Genomic Testing Insurance Denial

Page Contents:

• What is Genomic Testing and Who Does It Serve?
• What Types of Conditions Require Genomic Testing?
• Expanded Information Regarding Specific Brands of Genomic Tests
• Does Insurance Cover Genomic Testing and Why Are Claims Denied?
• Which Insurance Companies Are Known to Deny Genomic Testing?
• What Should You Do if You Receive an Insurance Denial for Genomic Testing?

What is Genomic Testing and Who Does It Serve?

Genomic testing is a relatively new field of genetics that refers to the process of observing the genes that make up an organism (genome). A person has about 25,000 different genes that are made up of some 3 billion DNA units. Genomic testing differs from genetic testing because it looks at all of a person’s genes instead of a specific gene. Genomic testing looks for any harmful changes in a person’s genetic code. Cancers contain mutations in the genetic code which cause the cancerous cells to grow and spread, leading to tumor development.

Genomic testing can identify specific genetic mutations in a person’s cancer which leads to a better understanding of the specific cancer, as well as how to treat it. Mutations and errors in our DNA are present only in the cancerous cells, which is what genomic testing discovers.  Genomic testing is usually done through a blood sample that looks for inherited genetic changes—the specific makeup of a person’s genes that could potentially affect their risk of cancer. If inherited gene mutations are found, other family members could also have the mutation.

What Types of Conditions Require Genomic Testing?

Genomic testing has a wide array of uses including determining the risk of developing specific diseases, screening, and even medical treatment. Genomic testing is especially used to detect (or provide the risk of developing) breast, prostate, colon, and ovarian cancers. Diagnostic genomic testing can be used to investigate an observed phenotype, which refers to an individual’s unique physical and behavioral characteristics.

As an example, diagnostic genomic testing can find germline mutations (changes to DNA inherited during conception), as well as somatic mutations (changes to DNA occurring after conception). These mutations can lead to conditions that affect your health, thus genomic testing allows for earlier detection and treatment. Genomic testing can even determine how you will respond to a specific drug, allowing a doctor to alter medications and dosage, particularly during cancer treatments.

Examples of genomic tests include Guardant 360, Tempus xT and FoundationOne Liquid CDx.

Expanded Information Regarding Specific Brands of Genomic Tests

The number of genomic tests has virtually exploded over the past decade or so. There are three major types of genetic testing available in laboratories:

• Cytogenic, which examines whole chromosomes
• Biochemical, which measures proteins produced by genes
• Molecular, which looks for small DNA mutations

The following are the most commonly used genomic tests and you may have received a genomic testing insurance claim denial for one of these tests.

• Guardant 360 is the first FDA-approved blood test for complete genomic testing and can be used for testing across all solid cancers from a single blood draw. Guardant 360 is also FDA-approved to identify advanced breast cancer patients with ESR1 mutations. Guardant 360 TissueNext offers comprehensive genomic profiling when tissue testing is appropriate.
• Tempus xT genomic test uses saliva and blood for germline DNA, and FFPE tissue for solid tumors and lymphoma. Bone marrow is used to identify tumor DNA. The Tempus xT gene panel is designed to specially target genes known to be linked with either resistance or response to targeted cancer therapies.
• Foundation One Liquid CDx helps doctors determine treatment options for an advanced cancer diagnosis. Foundation One Liquid CDx uses comprehensive genomic profiling to find information in the DNA of a cancerous tumor that assists oncologists in compiling a highly personalized cancer treatment plan. The difference in a tumor’s DNA has led to the development of treatments based on this DNA as well as identifying treatment options that will work best based on cancer DNA mutations.
• OmniSeq provides a comprehensive analysis of your body’s immune response and how that response interacts with your specific cancer. Using five different testing methods, the report provides your oncologist with a personalized summary of your immune profile along with potential immunotherapy treatment options.
• InSiGHT has a mission of improving the care of patients and families across the globe with hereditary conditions that result in gastrointestinal tumors. InSiGHT detects alterations in specific genes or groups of genes to help diagnose and treat Lynch syndrome, juvenile polyposis syndrome, hereditary diffuse gastric cancer, familial pancreatic cancer, and Peutz-Jeghers syndrome.

Some of the most accurate direct-to-consumer (at home) genomic tests include the following. It is unlikely that insurers will pay for these home tests, but they can be an important tool in determining your own personal health risks.

• Nebula Genomics offers the first direct-to-consumer genomics sequencing—free if the individual agrees to share his or her data. The company says it is building a health and genomic data marketplace for the medical community, researchers, and consumers. Nebula uses blockchain and encryption technologies to maintain control of the data and patient anonymity. It is expected that the genetic information amassed will help accelerate drug development and the development of personalized medicine.
• My Toolbox Genomics is another direct-to-consumer genomics testing service that analyzes not only your genetics but the microexpressions of your genes known as epigenetics. Epigenetics is the study of how your behaviors and environment cause changes that affect the way your genes work. Epigenetic changes are reversible, and do not change your actual DNA sequence, but can change how your body reads a DNA sequence.
• InsideTracker is an at-home DNA kit that analyzes 20,000 genetic markers that reveal an individual’s genetic potential for up to 38 wellness traits. InsideTracker identifies how your DNA influences your metabolism, cognition, gut health, heart health, and much more.

Does Insurance Cover Genomic Testing and Why Are Claims Denied?

Although genomic medicine has the capacity to truly revolutionize medical diagnoses and treatments, there is not yet a systematic agreement across insurers regarding paying for genomic testing. Insurance policies will detail whether genomic testing is covered in general. However,  even when it is covered, insurers may go out of their way to find exceptions. They may claim the test was inappropriate, not necessary, or even not scientifically valid. Coding for genomic testing can also cause incorrect denials—there are fewer than 200 Current Procedural Terminology (CPT) codes for more than 7,000 genomic tests. 

Which Insurance Companies Are Known to Deny Genomic Testing?

Any insurer—including Anthem Blue Cross, Blue Shield, Aetna, Kaiser, Health Net, UnitedHealthcare, and more—may go out of its way to find a way to deny a claim for genomic testing. One insurer, United Healthcare, faced a lawsuit in 2019 after denying genomic testing that would have allowed health providers to prescribe psychiatric medications that were specifically tailored to the patient’s genetic makeup. At the time, United claimed the tests were experimental or investigational but later agreed to cover genomic testing for mental health issues.

What Should You Do if You Receive an Insurance Denial for Genomic Testing?

If your insurer has denied coverage for genomic testing that your physician feels is medically necessary, you can appeal that decision. Your doctor will first write a letter to your insurer, asking for a medical exception, and detailing why the testing is medically necessary. If your insurer continues to deny your genomic testing coverage, you can file an appeal with the assistance of an experienced insurance denial attorney from the Law Offices of Scott Glovsky. We have been helping people who face insurance denials for over two decades and will fight zealously for your rights and your health. Contact Scott Glovsky today for a free consultation.