Clinical Policy Guideline

Transcription

1 Clinical Policy Guideline Policy Title: BRCA 1/BRCA 2 Testing and Related Genetic Counseling Policy No: B0111A.02 Effective Date: 01/20/2011, 06/26/2012 Date Reviewed: 04/23/2013, 01/22/2014, 05/21/14, 04/29/15, 12/15/15 I. DEFINITION BRCA1 and BRCA2 genetic tests are predictive tests that identify specific mutations in the BRCA1 and BRCA2 genes which are associated with an increased risk of breast cancer. An estimated one in 800 women carry the BRCA1 gene (the number of carriers of BRCA2 remain unknown). Women with inherited changes in either of these genes have up to an 80% chance of developing breast cancer in their lifetime. It is also thought that alterations in the BRCA2 gene may also account for a small percentage of male breast cancer. Genetic counseling is recommended both prior to and after testing by a qualified physician or genetic counselor. The American Society of Human Genetics defines genetic counseling as a communication process which deals with the human problems associated with the occurrence, or risk of occurrence, of a genetic disorder in a family. The process involves the attempt of the appropriately trained provider to help the individual or family to: Comprehend the medical facts including the diagnosis, probably course of the disorder, and the available management; Appreciate the way that heredity contributes to the disorder, and to the risk of recurrence (occurrence), in specific relatives; Understand the alternatives for dealing with the risk of recurrence (occurrence); Chose a course of action which seems to them appropriate in view of their risk, their family goals, and their ethical and religious standards and act in accordance with that decision; and Make the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence (occurrence) of that disorder. For the purposes of this guideline, close blood relative all of whom are on the same side of the family, is defined as: First Degree: Parents, Siblings, Offspring Page 1 of 5

2 Second Degree: Aunts/Uncles, Grandparents, Grandchildren, Nieces/Nephews, and Half-Siblings In addition, for the purpose of this guideline, a third degree relative is not considered a close blood relative. However, in reference to specific coverage criteria in this document, third degree is defined below: Third Degree: Great-Grandparents, Great Aunts, Great Uncles, Great-Grandchildren, and First Cousins II. POLICY/CRITERIA BRCA1 and BRCA2 testing is a covered benefit for members considered to be at high risk for breast and/or ovarian cancer. Informed consent is required for all genetic tests. Genetic counseling is a covered benefit and strongly recommended both prior to and after testing by a qualified physician or genetic counselor. U.S. Food and Drug Administration (FDA) approved test. Documentation supporting medical necessity must be demonstrated in the member s medical record. Documentation must be legible and contain relevant history and physical findings to meet the criteria listed below: 1. Women with a history of epithelial ovarian cancer, or 2. Women with personal history of breast cancer and any of the following: a. Breast cancer diagnosed at age 45 years or younger, with or without a family history; or b. Breast cancer diagnosed at age 50 years or younger, with any of the following: At least one close blood relative with breast cancer at age 50 years or younger; or At least one close blood relative with epithelial ovarian cancer; or Bilateral breast cancer, or two primary breast cancers with first primary diagnosed at age 50 years or younger; or Limited family structure or no family history available because member is adopted. c. Breast cancer is diagnosed at age 60 years or younger, and is triple negative d. Breast cancer is diagnosed at any age, with any of the following: At least two close blood relatives with breast cancer and/or epithelial ovarian cancer at any age; or The member has two breast primaries and also has at least one close blood relative with breast cancer diagnosed at age 50 years or younger; or Page 2 of 5

3 The member has two breast primaries and also has at least one close blood relative with epithelial ovarian cancer; or Close male blood relative with breast cancer; or At least one first, second, or third degree blood relative with a known BRCA1 or BRCA2 mutation; or If of Ashkenazi Jewish descent, or other ethnic descent associate with deleterious mutations, no additional family history is required. Two close blood relatives on the same side of the family with pancreatic adenocarcinoma at any age, or 3. Women with a personal history of pancreatic adenocarcinoma at any age with 2 close blood relatives with breast cancer, epithelial ovarian cancer, and/or pancreatic adenocarcinoma at any age, or 4. Women without a personal history of breast cancer or epithelial ovarian cancer, or pancreatic adenocarcinoma, and any of the following: a. At least two 1 st degree blood relatives with breast cancer, with one diagnosed at age 50 years or younger. b. A combination of 3 or more close blood relatives with breast cancer c. A combination of both breast and ovarian cancer among close blood relatives d. A close 1 st degree blood relative with bilateral breast cancer e. Two or more close blood relatives with ovarian cancer regardless of age at diagnosis f. A close blood relative with both breast and ovarian cancer at any age g. A history of breast cancer in a close blood male relative h. For women of Ashkenazi Jewish heritage, with at least one 1 st degree blood relative or at least two 2 nd degree blood relatives with breast or ovarian cancer i. Women with 1 or more first, second, or third-degree relatives with a known BRCA 1 or BRCA2 mutation, or 5. Men with any of the following: a. A first, second, or third degree blood relative who has a known BRCA1 or BRCA2 mutation, where the results will influence clinical utility; or b. A personal history of breast cancer. III. PRIOR AUTHORIZATION REQUIREMENTS A prior authorization by HPM Plan Medical Director is required for BRCA1 and BRCA2 genetic testing. IV. CODING/MODIFIERS Page 3 of 5

4 S0265 Genetic counseling, under physician supervision, each 15 minutes (not covered-not recognized by Medicare) Medical genetics and genetic counseling services, each 30 minutes face to face with patient/family (bundled payment-included in another procedure) BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis (new code effective 01/01/2016) BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA 1 (i.e., exon 13 del 3.835b, exon 13 dup 6kb, exon del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb) BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/ deletion variants (i.e., 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) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial Variant V. LOCATION OF SERVICE 22 - Outpatient 81- Laboratory VI. PRODUCT LINE COVERAGE Please reference contract benefit rider, benefit description, Master Plan Document, Evidence of Coverage (EoC) and Certificate of Coverage (CoC) for applicable limits and copayments, including other exceptions and/or exclusions for specific coverage. If there is a conflict between this medical policy and the individual or group insurance policy document, the terms of the individual or group insurance policy will govern, unless specifically noted. HMO: This policy applies to insured HMO plans; refer to the CoC or benefit rider for exceptions or exclusions. Page 4 of 5

5 PPO: This policy applies to PPO plans; refer to the CoC for any exceptions or exclusions. SELF-FUNDED OPTIONS: This policy applies to self-funded option plans; refer to the Master Plan Document for any exceptions or exclusions. MEDICARE ADVANTAGE: This policy applies to insured Medicare Advantage plans; refer to the EoC for any exceptions or exclusions. MEDICAID: This policy applies to Medicaid plans; refer to the subscriber contract for exceptions or exclusions. HEALTHY MICHIGAN PLAN: This policy applies to Healthy Michigan Plan; refer to the subscriber contract for any exceptions or exclusions. MICHILD: This policy applies to insured MICHILD plans; refer to the subscriber contract for any exceptions or exclusions. COUNTY HEALTH PLANS: This policy applies to County Health Plans; refer to the benefit description for any exceptions or exclusions. VII. REFERENCES References are available upon request. AMA CPT Copyright Statement: All Current Procedure Terminology (CPT) codes, descriptions, and other data are copyrighted by the American Medical Association. This policy is for informational use only; therefore it is not an authorization of services. HealthPlus of Michigan s clinical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, HealthPlus of Michigan reserves the right to review and update its clinical policies at its discretion. HealthPlus of Michigan s clinical policies are intended to serve as a resource to the plan; however they are not intended to limit the plan s interpretation of benefit language. HealthPlus of Michigan does not provide health care services and cannot guarantee results or outcomes. Treating providers are solely responsible for rendering medical advice and treatment to members. Page 5 of 5