Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer

Treatment: Breast Cancer gene (BRCA) mutation genetic testing (a blood test to identify if a BRCA mutation was passed on from family that increases the risk of cancer, code 81479) rendered. 

The insurer denied coverage for Breast Cancer gene (BRCA) mutation genetic testing (a blood test to identify if a BRCA mutation was passed on from family that increases the risk of cancer, code 81479) rendered. 

The denial is overturned.

The patient is an adult with no history of cancer but whose close family member was diagnosed with both breast and ovarian cancer and is now deceased. Two additional close family members tested positive for Checkpoint kinase 2 (CHEK2).

The National Comprehensive Cancer Network latest recommendations Criteria for genetic risk evaluation and possible testing for breast and/or ovarian cancer are: 

A. An individual with breast cancer (including invasive and ductal carcinoma) with any of the following: Breast cancer diagnosed 50 years, Triple-negative breast cancer diagnosed 60 years, Two breast cancers (in a single patient), Male breast cancer, Breast cancer diagnosed at any age, in addition to one of the following: 1 close blood relative with breast cancer diagnosed 50 years, or 1 close blood relative with ovarian, fallopian tube, or primary peritoneal cancer diagnosed at any age, or 1 close blood relatives with male breast cancer, pancreatic, and/or prostate cancer (Gleason score 7), or advanced prostate cancer, diagnosed at any age, 2 close blood relatives with breast cancer at any age.

The patient did not meet criteria A. 

B. An individual of any age with a known or likely pathogenic variant in a cancer susceptibility gene within the family or found on tumor testing. 

The patient met criteria B given that there is a pathogenic variant CHEK2 detected in close relatives in the family.

C. Personal and/or family history of three or more of the following on the same side of the family: Breast cancer, sarcoma, adrenocortical carcinoma, brain tumor or leukemia, Colon, endometrial, thyroid, or kidney cancer, dermatologic manifestations of Cowden syndrome, macrocephaly, or hamartomatous polyps of the gastrointestinal tract, Lobular breast cancer, diffuse gastric cancer, Breast cancer, gastrointestinal cancer or hamartomatous polyps, ovarian sex cord tumors, pancreatic cancer, testicular Sertoli cell tumors, or childhood skin pigmentation.

The patient did not meet criteria C. 

D. Personal history of ovarian, pancreatic, metastatic prostate, or male breast cancer.  

The patient did not meet criteria D.

E. Ashkenazi Jewish ancestry and breast cancer or high-grade (Gleason score 7) prostate cancer.

The patient did not meet criteria E.

F. An individual with no personal history of cancer but with: First- or second-degree relative with any of the following: breast cancer diagnosed 45 years, ovarian cancer, male breast cancer, pancreatic cancer, metastatic prostate cancer, or 2 breast cancer primaries in a single individual or on the same side of the family with at least one diagnosed 50 years.

The patient met criteria F given a close family member had both breast and ovarian cancer.

Since the patient fulfills criteria B and F, the testing was medically necessary.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Breast Cancer gene (BRCA) mutation genetic testing (a blood test to identify if a BRCA mutation was passed on from family that increases the risk of cancer, code 81479) rendered is substantiated.