2022 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 855.698.8887 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 “Relevant Clinical History” section of the 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.

Advance Beneficiary Notice of Noncoverage (ABN)

Not all services are covered by Medicare. For services that do not meet the coverage criteria established by Medicare, prior notice to a patient and completion of an ABN by the patient prior to the ordering of the test. This will document the patient’s understanding that the services may not be covered by Medicare and the patient assumes the responsibility for payment in the event services are not covered. To facilitate the above notice requirement, Guardant provides the ABN form in each sample collection kit and should accompany the sample and the TRF when they are shipped to Guardant Health.

Clinical Consultant

Guardant Health offers clinical consulting by our physician 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 855.698.8887.

Test Ordering

Guardant Health offers a comprehensive set of cancer tests that aim to support clinical decision making across a cancer patient’s treatment journey. One test is approved by the FDA while others are offered as laboratory developed tests (LDT) performed in our CLIA certified, CAP accredited laboratory:

  • Guardant360® CDx (FDA Approved) is a next generation sequencing (NGS)-based test for the detection of genetic alterations in 55 genes frequently mutated in cancer. It is a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients who may benefit from treatment with the targeted therapies listed in Guardant360CDx.com/technicalinfo. Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm.
  • Guardant360 is a next generation sequencing (NGS)-based liquid biopsy intended to provide comprehensive tumor genomic profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with advanced-stage solid malignancies.
    • Guardant Health is continuing to offer Guardant360 laboratory developed test (LDT) with the addition of several new biomarkers. As a result, the ordering provider is expected to select the most appropriate test on the TRF. A test order may not be changed once received by the laboratory. If Guardant360 LDT is ordered, the report delivered will not have been reviewed or approved by the FDA. Please note that the Guardant360 LDT has limited sensitivity for FGFR2 fusions.
  • Guardant360 TissueNext™ is a tissue-based comprehensive genomic profiling NGS LDT that detects all the same variant types as Guardant360 liquid biopsy.
    • If Guardant360 TissueNext is ordered alongside Guardant360 CDx*, a confirmatory test requisition form will be required to attest medical necessity after the Guardant360 CDx results are delivered.
    • If Guardant360 TissueNext is ordered alongside Guardant360 LDT, the liquid biopsy test will be converted to Guardant360 CDx.
    • PD-L1 immunohistochemistry is only available alongside the Guardant360 TissueNext order.
  • Guardant360 Response™ is a liquid biopsy intended to detect early changes in tumor-derived cell-free DNA associated with therapy response. The assay leverages Guardant360 technology by comparing baseline and early on-treatment timepoints in patients with advanced solid tumor malignancies.
  • Guardant Reveal™ is a qualitative liquid biopsy assay for tissue-independent detection of minimal residual disease and recurrence monitoring in patients with early-stage cancer following surgical resection and/or completion of standard of care adjuvant chemotherapy. The test is available only for patients with early-stage colorectal cancer, breast cancer, or lung cancer.
  • Guardant 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.

In certain localities, ordering a certain Guardant Health LDT may not be approved (e.g., New York State). If the test is ordered in those regions, Guardant Health may change the order to a version that is approved (if available), which may not include some features ordered by the provider. Alternatively, Guardant Health may cancel the ordered test. The ordering provider will be notified.

Test Reporting

While Guardant Health will issue a Guardant360 CDx report that includes both an FDA Approved Content section and a Professional Services section, in some cases as noted below, Guardant Health may only issue the Professional Services report that has not been reviewed or approved by the FDA. This process is anticipated to be performed in a small percentage of cases (approximately 5%). Examples of when this process change occurs include: low DNA input samples, patient history of solid organ or bone marrow/stem cell transplant, pregnancy, cases where the metrics used for Guardant360 CDx are not met but are acceptable within the scope of a CLIA laboratory developed test (LDT). In these cases, the same reagents, processes, and bioinformatics pipeline will be used for the LDT test as would otherwise have been used with the CDx test, but with the application of slightly different acceptance criteria and reporting of the results.

In some circumstances, for example when PD-L1 immunohistochemistry is ordered, 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.

Custom Profiles

Guardant Health does not offer custom profiles to ordering physicians.

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Martina Lefterova, MD PhD

Laboratory Director

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*Patients who have a negative Guardant360 CDx test result for an indicated companion diagnostic biomarker should be reflexed to tissue biopsy testing using an FDA approved tumor tissue test, if feasible.