Guardant Health Annual Notice
2023 Annual Notice to Physicians
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.
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
Services rendered by Guardant Health are typically documented in either Local Coverage Determinations (LCDs) or National Coverage Determinations (NCDs). LCDs and 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 which describe the patient’s unique medical condition.
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.
Guardant Health Screening offers the following laboratory developed test performed (LDT) in our CLIA certified, CAP accredited laboratory:
Shield™ is a liquid biopsy assay designed to detect colorectal neoplasia in individuals at average risk for developing colorectal cancer, by identifying genomic and epigenomic alterations in cell-free DNA in blood. The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods.
To order the Shield test, the TRF must be fully completed and signed by the ordering physician or other authorized medical professional. The order can be placed through the Guardant Health online portal at GuardantGo.com.
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, address, and directorship of the reference laboratory.
Guardant Health does not offer custom profiles to ordering physicians.
Martina Lefterova, MD PhD
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- The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods
- Patients with an "abnormal signal detected" Shield test result should be referred for colonoscopic evaluation
- A "normal signal detected" Shield test result does not preclude the presence of colorectal neoplasia, and patients should continue participating in guideline-recommended screening programs
- Shield was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing. This test has not been cleared or approved by the US FDA