Wednesday, November 13, 2019

CPT 81225, 81226, 81227 - Genotype-Guided Tamoxifen Treatment

Code Description CPT

81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17) 

81226 CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN) 

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6) 

81479 Unlisted molecular pathology procedure

81599 Unlisted multianalyte assay with algorithmic analysis



Genotype-Guided Tamoxifen Treatment

Introduction


Certain types of breast cancer are affected by hormones. Cancer cells that are said to be estrogen receptor positive (ER-positive) have receptors that attach to estrogen. Once attached, estrogen then acts like a fertilizer to help the cancer grow. Hormone therapy is used to prevent estrogen from connecting to the receptors. Tamoxifen is a type of hormone therapy that can be used for ER-positive breast cancer to prevent it from coming back and to treat breast cancer that’s already spread to other parts of the body. It’s also used for ER-positive ductal carcinoma in situ (DCIS). To process tamoxifen into its more active form, the body uses a specific, important enzyme (CYP2D6) that’s made by a particular gene. A small percentage of people (about 10%) have a form of the gene that doesn’t make as much of this important enzyme as most other people make. A genetic test has been developed to try to see if a person has the gene form that makes a smaller amount of the needed enzyme. This genetic test is investigational (unproven). Large, well-designed medical studies don’t show a strong link between this gene and tamoxifen’s effectiveness. More studies are needed. 

Note:  The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria  Test Investigational  Cytochrome P450 2D6 (CYP2D6) testing 

Coding 


Genotyping to determine cytochrome P450 2D6 (CYP2D6) variants is considered investigational for the purpose of managing treatment with tamoxifen for women at high risk for or with breast cancer.



Related Information 

Genetics Nomenclature Update


The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics. It is being implemented for genetic testing medical evidence review updates starting in 2017 (see Table 1).


The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology*“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”*to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA 

Previous  Updated  Definition
Mutation Disease-associated variant
Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology. 


Description

Tamoxifen is prescribed as a component of adjuvant endocrine therapy to prevent endocrine receptor-positive breast cancer recurrence, to treat metastatic breast cancer, and to prevent disease in high-risk populations and in women with ductal carcinoma in situ. Tamoxifen is a prodrug that undergoes extensive metabolism to yield its active form: 4-hydroxy tamoxifen and endoxifen (primary active form) via the CYP2D6 enzyme. Variants in the CYP2D6 gene are associated with significant alterations in endoxifen concentrations leading to the hypothesis that CYP2D6 variation may affect the clinical outcomes of women treated with tamoxifen but not with drugs not metabolized by CYP2D6, such as anastrozole. Gene Expression-Based Assays for Cancers of Unknown Primary

Thursday, October 17, 2019

CPT 81504, 81540, 81599 - Oncology (tissue of origin)

Coding    Code Description CPT

81479 Unlisted molecular pathology procedure

81504 Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores

81540 Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81599 Unlisted multianalyte assay with algorithmic analysis


Introduction

A primary site is the part of the body where cancer started. Cancers are named on this primary site, even when they spread to other parts of the body. For example, if cancer starts in the breast but spreads to the bones, lungs, or liver, it is still classified as breast cancer. Cancer treatment is often based on the primary cancer. In rare cases, a cancer may have already spread before the original cancer is found. This is known as cancer of unknown primary. Cancers of unknown primary happen in three to four percent of all cancers in the United States. Certain genetic tests are being studied as one way to try to find the original site of the cancer. There is not yet enough scientific evidence about how these genetic tests might affect overall health outcomes. These tests are considered unproven (investigational).


Policy Coverage Criteria 

Type of Test Investigational


Gene expression profiling Gene expression profiling is considered investigational to evaluate the site of origin of a tumor of unknown primary, or to distinguish a primary from a metastatic tumor.

Related Information 

Genetics Nomenclature Update


The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the Human Genome Organization, and by the Human Genome Variation Society itself.


The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA
Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence
 Variant Change in the DNA sequence 

Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives
Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification  Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of  genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing,  including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the  utilization of genetic testing substantially and may reduce  inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review 

Description


Cancers of unknown primary represent 3% to 4% of cancers diagnosed in the United States. These cancers are heterogeneous and many accompanied by poor prognoses. A detailed history and physical combined with imaging and tissue pathology can identify some, but not all, primary sources of secondary tumors. It is suggested that identifying the likely primary source with gene expression profiling to direct treatment may improve health outcomes.

Background

Cancers of Unknown Primary

Cancers of unknown primary (CUPs), or occult primary malignancies, are tumors that have metastasized from an unknown primary source; they make up about 3% to 4% of all cancers in the United States. Identifying the primary origin of a tumor can dictate cancer-specific treatment, expected outcome, and prognosis.

Most CUPs are adenocarcinomas or undifferentiated tumors; less commonly, they may be squamous carcinomas, melanoma, soft tissue sarcoma, or neuroendocrine tumors. Osteo- and chondrosarcomas rarely produce CUPs. The most common primary sites of CUPs are the lung and pancreas, followed by colon and stomach, then breast, ovary, prostate, and solid-organ carcinomas of the kidney, thyroid, and liver. Conventional methods used to aid in the identification of the origin of a CUP include a thorough history and physical examination; computed tomography scans of the chest, abdomen, and pelvis; routine laboratory studies; and targeted evaluation of specific signs and symptoms.

Diagnosis and Classification


Biopsy of a CUP with detailed pathology evaluation may include immunohistochemical (IHC) analysis of the tumor. IHC analysis identifies different antigens present in different types of tumors and can usually distinguish an epithelial tumor (ie, carcinoma) from melanoma or sarcoma. Detailed cytokeratin panels often allow further classification of carcinoma; however, tumors of different origins may show overlapping cytokeratin expression. Results of IHC may provide a narrow differential of possible sources of a tumor’s origin, but not necessarily a definitive answer.
Recent advances in the understanding of gene expression in normal and malignant cells have led researchers to explore molecular classification to improve the identification of the site of origin of a CUP. The molecular classification of cancers is based on the premise that, despite different degrees of differentiation, tumors retain sufficient gene expression “signatures” as to their cell of origin, even after metastasis. Theoretically, it is possible to build a gene expression database spanning many different tumor types to compare to the expression profile of very poorly differentiated tumors, or a CUP, to aid in the identification of the tumor type and organ of origin. The feasibility of using molecular classification schemes with gene expression profiling (GEP) to classify these tumors of uncertain origin has been demonstrated in several studies.

Tissue of Origin Testing, Treatment Selection, and Health Outcomes 


Patients with CUP have generally poor prognoses. For example, patients with disease limited to lymph nodes have a median survival of 6 to 9 months, and those with a disease that is extranodal 2 to 4 months.

The premise of tissue of origin testing in CUPs is that identifying a likely primary tumor site will inform treatment selection leading to improved survival and other outcomes or as a predictive test. To evaluate whether treatment selection can be improved, the ability of a test to suggest a likely site of origin (clinical validity) must be first be shown. But demonstrating clinical validity may be problematic because patients with CUPs have no identified primary tumor for a reference standard.
Imperfect reference standards must be relied on such as the available presumptive or a reference pathologic diagnosis, known tumor types, or comparisons IHC. A primary tumor diagnosed during follow-up might also be used as a reference standard, but its use would be subject to potential selection bias. Therefore, even substantial evidence supporting the ability of a test to suggest a likely site of origin will be insufficient to infer benefit. Convincing evidence for benefit requires demonstrating that using a test to select treatment will improve outcomes. 


The Tissue of Origin test (formerly known as the PathWork Tissue of Origin Test and ResponseDX: Tissue of Origin; Cancer Genetics) measures the expression of 2000 genes and compares the similarity of the GEP of a CUP to a database of known profiles from 15 tissues with more than 60 histologic morphologies. The report generated for each tumor comprises a “similarity score,” which is a measure of similarity of GEP of the specimen to the profile of the 15 known tumors in the database. Scores range from 0 (very low similarity) to 100 (very high similarity), and sum to 100 across all 15 tissues on the panel. If a single similarity score is 30 or more, it indicates that this is likely the tissue of origin. If every similarity score is between 5 and 30, the test result is considered indeterminate, and a similarity score of less than 5 rules out that tissue type as the likely origin. PathWork Diagnostics developed the test, but the company filed for bankruptcy in early 2013; Response Genetics purchased its assets, and it, in turn, was acquired by Cancer Genetics in late 2015.
An alternative method to measure gene expression is real-time quantitative polymerase chain reaction (RT-qPCR). RT-qPCR can be used at the practice level; however, it can only measure, at most, a few hundred genes, limiting tumor categorization to 7 or fewer types. Tumor classification accuracy rates using real-time polymerase chain reaction have been reported to be as high as 87%, but lower (71%) for more undifferentiated tumors.

 One assay that uses RT- qPCR is the CancerTYPE ID (Biotheranostics) assay, which measures the expression of messenger RNA in a CUP tissue sample. Samples for this are ormalin-fixed,  paraffin-embedded (FFPE) tissue sections or unstained 10 micron sections on glass slides. Expression levels of 92 genes (87 tumor-associated genes and 5 reference  genes for normalization) are used to detect 27 tumor types in a known database of 578 tumors with a range of 5 to 49 tumors per type. The report generated is the  probability for the main cancer type, possible subtypes, tumor types not able to be excluded, and those ruled out with 95% confidence calculated by K nearest neighbor  analysis.

Wednesday, September 25, 2019

CPT T1016, T1017 - Targeted case Managment services

CPT Code Definition

T1016 Case management, each 15 minutes
T1017 Targeted case management, each 15 minutes


DESCRIPTION OF SERVICES

Targeted case management (TCM) programs are available to assist participants with gaining access to the full range of available mental health services, as well as to any needed medical, social, financial, counseling, educational, housing, and other supportive services needed in order to maintain stability in the community.  TCM is available to adults, as well as children and adolescents. Each population must meet the state of Maryland’s medical necessity criteria for TCM services. Adult TCM services offer two levels of service intensity depending on the needs of the participant.

TCM providers will need to clearly articulate the requested intensity of services and rationale when entering authorization requests in ProviderConnect. Child and adolescent TCM (also known as care coordination services) providers have three levels of intensity to select depending on the needs of the participant. Child and adolescent TCM providers need to clearly articulate the requested intensity and rationale when entering authorization requests in Provider Connect.

SERVICE RULES

The TCM service provider is expected to exchange information and coordinate care with the participant’s PCP and other treatment (i.e. substance use disorder treatment, therapist, psychiatrist, etc.) providers when clinically appropriate and with consent when required.   One unit of TCM service for an adult is any service provided on any given date of service where the contact is a minimum of one hour of either face-to-face contact with the participant or contacts with stakeholders and service providers on behalf of the participant. The level of TCM services is based on the severity of the participant's mental illness (Please see Section 7.21 for more information). 


**Adult Level I (Adult General) TCM has a maximum of two units of service per month.  

**Adult Level II (Adult Intensive) TCM has a maximum of five units of service per month.  

One unit of service for a child or adolescent TCM is any service provided on any given date of service where the contact is a minimum of 15 minutes of face-to-face contact with the participant, the minor’s parent/guardian, or contacts with stakeholders and service providers on behalf of the participant. The level of TCM services is based on the severity of the participant's mental illness (Please see Section 7.20 for more information).

**Child and adolescent, Level I (General) TCM has maximum of 12 units of service per month.  A minimum of two units of face-to-face contacts with the participant are required. 

**Child and adolescent Level II (Moderate) TCM services have a maximum of 30 units per month and a minimum of four units of face-to-face contact with the participant. 

**Child and adolescent Level III (Intensive) TCM services have a maximum of 60 units per month. A minimum of six units of face-to-face contact with the participant are required.

For child and adolescent Level I and Level II TCM services, four additional units of service above and beyond the monthly maximum may be billed during the first month of service to the participant and every six months thereafter to allow for comprehensive assessment and reassessment of the participant.

A unit of service for telephonic contact for a child and adolescent TCM participant may not be reimbursed unless the provider has delivered at least eight minutes of service.



REIMBURSEMENT POLICY Mental Health-Targeted Case Management Services


Mental  Health-Targeted Case Management  (MH-TCM) services help adults with a serious and persistent mental  illness (SPMI) and children with a severe emotional disturbance (SED) gain access to needed medical, social, educational, vocational, financial and other necessary services as they relate to the recipient’s   mental  health needs. Coverage is a health plan responsi  bility  for Blue Plus® Minnesota Health Care Program (MHCP) groups.

Policy Statement

MH-TCM services are eligible for Minnesota Health Care Programs (MHCP) subscribers.  

Billing

MH-TCM is   a professional service billed on an 837P cl  aim fo rmat. When billing for MH-TCM,  submit the contracting provider NPI number cu  rrently on file with Blue Plus®. In addition, an individual rendering NPI number is   required when a county contracts   providers to do this   and they bill under a Behavioral Health Clin ic, and individual NPI number is   required on the claim. Without an individual NPI,   cl  aims rej ect as needing one. When a county bills   through a Soci  al Service Agency  , an individual NPI in not needed.

Codes Modifiers Brief Description  Service Limitation

T1017 for HIS/638 and FQHC billing only     HE, HA   Face-to-face encounter (child under age 18 years)       1 unit per encounter

T1017 for HIS/638 and FQHC billing only      HE      Face-to-face encounter (age 18 or older)      1 unit per encounter


CLAIMS PROCESS

**Providers should not submit claims unless the service has been authorized by Beacon 

**Claims should be submitted on a CMS 1500 form.  

**Case management assessment (CPT Code H0031) does not require pre-authorization for adults.  

**Adult TCM is billed as a per day rate (CPT code T1016) **Child and adolescent TCM is billed per unit (CPT code T1017).

**Claims must specify ICD-10 codes, not DSM 5 codes. **Claims for unauthorized services will be denied.


Perinatal Care Coordination

Perinatal care coordination is the process of planning and coordinating care and services to meet individual needs and maximize access to necessary medical, psychosocial, nutritional, educational and other services for the pregnant woman.

Perinatal Care Coordination Service Providers must be a licensed provider in Utah and one of the following qualified providers: 

**  Registered Nurse 
**  Certified Nurse-Midwife  
**  Certified Nurse Practitioner  
**  Social Service Worker 
**  Certified Social Worker 
**  Licensed Practical Nurse who works under the supervision of a registered nurse and has additional training and experience to be a perinatal care coordinator
**  Health Educator must have either a Bachelor’s degree in health education with a minimum of three years’ experience, at least one of which must be in a medical setting, a Master’s degree with a minimum of one year of experience working in a medical setting or with pregnant women, or a Bachelor’s degree and a certificate showing completion of a certification examination in health education.

The service is reported using HCPCS T1017 Targeted Case Management, each 15 minutes.  Limited to four (4) units in a 30-day period.

Sunday, July 21, 2019

CPT S0390, 11055, 11056, 11057, 11719, 11721, G0127, - Routine Foot Care Services

Coding   code Description CPT

11055 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); single lesion

11056 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions

11057 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); more than 4 lesions

11719 Trimming of nondystrophic nails, any number

11720 Debridement of nail(s) by any method(s); 1 to 5

11721 Debridement of nail(s) by any method(s); 6 or more

G0127 Trimming of dystrophic nails, any number

S0390 Routine foot care; removal and/or trimming of corns, calluses and/or nails and preventive maintenance in specific medical conditions (eg, diabetes), per visit

Routine Foot Care Services


Introduction


Most adults are able to provide their own routine foot care, such as trimming nails or filing calluses. Therefore, this type of foot care is not covered under the medical benefits. However, for some individuals with certain medical conditions, it may be important to have professional help with routine foot care in order to prevent serious problems. Routine foot care includes services such as cutting corns and calluses or trimming, cutting, clipping, or removing part of the nail (debridement). This benefit coverage guideline discusses when routine foot care may be covered.

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 
Coverage Guideline 

Indication Medical Necessity

Conditions associated with poor blood flow to the legs and feet

Routine foot care may be considered medically necessary for patients with conditions associated with poor blood flow to the legs and feet such as peripheral vascular disease and/or numbness (desensitization). 


Indication Medical Necessity

Routine foot care Routine foot care, such as trimming nails or removing corns and calluses, does not typically require the skills of a qualified provider of foot care services and is therefore considered not medically necessary.



ICD-10 Diagnosis Codes - Covered
A52.16 Charcot's arthropathy (tabetic)
B35.1 Dermatophitosis (Tinea unquium)
B37.2 Candidiasis of skin and nail
B52.0 Plasmodium malariae with neuropathy
E08.00 – E13.9 Diabetes Mellitus
O24.011 – O24.93 Diabetes mellitus in pregnancy
G13.0 – G13.1 Systemic atrophy and neuropathy
G6281 – G65.2 Polyneuropathies


Code Description
G73.3 Myasthenic syndromes in other diseases classified elsewhere
G90.09 Peripheral neuropathy
G99.0 Autonomic neuropathy
I70.201 – I70.799 Atherosclerosis of arteries, lower extremities
I73.00 – I79.8 Peripheral vascular disease
I80.00 – I80.3 Phlebitis and thrombophlebitis, lower extremities
I82.501 – I87.9 Chronic embolism and thrombosis, lower extremities
I89.0 Lymphedema
I99.8 Circulatory system disorder
L02.415 – L03.129 Infections of skin and subcutaneous tissue, lower limb
L11.0 Acquired keratosis follicularis
L60.0 – L60.9 Nail disorders
L84 – L85.2, L86, L87.0, L87.2, L97.501 – L97.529
Disorders of skin and subcutaneous tissue
M05.571 – M05.59 Polyarthropathies
M14.671 – M14.69 Arthropathies, Charcot's joint, ankle and foot  
M20.10 – M02.12 Hallus valgus
M34.83 Systemic sclerosis with polyneuropathy
M90.561 – M90.59 Osteonecrosis, lower ley, ankle and foot
M90.861 – M90.89 Osteopathy, lower leg, ankle and foot
Q82.0 Hereditary lymphedema
R20.0 – R20.9 Disorders of skin and subcutaneous tissue
R60.0 – R60.9 Edema
Note:  CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).


This coverage guideline describes the clinical indications for routine foot care services.  

Routine foot care includes:

* Cutting or removal of corns and calluses
* Trimming, cutting/clipping and debridement of nails

Generally, routine foot care services are performed by the member or the caregiver. However, if certain medical conditions are present they may pose a hazard when foot care is performed by a non-professional. 

The following conditions may pose a risk to life or limb loss, so a qualified provider of foot care services should perform the routine foot care. Conditions that may require a qualified provider to perform routine foot care include but are not limited to any of the following:

* Arteriosclerosis of the extremities
* Buerger’s disease (ie, thromboangiitis obliterans)
* Chronic thrombophlebitis of lower extremities
* Diabetes
* Peripheral neuropathies
* Peripheral vascular disease

This policy only addresses routine foot care. It does not address the treatment of symptomatic diseases and medical conditions of the feet, which may include:
* Bunion
* Bursitis
* Hammer toe
* Heel spur
* Ingrown toenail
* Neuroma
* Plantar fasciitis
* Sprain/strain of the foot
* Warts, including

Monday, March 11, 2019

CPT 0008M, 81460, 81465, 81504, 81520 , S3854 - Patients with Breast Cancer

Code Description CPT

0008M Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk  score (Prosigna) (code terminated 1/1/18)

81460 Whole mitochondrial genome (eg, Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with  ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence  analysis of entire mitochondrial genome with heteroplasmy detection 

81465 Whole mitochondrial genome large deletion analysis panel (eg, Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy


Code Description  detection, if performed 

81504 Oncology (tissue of origin), micro-array gene expression profiling of >2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores 

81519 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score (Oncotype DX)

81520 Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score (new code effective 1/1/18)

81521 Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffinembedded tissue, algorithm reported as index related to risk of distant metastasis (new code effective 1/1/18)

HCPCS

S3854 Gene expression profiling panel for use in the management of breast cancer treatment 




Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer


Introduction
Breast cancer is a complex disease. Scientists are learning more about breast cancer every year. In the past decade research has shown that measuring certain genes or markers in breast cancer tissue may provide information about prognosis that can be used to make decisions about therapy. Therapies for breast cancer may include surgery, radiation and chemotherapy. The size of the cancer, whether lymph nodes are involved, and what markers or genes are present in the cancer are all factors that are used to select the best treatments for a person with breast cancer. A number of tests are now offered which are specifically for early-stage, hormone-receptorpositive breast cancer. These tests provide an estimate of how likely the cancer is to recur after treatment. Using these tests, some women may decide not to have chemotherapy as a treatment when there is a low risk of recurrence. This policy describes when genetic testing to help make decisions about adjuvant treatment after breast cancer surgery may be considered medically necessary and paid for by the health plan. It also describes which tests the plan covers. Some tests need more published studies to show that they accurately describe the risk of recurrence, and those tests are considered investigational by the plan, and would not be paid for.


Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 
Policy Coverage Criteria 

Test  Medical Necessity  21-Gene reverse transcriptase polymerase chain reaction (RT-PCR) assay:

* Oncotype DX® * EndoPredict® * Breast Cancer Index® * Prosigna®

These tests may be considered medically necessary to determine recurrence risk in women with primary, invasive breast cancer meeting ALL of the following characteristics: * Unilateral tumor * Hormone receptor*positive (that is, estrogen receptor [ER]+
(positive) , or progesterone receptor [PR]+ (positive)) * Human epidermal growth factor receptor 2 (HER2)*(negative)  * Tumor size 0.6 to 1 cm with moderate/poor differentiation or  unfavorable features OR tumor size larger than 1 cm * Node-negative (lymph nodes with micrometastases which are  <2 adjuvant="" are="" aromatase="" be="" br="" chemotherapy="" considered="" decide="" eg="" endocrine="" in="" individual="" inhibitors="" mm="" nbsp="" negative="" node="" of="" on="" size="" tamoxifen="" test="" the="" therapy="" to="" treated="" use="" used="" will="" with="">treat the patient’s breast cancer (when chemotherapy is a therapeutic option)
* The test is ordered within 6 months after diagnosis * Only one of the tests is covered per individual tumor
o In unusual circumstances such as test failure or testing two separate breast cancers, individual consideration is applied

The use of these tests for other indications not outlined above are considered investigational, including but not limited to the following:  * Determination of  recurrence risk in invasive breast cancer  patients with positive lymph nodes


Test  Medical Necessity

* Predicting recurrence risk in patients with noninvasive ductal carcinoma in situ(ie, Oncotype DX® DCIS)
* Patients with bilateral breast cancer * The use of gene expression assays in men with breast cancer * To consider length of treatment with tamoxifen

Test Investigational  MammaPrint® BluePrint®

Use of 70 gene signature (MammaPrint®) for any indication is considered investigational.  The use of BluePrint® in conjunction with MammaPrint® or alone is considered investigational.

TargetPrint® Use of gene expression assays for quantitative assessment of ER, PR, and HER2 overexpression (eg, TargetPrint®) is considered investigational.
Other gene expression assays

Coding 

The use of other gene expression assays (Mammostrat® Breast Cancer Test, BreastOncPx™, NexCourse® Breast IHC4, BreastPRS™) for any indication is considered investigational.


Related Information 

Note About Testing

This policy addresses gene expression profiling in women. No peer reviewed published medical literature on the use of gene expression profiling in men with breast cancer has been identified.

Suggested Testing Management

The 21-gene RT-PCR assay Oncotype DX should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (ie, the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician- patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted for testing. It is not necessary to conduct testing on each tumor; treatment is based on the most aggressive lesion  Unfavorable features that may prompt testing in tumors from 0.6 to 1 cm in size include the following: angiolymphatic invasion, high histologic grade, or high nuclear  grade.

The 21-gene reverse transcriptase polymerase chain reaction (RT-PCR) assay Oncotype DX® should not be ordered as a substitute for standard estrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2 (HER2) testing. 

The current American Society of Clinical Oncology/College of American Pathologists joint guidelines on HER2 testing in breast cancer (Wolff et al, 2013) has defined positive, negative, and equivocal HER2 test results.

Evidence Review 

Description

Laboratory tests have been developed that detect the expression, via messenger RNA, of many different genes in breast tumor tissue and combine the results into a prediction of distant recurrence risk for women with early-stage breast cancer. Test results may help providers and patients decide whether to include adjuvant chemotherapy in postsurgical management of breast cancer or to alter treatment in patients with ductal carcinoma in situ (DCIS) , or to recommend extended endocrine therapy in patients who are recurrence-free at 5 years. This report summarizes the evidence of 5 tests, which are organized by indication: Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint, and Prosigna


Most read colonoscopy CPT codes