Procedure Code and Description
81211 BRCA1, BRCA2 (BREAST CANCER 1 AND 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND COMMON DUPLICATION/DELETION VARIANTS IN BRCA1 (IE, EXON 13 DEL 3.835KB, EXON 13 DUP 6KB, EXON 14-20 DEL 26KB, EXON 22 DEL 510BP, EXON 8-9 DEL 7.1KB)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
Genetic Testing, BRCA 1 & 2
CPT/HCPCS CODES 81162, 81211, 81212, 81213, 81214, 81215, 81216, 81217
CRITERIA FOR BRCA 1 AND 2 COMPREHENSIVE SEQUENCE ANALYSIS, FOUNDER MUTATIONS MUST MEET ALL OF THE FOLLOWING:
1. The results of the genetic testing will directly impact surveillance or treatment of the member.
2. One of the following criteria is met:
a. Three or more close relatives1 (including the member) on the same side of the family have breast (either invasive or non-invasive) or ovarian cancer (includes epithelial ovarian/fallopian tube/primary peritoneal cancers), irrespective of the age at diagnosis.
b. There are fewer than three close relatives on the same side of the family with breast or ovarian cancer, but any of the following are present:
1) The member or a close relative was diagnosed with breast cancer at = 45 years of age;
2) A close relative has been identified with a detectable BRCA 1 or 2 mutation;
3) The member or a close relative was diagnosed with breast cancer = 50 years of age and one of the following:
a) = 1 close relative was diagnosed with breast cancer at any age;
b) = 1 close relative with pancreatic cancer;
c) = 1 close relative with prostate cancer (Gleason score = 7);
d) two primary breast cancers (including bilateral disease or two or more separate primary tumors in the same breast);
e) there is an unknown or limited family history. 2
4) The member was diagnosed with breast cancer at any age and one of the following:
a) = 1 close relative was diagnosed with breast cancer = 50 years of age;
b) = 2 close relatives with breast cancer at any age;
c) = 2 close blood relatives with pancreatic cancer and/or aggressive prostate cancer (Gleason score = 7) at any age.
5) The member or a close relative was diagnosed with triple negative breast cancer = 60 years of age. 3
6) The member or a close relative was diagnosed with ovarian cancer, fallopian tube or primary peritoneal cancer at any age.
7) The member or a close relative with breast cancer is male.
8) The member or a close relative was diagnosed with breast cancer at any age and is at increased risk for specific mutation(s) due to ethnic background (for instance: Ashkenazi Jewish descent).4
c. The member or a close relative was diagnosed with pancreatic cancer at any age with = 1 close relative with ovarian cancer at any age or breast cancer = 50 or two relatives with breast, pancreatic or prostate cancer (Gleason score = 7) at any age.
d. The member or a close relative was diagnosed with prostate cancer (Gleason score =7) at any age with = 1 close relative with ovarian cancer at any age or breast cancer = 50 or two close relatives with breast, pancreatic or prostate cancer (Gleason score = 7) at any age.
e. A third-degree relative has breast and/or ovarian cancer (including fallopian tube or primary peritoneal cancer) and who has = two close relatives with breast cancer (at least one with breast cancer = 50) and/or ovarian cancer.
1 A close relative is defined as a 1st, 2nd or 3rd degree relative (a parent, full sibling, half sibling, child, grandparent, great-grandparent, grandchild, aunt, great aunt, uncle, great uncle, nephew, niece, or first cousin).
2 A limited family history is defined as fewer than two first- or second-degree female relatives or female relatives surviving beyond 45 years in either lineage (maternal and paternal). 3 Breast cancer that is negative for Estrogen receptor (ER), Progesterone receptor (PR) and HER2.
4 Authorization will initially be for the mutation(s) specific for the ethnic group in question (Multisite 3 BRACAnalysis® or equivalent testing for Founder Mutations). If the initial screening is negative, the member should be authorized for additional genetic testing (ComprehensiveSequence Analysis) only if he/she meets the remainder of the criteria.
Coverage Indications, Limitations, and/or Medical Necessity
This LCD provides limited coverage for the GeneSight® Psychotropic (AssureRx Health, Inc, Mason, OH) gene panel. GeneSight® testing may only be ordered by licensed psychiatristsor or neuropsychiatrists contemplating an alteration in neuropsychiatric medication for patients diagnosed with major depressive disorder (MDD) (in accordance with DSM IV/V criteria) who are suffering with refractory moderate to severe depression (as defined by the 17-item Hamilton Rating Scale for Depression (HAM-D17) score of 14 or greater) after at least one prior neuropsychiatric medication failure.
Background
GeneSight® Psychotropic is a multiplex pharmacogenomic test involving the analysis of fifty alleles (SNPs) from six different genes and a clinical outcomes-based decision support modeling tool that weights the influence of the various alleles/SNPs with respect to thirty-two different psychotropic pharmaceutical agents. The test results in the differentiation of psychoactive drugs that are likely to be effective and well-tolerated by a particular patient versus those that are not. In multiple prospective clinical studies, the use of GeneSight® to guide neuropsychiatric pharmaceutical selection and prescription has demonstrated an increased patient response to treatment from 60% to 250% (as measured by the standardized 17-item Hamilton Rating Scale for Depression or HAM-17; response is defined as = 50% reduction in HAM-D17 score) versus unguided, empirical treatment (or treatment as usual).
GeneSight® has particular relevance for Medicare beneficiaries, 26% of whom experience a mental disorder each year. Additionally, six out of ten disabled Medicare beneficiaries (~3.7 million) under age 65, representing roughly 17% of all beneficiaries, have a diagnosis of mental disorder. Furthermore, the American Psychiatric Association (APA) recognizes depression as the most common mental disorder in people aged 65 and older. It frequently appears as a co-morbid symptom to other conditions and can even mimic the symptoms of dementia. As a group, seniors generally take more medications than other age groups, increasing their risk of drug-drug interactions and adverse drug events (ADEs).
The GeneSight® report segments and displays these psychotropic medications into three “traffic light” categories or “bins” – green, yellow and red. Based on the patient’s genetic make-up and the drug’s metabolic and therapeutic pathways, the green bin identifies drugs that will likely be well tolerated and efficacious for the tested patient; the yellow bin identifies drugs with an intermediate effect; and the red bin identifies drugs likely to be poorly tolerated and/or ineffective. The report also identifies common drug-drug interactions that are similarly influenced by the patient’s genetic composition.
Pine Rest Study
The Pine Rest study was a prospective, patient- and rater-blinded, randomized controlled trial evaluating the clinical impact of GeneSight® on antidepressant selection and treatment outcomes in depressed outpatients (GeneSight®, N=25 vs treatment as usual (TAU), N=24). Patients were assessed for symptom improvement, remission and response from baseline (week 0) and at 2, 4, and 8 weeks, using the HAM-D17 rating.
Subjects in the GeneSight® arm had a greater average decrease in the 17-item Hamilton Rating Scale for Depression (HAM-D17) scores from baseline at 8 weeks (p = 0.30) and a higher response rate (p = 0.055) and significantly higher remission rate (p = 0.012) at any time point. Response rates in the GeneSight®-guided arm were 73% higher compared to the unguided TAU arm. Retrospective analysis of the TAU subjects at the end of the study after un-blinding and stratifying by GeneSight® results proved the clinical validity of GeneSight®, with 30% of subjects unknowingly on red bin medications showing a significant worsening of depressive symptoms in contrast to significant improvements in depressive symptoms experienced by 30% of subjects unknowingly on green bin medications (p = 0.07). Additionally, surveys from the treating clinicians revealed that the GeneSight® composite report had a significant influence on treatment decisions for 65% of the GeneSight® subjects.
Hamm Study
The Hamm Clinic prospective cohort study with two arms (GeneSight® (n = 22) vs. TAU (n = 22)) enrolled adult patients with a primary diagnosis of major depressive disorder utilizing DSM-IV criteria for depression not otherwise specified. GeneSight® subjects achieved greater reductions in depression symptoms between the baseline and the week 8 visits compared to TAU subjects using the Quick Inventory of Depressive Symptomatology – Clinician version (QIDS-C16) (p = 0.0024) and HAM-D17 (p = 0.042) ratings. Both the response and remission rate were more than doubled in the GeneSight® arm compared to the TAU arm. Upon unblinding the TAU group at the end of 8 weeks, TAU subjects were being prescribed significantly more red and yellow bin medications and less green bin medications compared to the GeneSight® guided subjects (p = 0.02).
La Crosse
In the La Crosse prospective cohort study (GeneSight® (n = 72) vs. TAU (n = 93)) at the Franciscan Skemp Hospital in La Crosse, Wisconsin, patients with a primary diagnosis of MDD or depression not otherwise specified with a minimum score of 14 on HAM-D17 were enrolled. Diagnosis was confirmed by checking the diagnosis reported in the physician clinical notes in the electronic medical record (EMR). Samples were collected at baseline in both arms, while only the physicians in the GeneSight® arm were provided with test results to inform treatment decisions. In addition to the prospective comparisons, retrospective analysis in the TAU subjects at the end of the study was implemented after un-blinding the GeneSight® results to test for clinical validity.
A greater reduction in depression scores from baseline to the week 8 visit was observed in the GeneSight® arm for all three measures of depression: QIDS-C16 (p < 0.0001), HAM-D17 (p < 0.0001), and PHQ-9 (p < 0.0001). In all measures, a faster reduction of symptoms was observed in the GeneSight® arm subjects compared to the TAU arm subjects (QIDS-C16 and HAM-D17 (p < 0.0001), PHQ-9 (p = 0.002)). The GeneSight® arm had a significantly higher remission rate based on the QIDS-C16 score (p = 0.03), and significantly higher response rates based on QIDS-C16 (p = 0.005), HAM-D17 (p = 0.03), and PHQ-9 (p = 0.01).
Physicians changed medications more often for subjects in the GeneSight®-guided group (57.9%) than the unguided group (25.9%) (p = 0.0007). Of the 15 GeneSight®-guided subjects classified in the red bin category at baseline, fourteen (93.3%) experienced a medication change or dose adjustment during the eight week study period, compared with 8 out of 18 subjects in the unguided group (44.4%) in the red bin category (p = 0.002). A significant association between bin status and outcome was observed within the unguided group (p = 0.028). Subjects classified in the red bin category had less improvement (11%) eight than those classified in the green or yellow categories (31.9%, p = 0.047), further demonstrating the deleterious effects of red bin medications on patient outcomes.
Dayton Study
This retrospective study, in collaboration with Union Health Services (UHS, a staff model HMO located in Chicago, Illinois), examined healthcare utilization in relation to medication categories (binning) using GeneSight®. Ninety-six patients previously diagnosed with a depressive disorder or anxiety disorder and treated with one of the medications included in the GeneSight® panel were included in the study. The GeneSight® bin assignments of patient psychiatric medications were compared to the medical records for patient medication prescriptions, healthcare utilization, medical absence days, and disability claims for the previous 12 months.
Subjects whose medication regimen included a medication in the GeneSight® red bin (“use with caution and more frequent monitoring”) had 69% more total healthcare visits (p = 0.005), 67% more general medical visits (p = 0.02), greater than 3-fold more medical absence days (p = 0.06), and greater than 4-fold more disability claims (p = 0.004) than subjects taking drugs in the green (“use as directed”) or yellow bin (“use with caution”). The mean healthcare utilization cost calculated for red bin subjects during the previous 12 month period was higher at $8,627, compared to $3,453 calculated for green bin subjects (p = 0.024) and $3,426 for yellow bin subjects (p = 0.027), yielding an average annual increase in healthcare cost of $5,188 for subjects on GeneSight® red bin medications.
Meta-analysis of GeneSight® Prospective 2-Armed Studies
In a meta-analysis of three prospective, 2-armed clinical trials (Pine Rest, Hamm, and La Crosse), use of the test to aid in therapeutic selection has improved patient responses to treatment by 73% on average, which is consistent with the results from each study individually, and is highly significant (p=0.004). These findings support the value of the GeneSight® test in improving patient outcomes.
Documentation Requirements
Documentation supporting the medical need for these tests, including substantiating documentation for the ICD-9 code(s) submitted, must be maintained in the patient’s medical record. In order to be considered medically necessary, the patient must have failed or currently be failing on at least one neuropsychiatric medication, and the healthcare provider must be contemplating an alteration in neuropsychiatric medication treatment. Prior medication failure and intent to alter medication course consistent with the test results must be documented in the patient’s medical record and noted with the test requisition.
Billing/Coding/Physician Documentation Information
This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.
Applicable codes: Effective in 2013, if the specific analyte is listed in codes 81200-81355 or 81400-81408, that CPT code would be reported. If the specific analyte is not listed in the more specific CPT
codes, unlisted code 81479 would be reported.
BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
ICD-10 Codes that Support Medical Necessity
ICD-10 CODE DESCRIPTION
F32.1 Major depressive disorder, single episode, moderate
F32.2 Major depressive disorder, single episode, severe without psychotic features
F32.3 Major depressive disorder, single episode, severe with psychotic features
F32.4 Major depressive disorder, single episode, in partial remission
F32.9 Major depressive disorder, single episode, unspecified
F33.1 Major depressive disorder, recurrent, moderate
F33.2 Major depressive disorder, recurrent severe without psychotic features
F33.3 Major depressive disorder, recurrent, severe with psychotic symptoms
F33.40 Major depressive disorder, recurrent, in remission, unspecified
F33.41 Major depressive disorder, recurrent, in partial remission
F33.9 Major depressive disorder, recurrent, unspecified
Coverage for BRCA1 and BRCA 2 Testing
Coverage Indications, Limitations, and/or Medical Necessity
Germline genetic testing of BRCA1 and BRCA2 is available to identify individuals at increased risk for breast and ovarian cancers, as individuals with an inherited cancer syndrome may benefit from screening and prevention strategies to reduce their risk. The prevalence of BRCA mutations in the population is estimated between 1 in 300 and 1 in 800; however, specific mutations known as founder mutations occur more often in populations founded by a small ancestral group, including Ashkenazi (Eastern European) Jews, French Canadians, and Icelanders. The prevalence of BRCA mutations in the Ashkenazi Jewish population is approximately 1 in 40. Three recurrent BRCA1 and BRCA2 mutations have been identified in Ashkenazi Jewish individuals (i.e., a genetically distinct population of Jewish people of eastern and central European ancestry) and make up the vast majority of BRCA mutations that occur in this population. Rearrangements, such as large genomic alterations including translocations, inversions, large deletions and insertions are believed to be responsible for 12% to 18% of BRCA1 inactivating mutations but are less common in BRCA2 and in individuals of Ashkenazi Jewish descent. The NCCN guidelines note that comprehensive genetic testing includes full sequencing of BRCA1/BRCA2 and the detection of large genomic rearrangements. The NCCN recommends that since certain large genomic rearrangements are not detectable by a primary sequencing assay, additional testing may be needed in some cases.
Evidence in the published, peer-reviewed scientific literature indicates that BRCA1 and BRCA2 genetic testing is appropriate for a specific subset of adult individuals who have been identified to be at high risk for hereditary breast and ovarian cancers. Furthermore, several specialty organizations, including NCCN, American College of Medical Genetics (ACMG), and American Society of Clinical Oncology (ASCO), have issued statements recognizing the role of pre- and post-test genetic counseling and BRCA testing in the management of at risk patients. The U.S. Preventive Services Task Force (USPSTF) has published recommendations regarding genetic risk assessment, genetic counseling and BRCA mutation testing for breast and ovarian cancer susceptibility. Based on this USPSTF recommendation, the Patient Protection and Affordable Care Act (ACA) requires that private group and individual health plans provide coverage for genetic counseling and, if appropriate, genetic testing for women at risk for hereditary breast ovarian cancer syndrome (HBOC) as a preventive service with no out of pocket expense.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor inhibitor approved by the FDA as monotherapy in patients with ovarian cancer, with deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation who have been treated with three or more prior lines of chemotherapy. Testing of ovarian cancer patients in this clinical scenario is indicated to guide treatment.
Mutations in the BRCA1 and BRCA2 genes are passed down in families through an autosomal dominant inheritance pattern meaning that the associated cancer predisposition can be inherited through either the mother’s or father’s side of the family and transmitted by a male or female. When a parent carries a BRCA mutation, there is a 50% chance of passing down the gene mutation with every pregnancy. Although the risk of inheriting the predisposition from a parent who carries a mutation is 50%, not everyone with an inherited mutation will develop cancer. The likelihood that a woman with a mutation will develop a related cancer (i.e., penetrance of a BRCA mutation) is estimated between 41% and 90% and is much lower for men. The risk of developing cancer depends on numerous variables, including the penetrance of the specific mutation, the genetic makeup of the individual, environmental risk factors, the gender of the individual and their age.
Several national evidence based and expert opinion guidelines and accrediting bodies recommend that genetic testing should be undertaken only in conjunction with independent pre-test genetic counseling services in order to assist patients in complex clinical decision-making. Post genetic testing counseling is also strongly recommended. The NCCN guidelines [2015] state that genetic counseling is a critical component of the cancer risk assessment process. In addition, the guidelines state that pretest counseling should include a discussion of why the test is being offered and how test results may impact medical management, cancer risks associated with the genes being tested, the significance of possible test results for the individual and family, the likelihood of a positive result, technical aspects and accuracy of the test, and economic considerations. Per the guidelines, posttest counseling includes disclosure of results, discussion of the significance of the results for the individual and relevant family members, a discussion of the impact of the results on psychosocial aspects and on the medical management of the individual, and how and where the patient will receive followup care and access to additional resources.
Medicare is a defined benefit program and requires that testing is only performed on patients with signs and symptoms of disease. Testing of unaffected individuals or family members is not a covered Medicare services. However, once a mutation is identified in the family, Medicare eligible relatives with signs and symptoms of breast cancer are typically tested for that specific mutation only. For patients of Ashkenazi Jewish descent, initial testing is generally done for the three specific mutations that account for most hereditary breast and ovarian cancer in that population: 185delAG and 5382insC (also called 5385insC) in the BRCA1 gene and 6174delT in the BRCA2 gene. If the test results are negative, full analysis of the BRCA1 and BRCA2 genes is only considered if testing criteria for non Jewish individuals are met. Nonetheless, Medicare does not cover testing for patients without signs and symptoms of breast or ovarian cancer.
While not required for payment, NCCN Guidelines recommend referral to a cancer genetics professional with expertise and experience in cancer genetics prior to genetic testing and after genetic testing. Examples of cancer genetics professionals with expertise and experience in cancer genetics include: an American Board of Medical Genetics or American Board of Genetic Counseling certified or board eligible Clinical Geneticist, Medical Geneticist or Genetic Counselor not employed by a commercial genetic testing laboratory (excludes individuals employed by or contracted with a laboratory that is part of an Integrated Health System which routinely delivers health care services beyond just the laboratory test itself as these individuals are also considered inter dependent); medical oncologist, obstetrician-gynecologist or other physician trained in medical cancer genetics, a genetic nurse credentialed as either a Genetic Clinical Nurse (GCN) or an Advanced Practice Nurse in Genetics (APGN) by either the Genetic Nursing Credentialing Commission (GNCC) or the American Nurses Credentialing Center (ANCC) who is not employed by a commercial genetic testing laboratory (excludes individuals employed by or contracted with a laboratory that is part of an Integrated Health System which routinely delivers health care services beyond just the laboratory test itself as these individuals are also considered inter dependent).
Indications
This is a limited coverage policy for BRCA 1 and BRCA 2 genetic testing. BRCA 1 and BRCA 2 genetic testing has been found to be reasonable and necessary in the following instances.
Personal History of Female Breast Cancer
BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer is covered in adults [by full sequence analysis and duplication/deletion analysis of common variants (CPT codes 81211 and 81213) as medically reasonable and necessary when there is a personal history of breast cancer (invasive breast cancer or ductal carcinoma in situ) and ANY of the following indications:
Diagnosed at age 60 or younger with a triple negative breast cancer (estrogen receptor (ER) negative, progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (HER2) negative);
Diagnosed at age 50 or younger with a limited family history (e.g., fewer than two first- or second degree female relatives or female relatives surviving beyond 45 years in the relevant maternal and/or paternal lineage);
Diagnosed at any age and there are at least two close blood relatives* with breast cancer at any age;
Diagnosed at any age with at least one close blood relative* with breast cancer at age 50 or younger;
Diagnosed at any age and there are at least two close blood relatives* with pancreatic cancer or prostate cancer with Gleason score >7 at any age;
Diagnosed at any age with at least one close blood relative* with epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer;
Close male blood relative* with breast cancer;
Individual of Ashkenazi Jewish descent begin testing with Ashkenazi Jewish founder specific mutations (a gene mutation observed with high frequency in a group that is or was geographically or culturally isolated, in which one or more of the ancestors was a carrier of the mutant gene) (CPT code 81212). If negative, complete analysis (CPT 81211 and 81213) may be considered if ancestry also includes non-Ashkenazi Jewish relatives or other criteria for BRCA1/BRCA2 genetic testing are met.
*NCCN defines blood relative as first- (parents, siblings and children), second- (grandparents, aunts, uncles, nieces and nephews, grandchildren and half-siblings), and third degree-relatives (great grandparents, great aunts, great uncles, great grandchildren and first cousins) on same side of family. Genetic testing for a known mutation in a family is a covered service for individuals with signs and/or symptoms of breast cancer. Testing of an unaffected Medicare eligible individual or family member is not a covered Medicare service.
Personal History of Other Cancer
BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer is covered in adults [by full sequence analysis and duplication/deletion analysis of common variants (CPT codes 81211) and uncommon duplication/deletion analysis (CPT 81213)] as medically necessary when there is a personal history of ANY of the following indications:
Personal history of epithelial ovarian, fallopian tube, or primary peritoneal cancer;
Personal history of male breast cancer;
Personal history of pancreatic cancer or prostate cancer with Gleason score =7 at any age, =1 close blood relatives* with breast (=50 y), invasive ovarian, pancreatic cancer, or prostate cancer with Gleason score=7 at any age;
Personal history of pancreatic cancer at any age with Ashkenazi Jewish ancestry (Begin testing with Ashkenazi Jewish founder specific mutations [CPT code 81212]. If negative, complete analysis (CPT 81211 and 81213) should be performed. Complete analysis (CPT 81211 and 81213) may be considered if ancestry also includes non-Ashkenazi Jewish relatives and other criteria for BRCA1/BRCA2 genetic testing are met.
Genetic testing for a known mutation in a family is a covered service for individuals with signs and/or symptoms of another inheritable cancer. Testing of an unaffected Medicare eligible individual or family member is not a covered Medicare service.
Multigene Panels
BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer with multi-gene next –generation sequencing (NGS) panels is covered as medically necessary when ALL of the following criteria are met:
Pre-test genetic counseling by a cancer genetics professional independent of the laboratory has been performed and post-test genetic counseling by a cancer genetics professional independent of the laboratory is planned;
All genes in the panel are relevant to the personal and family history for the individual being tested (large panels with genes that are not relevant to the individual’s personal and family history are not reasonable and necessary);
Criteria listed under Section 1, Personal history of female breast cancer and/or Section 2 Personal history of other cancer are met.
Individual also meets criteria for at least ONE other hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to Li-Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome.
Limitations
Any test must also meet:
Availability of a clinically valid test, based on published peer reviewed medical literature; AND
Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) analytical validity and clinical utility.
BRCA1/BRCA2 genetic testing for susceptibility to breast or ovarian cancer is not covered for any other indication including any of the following because it is considered not medically reasonable and necessary for these indications:
Genetic screening in the general population. Such testing is considered screening and is excluded by Medicare statute. An ABN must be obtained for BRCA 1 and BRCA 2 testing for individuals without signs and symptoms of breast, ovarian or other hereditary cancer syndromes as indicated in this policy.
Testing of individuals with no personal history of breast, ovarian, fallopian tube, primary peritoneal, pancreatic, or prostate cancer. Such testing is considered screening and is excluded by Medicare statute.
An ABN must be obtained for BRCA 1 and BRCA 2 testing for individuals without signs and symptoms of breast, ovarian or other hereditary cancer syndromes as indicated in this policy.
Testing of individuals under 18 years of age.
Generic (not disease specific) genomic sequence panels (NGS comprehensive definitive cancer testing panel/s) of 51 or greater genes are non-covered at this time (specific testing of 51 or greater genes as expressed by disease specific coding, e.g. Prosigna breast cancer assay, can be medically necessary).
CPT/HCPCS Codes
Group 1 Paragraph: N/A
Group 1 Codes:
cpt 81211 BRCA1, BRCA2 (BREAST CANCER 1 AND 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND COMMON DUPLICATION/DELETION VARIANTS IN BRCA1 (IE, EXON 13 DEL 3.835KB, EXON 13 DUP 6KB, EXON 14-20 DEL 26KB, EXON 22 DEL 510BP, EXON 8-9 DEL 7.1KB)
81212 BRCA1, BRCA2 (BREAST CANCER 1 AND 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; 185DELAG, 5385INSC, 6174DELT VARIANTS
81213 BRCA1, BRCA2 (BREAST CANCER 1 AND 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; UNCOMMON DUPLICATION/DELETION VARIANTS
81214 BRCA1 (BREAST CANCER 1) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND COMMON DUPLICATION/DELETION VARIANTS (IE, EXON 13 DEL 3.835KB, EXON 13 DUP 6KB, EXON 14-20 DEL 26KB, EXON 22 DEL 510BP, EXON 8-9 DEL 7.1KB)
81215 BRCA1 (BREAST CANCER 1) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; KNOWN FAMILIAL VARIANT
81216 BRCA2 (BREAST CANCER 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS
81217 BRCA2 (BREAST CANCER 2) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; KNOWN FAMILIAL VARIANT
81445 TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN NEOPLASM, DNA ANALYSIS, AND RNA ANALYSIS WHEN PERFORMED, 5-50 GENES (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), INTERROGATION FOR SEQUENCE VARIANTS AND COPY NUMBER VARIANTS OR REARRANGEMENTS, IF PERFORMED
81455 TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN OR HEMATOLYMPHOID NEOPLASM, DNA ANALYSIS, AND RNA ANALYSIS WHEN PERFORMED, 51 OR GREATER GENES (EG, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), INTERROGATION FOR SEQUENCE VARIANTS AND COPY NUMBER VARIANTS OR REARRANGEMENTS, IF PERFORMED
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
ICD-10 Codes that Support Medical Necessity
Group 1Codes
ICD-10 CODE DESCRIPTION
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
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
C56.9 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
D05.00 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 – D05.82 – Opens in a new window Other specified type of carcinoma in situ of unspecified breast – Other specified
type of carcinoma in situ of left breast
D05.90 – D05.92 – Opens in a new window Unspecified type of carcinoma in situ of unspecified breast – Unspecified type of
carcinoma in situ of left breast
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.43 Personal history of malignant neoplasm of ovary
Z85.46 Personal history of malignant neoplasm of prostate
