Does Medicare Cover Genetic Testing

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Your genes carry a wealth of information about your health. Changes in your genes, called variants or mutations, can cause health conditions.

Genetic testing looks for mutations in your genes, which can provide valuable information to help you make healthcare decisions. To do a genetic test, a healthcare professional takes a small sample, usually of blood or saliva, and sends it to a lab to be examined. Understanding how Medicare covers genetic testing is important if you're considering these tests.

Does Medicare cover genetic testing?

Yes. Medicare Part B covers various types of genetic testing. These may include tests to diagnose inherited disorders or guide medical treatment decisions. For example, Medicare might cover genetic testing for certain cancer risks. It may also cover genetic tests to determine how a person may respond to specific medications or to diagnose genetic disorders.

Generally, you must have signs and symptoms of a condition for Medicare to cover genetic testing. Additionally, three things need to happen:

• A healthcare professional must order the test.

• The test must be medically necessary to diagnose or treat a medical condition.

• The FDA must have approved or cleared the test.

In some cases, the test must also be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. This means the laboratory meets federal quality standards for accuracy and reliability.

Medicare makes coverage decisions in two ways:

1. National Coverage Determinations (NCDs): These are nationwide rules that all Medicare Administrative Contractors (MACs) must follow. MACs are private companies that manage Medicare claims and payments in specific regions of the U.S.

2. Local Coverage Determinations (LCDs): When no NCD is available for a medical service, such as genetic testing, local MACs can decide whether to cover it in their area.

Genetic testing may be covered either under an NCD or an LCD. Different MACs cover different regions of the country. This means if the test you need is covered by an LCD, coverage requirements may vary slightly depending on where you live. However, LCD coverage rules for genetic testing can be quite similar.

What genetic tests does Medicare cover?

Here's an overview of some genetic tests that Medicare may cover:

1. Next Generation Sequencing (NGS)

This is a testing method that allows scientists to quickly read many DNAs at once. It can be used to check for changes in several genes. Medicare covers NGS for both somatic (acquired during life) and germline (inherited) cancer testing. NGS can help healthcare professionals better understand gene changes in a person's cancer. This information can guide them in choosing the most effective treatment options.

2. Pharmacogenomic testing:

This test helps predict how you might respond to certain medications based on your genes. For example, it can determine if you're likely to have side effects from a specific antidepressant.

3. Molecular diagnostic testing

These tests look for changes in genes, proteins, or other molecules to help diagnose health conditions or guide treatment. For example, a molecular diagnostic test might confirm a diagnosis of cystic fibrosis by checking for specific genetic mutations for that condition.

What genetic tests are not covered by Medicare?

Medicare usually doesn't cover:

1. Direct-to-consumer genetic tests

These are tests you can order online without a healthcare professional's involvement, such as those offered by 23andMe.

2. Screening genetic tests

These include genetic screening to assess your risk of having a condition. These tests are usually done for people without signs or symptoms or without a specific medical reason. There's one exception: Medicare does cover the Cologuard stool DNA test for colorectal cancer screening.

3. Ancestry testing

These may include tests that tell you about your genetic heritage.

Does Medicare cover genetic testing for cancer?

Yes. Medicare covers genetic testing for cancer when specific criteria are met. Some of these tests include:

1. BRCA1 and BRCA2 testing

BRCA1 and BRCA2 are genes that, when mutated, can increase the risk of breast and ovarian cancer. BRCA testing may be covered by Medicare for people with:

• Breast cancer diagnosed at age 45 or younger

• Male breast cancer

• Ovarian, fallopian tube, or primary peritoneal cancer

• Triple-negative breast cancer diagnosed at age 60 or younger

• Pancreatic cancer or prostate cancer with a Gleason score equal to or greater than 7

• Ashkenazi Jewish ancestry with breast cancer

• Breast cancer at age 50 or younger with close relatives having breast cancer

• Two primary breast cancers, with the first diagnosed before age 50

• Breast cancer at any age with a family history of related cancers

BRCA testing coverage requirements may vary depending on your location and the MAC in your area. For instance, some MACs might cover BRCA testing for people who are adopted and diagnosed with breast or ovarian cancer at a young age. However, these exact rules might not be the same in all areas.

2. Lynch syndrome testing

Lynch syndrome is an inherited condition that increases the risk of certain cancers, especially colorectal and endometrial cancer. Genetic testing for Lynch syndrome may be covered by Medicare for people with:

• Colorectal cancer diagnosed at age 70 or younger

• Colorectal cancer diagnosed after age 70 who meet specific criteria

• Endometrial cancer at any age

As with BRCA testing, coverage requirements for Lynch syndrome testing may vary depending on your location and the MAC in your area.

However, these are general guidelines. A healthcare professional can help determine if these tests are appropriate for you and if you meet the criteria for Medicare coverage.

How much does a genetic test cost?

Genetic test costs range widely, from under $100 to over $2,000. The cost depends on the test's complexity and how many genes it examines. Sometimes, testing family members is also necessary, which can increase the overall expense.

Luckily, many labs provide patient assistance programs to help make testing more affordable. Depending on your situation, you might qualify for reduced costs or even free testing. This is also true if you have Medicare and don't meet the coverage requirements. However, if you have Medicare and meet the genetic test coverage criteria, you typically won't have any out-of-pocket costs.

It's always a good idea to check with your insurance provider about coverage before getting any genetic test. They can give you specific price information and help you understand your insurance coverage.

Who should consider getting genetic testing?

Getting genetic testing is a decision best made together with a qualified healthcare professional. They may recommend genetic testing for you for several reasons. These include a family history of genetic conditions or a personal diagnosis that might have a genetic component. Certain ethnic groups with higher risks of some disorders may also benefit from testing. Testing could also be useful to guide treatment for a diagnosed condition.

However, genetic testing isn't always necessary or beneficial for everyone. A healthcare professional or genetic counselor will consider your unique circumstances and weigh the potential benefits and risks for you. They can also help you understand what your test results might mean for you and your family.

How to check if Medicare will cover genetic testing

Here are a few ways to check if Medicare will cover a specific genetic test:

• Talk to the ordering healthcare professional. They can help determine if a genetic test is medically necessary for your condition. They can also check if the test meets Medicare's coverage criteria.

• Contact Medicare. Call Medicare directly at 1-800-MEDICARE (1-800-633-4227) to ask about coverage. Have your Medicare number ready when you call.

• Ask the testing laboratory. Many laboratories have information about Medicare criteria for genetic testing. In most cases, the laboratory staff can help check Medicare coverage.

Keep in mind that Medicare coverage for genetic tests depends on individual circumstances. Even if Medicare usually covers a test, you will still need to meet the coverage requirements. Always verify coverage before proceeding with any genetic test to avoid unexpected costs.

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