Preauthorization is not required for the following specific
Bone marrow biopsy chromosome analysis for patients with:
Acute or chronic myeloid and lymphoid leukemia
BCR-ABL gene testing in patients with Chronic Myelogenous Leukemia (CML)
Protease Inhibitor typing or SERPINA1 Targeted Mutation Analysis for
suspected alpha-1-antitrypsin deficiency
Chromosome analysis for suspected Down’s Syndrome
Prenatal detection of chromosomal abnormalities in the babies of pregnant
women over age 35 (see policies BI017:
Amniocentesis, BI072: Chorionic Villus Sampling, and
BI205: Prenatal Testing).
Afirma genomic testing in members with thyroid nodules.
The following tumor marker testing on solid tumors:
BRAF V600E targeted analysis (note that full BRAF sequencing still
EGFR targeted mutation analysis
KIT targeted sequence analysis
KIT D816 targeted mutation analysis
KRAS exon 2 targeted mutation analysis
KRAS additional codon targeted mutation analysis
MGMT promoter methylation analysis
NRAS exon 2 and exon 3 analysis
Oncotype DX breast cancer test for women with breast cancer – see
BI129: Tumor Markers for specific
indications (once per lifetime).
Prolaris (81541) requires prior authorization to ensure it is being used
according to NCCN guidelines (post biopsy for NCCN low or favorable intermediate
risk prostate cancer in patients with at least 10 years life expectancy who have
not yet received treatment for prostate cancer and are candidates for active
surveillance or definitive therapy). Although NCCN guidelines indicate
OncotypeDx Prostate or ProMark may be used in this same clinical scenario, these
tests offer no advantage over Prolaris and will not be covered.
Decipher Prostate CA Classifier (81542)
requires prior authorization to ensure it is being used according to NCCN
MyPath Melanoma requires preauthorization. This is used when a skin
lesion is not clearly benign or malignant based on histopathological features.
The sample is derived from primary excision of a non-metastatic, melanocytic
lesion that has not been previously treated, and the
results will be used in conjunction with other information from clinical
evaluation, histopathological features, and other diagnostic procedures to
determine whether the lesion is benign or malignant.
Melanoma (81552) also requires prior authorization.
Companion diagnostic testing (identifying a genetic variant that would
qualify a patient for personalized treatment with a specific medication) will
only be covered when there is research demonstrating improved outcomes. While
companion diagnostic testing holds great promise for personalized medicine, this
is an area where medical practice is still evolving. Despite FDA approval of
companion testing, there are instances where the theoretic benefits are not yet
supported by research showing improved outcomes. As described above in the
Public Statement, there needs to be evidence the associated treatment will make
a difference in outcomes.
Normally, broad genetic panels are not covered because their usefulness for
informing clinical management decisions and changing outcomes is unproven.
However, NCCN and DNA Direct are now recommending the use of genetic panel
screening for women who qualify for BRCA screening and either men or women who
qualify for Lynch Syndrome screening. QualChoice will follow this
recommendation—only for specific genetic panels that have been shown to be cost
effective. The reason for the change in position by NCCN and DNA Direct is that
BRCA mutations and Lynch Syndrome mutations account for only about 50% of the
cancers in these two high risk groups. The Myriad myRisk screening panel (which
includes additional clinically relevant mutations for patients at high risk for
breast/ovarian/peritoneal cancer or Lynch Syndrome) will be covered in this
genetic panel is now also indicated for patients with certain advanced stage
cancers, such as non-small cell lung cancer (NSCLC), melanoma, colorectal
cancer, breast cancer or ovarian
cancerQualChoice specifically covers the Foundation1CDx panel (CPT 0037U) based
on NCCN and DNA Direct criteria.
Red cell antigen genotyping (0180U – 201U) requires prior authorization.
It is not medically necessary for routine transfusions.
Red cell antigen genotyping is only indicated when there is a high risk
of alloimmunization—as in transfusion-dependent sickle cell patients.
The following tests are considered experimental or investigational, and
are not covered (this list is not exhaustive):
Corus CAD gene expression test
CYP2C9 or VKORC1 testing for warfarin response
CYP2D6 testing for Tamoxifen response
CDKN2A or CDK4 testing for familial malignant melanoma
The use of cell free circulating tumor DNA to identify genetic mutations
present in a tumor (also known as a liquid biopsy)
Mammaprint and Mammostrat for breast cancer prognosis
Oncotype DX colon cancer assay
Cancer of Unknown Primary testing, such as (but not limited to)
CancerTYPE ID, Cancer Origin Test, and ResponseDX Tissue of Origin Test
UroVysion FISH testing for bladder cancer
other genetic, genomic, and pharmacogenetic tests and chromosome analyses
require pre-authorization. Since the development and clinical use of these types
of tests is continually evolving and changing rapidly (based on new research),
it is not practical to continually maintain a current list of all the relevant
tests. Any such list quickly becomes out of date. For any tests not specifically
mentioned, the medical necessity criteria for preauthorization will be
determined by referring to the most current recommendations from DNA Direct or
other sources of evidence-based guidelines considered by QualChoice to be
credible and unbiased. This will ensure the use of the tests is clinically
relevant and medically necessary rather than letting the marketing get ahead of
the science. See BI205 for fetal
Codes Used In This BI:
Carolyn J. Presley MD, Daiwei Tang
BS, Association of Broad-Based Genomic Sequencing With Survival Among Patient
With Advanced Non-Small Cell Lung Cancer In the Community Oncology Setting. JAMA.
August 2018, Vol320, Number 5, 469-477.
Application to Products
applies to all health plans and products administered by QualChoice, both those
insured by QualChoice and those that are self-funded by the sponsoring employer,
unless there is indication in this policy otherwise or a stated exclusion in
your medical plan booklet. Consult the individual plan sponsor Summary Plan
Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC)
or Certificate of Coverage (COC) for those plans or products insured by
QualChoice. In the event of a discrepancy between this policy and a
self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC,
or COC, as applicable, will prevail. State and federal mandates will be
followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.