Frequently Asked Questions

Will Variantyx bill insurance companies directly?

Yes, we will conduct a benefits investigation for new test orders, managing the authorization process and keeping the patient informed of their payment options.

Will Variantyx obtain insurance pre-authorization?

As part of the benefits authorization process, we will work with the patient’s insurance company to obtain pre-authorization.

What information is needed to initiate benefits investigation?

To initiate benefits investigation, we require:

  • Signed test requisition form
  • Copy of the patient’s insurance card
  • Statement of medical necessity

Once an order is initiated (see Test Order Form), a clinical coordinator will work with the ordering clinician to obtain the necessary information.

Does Variantyx accept Medicare or Medicaid?

In some cases we are able to accept Medicaid or Medicare. Please contact a clinical coordinator about the details of your case.

What payment options are available if insurance billing is not possible?

We accept institutional billing as well as direct patient payment.

Is whole genome sequencing (WGS) reimbursable by insurance companies?

As far as we are aware, most, if not all, insurance providers classify whole genome sequencing for diagnosis of genetic disorders (CPT codes 81425, 81426 and 81427) as investigational and not reimbursable. This assessment is based mainly on the traditionally high cost of whole genome sequencing. As far as we are aware, it is not based on WGS’s use as a sequencing method for investigating the exome, mitochondrial genome and specific genomic regions of disease relevance. With the cost of WGS decreasing year after year, we believe it is more cost efficient to use WGS to sequence once, store the data and perform more targeted testing through in-silico analysis. Please see the table below for information about specific tests that can be performed using WGS data.

Is whole exome sequencing (WES) reimbursable by insurance companies?

The reimbursement picture for whole exome sequencing is constantly changing as more insurance providers amend their policies to cover exome sequencing as a medically necessary procedure under certain conditions. As of December 2017, insurance providers covering exome sequencing under certain conditions include Cigna, Geisinger Health Plan, United Healthcare and Blue Cross Blue Shield of Massachusetts and California. As an example, Blue Cross Blue Shield of Massachusetts and California each recently amended their policies to recognize whole exome sequencing as medically necessary under the following conditions:

Whole exome sequencing (WES) may be considered medically necessary for the evaluation of unexplained congenital or neurodevelopmental disorders in children when ALL of the following criteria are met:

  1. The patient has been evaluated by a clinician with expertise in clinical genetics and counseled about the potential risks of genetic testing, AND
  2. There is potential for a change in management and clinical outcome for the individual being tested, AND
  3. A genetic etiology is considered the most likely explanation for the phenotype despite previous genetic testing (eg, chromosomal microarray analysis and/or targeted single-gene testing), OR when previous genetic testing has failed to yield a diagnosis and the affected individual is faced with invasive procedures or testing as the next diagnostic/therapeutic step (eg, muscle biopsy, organ transplant).

See Massachusetts policy

See California policy

We expect insurance providers in other states to follow Blue Cross Blue Shield of Massachusett’s and California’s lead shortly, but it is best to check directly with the relevant provider to determine current exome reimbursement status.

Do Medicare or Medicaid reimburse for whole genome and/or whole exome sequencing?

As far as we are aware, as of December 2017, Medicare and Medicaid do not provide reimbursement for either whole genome or whole exome sequencing. However, we expect this to change in the future given Blue Cross Blue Shield of Massachusett’s and California’s recent policy revision to recognize whole exome sequencing as medically necessary under certain conditions.

What CPT codes are used for whole exome sequencing (WES)?

CPT code 81415 is used for exome sequencing of a proband. CPT code 81416 is used for exome sequencing of each additional sample as part of a trio or family WES analysis. CPT code 81417 is used for reanalysis of previously obtained exome sequencing data.

What CPT codes are used for whole genome sequencing (WGS)?

There are CPT codes specific for whole genome sequencing including 81425, 81426 and 81427. But because WGS is not reimbursable as a test itself at this time, it is more useful to consider CPT codes for genomic tests that are reimbursable for at least some providers under certain circumstances, and that can be accomplished using WGS as the underlying technology. Whole genome testing through Variantyx provides results that are compatible with the following CPT codes:

Test Type CPT Code CPT Code Description
 Exome analysis  81415 Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis
 Exome analysis  81416 Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator exome (e.g., parents, siblings) (List separately in addition to code for primary procedure)
 Exome analysis  81417 Exome (e.g., unexplained constitutional or heritable disorder or syndrome); reevaluation of previously obtained exome sequence (e.g., updated knowledge or unrelated condition/syndrome)
 Mitochondrial genome analysis  81460 Whole mitochondrial genome (e.g., Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection
Mitochondrial genome large deletion analysis 81465 Whole mitochondrial genome large deletion analysis panel (e.g., Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed

table data for mobile display

It is best to check directly with the relevant provider to determine current reimbursement status for individual CPT codes.

Can I do whole genome sequencing (WGS) and bill for reimbursement using the CPT codes for whole exome sequencing (WES)?

With the cost of WGS continuing to decrease, it is becoming more cost efficient and beneficial to use WGS to sequence once and then use in-silico testing to perform more targeted analysis of the data. Please see the table above for information about specific tests that can be performed using WGS data.

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