Medical Policy Update

Revised Medical Policies

Medical Policy:

Effective: 01/01/2023
Preauthorization Required: Yes 

Policy Statement remains unchanged, adding CPT 61783 Stereotactic computer-assisted (navigational) procedure; spinal as investigational.

1. Computer-assisted musculoskeletal surgical navigation for orthopedic procedures of the pelvis, appendicular skeleton, and lumbar spine is investigational.
2. Radiology studies performed solely to support preoperative surgical navigation for orthopedic procedures of the pelvis, appendicular skeleton, and lumbar spine is investigational.
3. Computer-assisted surgical navigation, including the preoperative CT or MRI (e.g., MAKOplasty/MAKO Tactile Guidance System) for hip and knee replacement is considered investigational.

Medical Policy: V.58 Oncology: Algorithmic Testing

Effective: 01/01/2023
Preauthorization Required: Yes

1. The member is female or male, AND
2. The member has primary breast cancer that is ductal/NST, lobular, mixed or micropapillary, AND
3. The member’s tumor is hormone receptor-positive (estrogen receptor-positive or progesterone receptor-positive), AND
4. The member’s tumor is human epidermal growth factor receptor 2 (HER2)-negative, AND
5. The member is considering treatment with adjuvant therapy (for example, tamoxifen, aromatase inhibitors, immunotherapy), AND
6. The member meets one of the following based on menopausal status:
   1. The member is premenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm and node negative (pN0), OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastases), OR
      3. Lymph nodes are pN1 (1-3 positive nodes), OR
   2. The member is postmenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm, OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastasis), OR
      3. Lymph nodes are pN1 (1-3 positive nodes), OR

The use of a breast cancer treatment and prognostic algorithmic test (specifically Breast Cancer Index BCI) (S3854, 81518) is considered medically necessary when:

1. The member is female, AND
2. The member has primary breast cancer that is ductal/NST, lobular, mixed or micropapillary, AND
3. The member’s tumor is hormone receptor-positive (estrogen receptor-positive or progesterone receptor-positive), AND
4. The member’s tumor is human epidermal growth factor receptor 2 (HER2)-negative, AND
5. The member is considering treatment with adjuvant therapy (for example, tamoxifen, aromatase inhibitors, immunotherapy), AND
6. The member meets one of the following based on menopausal status:
   1. The member is premenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm and node negative (pN0), OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastases), OR
      3. Lymph nodes are pN1 (1-3 positive nodes), OR
   2. The member is postmenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm, OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastasis), OR
      3. Lymph nodes are pN1 (1-3 positive nodes)

Breast Cancer Prognostic Algorithmic Tests
The use of a hormone receptor positive breast cancer prognostic algorithmic test (examples: Endopredict, Promina, Mammaprint (S3854, 81520, 81521, 81522, 81523,) is considered medically necessary when: 

1. The member is female, AND
2. The member has primary breast cancer that is ductal/NST, lobular, mixed or micropapillary, AND
3. The member’s tumor is hormone receptor-positive (estrogen receptor-positive or progesterone receptor-positive), AND
4. The member’s tumor is human epidermal growth factor receptor 2 (HER2)-negative, AND
5. The member is considering treatment with adjuvant therapy (for example, tamoxifen, aromatase inhibitors, immunotherapy), AND
6. The member meets one of the following based on menopausal status:
   1. The member is premenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm and node negative (pN0), OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastases), OR
      3. Lymph nodes are pN1 (1-3 positive nodes), OR
   2. The member is postmenopausal and meets one of the following:
      1. Tumor is greater than 0.5 cm, OR
      2. Lymph nodes are pN1mi (2mm or smaller axillary node metastasis), OR
      3. Lymph nodes are pN1 (1-3 positive nodes)

Cutaneous Melanoma Diagnostic Algorithmic Tests

1. Cutaneous melanoma diagnostic algorithmic tests (0090U) are considered medically necessary when:
   1. The member has a melanocytic neoplasm that is diagnostically uncertain or equivocal after histopathology
2. Cutaneous melanoma diagnostic algorithmic tests (0090U) are considered investigational when:
   1. A melanocytic neoplasm has pathology definitive for melanoma, desmoplastic melanoma, or sclerosing nevus.
3. Cutaneous melanoma diagnostic algorithmic tests (0090U) are considered investigational for all other indications. 

Medical Policy: V.59 Genetic Testing: Hereditary Cancer Susceptibility

Effective: 01/01/2023
Preauthorization Required: Yes

1. Genetic testing using a hereditary colorectal cancer susceptibility panel (81435, 81436, 0101U) is considered medically necessary when:
   1. The member is 18 years or older, AND
   2. The member meets at least one of the following:
      1. The member has a personal history of, or a single family member with any of the following:
         1. At least 10 adenomatous polyps, OR
         2. At least 2 hamartomatous polyps, OR
         3. At least 5 serrated polyps/lesions proximal to the rectum, OR
      2. The member has a personal history of colorectal cancer with any of the following:
         1. Member is under 50 years of age at diagnosis of colorectal cancer, OR
         2. Member’s tumor has deficient mismatch repair (dMMR), indicated by any of the following:
            1. Microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS), OR
            2. Abnormal/deficient MMR protein expression (dMMR) on immunochemistry (IHC) without concurrent MLH1 promoter hypermethylation or BRAF V600E mutation, OR
         3. Member meets Lynch syndrome criteria in MLH1, MSH2, MSH6, PMS2, EPCAM Sequencing and/or Deletion/Duplication Analysis, OR
      3. The member has the following:
         1. A family history of a Lynch syndrome-related cancer that meets Lynch syndrome criteria in MLH1, MSH2, MSH6, PMS2, EPCAM Sequencing and/or Deletion/Duplication Analysis. 
            1. Lynch syndrome-related cancers include colorectal, endometrial, gastric, ovarian, pancreas, urothelial, brain (usually glioblastoma), biliary tract, small intestine, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas
   3. The panel includes, at a minimum, sequencing of the following genes: APC, MUTYH, MLH1, MSH2, MSH6, PMS2, EPCAM, BMPR1A, SMAD4, PTEN, STK11

Medical Policy: V.65 Genetic Testing: Epilepsy, Neurodegenerative and Neuromuscular Disorders

Effective: 01/01/2023
Preauthorization Required: Yes 

2. For BMD, the member meets the following: 
   1. The member has an elevated serum creatine kinase serum concentration, typically more than 5 times the normal level

1. FXN repeat analysis (81284) or sequencing analysis (81286) to establish or confirm a diagnosis of Friedreich’s Ataxia is considered medically necessary when:
   1. The member has at least two of the following from 1-6:
      1. Neurologic findings, typically with onset before age 25 years 
         1. Progressive ataxia of gait and limbs 
         2. Dysarthria 
         3. Decrease in/loss of position sense and/or vibration sense in lower limbs 
         4. Pyramidal weakness of the legs, extensor plantar responses, AND/OR 
      2. Musculoskeletal features:
         1. Muscle weakness 
         2. Scoliosis 
         3. Pes cavus, AND/OR 
      3. Hypertrophic non-obstructive cardiomyopathy, AND/OR 
      4. Endocrinologic features: 
         1. Glucose intolerance
         2. Diabetes mellitus, AND/OR
      5. Optic atrophy and/or deafness, AND/OR 
      6. Family history consistent with autosomal recessive inheritance, AND
      7. Non-genetic causes for the ataxia have been ruled out (examples: alcoholism, vitamin deficiencies, multiple sclerosis, vascular disease, tumors)

Medical Policy: V.72 Genetic Testing: Immune, Autoimmune, and Rheumatoid Disorders

Effective: 01/01/2023
Preauthorization Required: Yes

1. The use of genetic algorithmic rheumatoid arthritis tests to determine appropriateness of TNFi treatment (i.e., PrismRA) (81599, 81479) is considered investigational.