Medical Policy Update

To align with CMS guidelines Hospital Readmissions Reduction Program (HRRP), facilities are encouraged to improve communication and care coordination for patients and caregivers in discharge planning to reduce avoidable readmissions. Patients are more likely to have better outcomes, functional ability, survivability, and quality of life. 

• Blue Cross and Blue Shield Nebraska (BCBSNE) will perform a clinical review of acute care facility readmissions that occur within 30 days of discharge from the 
  same healthcare system or under the same provider contract.

Medical Policy V.78 Laboratory Testing for Cardiac Transplant Rejection

Adding Policy Statement:

1. The use of post heart transplant gene expression panels for rejection risk via tissue (0087U) is considered investigational for all indications.

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

Changing Policy statement:
Genetic testing of HTT repeat analysis to establish a diagnosis or for predictive testing of Huntington’s disease (HD) (81271, 81274) is considered medically necessary when:

1. The member displays clinical features of Huntington’s disease (i.e., progressive motor disability featuring chorea, where voluntary movement may also be affected), OR 
2. The member has a clinical diagnosis of Huntington’s Disease, OR
3. The member is undergoing predictive testing*, AND
   1. The member is presymptomatic/asymptomatic, AND
      1. The member has a close relative with CAG trinucleotide repeat expansion of 27 or more in HTT, OR
      2. The member has a first-degree relative with a clinical diagnosis of HD without prior genetic testing.

2. Genetic testing of HTT repeat analysis to establish a diagnosis or for predictive testing of Huntington’s disease (HD) (81271, 81274) is considered investigational for all other indications.

Medical Policy V.36 Genetic Testing: Exome and Genome Sequencing for Diagnosing Genetic Disorders

Adding Policy Statement:

1. Repeat standard exome sequencing (81415, 81416, 0214U, 0215U) is considered not medically necessary.

Medical Policy V.62 Genetic Testing: Multisystem Inherited Disorders, Intellectual Disabilities and Developmental Delays

Updated Policy Statement
CFTR Sequencing and/or Deletion/Duplication Analysis 

1. CFTR sequencing and/or deletion/duplication analysis (81222, 81223) to establish or confirm a diagnosis of cystic fibrosis is considered medically necessary when: 
   1. The member has a positive (greater than or equal to 60 mmol/L) or inconclusive sweat chloride test (30-59 mmol/L)
2. CFTR sequencing and/or deletion/duplication analysis (81222, 81223) to establish or confirm a diagnosis of cystic fibrosis is considered investigational for all other indications

Noonan Spectrum Disorders/RASopathies Multigene Panel

1. The use of a multigene panel to confirm or establish a diagnosis of a Noonan spectrum disorder/RASopathy (e.g., Noonan syndrome, Legius syndrome, Costello syndrome, Cardio-facial-cutaneous syndrome, NF1, Noonan-like syndrome) (81442) is considered medically necessary when:
   1. The member has at least one of the following:
      1. Characteristic facies (low-set, posteriorly rotated ears with fleshy helices, vivid blue or blue-green irises, widely spaced, down slanted eyes, epicanthal folds, ptosis), OR
      2. Short stature, OR
      3. Congenital heart defect (most commonly pulmonary valve stenosis, atrial septal defect, and/or hypertrophic cardiomyopathy), OR
      4. Developmental delay, OR
      5. Broad or webbed neck, OR
      6. Unusual chest shape with superior pectus carinatum, inferior pectus excavatum, OR
      7. Widely spaced nipples, OR
      8. Cryptorchidism in males, OR
      9. Lentigines, OR
      10. Café au lait macules, AND
   2. The panel includes, at a minimum, the following genes: PTPN11, SOS1, SPRED1, RAF1, and RIT1.
2. The use of a multigene panel to confirm or establish a diagnosis of a Noonan spectrum disorder/RASopathy (e.g., Noonan syndrome, Legius syndrome, Costello syndrome, Cardio-facial-cutaneous syndrome, NF1, Noonan-like syndrome) (81442) is considered investigational for all other indications.

Medical Policy V.58 Oncology: Algorithmic Testing 

Updated Policy Statement
Prostate Cancer Treatment and Prognostic Algorithmic Tests 

1. The use of the prostate cancer treatment and prognostic algorithmic test Decipher assay (81542) is considered medically necessary when:
   1. For initial risk stratification, the member meets the following:
      1. The member has a life expectancy of 10 years or more, AND
      2. The member has any of the following: 
         1. Low-risk prostate cancer, OR
         2. Favorable intermediate prostate cancer, OR
         3. Unfavorable intermediate prostate cancer, OR
         4. High-risk prostate cancer, OR
   2. The member meets the following:
      1. The member has a life expectancy of more than 5 years, AND
      2. The test is being used to inform adjuvant treatment and counseling for risk stratification, as an alternative to PSADT, OR
      3. Adverse features were found post-radical prostatectomy, including but not limited to PSA persistence/recurrence. 

The use of a prostate cancer treatment and prognostic algorithmic test (0047U, 81541, 81542) is considered investigational for all other indications.

Medical Policy V.61 Oncology: Circulating Tumor DNA and Circulating Tumor Cells

Updated Policy Statement
PIK3CA Variant Analysis via ctDNA

1. PIK3CA variant analysis (0177U, 81309) via circulating tumor DNA (ctDNA) is considered medically necessary when:
   1. The member has recurrent, unresectable, or stage IV hormone receptor-positive/HER2-negative breast cancer, AND
   2. The member is considering treatment with alpelisib plus fulvestrant, AND
   3. The member has had progression on at least one line of therapy.
2. PIK3CA variant analysis (0177U, 81309) via circulating tumor DNA (ctDNA), is considered investigational for all other indications.

Medical Policy V.60 Oncology: Molecular Analysis of Solid Tumors and Hematologic Malignancies

Updated Policy Statement
Tumor-Type Agnostic Solid Tumor Molecular Profiling Panel Tests

1. Repeat testing via a tumor-type agnostic solid tumor molecular profiling panel (81445, 81455, 0037U, 0048U, 0211U, 0244U, 0250U, 0334U, 0379U) is considered medically necessary when:
   1. The member has progression of any of the following:
      1. Advanced or metastatic non-small cell lung cancer (NSCLC), OR
      2. Advanced or metastatic gastric adenocarcinoma, OR
      3. Metastatic prostate cancer

Targeted RNA Fusion Panel Tests

1. RNA specific fusion panel tests with 5-50 genes performed on peripheral blood, bone marrow or solid tumors (81449, 81451) are considered medically necessary when:
   1. The member is undergoing workup for adult or pediatric acute lymphoblastic leukemia (ALL), OR
   2. The member has a diagnosis of glioma, OR
   3. The member is undergoing workup for histiocytosis, OR
   4. The member is undergoing workup for a sarcoma, OR
   5. The member has a gastrointestinal stromal tumor, AND
      1. The tumor is negative for KIT and PDGFRA somatic mutations, OR
   6. The member has non-small cell lung cancer, AND
      1. DNA based NGS tumor profiling was negative for actionable mutations, OR
   7. The member has a metastatic or advanced solid tumor, AND
      1. There is a fusion-targeted therapy with regulatory approval for that cancer type, OR
      2. DNA-based panel testing was negative for oncogenic driver mutations.

RNA specific fusion panel tests (81449, 81451) are considered investigational for all other indications.

Broad RNA Fusion Panel Tests

1. RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone (81456) are considered investigational.

Medical Policy V.17 Non-Invasive Prenatal Screening

Updated Policy Statement
Non-invasive Prenatal Screening (NIPS) for Chromosome 13, 18, 21, X and Y Aneuploidies

1. Noninvasive Prenatal Screening (NIPS) for 13, 18, 21, X and Y aneuploidy (81420, 81507, 0327U) may be considered medically necessary when:
   1. The member has a singleton or twin pregnancy, AND
   2. The member has NOT previously had a non-invasive prenatal screening (NIPS) in the current pregnancy AND
   3. The member has received appropriate counseling about the benefits and limitations of this test by a prenatal care provider, a trained designee, or a genetic counselor.