Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Possible genetic variant.

Treatment: gene test, BRCA, procedure code 81162.

The insurer denied coverage for the gene test, BRCA, procedure code 81162.

The denial is overturned.

 
The insurer has denied coverage for the gene test, BRCA (Breast Cancer gene), procedure code 81162, as not medically necessary. In a Final Adverse Determination letter, they stated that BRCA testing was ordered to check the patient's risk for cancer of the breast or ovaries. The requested service can be approved when the following criteria are met: 

The patient has breast cancer and might benefit from polymerase inhibitor therapy. 

-	There is a personal or family history of certain cancers suggesting an increased risk of cancer. 

-	A certain test is needed. 

The patient did not meet the criteria for approval. The requested service is denied based on the guideline Genetic Testing for Breast and/or Ovarian Cancer Syndrome (CG-GENE-16).
The patient is appealing. He feels that he fulfills the criteria because his brother is a carrier of BRCA.

According to the National Comprehensive Cancer Network's latest recommendations
Criteria for genetic risk evaluation and possible testing for breast and/or ovarian cancer

A- An individual with breast cancer (including invasive and ductal carcinoma) with any of the following:

Breast cancer was 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 relative 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

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. CONDITION MET - His brother has a pathogenic variant.

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

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

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

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 maternal grandmother had both breast and ovarian cancer.

The patient fulfills the above criteria for testing as his brother tested positive for BRCA. 
Since the patient fulfills the above criteria, the testing was medically necessary.

Based on the above, the insurer's denial must be reversed. 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 the gene test, BRCA, procedure code 81162 is substantiated.