:

Group 6 Codes
Code Description
C92.40 - C92.42 Acute promyelocytic leukemia, not having achieved remission - Acute promyelocytic leukemia, in relapse

Group 7

(44 Codes)
Group 7 Paragraph

CPT code 81225 (CYP2C19) is considered medically necessary for the following ICD-10-CM codes:

Group 7 Codes
Code Description
I20.0 Unstable angina
I20.1 Angina pectoris with documented spasm
I20.81 Angina pectoris with coronary microvascular dysfunction
I20.89 Other forms of angina pectoris
I20.9 Angina pectoris, unspecified
I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery
I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall
I21.29 ST elevation (STEMI) myocardial infarction involving other sites
I21.3 ST elevation (STEMI) myocardial infarction of unspecified site
I21.4 Non-ST elevation (NSTEMI) myocardial infarction
I24.0 Acute coronary thrombosis not resulting in myocardial infarction
I24.1 Dressler's syndrome
I24.81 Acute coronary microvascular dysfunction
I24.89 Other forms of acute ischemic heart disease
I24.9 Acute ischemic heart disease, unspecified
I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris
I25.119 Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris
I25.700 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris
I25.701 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm
I25.708 Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris
I25.710 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris
I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris
I25.719 - I25.721 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris - Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.728 - I25.731 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris - Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris
I25.739 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris
I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina
I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm
I25.758 - I25.761 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris - Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm
I25.769 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris
I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris
I25.791 Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.798 Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris
I25.799 Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris

Group 8

(2 Codes)
Group 8 Paragraph

CPT code 81226  (CYP2d6) is considered medically necessary for the following ICD-10-CM codes:
PLA code 0070U is effective for services, rendered on or after May 15, 2021.

Group 8 Codes
Code Description
E75.22 Gaucher disease
G10 Huntington's disease

Group 9

(17 Codes)
Group 9 Paragraph

CPT code 81235 (EGFR) is considered medically necessary for the following ICD-10-CM codes:



Group 9 Codes
Code Description
C33 - C34.92 Malignant neoplasm of trachea - Malignant neoplasm of unspecified part of left bronchus or lung

Group 10

(28 Codes)
Group 10 Paragraph

CPT code 81245, 81246 (FLT3) are considered medically necessary for the following ICD-10-CM codes:

Group 10 Codes
Code Description
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 11

(5 Codes)
Group 11 Paragraph

CPT code 81256 (HFE) is considered medically necessary the following ICD-10-CM codes:

Group 11 Codes
Code Description
E83.10 Disorder of iron metabolism, unspecified
E83.110 Hereditary hemochromatosis
E83.118 Other hemochromatosis
E83.119 Hemochromatosis, unspecified
E83.19 Other disorders of iron metabolism

Group 12

(211 Codes)
Group 12 Paragraph

CPT codes 81261-81264 (IGH) are considered medically necessary for the following ICD-10-CM codes:

Group 12 Codes
Code Description
C82.00 - C83.99 Follicular lymphoma grade I, unspecified site - Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites
C85.10 - C85.99 Unspecified B-cell lymphoma, unspecified site - Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.11 Chronic leukemia of unspecified cell type, in remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
D72.828 Other elevated white blood cell count
D72.89 Other specified disorders of white blood cells

Group 13

(34 Codes)
Group 13 Paragraph

CPT codes 81270 (JAK2), 81338 (MPL), 81339 (MPL), 81279 (JAK2 exons 12 and 13), 81219 (CALR), and 0027U (JAK2 exons 12-15) are considered medically necessary for the following ICD-10-CM codes when criteria in Indications and Limitations of Coverage are met:

Group 13 Codes
Code Description
C88.8 Other malignant immunoproliferative diseases
C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C93.12 Chronic myelomonocytic leukemia, in relapse
C93.Z0 Other monocytic leukemia, not having achieved remission
C93.Z2 Other monocytic leukemia, in relapse
C93.90 Monocytic leukemia, unspecified, not having achieved remission
C93.92 Monocytic leukemia, unspecified in relapse
C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
C94.41 Acute panmyelosis with myelofibrosis, in remission
C94.42 Acute panmyelosis with myelofibrosis, in relapse
C94.6 Myelodysplastic disease, not elsewhere classified
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
D45 Polycythemia vera
D47.1 Chronic myeloproliferative disease
D47.3 Essential (hemorrhagic) thrombocythemia
D47.4 Osteomyelofibrosis
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
D72.821 Monocytosis (symptomatic)
D72.828 Other elevated white blood cell count
D72.829 Elevated white blood cell count, unspecified
D72.89 Other specified disorders of white blood cells
D72.9 Disorder of white blood cells, unspecified
D75.1 Secondary polycythemia
D75.81 Myelofibrosis
D75.89 Other specified diseases of blood and blood-forming organs
D75.9 Disease of blood and blood-forming organs, unspecified
D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 14

(101 Codes)
Group 14 Paragraph

CPT code 81272 (KIT) is considered medically necessary for the following ICD-10-CM codes: CPT code 81273 (KIT) is considered medically necessary only for the diagnosis of mastocytosis.

Group 14 Codes
Code Description
C43.0 - C43.9 Malignant melanoma of lip - Malignant melanoma of skin, unspecified
C49.A0 - C49.A9 Gastrointestinal stromal tumor, unspecified site - Gastrointestinal stromal tumor of other sites
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
C96.20 Malignant mast cell neoplasm, unspecified
C96.21 Aggressive systemic mastocytosis
C96.22 Mast cell sarcoma
C96.29 Other malignant mast cell neoplasm
D03.0 - D03.9 Melanoma in situ of lip - Melanoma in situ, unspecified
D47.01 Cutaneous mastocytosis
D47.02 Systemic mastocytosis
D47.09 Other mast cell neoplasms of uncertain behavior
D48.110 - D48.19 Desmoid tumor of head and neck - Other specified neoplasm of uncertain behavior of connective and other soft tissue
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified
Z85.820 Personal history of malignant melanoma of skin

Group 15

(40 Codes)
Group 15 Paragraph

CPT code 81275 and 81276 (KRAS) are considered medically necessary for the following ICD-10-CM codes:

Group 15 Codes
Code Description
C17.0 - C17.9 Malignant neoplasm of duodenum - Malignant neoplasm of small intestine, unspecified
C18.0 - C19 Malignant neoplasm of cecum - Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
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
C33 - C34.92 Malignant neoplasm of trachea - Malignant neoplasm of unspecified part of left bronchus or lung
Z85.038 Personal history of other malignant neoplasm of large intestine
Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus

Group 16

(10 Codes)
Group 16 Paragraph

CPT code 81287 (MGMT) is considered medically necessary for the following ICD-10-CM codes:

Group 16 Codes
Code Description
C71.0 - C71.9 Malignant neoplasm of cerebrum, except lobes and ventricles - Malignant neoplasm of brain, unspecified

Group 17

(40 Codes)
Group 17 Paragraph

CPT code 81301 Microsatellite instability analysis (e.g., hereditary non-polyposis colorectal cancer, Lynch syndrome) is considered medically necessary for the following ICD-10-CM codes:

Group 17 Codes
Code Description
C17.0 - C17.9 Malignant neoplasm of duodenum - Malignant neoplasm of small intestine, unspecified
C18.0 - C19 Malignant neoplasm of cecum - Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
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
C33 - C34.92 Malignant neoplasm of trachea - Malignant neoplasm of unspecified part of left bronchus or lung
Z85.038 Personal history of other malignant neoplasm of large intestine
Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus

Group 18

(23 Codes)
Group 18 Paragraph

CPT Code 81311 (NRAS) is considered medically necessary for the following ICD-10-CM codes

Group 18 Codes
Code Description
C17.0 - C17.9 Malignant neoplasm of duodenum - Malignant neoplasm of small intestine, unspecified
C18.0 - C19 Malignant neoplasm of cecum - Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
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
Z85.038 Personal history of other malignant neoplasm of large intestine
Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus

Group 19

(24 Codes)
Group 19 Paragraph

CPT Code 81314 (PDGFRA only) is considered medically necessary for the following ICD-10-CM codes:

Group 19 Codes
Code Description
C49.A0 - C49.A9 Gastrointestinal stromal tumor, unspecified site - Gastrointestinal stromal tumor of other sites
C92.10 - C92.12 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission - Chronic myeloid leukemia, BCR/ABL-positive, in relapse
C93.10 - C93.12 Chronic myelomonocytic leukemia not having achieved remission - Chronic myelomonocytic leukemia, in relapse
D48.110 - D48.19 Desmoid tumor of head and neck - Other specified neoplasm of uncertain behavior of connective and other soft tissue

Group 20

(1 Code)
Group 20 Paragraph

CPT code 81332 (SERPINA1) is considered medically necessary for the following ICD-10-CM code:

Group 20 Codes
Code Description
E88.01 Alpha-1-antitrypsin deficiency

Group 21

(23 Codes)
Group 21 Paragraph

CPT codes 81340 (TRB@, PCR), 81341 (TRB@ Southern blot), and 81342 (TRG@) are considered medically necessary for the following ICD-10-CM codes:

Group 21 Codes
Code Description
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C95.90 - C95.92 Leukemia, unspecified not having achieved remission - Leukemia, unspecified, in relapse
C96.20 Malignant mast cell neoplasm, unspecified
C96.21 Aggressive systemic mastocytosis
C96.22 Mast cell sarcoma
C96.29 Other malignant mast cell neoplasm
D47.01 Cutaneous mastocytosis
D47.02 Systemic mastocytosis
D47.09 Other mast cell neoplasms of uncertain behavior
D60.0 Chronic acquired pure red cell aplasia
D60.1 Transient acquired pure red cell aplasia
D60.8 Other acquired pure red cell aplasias
D61.01 Constitutional (pure) red blood cell aplasia
D61.09 Other constitutional aplastic anemia
D61.1 Drug-induced aplastic anemia
D61.2 Aplastic anemia due to other external agents
D61.3 Idiopathic aplastic anemia
D61.89 Other specified aplastic anemias and other bone marrow failure syndromes
D61.9 Aplastic anemia, unspecified

Group 22

(40 Codes)
Group 22 Paragraph

CPT code 81168 CCND1/IGH is considered medically necessary for patients who have non- Hodgkin’s lymphoma.

Group 22 Codes
Code Description
C85.10 - C85.99 Unspecified B-cell lymphoma, unspecified site - Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites

Group 23

(6 Codes)
Group 23 Paragraph

CPT codes 81404 and 81405 (RET- MEN Types 2B (81404) and 2A (81405) are considered medically necessary for the following ICD-10-CM codes:

Group 23 Codes
Code Description
C73 Malignant neoplasm of thyroid gland
C74.10 - C74.12 Malignant neoplasm of medulla of unspecified adrenal gland - Malignant neoplasm of medulla of left adrenal gland
C75.0 Malignant neoplasm of parathyroid gland
D35.1 Benign neoplasm of parathyroid gland

Group 24

(1 Code)
Group 24 Paragraph

CPT code 81406 (ATP7B) is considered medically necessary for the following ICD-10-CM code:

Group 24 Codes
Code Description
E83.01 Wilson's disease

Group 25

(67 Codes)
Group 25 Paragraph

CPT codes 81518, 81519, 81522, 81523 (Oncology, breast mRNA) and CPT 81520 Prosigna® Breast Cancer Prognostic Gene Signature Assay are considered medically necessary for the following ICD-10-CM codes:

Group 25 Codes
Code Description
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
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
Z17.0 Estrogen receptor positive status [ER+]

Group 26

(2 Codes)
Group 26 Paragraph

CPT code 81595 Cardiology (heart transplant), mRNA is considered medically necessary for the following ICD-10-CM codes:

Group 26 Codes
Code Description
Z48.21 Encounter for aftercare following heart transplant
Z94.1 Heart transplant status

Group 27

(28 Codes)
Group 27 Paragraph

CPT code 81310 NPM1 (nucleophosmin) is considered medically necessary for the following ICD-10-CM codes:

Group 27 Codes
Code Description
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 28

(84 Codes)
Group 28 Paragraph

CPT codes 81352 TP53 (tumor protein 53) (e.g. tumor samples), targeted sequence analysis of 2-5 exons, and CPT code 81351 TP53 (tumor protein 53) (e.g. Li-Fraumeni syndrome, tumor samples), full gene sequence or targeted sequence analysis of >5 exons are considered medically necessary for the following ICD-10-CM codes

Group 28 Codes
Code Description
C88.8 Other malignant immunoproliferative diseases
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C93.12 Chronic myelomonocytic leukemia, in relapse
C93.Z0 Other monocytic leukemia, not having achieved remission
C93.Z2 Other monocytic leukemia, in relapse
C93.90 Monocytic leukemia, unspecified, not having achieved remission
C93.92 Monocytic leukemia, unspecified in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
C94.41 Acute panmyelosis with myelofibrosis, in remission
C94.42 Acute panmyelosis with myelofibrosis, in relapse
C94.6 Myelodysplastic disease, not elsewhere classified
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
C96.9 Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
D45 Polycythemia vera
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D47.1 Chronic myeloproliferative disease
D47.3 Essential (hemorrhagic) thrombocythemia
D47.4 Osteomyelofibrosis
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
D61.818 Other pancytopenia
D69.49 Other primary thrombocytopenia
D69.6 Thrombocytopenia, unspecified
D69.8 Other specified hemorrhagic conditions
D69.9 Hemorrhagic condition, unspecified
D70.8 Other neutropenia
D70.9 Neutropenia, unspecified
D72.810 Lymphocytopenia
D72.818 Other decreased white blood cell count
D72.819 Decreased white blood cell count, unspecified
D72.821 Monocytosis (symptomatic)
D72.828 Other elevated white blood cell count
D72.829 Elevated white blood cell count, unspecified
D72.89 Other specified disorders of white blood cells
D72.9 Disorder of white blood cells, unspecified
D75.81 Myelofibrosis
D75.89 Other specified diseases of blood and blood-forming organs
D75.9 Disease of blood and blood-forming organs, unspecified
D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 29

(14 Codes)
Group 29 Paragraph

CPT code 81335 TPMT gene is considered medically necessary for the following ICD-10-CM codes:

Group 29 Codes
Code Description
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission
C91.40 Hairy cell leukemia not having achieved remission
C91.50 Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission
C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission
C91.A0 Mature B-cell leukemia Burkitt-type not having achieved remission
C91.Z0 Other lymphoid leukemia not having achieved remission
K50.00 Crohn's disease of small intestine without complications
Z94.84 Stem cells transplant status

Group 30

(63 Codes)
Group 30 Paragraph

CPT code 81334 RUNX1 gene is considered medically necessary for the following ICD-10-CM codes:

Group 30 Codes
Code Description
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C93.12 Chronic myelomonocytic leukemia, in relapse
C93.Z0 Other monocytic leukemia, not having achieved remission
C93.Z2 Other monocytic leukemia, in relapse
C93.90 Monocytic leukemia, unspecified, not having achieved remission
C93.92 Monocytic leukemia, unspecified in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.6 Myelodysplastic disease, not elsewhere classified
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
C96.9 Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D61.818 Other pancytopenia
D69.49 Other primary thrombocytopenia
D69.6 Thrombocytopenia, unspecified
D69.8 Other specified hemorrhagic conditions
D69.9 Hemorrhagic condition, unspecified
D70.8 Other neutropenia
D70.9 Neutropenia, unspecified
D72.810 Lymphocytopenia
D72.818 Other decreased white blood cell count
D72.819 Decreased white blood cell count, unspecified
D75.89 Other specified diseases of blood and blood-forming organs
D75.9 Disease of blood and blood-forming organs, unspecified
D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 31

(81 Codes)
Group 31 Paragraph

CPT codes 81175-81176-ASXL1 gene is considered medically necessary for the following ICD-10-CM codes:

Group 31 Codes
Code Description
C88.8 Other malignant immunoproliferative diseases
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C93.12 Chronic myelomonocytic leukemia, in relapse
C93.Z0 Other monocytic leukemia, not having achieved remission
C93.Z2 Other monocytic leukemia, in relapse
C93.90 Monocytic leukemia, unspecified, not having achieved remission
C93.92 Monocytic leukemia, unspecified in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
C94.41 Acute panmyelosis with myelofibrosis, in remission
C94.42 Acute panmyelosis with myelofibrosis, in relapse
C94.6 Myelodysplastic disease, not elsewhere classified
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
C96.9 Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
D45 Polycythemia vera
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D47.1 Chronic myeloproliferative disease
D47.3 Essential (hemorrhagic) thrombocythemia
D47.4 Osteomyelofibrosis
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
D61.818 Other pancytopenia
D69.49 Other primary thrombocytopenia
D69.6 Thrombocytopenia, unspecified
D69.8 Other specified hemorrhagic conditions
D69.9 Hemorrhagic condition, unspecified
D70.8 Other neutropenia
D70.9 Neutropenia, unspecified
D72.810 Lymphocytopenia
D72.818 Other decreased white blood cell count
D72.819 Decreased white blood cell count, unspecified
D72.821 Monocytosis (symptomatic)
D72.828 Other elevated white blood cell count
D72.829 Elevated white blood cell count, unspecified
D72.89 Other specified disorders of white blood cells
D72.9 Disorder of white blood cells, unspecified
D75.81 Myelofibrosis
D75.89 Other specified diseases of blood and blood-forming organs
D75.9 Disease of blood and blood-forming organs, unspecified
D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 32

(68 Codes)
Group 32 Paragraph

CPT codes 81120-81121, IDH1 and IDH2, are considered medically necessary for the following ICD-10-CM codes:

CPT code 81345, TERT, is considered medically necessary for C71.0-C71.9 only.

Group 32 Codes
Code Description
C71.0 - C71.9 Malignant neoplasm of cerebrum, except lobes and ventricles - Malignant neoplasm of brain, unspecified
C88.8 Other malignant immunoproliferative diseases
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.30 Myeloid sarcoma, not having achieved remission
C92.32 Myeloid sarcoma, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C92.Z0 Other myeloid leukemia not having achieved remission
C92.Z2 Other myeloid leukemia, in relapse
C92.90 Myeloid leukemia, unspecified, not having achieved remission
C92.92 Myeloid leukemia, unspecified in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C93.12 Chronic myelomonocytic leukemia, in relapse
C93.Z0 Other monocytic leukemia, not having achieved remission
C93.Z2 Other monocytic leukemia, in relapse
C93.90 Monocytic leukemia, unspecified, not having achieved remission
C93.92 Monocytic leukemia, unspecified in relapse
C94.00 Acute erythroid leukemia, not having achieved remission
C94.02 Acute erythroid leukemia, in relapse
C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
C94.41 Acute panmyelosis with myelofibrosis, in remission
C94.42 Acute panmyelosis with myelofibrosis, in relapse
C94.80 Other specified leukemias not having achieved remission
C94.82 Other specified leukemias, in relapse
C95.00 Acute leukemia of unspecified cell type not having achieved remission
C95.02 Acute leukemia of unspecified cell type, in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
C95.90 Leukemia, unspecified not having achieved remission
C95.92 Leukemia, unspecified, in relapse
C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
D45 Polycythemia vera
D47.1 Chronic myeloproliferative disease
D47.3 Essential (hemorrhagic) thrombocythemia
D47.4 Osteomyelofibrosis
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
D72.821 Monocytosis (symptomatic)
D72.828 Other elevated white blood cell count
D72.829 Elevated white blood cell count, unspecified
D72.89 Other specified disorders of white blood cells
D72.9 Disorder of white blood cells, unspecified
D75.81 Myelofibrosis
D75.89 Other specified diseases of blood and blood-forming organs
D75.9 Disease of blood and blood-forming organs, unspecified
D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere
R16.1 Splenomegaly, not elsewhere classified
R16.2 Hepatomegaly with splenomegaly, not elsewhere classified

Group 33

(21 Codes)
Group 33 Paragraph

CPT code 81305 MYD88 is considered medically necessary for the following ICD-10-CM codes:

Group 33 Codes
Code Description
C83.00 - C83.09 Small cell B-cell lymphoma, unspecified site - Small cell B-cell lymphoma, extranodal and solid organ sites
C85.80 - C85.89 Other specified types of non-Hodgkin lymphoma, unspecified site - Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites
C88.0 Waldenstrom macroglobulinemia

Group 34

(1 Code)
Group 34 Paragraph

Use CPT code 81227 CYP2C9 for individuals who have relapsing forms of multiple sclerosis. The following ICD-10-CM diagnosis code is effective for services rendered on or after July 1. 2020.

Group 34 Codes
Code Description
G35 Multiple sclerosis

Group 35

(211 Codes)
Group 35 Paragraph

CPT code 81261, 81262, 81263, and 81264 (IGH) are considered medically necessary for the following ICD-10-CM diagnosis codes. Please use Modifier 91 as appropriate, based on the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1. Modifier 91 may be is used "to indicate that a test was performed more than once on the same day for the same patient., only when it is necessary to obtain multiple results in the course of treatment."

Group 35 Codes
Code Description
C82.00 - C83.99 Follicular lymphoma grade I, unspecified site - Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites
C85.10 - C85.99 Unspecified B-cell lymphoma, unspecified site - Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites
C91.00 - C91.02 Acute lymphoblastic leukemia not having achieved remission - Acute lymphoblastic leukemia, in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
C95.10 Chronic leukemia of unspecified cell type not having achieved remission
C95.11 Chronic leukemia of unspecified cell type, in remission
C95.12 Chronic leukemia of unspecified cell type, in relapse
D72.828 Other elevated white blood cell count
D72.89 Other specified disorders of white blood cells
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

(9 Codes)
Group 1 Paragraph

The following ICD-10-CM codes are considered non-covered for all molecular pathology procedures:

Group 1 Codes
Code Description
Z13.71 Encounter for nonprocreative screening for genetic disease carrier status
Z13.79 Encounter for other screening for genetic and chromosomal anomalies
Z31.430 Encounter of female for testing for genetic disease carrier status for procreative management
Z31.438 Encounter for other genetic testing of female for procreative management
Z31.440 Encounter of male for testing for genetic disease carrier status for procreative management
Z31.441 Encounter for testing of male partner of patient with recurrent pregnancy loss
Z31.448 Encounter for other genetic testing of male for procreative management
Z31.5 Encounter for procreative genetic counseling
Z36.0 Encounter for antenatal screening for chromosomal anomalies
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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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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.

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
01/01/2024 R24

- ICD-10-CM codes C91.10 and C91.11 have been added to the ICD-10-CM Codes that Support Medical Necessity section- Group 29.

- Due to the 1/1/2024 CPT/HCPCS quarterly update, the following code descriptors have been changed in Group1- 81449 and 81456. Group 3- 81171, 81172, 81243, and 81244.

10/01/2023 R23

Effective for services rendered on or after 10/1/2023, due to the annual ICD-10-CM update, the ICD-10-CM That Supports Medical Necessity section- Group 7 was updated with the following: diagnosis codes I20.8 was deleted and replaced by I20.81 and I20.89. Diagnosis code I24.8 was deleted and replaced by I24.81 and I24.89.

The ICD-10-CM That Supports Medical Necessity section- Groups 14 and 19 was updated with the following: diagnosis codes: D48.1 was deleted and replaced by code range D48.110 through D48.19. 

 

 

08/06/2023 R22

Due to a typographical error in the Notice Period, the effective date has been moved to August 6, 2023.

08/01/2023 R21

- Deleted CPT code 81352 from CPT/HCPS Section Group 2

- Established Group 35 under the "ICD-10-CM Codes that Support Medical Necessity" section for CPT codes 81261-81264, effective for services rendered on or after August 1, 2023.

- Added Modifier 91 to the CPT/HCPCS Modifier section. The 91 modifier is used for laboratory tests paid under the clinical laboratory fee schedule, as stated in the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1.

- Added the following Modifier 91 information to the Article Text:

Modifier 91

Please use Modifier 91 as appropriate, based on the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1. Modifier 91 may be is used "to indicate that a test was performed more than once on the same day for the same patient., only when it is necessary to obtain multiple results in the course of treatment."

01/01/2023 R20

Added CPT codes 81449, 81451, and 81456 to Specific Coding of Molecular Testing Panels in the "Article Text" section.

Added CPT codes 81418 and 81441 to the "CPT/HCPCS Code" section-Group 2 (Individual Review).

Deleted the “ICD10 Codes That Support Medical Necessity “ section- Group 6- CPT Code 81313 (PCA3). Please refer to L37733 Biomarker Testing for Prostate Cancer.

11/01/2022 R19

CPT code 81313 has been removed from Group 1- Tier 1 Covered codes section ( Please refer to L37733 Biomarkers for Prostate Cancer Diagnosis)

CPT code 81551 has been removed from Group 3 Tier 1 Non-covered codes section ( Please refer to L37733 Biomarkers for Prostate Cancer Diagnosis)

Duplicative language currently in L35000 regarding medical necessity ( Abstract and Indications of Coverage by CPT Code) have been removed from A56199. ( Please refer to L35000)

10/01/2022 R18

Due to the annual ICD-10-CM code update, the following codes had descriptor changes occur in the ICD-10-CM section that supports Medical Necessity.: C94.6 descriptor was changed in Group 14; C94.6 descriptor was changed in Group 29; 
C94.6 descriptor was changed in Group 31; C94.6 descriptor was changed in Group 32. 

05/01/2022 R17

5/1/2022  Correction: ICD-10-CM diagnosis code, C56.3  is effective for services rendered on or after 10/1/2021,

05/01/2022 R16

Added ICD-10-CM diagnosis code C56.3 to the "ICD-10-CM Codes that Support Medical Necessity" section- Group1, effective for services rendered on or after 5/1/2022.

04/01/2022 R15

The following, underlined language was added to the Correct Coding of Molecular Testing Panels under Specific Coding of Molecular Testing Panels in the Article text:

CPT code 81455 should be billed when 51 or greater genes are ordered for molecular biomarkers. Please refer to Local Coverage Determination L37810 Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms and the associated Article A56867

CPT code 81455 was removed from CPT/HCPCS Code section-Group 3.

 

01/01/2022 R14

Due to the annual CPT/HCPCS code update, CPT code 81523 was added to the CPT/HCPCS Codes section- Group 1,  and CPT code 81349 was added to the CPT/HCPCS Codes section- Group 3.

CPT codes 81522 and 81523 were added to the "ICD-10-CM Codes that Support Medical Necessity" section- Group 26 paragraph, effective for services rendered on or after 1/1/2022.

11/30/2021 R13

CPT code 81546 was deleted from CPT/HCPCS Codes section- Group 2. Please refer to LCD L38968 Thyroid Nodule Molecular Testing and Billing and Coding Article A58656.

05/15/2021 R12

-The following clarifying guidance which was published on our website on 7/29/2021 regarding the Correct Coding of Molecular Testing Panels was added under Specific Coding of Molecular Testing Panels in the Article text above:

The submission of claims using individual gene CPT codes, when either 5-50 or >50 gene panels are ordered, is considered incorrect coding. Correct coding requires that when a panel code is ordered, it should be billed, rather than the individual gene codes. CPT code 81445 or 81450 should be billed when 5 to 50 genes are ordered. CPT code 81455 should be billed when 51 or greater genes are ordered for molecular biomarkers. When a panel with greater than one or less than five genes is ordered, use the corresponding existing panel CPT code or CPT code 81479 if none exists.

-The following note was added to the CPT/HCPCS Section paragraph- Group 4:

Note: When a panel with greater than one or less than five genes is ordered, use the corresponding existing panel CPT code or CPT code 81479 if none exists.

05/15/2021 R11

Added CPT code 81353 which had been inadvertently omitted to CPT/HCPCS Code section-Group2, effective January 1, 2021.

Deleted SCA1 CPT code 81479 from the CPT/HCPCS code section- Group 4 Paragraph, Tier 2/NOC Non-covered Code/Gene Combinations, due to the inadvertent inclusion of SCA1 as a gene in error.

Added PLA code 0070U to the ICD-10-CM Diagnosis Codes That Support Medical Necessity and to the Paragraph, Group 9, effective May 15, 2021

Added PLA code 0070U to CPT/HCPCS Code Section- Group 1, effective May 15, 2021

04/01/2021 R10

Added Proprietary Laboratory Analysis (PLA) code 0027U  to the coding information section.:

CPT Codes 81279 JAK2 (Janus kinase 2) (eg, myeloproliferative disorder), (exon 12 sequence and exon 13 sequence) and 0027U (Janus kinase 2) (e.g., myeloproliferative disorder), gene analysis, targeted sequence analysis exons 12-15 are considered medically necessary in the initial work-up of BCR-ABL and JAK2 (V617F variant) negative adults with clinical, laboratory, or pathological findings suggesting polycythemia vera.

Added PLA code 0027U to the CPT/HCPCS Code section-Group 1.

Added PLA code 0027U to the ICD-10-CM Diagnosis Codes That Support Medical Necessity section-Group 14.

01/01/2021 R9

Due to the HCPCS update, effective 1/1/2021, the following CPT codes were added to the Group 1 tabular CPT code listing: 81168, 81338, 81339, 81347, 81348, 81351, 81352 and removed from the Group 1 paragraph section.

Due to the HCPCS update, effective 1/1/2021, the following CPT codes were added to the Group 2 tabular code listing: 81191, 81192, 81193, 81194, 81353, 81357, 81419, 81529, 81546, 81554, and 81360 and removed from the Group 2 paragraph section.

Due to the annual HCPCS update, CPT code 81545 was deleted from Group 3, effective 1/1/2021:



01/01/2021 R8

The Indications of Coverage by CPT code section was revised as follows:

CPT Code 81401 was replaced by CPT codes (81168) CCND1/IGH;(81278) BCL1/IgH, t

CPT Code 81402 was replaced by CPT code (81338) MPL

CPT Code 81403 was replaced by CPT code 81339) MPL

CPT Code 81403 was replaced by CPT code (81279) JAK2

CPT code 81404 was replaced by CPT code (81352) TP53, and CPT code 81405 was replaced by CPT code (81351) TP53

CPT code 81479 was replaced by CPT code (81347) RARS

The CPT/HCPCS Codes Section was revised as follows:

Group 1 Tier 1 Covered Codes: Added CPT codes 81168, 81338, 81339, 81347, 81348, 81351, 81352.

Group 2 Tier 1 Individual Review Codes: Added CPT codes 81191, 81192, 81193, 81194, 81353, 81357, 81419, 81529, 81546, 81554, 81360.

Group 4 Tier 2 CPT and NOC Codes: CPT code 81401 CND1/IGH was replaced by 81168-now in Group 1; CPT code 81405 TP53 was replaced by 81353- now in Group 2 ; CPT code 81479 RARS was replaced by 81347- now in Group 1.

ICD-10 Codes that Support Medical Necessity Section was revised as follows

Group 14: Paragraph: CPT codes Deleted code 81402 MPL was replaced by 81338; 81403 MPL was replaced by 81339, and 81403 JAK2 was replaced by 81279.

Group 23: Paragraph: CPT code 81401 CCND1/IGH was replaced by 81168.

Group 29: Paragraph: CPT codes 81404 TP53 was replaced by 81352; CPT code 81405 TP53 was replaced by 81351.

 

 

07/01/2020 R7

Deleted 81227 from the CPT/HCPCS section Group 3 and added CPT code 81227 to the “CPT/HCPCS section” Group 1.

Added 81227 to the “ICD-10-CM that support Medically Necessity section-Group 35

Added the following explanatory language to the Article Text: Use 81227 for CYP2C9 genotyping for individuals who have a relapsing form of multiple sclerosis, and require CYP2C9 genotyping for dosing in accordance with the FDA prescribing information for Mayzent. CYP2C9 testing must include the *1, *2, and *3 alleles that are necessary to safely dose the FDA-approved drug Mayzent.

01/01/2020 R6

The following wording for CPT code 81445 was corrected:

"please refer to LCD L36376" was revised to read "please refer to L37810".

01/01/2020 R5

Due to the annual CPT/HCPCS code update, CPT codes 81307-81309, 81522, and 81552 have been added to Group1- Tier 1 Covered Codes. CPT codes 81277 and 81542 have been added to CPT/HCPCS Codes Group2- Individual Review, effective for services rendered on or after January 1, 2020.

 

The following Revision History language, effective for services rendered on or after 1/1/2019, was relocated from the Article Text section to the Revision History section:

" Annual CPT/HCPCS Revisions Effective 1/1/2019

Due to the annual CPT/HCPCS Code update and transition of coding guidance to this article, the following codes have been deleted from Group 1 in LCD L35000: CPT codes 81211, and 81213 have been deleted- to report see CPT code(s) 81162, 81163, 81164; CPT code 81214 has been deleted- to report see CPT codes 81165, 81166.

Due to the annual new CPT/HCPCS Code update and transition of coding guidance to this article, the following new 2019 CPT codes have been added to The CPT/HCPCS section -Group 2 which will require individual review: CPT codes 81177, 81178, 81179, 81180, 81181, 81182, 81183, 81184, 81185, 81186, 81187, 81188, 81189, 81190, 81233, 81306, 81312, 81320, 81333, 81343, 81344.

Due to the annual new CPT/HCPCS Code update and transition of coding guidance to this article, the following new Tier 1, 2019 CPT codes replaced existing Tier 2 Non-covered codes and have been added to the CPT/HCPCS section- Group 3: CPT codes 81171, 81172, 81173, 81174, 81204, 81234, 81239, 81271, 81274, 81284, 81285, 81286, 81289, 81329, 81336, and 81337. CPT code 81443 was added to CPT/HCPCS section- Group 3 because it is considered screening and is not covered.

Due to the annual new CPT/HCPCS Code update and transition of coding guidance to this article, the following new Tier 1, 2019 CPT codes 81305, and 81518 replaced existing Tier 2 Covered codes and were added to CPT/HCPCS section- Group 1. CPT codes 81236, 81237, and 81345 were added to CPT/HCPCS Group 1 due to prior existing coverage.

CPT code 81518 was added to ICD10-CM That Supports Medical Necessity section -Group 26.

CPT code 81305 replaced 81479 and was added to ICD10-CM That Supports Medical Necessity section -Group 34.

CPT codes 81163, 81164, 81165, 81166, and 81167 were added to ICD10-CM That Supports Medical Necessity section -Group 1.

CPT code 81345 was added to ICD10-CM That Supports Medical Necessity section -Group 33."

10/15/2019 R4

Added ICD-10-CM diagnosis code D45 to the "ICD-10 Codes that Support Medical Necessity" section-Group 14, effective for services rendered on or after 10/15/2019.

10/03/2019 R3

This article was converted to the new Billing and Coding Article type.

Bill types and Revenue codes have been removed from this article. Guidance on these codes is available in the Bill type and Revenue code sections.

08/15/2019 R2

The title has been changed from "Molecular Pathology Procedures- Related to Molecular Policy Procedures LCD (L35000)" to Billing and Coding: Molecular Pathology Procedures.

01/01/2019 R1

Corrected URL.

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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
L35000 - Molecular Pathology Procedures
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
Title XVIII of the Social Security Act (SSA)
Description: Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
Title XVIII of the Social Security Act (SSA)
Description: Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Title XVIII of the Social Security Act (SSA)
Description: Section 1862(a)(7) excludes routine physical examinations, unless otherwise covered by statute.
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Rules and Regulations URLs
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CMS Manual Explanations URLs
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.1
Description: Laboratory services must meet applicable requirements of CLIA
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 16, Section 40.7
Description: Billing for Noncovered Clinical Laboratory Tests Section and 120.1 Clarification of the Use of the Term “Screening” or “Screen”
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50
Description: Advance Beneficiary Notice of Noncoverage (ABN)
CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.6. 5
Description: Describes the Surgical/Cytopathology Exception.
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Other URLs
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Public Versions
Updated On Effective Dates Status
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09/18/2023 10/01/2023 - 12/31/2023 Superseded View
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Keywords

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