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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). The rules say that services that are not medically necessary are not covered. The rules also say that experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 411.15(o). The following indications for BRCA 1 and BRCA 2 testing are covered by Medicare: - Personal history of breast, ovarian, pancreatic or prostate cancer with the following RISK Assessment (stratification) items (1-8 below) that are to be considered before testing in those patients with one of the four mentioned cancers that is suspected to be of hereditary origin. - Personal history of ovarian carcinoma - Personal history of male breast cancer - Individual from a family with a known deleterious BRCA1/BRCA2 gene pathogenic mutation - Personal history of breast cancer and one or more of the following indications: - Diagnosed at 45 years of age or less; - Diagnosed at 50 years of age or less with: - An additional breast cancer primary at any age; - at least 1 close blood relative** with breast cancer at any age; - An unknown or limited family history; - Diagnosed at 60 years of age or less 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 any age with: - at least 1 close blood relative with breast cancer diagnosed at 50 years of age or less; or - at least 1 close blood relative with ovarian cancer; or - at least 1 close blood relative with pancreatic cancer; or - at least 1 close blood relative with prostate cancer (Gleason score greater than or equal to 7 or
metastatic); or - at least 1 close male blood relative with breast cancer; or - at least 2 additional diagnoses of breast cancer in patient and/or in close blood relative(s) at any age; - Individual of ethnicity associated with higher pathogenic mutation frequency (e.g. Ashkenazi Jewish) - Personal history of pancreatic cancer - Personal history of prostate cancer (Gleason score greater than or equal to 7) at any age with - at least 1 close blood relative with ovarian cancer, pancreatic cancer, or metastatic prostate cancer at
any age or breast cancer (at 50 years of age or less); or - at least 2 close blood relatives with breast cancer, or prostate cancer (any grade) at any age; or - Ashkenazi Jewish ancestry
- Personal history of metastatic prostate cancer - BRCA1/2 pathogenic mutation detected by tumor profiling on any tumor type in the absence of germline pathogenic mutation analysis - Personal history of cancer types listed above with a family history only (significant limitations of interpreting test results for an unaffected individual exists and therefore are not a covered benefit): - First- or second-degree blood relative meeting any of the above criteria - Third-degree blood relative who has breast cancer or ovarian carcinoma and who has at least 2 close
blood relatives with breast cancer (at least one with breast cancer at 50 years of age or less) or ovarian
carcinoma
Similar to all testing, the following situations require explanation of medical necessity for BRCA testing in the patient's medical record: - Individuals with little known family health history, - Individuals who come from small families, and - In the case of sex-specific conditions, individuals who have few female/male relatives at risk of developing a particular condition. - Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor approved by the FDA as monotherapy in patients with ovarian* cancer, with deleterious or suspected deleterious germline BRCA1 or BRCA2 pathogenic 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. You can find this information in the Local Coverage Determination (LCD): BRCA1 and BRCA2 Genetic Testing (L36715).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.