2024 Annual Notice to Physicians | Screening

This letter serves as an annual notice on updates regarding the ordering and processing of clinical laboratory tests performed by Guardant Health, Inc. Guardant may update you more than once a year if there are material changes to the testing panel, such as FDA approval or a new product release.

Please review the attached information in this notice and contact Client Services at 855.722.7335 if you have any questions.

Medical Necessity

Medicare pays for services that are reasonable and necessary and meet specified Medicare coverage criteria for the beneficiary’s unique medical condition.

As a participating Medicare provider, Guardant Health has the responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner that is consistent with federal and state statutes and regulations. The OIG takes the position that ordering providers authorized by law to order clinical laboratory tests for Medicare beneficiaries share the burden of ensuring that only medically necessary services are ordered and billed to Federally funded programs. Providers who submit false claims may be subject to sanctions or remedies available under civil and administrative law. 

Guardant attempts to have a comprehensive set of attestations on the Test Requisition Form (TRF) to determine the coverage status for Medicare services. Completion of the entire TRF enables appropriate determination of coverage for rendered services.

Medicare Coverage Determinations

Shield^TM is FDA approved for CRC cancer screening and meets the coverage criteria for Medicare defined in NCD 210.3. NCDs have sections describing what medical conditions are covered and the ICD-10 codes that are covered. All clinical orders sent to Guardant Health must include at least one ICD-10 code and should include all appropriate ICD-10 codes that are applicable to the testing that is being ordered.

Clinical Consultant

Guardant Health offers clinical consulting by our Laboratory Directors. Discussions related to appropriate testing and test ordering as well as questions related to the reports may be scheduled by client services at 855.722.7335. 

Test Ordering

Guardant Health Screening offers the following FDA approved test performed in our CLIA certified, CAP accredited laboratory:

The Shield test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit. Shield is indicated for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

To order the Shield test, the requisition or online order must be fully completed and signed by the ordering provider or other authorized medical professional. The order can be placed through the Guardant Health online portal.

Test Reporting

In some circumstances, Guardant Health may forward the specimen to another laboratory, certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) and licensed in all applicable localities. In the event that a specimen is forwarded to a reference laboratory, the final report will list the name and  address of the reference laboratory.

Custom Profiles

Guardant Health does not offer custom profiles to ordering physicians.

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Martina Lefterova, MD PhD 

Laboratory Director