2021 Annual Notice to Physicians

The office of the Inspector General (OIG) of the Department of Health and Human Services recommends that laboratories send an annual notice to physicians and other providers advising them on the elements of the laboratory’s compliance program. This letter serves as the annual notice and includes information regarding 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 an ABN should be completed by the patient prior to ordering 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. ABNs are provided 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:

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.

After the launch of Guardant360 CDx, Guardant Health is continuing to offer a laboratory developed test (LDT) version of Guardant360 with the addition of several new biomarkers. As a result, the ordering provider is expected to make a selection of the appropriate test on the TRF. A test order may not be changed once received by the laboratory. If the LDT version of Guardant360 is ordered, the report delivered will not have been reviewed or approved by the FDA.

Guardant360 TissueNext is a tissue-based comprehensive genomic profiling NGS test that detects all of the same variant types as Guardant360 CDx as well as microsatellite instability and tumor mutational burden. It is available as an automatic reflex when ordered by the physician when no actionable biomarker is identified with Guardant360 CDx.

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.

In certain localities, a given Guardant Health test 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.

Reflex Testing

Reflex testing is additional testing, separately billed, that is automatically performed on the basis of the initial results. The “Liquid to Tissue Profiling” test offering contains a reflex pathway. Further information about this reflex pathway can be found on the Guardant Health website (Guardant360CDx.com/Tissue-Next). Note that Tissue Profiling is not available as an add-on to completed Guardant360 orders.

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. 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. 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.

Martina Lefterova, MD PhD
Sr. Medical Director & Clinical Laboratory Director