Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate cancer
Treatment: Molecular profiling panel
The insurer denied coverage for molecular profiling panel
The denial is overturned.

This is a male with prostate cancer, Gleason score of 8, who had a Germline Prostate Panel performed.

Per National Comprehensive Cancer Network (NCCN) guidelines Prostate Cancer Version 4.2022, "Germline breast cancer (BRCA) 1 or BRCA2 mutations have been associated with an increased risk for prostate cancer in numerous reports. In particular, BRCA2 mutations have been associated with a 2 to 6 fold increase in the risk for prostate cancer, whereas the association of BRCA1 mutations and increased risks for prostate cancer are less consistent. In addition, limited data suggest that germline mutations in ATM, PALB2, and CHEK2 increase the risk of prostate cancer. Furthermore, prostate cancer in individuals with germline BRCA mutations appears to occur earlier, has a more aggressive phenotype, and is associated with significantly reduced survival times than in non-carrier patients." Thus, testing germline mutations is necessary in those with prostate cancer or risk of prostate cancer. The molecular profiling panel is considered medically necessary for this patient.

The patient has a Gleason score of 8, which puts him at a very high risk of prostate cancer, thus, testing is medically necessary, as this can guide the treating provider in planning treatment for the patient.

"Oncologists and urologists need to be familiar with current NCCN Prostate Cancer (PCA) genetic testing guidelines. Supported by expert consensus opinion, current testing criteria per NCCN guidelines may be summarized as follows: (1) all men with metastatic PCA regardless of family history; (2) all men with high-risk to regional disease per NCCN risk categories regardless of family history; (3) men with very low to unfavorable intermediate risk disease with brother, father, or multiple male relatives diagnosed with PCA at younger than 60 year of age, known germline deoxyribonucleic acid (DNA) repair mutation in the family, or greater than one relative with family history suggestive of hereditary breast and ovarian cancer (HBOC) or Lynch syndrome; (4) men with Gleason score of 7 or greater with one or more blood relative with ovarian cancer, pancreatic cancer, metastatic PCA, or breast cancer younger than 50 years of age or two or more relatives with breast or prostate cancer (any grade) at any age, or Ashkenazi Jewish ancestry; or (5) BRCA mutations in tumor profiling. Therefore, in their practices, providers must perform intake of maternal and paternal family cancer history that covers a broad spectrum of cancers. Men meeting any of these criteria should consider genetic testing, necessitating that these men understand the implications of genetic testing for themselves and their families to make an informed decision, as advocated by multiple national organizations." (Giri et al., 2019)

"Available evidence supports routine implementation of germline genetic testing for many aspects of PCA decision making. The purpose of obtaining genetic testing for newly diagnosed men would be focused on identifying mutations that predispose to aggressive PCA." (Helfand et al., 2021)                                                         

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for molecular profiling panel is overturned. Medical Necessity is substantiated.