MEDICAL POLICY Genetic Testing for Breast and Ovarian Cancers
|
|
- Lorena Long
- 5 years ago
- Views:
Transcription
1 POLICY: PG0067 ORIGINAL EFFECTIVE: 07/30/02 LAST REVIEW: 01/25/18 MEDICAL POLICY Genetic Testing for Breast and Ovarian Cancers GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. DESCRIPTION Among women, breast cancer is the most commonly diagnosed cancer after non-melanoma skin cancer and is the second leading cause of cancer death after lung cancer. Ovarian cancer is the ninth most common cancer and is noted to be the fifth most deadly. Epithelial ovarian cancer, which is cancer that begins in the cells on the surface of the ovary, comprises the majority of malignant ovarian neoplasm. Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and its fifth most common cause of cancer mortality in women. BRCA testing is to detect mutation in BRCA1 and BRCA2, the two genes associated with most cases of familial breast cancer. Testing is performed to determine whether an individual has inherited a mutated version of the gene. Inheriting a mutation places a woman at very high risk of developing breast cancer and, for BRCA1, ovarian cancer or cancer of the peritoneum. For a man, it means the possibility of passing the mutated gene on to children and in some cases an increased risk of either male breast cancer or other malignancies. BRACAnalysis Rearrangement Test (BART) (Myriad Genetic Laboratories, Inc., Salt Lake City, UT) is utilized to detect rare, large rearrangements of DNA in the BRCA1 and BRCA2 genes. It is intended for use only in individuals at an exceptionally high risk for breast cancer who have previously tested negative for sequence mutations and common large rearrangements on Myriad Genetics standard BRACAnalysis test. On December 19, 2014, the Food and Drug Administration (FDA) approved Lynparza (olaparib; AstraZeneca) for the treatment of advanced ovarian cancer in patients who have previously been treated with 3 lines of chemotherapy and who test positive with the BRACAnalysis CDx test (Myriad Genetics Inc.). The BRACAnalysis CDx test, also FDA approved on December 19, 2014, is a test for deleterious or suspected deleterious germline BRCA mutation, and is intended as an aid in identifying ovarian cancer patients eligible for treatment with Lynparza. Until recently, genetic testing for cancer susceptibility was generally carried out by direct sequencing which analyzes a specific gene for a particular mutation. However, next-generation sequencing, (including but not limited to massively parallel sequencing, and microarray testing) has made it possible to conduct panel testing which involves the analysis of multiple genes for multiple mutations simultaneously. Panel testing has the potential benefit of analyzing multiple genes more rapidly and thereby providing the results of the genetic work-up in a more timely fashion. While testing these genes may be appropriate in individuals with clinical or family histories suggestive of a specific syndrome, there is no evidence that mass screening of multiple genes in individuals suspected of having or being at risk for breast and/or ovarian cancer syndrome improves clinical outcomes. The specific genes included in these test panels and the particular next-generation sequencing technology utilized may differ between manufacturers. At the present time, there is limited published information on their analytical validity, clinical utility or clinical validity. POLICY BRCA & BART Testing, including BRACAnalysis CDx, requires prior authorization for all product lines. Code is non-covered for HMO, PPO, Individual Marketplace, & Elite. Code requires prior authorization for Advantage. Multigene panels (including next-generation sequencing [NGS]) for hereditary cancer susceptibility require prior authorization for Elite. Multigene panels (including next-generation sequencing [NGS]) for hereditary cancer susceptibility are non-covered for HMO, PPO, Individual Marketplace, & Advantage. These tests include, but may not be limited to, the following:
2 - 2 - BRCAplus BRCAvantage Plus BreastNext BreastTrue High Risk Panel BREVAGen Invitae Breast Cancer High-Risk Panel myrisk Hereditary Cancer OvaNext OncoVue Breast Cancer Risk Test BRCA & BART Testing, including BRACAnalysis CDx, may be covered with prior authorization. Paramount utilizes InterQual criteria sets for medical necessity determinations. Evidence supports the use of diagnostic testing for BRCA1 and BRCA2 mutations for: Individuals in families in which a known deleterious mutation is present Individuals with breast and/or ovarian cancer who are members of families in which the frequency and distribution of breast and ovarian cancer suggests a pattern of autosomal dominant inheritance Individuals with ovarian cancer, regardless of age at diagnosis or family history of disease Individuals diagnosed at a young age Male individuals diagnosed with breast cancer Individuals diagnosed with two primary tumors Individuals diagnosed with breast and/or ovarian cancer who are of Ashkenazi Jewish descent Individuals less than age 40 with estrogen receptor (ER) negative, progesterone receptor (PR)negative, and HER2 negative breast cancer Consultants agree that criteria for testing in individuals of Ashkenazi Jewish descent are less stringent that for those who are not of Ashkenazi Jewish descent In some cases, individuals diagnosed with breast and/or ovarian cancers who have a limited family structure (defined as having fewer than two first or second degree female relatives in each lineage) may be candidates for testing Evidence supports the use of predictive testing for BRCA1 and BRCA2 mutations for: Individuals in families in which a known deleterious mutation is present Individuals who are members of families in which the frequency and distribution of breast and ovarian cancer suggests a pattern of autosomal dominant inheritance Consultants agree that criteria for testing in individuals of Ashkenazi Jewish descent are less stringent than for those who are not of Ashkenazi Jewish descent Individuals with male relative(s) diagnosed with breast cancer Males who are undergoing testing in order to provide information on a family member s mutation status Genetic counseling before and after BRCA-related testing is evidence supported. Paramount considers BRCA testing (e.g., BRACAnalysis CDx) (81211) medically necessary for individuals with ovarian cancer who have been treated with three or more prior lines of chemotherapy and are being considered for Lynparaza (olaparib). BRCA testing is considered experimental and investigational for all other indications not listed above, including screening of breast or ovarian cancers, as well as assessment of risk of other cancers such as pancreatic cancer, prostate cancer, and colon cancer because its effectiveness for these indications has not been established. Elite While there is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and longterm outcomes of multi-gene next generation sequencing (NGS) panels, The Centers for Medicare & Medicaid Services (CMS) requires these panels be reviewed for medical necessity. Therefore these panels may be covered with a prior authorization for Elite members. 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: o Pretest and posttest genetic counseling has been performed;
3 - 3 - o All genes in the panel are relevant to the personal and family history for the individual being tested (panels with genes that are not relevant to the individual s personal and family history are not reasonable and necessary); o Criteria for BRCA1 and BRCA2 mutations testing listed above are met. Individual also meets criteria for at least ONE hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to HBOC, Li- Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome. HMO, PPO, Individual Marketplace, Advantage Multigene panels (including next-generation sequencing [NGS]) for hereditary cancer susceptibility are considered experimental and investigational and therefore are non-covered. These tests include, but may not be limited to, the following: BRCAplus BRCAvantage Plus BreastNext BreastTrue High Risk Panel BREVAGen Invitae Breast Cancer High-Risk Panel myrisk Hereditary Cancer OvaNext OncoVue Breast Cancer Risk Test CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis 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 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb) BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants 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 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb) BRCA1 (breast cancer 1) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant BRCA2 (breast cancer 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis BRCA2 (breast cancer 2) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 14 genes, including ATM, BRCA1, BRCA2, BRIP1, CDH1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK 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 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 ICD-10 Codes that Support Medical Necessity 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
4 - 4 - C48.1 Malignant neoplasm of specified parts of peritoneum C Malignant neoplasm of nipple and areola, right female breast C Malignant neoplasm of nipple and areola, left female breast C Malignant neoplasm of nipple and areola, unspecified female breast C Malignant neoplasm of nipple and areola, right male breast C Malignant neoplasm of nipple and areola, left male breast C Malignant neoplasm of nipple and areola, unspecified male breast C Malignant neoplasm of central portion of right female breast C Malignant neoplasm of central portion of left female breast C Malignant neoplasm of central portion of unspecified female breast C Malignant neoplasm of central portion of right male breast C Malignant neoplasm of central portion of left male breast C Malignant neoplasm of central portion of unspecified male breast C Malignant neoplasm of upper-inner quadrant of right female breast C Malignant neoplasm of upper-inner quadrant of left female breast C Malignant neoplasm of upper-inner quadrant of unspecified female breast C Malignant neoplasm of upper-inner quadrant of right male breast C Malignant neoplasm of upper-inner quadrant of left male breast C Malignant neoplasm of upper-inner quadrant of unspecified male breast C Malignant neoplasm of lower-inner quadrant of right female breast C Malignant neoplasm of lower-inner quadrant of left female breast C Malignant neoplasm of lower-inner quadrant of unspecified female breast C Malignant neoplasm of lower-inner quadrant of right male breast C Malignant neoplasm of lower-inner quadrant of left male breast C Malignant neoplasm of lower-inner quadrant of unspecified male breast C Malignant neoplasm of upper-outer quadrant of right female breast C Malignant neoplasm of upper-outer quadrant of left female breast C Malignant neoplasm of upper-outer quadrant of unspecified female breast C Malignant neoplasm of upper-outer quadrant of right male breast C Malignant neoplasm of upper-outer quadrant of left male breast C Malignant neoplasm of upper-outer quadrant of unspecified male breast C Malignant neoplasm of lower-outer quadrant of right female breast C Malignant neoplasm of lower-outer quadrant of left female breast C Malignant neoplasm of lower-outer quadrant of unspecified female breast C Malignant neoplasm of lower-outer quadrant of right male breast C Malignant neoplasm of lower-outer quadrant of left male breast C Malignant neoplasm of lower-outer quadrant of unspecified male breast C Malignant neoplasm of axillary tail of right female breast C Malignant neoplasm of axillary tail of left female breast C Malignant neoplasm of axillary tail of unspecified female breast C Malignant neoplasm of axillary tail of right male breast C Malignant neoplasm of axillary tail of left male breast C Malignant neoplasm of axillary tail of unspecified male breast C Malignant neoplasm of overlapping sites of right female breast C Malignant neoplasm of overlapping sites of left female breast C Malignant neoplasm of overlapping sites of unspecified female breast C Malignant neoplasm of overlapping sites of right male breast C Malignant neoplasm of overlapping sites of left male breast C Malignant neoplasm of overlapping sites of unspecified male breast C Malignant neoplasm of unspecified site of right female breast C Malignant neoplasm of unspecified site of left female breast C Malignant neoplasm of unspecified site of unspecified female breast C Malignant neoplasm of unspecified site of right male breast C Malignant neoplasm of unspecified site of left male breast C 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
5 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 Z85.43 Personal history of malignant neoplasm of ovary Z85.46 Personal history of malignant neoplasm of prostate TAWG REVIEW DATES: 07/30/2002, 11/06/2003, 05/18/2005, 01/18/2006, 11/08/2006, 11/14/2007, 01/13/2010, 08/10/2011, 07/11/2012, 03/13/2013, 12/17/2015, 03/25/2016, 11/18/2016, 01/25/ REVISION HISTORY EXPLANATION 03/31/12: Codes S3818-S3820, S3822, and S3823 were deleted 09/18/12: Updated 05/21/13: Codes 83891, 83898, 83904, 83909, 83912, were deleted as of 1/1/2013. Add/configuration of codes 81211, 81212, 81213, 81214, 81215, 81216, Per The United States Department of Labor Employee Benefits Security Administration, determination - BRAC testing (81211, 81212, 81213, 81214, 81215, 81216, 81217) and genetic counseling (S0265) are within the scope of preventive care (member no cost share). Reviewed & approved per Medical Policy Steering Committee. 09/09/14: Changed title of policy from BRCA Testing for Breast and/or Ovarian Cancers to Genetic Testing for Breast and Ovarian Cancers. Code S0265 removed. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 04/14/15: Added BRACAnalysis CDx (81211). Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 12/17/15: Added effective 1/1/16 new codes 81162, 81432, & Policy reviewed and updated to reflect most current clinical evidence per TAWG. 03/25/16: Added codes 81445, & Code is now non-covered for HMO, PPO, Individual Marketplace, & Elite. Policy reviewed and updated to reflect most current clinical evidence per TAWG. 11/18/16: Multigene panels for hereditary cancer susceptibility are non-covered. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 11/23/16: Gender verbiage changes completed per Meaningful Access Section 1557 of the Affordable Care Act. 01/25/18: Multigene panels (including next-generation sequencing [NGS]) for hereditary cancer susceptibility are now covered with prior authorization for Elite per CMS guidelines. Added ICD-10 diagnosis codes per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc.
Genetic Testing for BRCA1 and BRCA2 Genes
Genetic Testing for BRCA1 and BRCA2 Genes MP9478 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Pre and post-test genetic counseling
More informationPolicy and Procedure. Department: Utilization Management. SNP, CHP, MetroPlus Gold, Goldcare I&II, Market Plus, Essential, HARP
Retired Date: Page 1 of 9 1. POLICY DESCRIPTION: BRCA 1&2 Genetic Testing 2. RESPONSIBLE PARTIES: Medical Management Administration, Utilization Management, Integrated Care Management, Pharmacy, Claim
More informationGenetic Testing for BRCA1 and BRCA2 Genes
Genetic Testing f BRCA1 and BRCA2 Genes MP9478 Covered Service: Pri Authization Required: Additional Infmation: Yes when meets criteria below Yes--as shown below Pre and post-test genetic counseling is
More informationPROVIDER POLICIES & PROCEDURES
PROVIDER POLICIES & PROCEDURES GENETIC CANCER SUSCEPTIBILITY PANELS USING NEXT GENERATION SEQUENCING The purpose of this document is to assist providers enrolled in the Connecticut Medical Assistance Program
More informationMEDICAL POLICY Gene Expression Profiling for Cancers of Unknown Primary Site
POLICY: PG0364 ORIGINAL EFFECTIVE: 04/22/16 LAST REVIEW: 07/26/18 MEDICAL POLICY Gene Expression Profiling for Cancers of Unknown Primary Site GUIDELINES This policy does not certify benefits or authorization
More informationContractor Information. LCD Information. Local Coverage Determination (LCD): MolDX: BRCA1 and BRCA2 Genetic Testing (L36082) Document Information
Local Coverage Determination (LCD): MolDX: BRCA1 and BRCA2 Genetic Testing (L36082) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Contractor Information
More informationMEDICAL POLICY. SUBJECT: MOLECULAR PANEL TESTING OF CANCERS TO IDENTIFY TARGETED THERAPIES (Excluding NSCLC and CRC) EFFECTIVE DATE: 12/21/17
MEDICAL POLICY SUBJECT: MOLECULAR PANEL TESTING OF PAGE: 1 OF: 5 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial product, including
More informationLinks in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website.
Local Coverage Determination (LCD): Pathology and Laboratory: BRCA1 and BRCA2 Genetic Testing (L36741) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website.
More informationPolicy Specific Section: Medical Necessity and Investigational / Experimental. October 15, 1997 October 9, 2013
Medical Policy Genetic Testing for Hereditary Breast and/or Ovarian Cancer Type: Medical Necessity and Investigational / Experimental Policy Specific Section: Laboratory/Pathology Original Policy Date:
More informationLinks in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website.
Local Coverage Determination (LCD): MolDX: BRCA1 and BRCA2 Genetic Testing (L36161) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Contractor Information
More informationContractor Information
Local Coverage Determination (LCD): MolDX: BRCA1 and BRCA2 Genetic Testing (L36163) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Contractor Information
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
BRCA1 and BRCA2 Testing Page 1 of 26 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: BRCA1 and BRCA2 Testing Pre-Determination of Services IS REQUIRED by the Member
More informationGENETIC TESTING FOR HEREDITARY BREAST AND OVARIAN CANCER SYNDROME BRCA1 BRCA2
SYNDROME BRCA1 BRCA2 Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationCLINICAL MEDICAL POLICY
Policy Name: Policy Number: Responsible Department(s): CLINICAL MEDICAL POLICY BRCA1 and BRCA2 Genetic Mutation Testing and Related Genetic Counseling MP-011-MD-DE Medical Management Provider Notice Date:
More informationPROVIDER POLICIES & PROCEDURES
PROVIDER POLICIES & PROCEDURES BRCA GENETIC TESTING The purpose of this document is to assist providers enrolled in the Connecticut Medical Assistance Program (CMAP) with the information needed to support
More informationPrior Authorization. Additional Information:
Genetic Testing for Cowden Syndrome - PTEN Gene MP9488 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Pre and post-test genetic
More informationGENETIC TESTING FOR HEREDITARY BREAST AND OVARIAN CANCER BRCA1 BRCA2
GENETIC TESTING FOR HEREDITARY BREAST AND OVARIAN CANCER BRCA1 BRCA2 Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific
More informationMyriad Financial Assistance Program (MFAP)
Myriad Financial Assistance Program (MFAP) MEDICAL CRITERIA Hereditary Cancer Products The Myriad Financial Assistance Program offers aid to patients who meet specific financial and medical requirements.
More informationMEDICAL POLICY SUBJECT: GENETIC TESTING FOR HEREDITARY BRCA MUTATIONS. POLICY NUMBER: CATEGORY: Laboratory Test
MEDICAL POLICY SUBJECT: GENETIC TESTING FOR HEREDITARY BRCA MUTATIONS POLICY NUMBER: 2.02.06 CATEGORY: Laboratory Test EFFECTIVE DATE: 01/17/02 REVISED DATE: 08/21/03, 09/16/04, 08/18/05, 06/15/06, 04/17/14,
More informationHereditary Cancer Products
Hereditary Products Integrated BRACAnalysis (BRCA1 and BRCA2 sequencing and large rearrangement testing (BART)), covered when: PERSONAL HISTORY of Breast (must meet at least 1) Diagnosed
More informationGenetic Testing: who, what, why?
Genetic Testing: who, what, why? Gina Westhoff MD LMG Gynecologic Oncology March 16, 2019 Disclosures Speaker for Merck (unrelated to today s topic) Objectives Determine who should undergo genetic risk
More informationCorporate Medical Policy Genetic Testing for Breast and Ovarian Cancer
Corporate Medical Policy Genetic Testing for Breast and Ovarian Cancer File Name: Origination: Last CAP Review: Next CAP Review: Last Review: genetic_testing_for_breast_and_ovarian_cancer 8/1997 8/2017
More informationGENETIC TESTING FOR HEREDITARY CANCER
UnitedHealthcare Oxford Clinical Policy GENETIC TESTING FOR HEREDITARY CANCER Policy Number: DIAGNOSTIC 004.27 T2 Effective Date: November 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 CONDITIONS
More informationBRCA Precertification Information Request Form
BRCA Precertification Information Request Form Failure to complete this form in its entirety may result in the delay of review. Fax to: BRCA Precertification Department Fax number: 1-860-975-9126 Section
More informationCLINICAL MEDICAL POLICY
Policy Name: Policy Number: Responsible Department(s): CLINICAL MEDICAL POLICY Oncologic Genetic Testing Panels MP-074-MD-PA Medical Management Provider Notice Date: 11/15/2018 Issue Date: 12/15/2018 Effective
More informationHereditary Breast and Ovarian Cancer Rebecca Sutphen, MD, FACMG
Hereditary Breast and Ovarian Cancer 2015 Rebecca Sutphen, MD, FACMG Among a consecutive series of 11,159 women requesting BRCA testing over one year, 3874 responded to a mailed survey. Most respondents
More informationMedical Policy Manual. Topic: Genetic Testing for Hereditary Breast and/or Ovarian Cancer. Date of Origin: January 27, 2011
Medical Policy Manual Topic: Genetic Testing for Hereditary Breast and/or Ovarian Cancer Date of Origin: January 27, 2011 Section: Genetic Testing Last Reviewed Date: July 2014 Policy No: 02 Effective
More informationWHAT IS A GENE? CHROMOSOME DNA PROTEIN. A gene is made up of DNA. It carries instructions to make proteins.
WHAT IS A GENE? CHROMOSOME GENE DNA A gene is made up of DNA. It carries instructions to make proteins. The proteins have specific jobs that help your body work normally. PROTEIN 1 WHAT HAPPENS WHEN THERE
More informationWHAT IS A GENE? CHROMOSOME DNA PROTEIN. A gene is made up of DNA. It carries instructions to make proteins.
WHAT IS A GENE? CHROMOSOME E GEN DNA A gene is made up of DNA. It carries instructions to make proteins. The proteins have specific jobs that help your body work normally. PROTEIN 1 WHAT HAPPENS WHEN THERE
More informationGYNplus. genetic testing for hereditary ovarian and/or uterine cancer
GYNplus genetic testing for hereditary ovarian and/or uterine cancer What Are the Causes of Hereditary Ovarian and Uterine Cancer? uterine cancer ovarian cancer sporadic 70-80% hereditary 5% Lynch syndrome
More information6/8/17. Genetics 101. Professor, College of Medicine. President & Chief Medical Officer. Hereditary Breast and Ovarian Cancer 2017
Genetics 101 Hereditary Breast and Ovarian Cancer 2017 Rebecca Sutphen, MD, FACMG Professor, College of Medicine President & Chief Medical Officer INVASIVE CANCER GENETICALLY ALTERED CELL HYPERPLASIA DYSPLASIA
More informationGYNplus: A Genetic Test for Hereditary Ovarian and/or Uterine Cancer
GYNplus: A Genetic Test for Hereditary Ovarian and/or Uterine Cancer Causes of Hereditary Ovarian and Uterine Cancer uterine cancer ovarian cancer Sporadic 75-90% Sporadic 70-80% Hereditary, 5% Lynch syndrome
More informationApplies to: All Aetna plans, except Traditional Choice plans. All Innovation Health plans, except indemnity plans
BRCA Precertification Information Request Form Applies to: All Aetna plans, except Traditional Choice plans All Innovation Health plans, except indemnity plans All Health benefits and health insurance
More informationFamily Assessment. Objectives. Comprehensive Family History Important Inexpensive Underutilized genetic tool
Besides the BRCA genes, what else to consider in hereditary breast and ovarian cancer? Laurie M. Connors DNP, APNG, FNP-BC, AGN-BC Objectives Evaluate personal & family history to assess risk for hereditary
More informationBRCAplus. genetic testing for hereditary breast cancer
BRCAplus genetic testing for hereditary breast cancer Developed in collaboration with Fox Chase Cancer Center and the Arcadia University Genetic Counseling Program. Causes of Hereditary Breast Cancer familial
More informationOut-Patient Billing CPT Codes
Out-Patient Billing CPT Codes Updated Date: August 3, 08 Client Billed Molecular Tests HPV DNA Tissue Testing 8764 No Medicare Billed - Molecular Tests NeoARRAY NeoARRAY SNP/Cytogenetic No 89 NeoLAB NeoLAB
More informationMP Genetic Testing for BRCA1 or BRCA2 for Hereditary Breast/Ovarian Cancer Syndrome and Other High-Risk Cancers
Medical Policy MP 2.04.02 Genetic Testing for BRCA1 or BRCA2 for Hereditary Breast/Ovarian Cancer Syndrome and Other High-Risk BCBSA Ref. Policy: 2.04.02 Last Review: 11/15/2018 Effective Date: 02/15/2019
More informationMEDICAL POLICY SUBJECT: GENETIC TESTING FOR SUSCEPTIBILITY TO HEREDITARY CANCERS EFFECTIVE DATE: 06/19/14, 09/15/15.
MEDICAL POLICY SUBJECT: GENETIC TESTING FOR SUSCEPTIBILITY PAGE: 1 OF: 7 If the member's subscriber contract excludes coverage for a specific service it is not covered under that contract. In such cases,
More informationClinical Cancer Genetics
Clinical Cancer Genetics Lisen Axell, MS, CGC University of Colorado Cancer Center Individuals with cancer Making surgical decisions (lump vs. mast) Making treatment decisions (XRT) Concerns for additional
More informationThe Next Generation of Hereditary Cancer Testing
The Next Generation of Hereditary Cancer Testing Why Genetic Testing? Cancers can appear to run in families. Often this is due to shared environmental or lifestyle patterns, such as tobacco use. However,
More informationRe: NC Medicaid and NC Health Choice Program coverage of genetic testing for susceptibility to breast and ovarian cancer
March 23, 2018 North Carolina (NC) Division of Medical Assistance (DMA), Clinical Policy Section C/O Pam Greeson, BSN, RN-C, pam.greeson@dhhs.nc.gov Nurse Consultant, Division of Medical Assistance Practitioners,
More informationBe Ready Pack Learn more about how Myriad myrisk is revolutionizing hereditary cancer testing.
Be Ready Pack Learn more about how Myriad myrisk is revolutionizing hereditary cancer testing. Hereditary cancer and you Approximately 5% to 10% of all cancers develop because a person inherited a genetic
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
BRCA1 and BRCA2 Testing Page 1 of 33 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: BRCA1 and BRCA2 Testing Pre-Determination of Services IS REQUIRED by the Member
More informationCorporate Medical Policy
Corporate Medical Policy Moderate Penetrance Variants Associated with Breast Cancer in File Name: Origination: Last CAP Review: Next CAP Review: Last Review: moderate_penetrance_variants_associated_with_breast_cancer_
More informationCLINICAL MEDICAL POLICY
CLINICAL MEDICAL POLICY Policy Name: Faslodex (fulvestrant) Policy Number: MP-044-MD-DE Responsible Department(s): Medical Management; Clinical Pharmacy Provider Notice Date: 10/01/2017 Original Effective
More informationA Patient s Guide to Hereditary Cancer. Is Hereditary Cancer Testing Right for You?
A Patient s Guide to Hereditary Cancer Is Hereditary Cancer Testing Right for You? What is Hereditary Cancer? Most cancers occur in people who do not have a strong family history of that cancer. This is
More informationMEDICAL POLICY Acupuncture
POLICY: PG0382 ORIGINAL EFFECTIVE: 12/13/16 LAST REVIEW: 06/12/18 MEDICAL POLICY Acupuncture GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual
More informationGenetic Risk Assessment for Cancer
Genetic Risk Assessment for Cancer Jennifer Siettmann, MS CGC Certified Genetic Counselor/Cancer Risk Counselor Banner Good Samaritan Cancer Screening & Prevention Program Objectives Describe the role
More informationAugust 17, Dear Valued Client:
August 7, 08 Re: CMS Announces 6-Month Period of Enforcement Discretion for Laboratory Date of Service Exception Policy Under the Medicare Clinical Laboratory Fee Schedule (the 4 Day Rule ) Dear Valued
More informationGenetic Testing Today: What Genes Can Tell Us. Living Beyond Breast Cancer Conference Kara N. Maxwell, MD, PhD University of Pennsylvania
Genetic Testing Today: What Genes Can Tell Us Living Beyond Breast Cancer Conference Kara N. Maxwell, MD, PhD University of Pennsylvania Overview of talk PART 1: Overview of Genetics PART 2: BRCA1/2 PART
More informationTargeted Agent and Profiling Utilization Registry (TAPUR ) Study. February 2018
Targeted Agent and Profiling Utilization Registry (TAPUR ) Study February 2018 Precision Medicine Therapies designed to target the molecular alteration that aids cancer development 30 TARGET gene alterations
More informationMEDICAL POLICY Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of
POLICY: PG0367 ORIGINAL EFFECTIVE: 08/26/16 LAST REVIEW: 09/27/18 MEDICAL POLICY Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of Prostate Cancer GUIDELINES This policy does not certify
More informationGenetic Cancer Susceptibility Panels Using Next Generation Sequencing. Policy Specific Section: September 27, 2013 January 30, 2015
Medical Policy Genetic Cancer Susceptibility Panels Using Next Generation Sequencing Type: Investigational / Experimental Policy Specific Section: Laboratory/Pathology Original Policy Date: Effective Date:
More informationCentoCancer STRIVE FOR THE MOST COMPLETE INFORMATION
CentoCancer STRIVE FOR THE MOST COMPLETE INFORMATION CentoCancer our most comprehensive oncogenetics panel for hereditary mutations Hereditary pathogenic variants confer an increased risk of developing
More informationThe benefit of. knowing. Genetic testing for hereditary cancer. A patient support guide
The benefit of knowing Genetic testing for hereditary cancer A patient support guide Does cancer run in your family? Cancer is more common in some families. Sometimes cancer is caused by a change in a
More informationA guide to genetic testing for hereditary cancers
Cancer Testing Solutions A guide to genetic testing for hereditary cancers The benefit of knowing TM Hereditary cancer genetic testing can play a critical role in managing health Cancer touches millions
More informationPrior Authorization. Additional Information:
Genetic Testing for Lynch Syndrome MP9487 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes-as shown below Pre and post test genetic counseling is
More informationHereditary Aspects of Pancreatic Cancer
Pancreatic Cancer Seminar San Francisco, CA Hereditary Aspects of Pancreatic Cancer Genetic Risk Assessment and Counseling for Familial Pancreatic Cancer February 3, 2016 Amie Blanco, MS, CGC Gordon and
More informationMEDICAL POLICY Cardiac Event Monitors/ Cardiac Event Detection
POLICY: PG0039 ORIGINAL EFFECTIVE: 10/01/11 LAST REVIEW: 12/12/17 MEDICAL POLICY Cardiac Event Monitors/ Cardiac Event Detection GUIDELINES This policy does not certify benefits or authorization of benefits,
More informationMEDICAL POLICY Children's Intensive Behavioral Service/ Applied Behavioral Analysis (ABA)
POLICY: PG0335 ORIGINAL EFFECTIVE: 12/17/15 LAST REVIEW: 07/10/18 MEDICAL POLICY Children's Intensive Behavioral Service/ Applied Behavioral Analysis (ABA) GUIDELINES This policy does not certify benefits
More informationGenetic Risk Assessment for Cancer
Genetic Risk Assessment for Cancer Jennifer Siettmann, MS CGC Certified Genetic Counselor Banner MD Anderson Cancer Center Objectives Describe the role of genetic counseling and genetic testing in patient
More informationOvaNext. patient guide. genetic testing for hereditary breast, ovarian, and uterine cancer
patient guide OvaNext genetic testing for hereditary breast, ovarian, and uterine cancer Because knowing your risk can mean early detection and prevention About half of the women diagnosed with uterine
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Abraxane) Reference Number: CP.PHAR.176 Effective Date: 07.01.15 Last Review Date: 05.18 Line of Business: HIM, Medicaid Coding Implications Revision Log See Important Reminder at the
More informationLearn your genetic risk for the most common hereditary cancers.
Learn your genetic risk for the most common hereditary cancers. color.com Color analyzes 30 genes including BRCA1 and BRCA2 to help women and men understand their risk for the most common hereditary cancers,
More informationMedia Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801)
News Release Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) 584-3065 (801) 584-1143 rrogers@myriad.com sgleason@myriad.com Myriad Receives FDA Approval of BRACAnalysis CDx as Companion
More informationMultigene Panel Testing for Hereditary Cancer Risk
Multigene Panel Testing for Hereditary Cancer Risk Dana Zakalik, M.D. Director, Nancy and James Grosfeld Cancer Genetics Center Professor, OUWB Medical School MCC Annual Meeting November 4, 2015 Outline
More informationGenetic Testing for Lynch Syndrome
Genetic Testing for Lynch Syndrome MP9487 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes-as shown below Pre and post-test genetic counseling is
More informationThe Genetics of Breast and Ovarian Cancer Prof. Piri L. Welcsh
The Genetics of Breast Piri L. Welcsh, PhD Research Assistant Professor University of Washington School of Medicine Division of Medical Genetics 1 Genetics of cancer All cancers arise from genetic and
More informationGermline Testing for Hereditary Cancer with Multigene Panel
Germline Testing for Hereditary Cancer with Multigene Panel Po-Han Lin, MD Department of Medical Genetics National Taiwan University Hospital 2017-04-20 Disclosure No relevant financial relationships with
More informationGenetic Testing for Inherited Conditions
Genetic Testing for Inherited Conditions Policy Number: 2018-101 Effective Date: January 26, 2018 Review Date: January 26, 2018 Next Review Date: January 26, 2019 Important Information - Please Read Before
More informationAccel-Amplicon Panels
Accel-Amplicon Panels Amplicon sequencing has emerged as a reliable, cost-effective method for ultra-deep targeted sequencing. This highly adaptable approach is especially applicable for in-depth interrogation
More informationNumber: Policy *Please see amendment for Pennsylvania Medicaid at the. Last Review 02/23/2017 Effective: 04/07/1998 Next Review: 02/22/2018
1 of 76 Number: 0227 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. Prophylactic Mastectomy Aetna considers prophylactic mastectomy medically necessary for reduction of
More informationGenetic Testing of Inherited Cancer Predisposition Genetic Testing - Oncology
Genetic Testing of Inherited Cancer Predisposition Genetic Testing - Oncology Policy Number: Original Effective Date: MM.02.010 05/01/2010 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration
More information10/21/ New Release, Quest Diagnostics Nichols Institute, Valencia
NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date
More informationMEDICAL POLICY Drug Testing
POLICY: PG0069 ORIGINAL EFFECTIVE: 01/01/11 LAST REVIEW: 11/13/18 MEDICAL POLICY Drug Testing GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each
More informationGenetic Determinants, Risk Assessment and Management
Genetic Determinants, Risk Assessment and Management Rachel Rando, MS, CGC Genetic Counselor Hunterdon Regional Cancer Center Flemington, NJ I have no disclosures. Acknowledgements: Staff of Hunterdon
More informationGermline Multigene Panel Testing in Oncology: Genetic Counseling Perspective
Germline Multigene Panel Testing in Oncology: Genetic Counseling Perspective Sarah L. Campian, MS CGC Certified Genetic Counselor Nancy & James Grosfeld Cancer Genetics Center Objectives Identify patients/families
More informationChapter 18 Section 13
Demonstrations Chapter 18 Section 13 TRICARE Evaluation Of Centers For Medicare And Medicaid Services (CMS) Approved Laboratory Developed Tests (LDTs) Demonstration Project 1.0 PURPOSE The purpose of the
More informationGenetics and Cancer Care. Cynthia Forster-Gibson, MD, PhD and Loren Mackay- Loder, MSc Genetics Program, THP
Genetics and Cancer Care Cynthia Forster-Gibson, MD, PhD and Loren Mackay- Loder, MSc Genetics Program, THP Faculty/Presenter Disclosure Faculty: Cynthia Forster-Gibson Relationships with commercial interests:
More informationCancer Survivorship Symposium Cancer and Heredity January 16, Jeanne P. Homer, MS Licensed Certified Genetic Counselor
Cancer Survivorship Symposium Cancer and Heredity January 16, 2017 Jeanne P. Homer, MS Licensed Certified Genetic Counselor Outline Cancer and Heredity Hereditary Cancer Risk Assessment & Genetic testing
More informationGenomic Medicine: What every pathologist needs to know
Genomic Medicine: What every pathologist needs to know Stephen P. Ethier, Ph.D. Professor, Department of Pathology and Laboratory Medicine, MUSC Director, MUSC Center for Genomic Medicine Genomics and
More informationNon-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document.
MRI OF THE BREAST Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationMyriad Genetics Corporate Presentation 6/4/13
Myriad Genetics Corporate Presentation 6/4/13 Forward Looking Statement Some of the information presented here today may contain projections or other forward-looking statements regarding future events
More informationA Patient s Guide to. Hereditary Ovarian Cancer: Is Hereditary Cancer Testing Right for You?
A Patient s Guide to Hereditary Ovarian Cancer: Is Hereditary Cancer Testing Right for You? What is Hereditary Cancer? Most cancers occur in people who do not have a strong family history of that cancer.
More informationClinical Policy Title: Genetic testing for breast and ovarian cancer
Clinical Policy Title: Genetic testing for breast and ovarian cancer Clinical Policy Number: 02.01.02 Effective Date: September 1, 2013 Initial Review Date: March 21, 2013 Most Recent Review Date: May
More informationAssessment and Management of Genetic Predisposition to Breast Cancer. Dr Munaza Ahmed Consultant Clinical Geneticist 2/7/18
Assessment and Management of Genetic Predisposition to Breast Cancer Dr Munaza Ahmed Consultant Clinical Geneticist 2/7/18 Overview The role of the Cancer Genetics team NICE guidelines for Familial Breast
More informationThe Role of Genetics in Ovarian Cancer Screening. Dawn DeLozier, Ph.D. Medical Geneticist, SAMC Associate Professor UCSF-Fresno
The Role of Genetics in Ovarian Cancer Screening Dawn DeLozier, Ph.D. Medical Geneticist, SAMC Associate Professor UCSF-Fresno How Much Breast and Ovarian Cancer Is Hereditary? 15%-20% 5%-10% Breast Cancer
More informationHEREDITY & CANCER: Breast cancer as a model
HEREDITY & CANCER: Breast cancer as a model Pierre O. Chappuis, MD Divisions of Oncology and Medical Genetics University Hospitals of Geneva, Switzerland Genetics, Cancer and Heredity Cancers are genetic
More informationpatient guide BreastNext genetic testing for hereditary breast cancer Because knowing your risk can mean early detection and prevention
patient guide BreastNext genetic testing for hereditary breast cancer Because knowing your risk can mean early detection and prevention Know the Basics Breast cancer is the most common cancer in women
More informationDoes Cancer Run in Your Family?
Does Cancer Run in Your Family? A Patient s Guide to Hereditary Breast and Ovarian Cancer Syndrome What is Hereditary Cancer? Most cancers occur in people who do not have a strong family history of that
More informationUse of panel tests in place of single gene tests in the cancer genetics clinic
Clin Genet 2015: 88: 278 282 Printed in Singapore. All rights reserved CLINICAL GENETICS doi: 10.1111/cge.12488 Short Report se of panel tests in place of single gene tests in the cancer genetics clinic
More informationAssessing Your Patient s Breast Cancer Risk: Is Genetic Testing Necessary?
May 16, 2016 Assessing Your Patient s Breast Cancer Risk: Is Genetic Testing Necessary? Presenter: Emily Kuchinsky, MS, CGC 1 Experiences with Genetic Testing Adverse Events in Cancer Genetic Testing:
More informationLYNPARZA (olaparib) oral capsule and tablet
LYNPARZA (olaparib) oral capsule and tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
More informationPharmacogenetic and Pharmacodynamic Testing PHARMACOGENETIC AND PHARMACODYNAMIC TESTING HS-318. Policy Number: HS-318
Easy Choice Health Plan, Inc. Exactus Pharmacy Solutions, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Incorporated WellCare Health Insurance of Arizona, Inc., operating in Hawai i as Ohana
More informationHereditary Cancer Risk Assessment for Gynecological Cancers. FarrNezhatMD.com
Hereditary Cancer Risk Assessment for Gynecological Cancers FarrNezhatMD.com Image credit: PLOS blogs 5-10% hereditary 10-20% 70-80% sporadic Genetic Changes and Cancer Cancer begins with a genetic
More informationGEN ETICS AN D GEN OM ICS IN CANCER PREVENTION AN D TREATM EN T. Robert Nathan Slotnick MD PhD Director, Medical Genetics and Genomics
GEN ETICS AN D GEN OM ICS IN CANCER PREVENTION AN D TREATM EN T Robert Nathan Slotnick MD PhD Director, Medical Genetics and Genomics The Medical/Surgical/Radiation Oncologist s View of Genetics Cancer
More informationThe Center for PERSONALIZED DIAGNOSTICS
The Center for PERSONALIZED DIAGNOSTICS Precision Diagnostics for Personalized Medicine A joint initiative between The Department of Pathology and Laboratory Medicine & The Abramson Cancer Center The (CPD)
More informationCorporate Medical Policy
Corporate Medical Policy Molecular Panel Testing of Cancers to Identify Targeted Therapies File Name: Origination: Last CAP Review: Next CAP Review: Last Review: molecular_panel_testing_of_cancers_to_identify_targeted_therapies
More information