Billing and Reimbursement Support
Foundation Medicine is committed to helping patients access our testing services. Through our FoundationAccess™ support program, we complete a benefits investigation for each test ordered and reach out to any patients we expect may have out of pocket costs. Depending on the specific test, patients may already have coverage through Medicare or private insurance. We also offer a need based Financial Assistance program for eligible patients.
Some commercial health plans such as Cigna and many BlueCross BlueShield plans offer coverage for Foundation Medicine testing services. Medicare covers FoundationOne®CDx, FoundationOne®Liquid CDx, and FoundationOne®Heme for qualifying patients. FoundationOne CDx is also covered by TRICARE for qualifying patients. FoundationOne Heme has limited commercial health plan coverage at this time.
Regardless of network status, all commercial health plan coverage is pursuant to the applicable health plan’s medical policy and specific patient benefit levels.
The Foundation Medicine FoundationAccess™ program supports providers and their patients through the coverage and billing process. For each comprehensive genomic profiling test ordered, we complete a benefits investigation and reach out to patients whom we expect may have out of pocket costs. Additionally, we support providers and patients by helping obtain prior authorizations when required, billing the patient’s health plan for the test, and appealing denials with the patient’s consent.
We reach out to all patients with expected out of pocket costs
We help obtain prior authorizations (PAs) when we are aware one is required
We bill the patient’s health plan for the test and appeal denials as necessary
How does the FoundationAccess Program Work?
After receipt of a Foundation Medicine comprehensive genomic profiling (CGP) test order, Foundation Medicine will reach out to the patient’s insurance company to obtain benefit information (e.g. confirm insurance information, un-met deductible amounts, and lab benefit levels) as available.
Foundation Medicine will proactively reach out to all patients with expected out-of-pocket costs to discuss high level information about the testing their provider ordered and how the FoundationAccess program works to support them through the coverage and reimbursement process.
When we expect that a patient will not have any out-of-pocket expenses for the ordered CGP test(s), they will not receive outreach via phone but will receive mailed materials informing them that we expect them to have no out-of-pocket costs for their Foundation Medicine CGP testing.
If Foundation Medicine is aware of a prior authorization (PA) requirement and allowed to seek a PA by the health plan, Foundation Medicine will attempt to submit a PA request on behalf of the patient.
In situations where the treating physician must submit the PA request, Foundation Medicine will contact your office and provide the information to use for PA submission.
Natera manages all aspects of the FoundationOne Tracker billing process including the Compassionate Care financial assistance program which supports patients’ access to FoundationOne Tracker.
For additional information on patient access to FoundationOne Tracker, including Natera's financial assistance program, please visit: https://www.natera.com/oncology/foundationone-tracker-patientaccess
Foundation Medicine understands that prior authorization requirements may present a challenge to patient access to comprehensive genomic profiling. In order to support completion of prior authorization requirements, when:
- Foundation Medicine is aware of a prior authorization requirement, and
- Foundation Medicine is able to submit for prior authorization,
Foundation Medicine will submit prior authorization for FoundationOne CDx, FoundationOne Liquid CDx, and FoundationOne Heme.
If Foundation Medicine is unable to submit the prior authorization, and only the ordering provider is able to submit, Foundation Medicine will contact the ordering physician to inform them of the prior authorization requirement.
Financial Assistance Program
For patients with out-of-pocket costs, financial assistance is available for those who qualify.* Anyone can apply at any time, and qualifying patients pay no more than $100 out-of-pocket.
State Medicaid recipients pay $0 out-of-pocket and don’t need to apply. Managed Medicaid patients should apply for assistance.
Financial assistance is based on need and can be applied for at any point during the testing process. If a patient doesn’t qualify for financial assistance, payment plans may be available.
*Financial assistance is only available for tests ordered within the U.S. and its territories.
If a patient experiences a change in their financial status, they can re-apply by updating their financial assistance application form and/or by submitting additional documents documenting the changes or new information.
Foundation Medicine’s tests may be covered by Original Medicare† and Medicare Advantage.‡
FoundationOne®CDx and FoundationOne®Liquid CDx
Covered§ if all of the below patient coverage criteria are met. An ABN is required if the patient does not meet the patient coverage criteria or if the person ordering the test is not a treating physician.¶
Qualifying Original Medicare† beneficiaries have no out of pocket costs for Foundation Medicine NGS testing.
Patient Coverage Criteria
i. Patient has been diagnosed with a solid malignant neoplasm; AND
ii. Patient has either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer (only requires one of these to be met); AND
iii. Patient has not been previously tested with the same test using NGS for the same cancer genetic content; AND
iv. Patient has decided to seek further cancer treatment (e.g., therapeutic chemotherapy)
Covered# if all of the below patient coverage criteria are met. An ABN is required if the patient does not meet the patient coverage criteria or if person ordering the test is not a treating physician.¶
Qualifying Original Medicare† beneficiaries have no out of pocket costs for Foundation Medicine NGS testing. Patient Coverage Criteria**
i. Patient has been diagnosed with refractory/metastatic acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN) or patient has a suspected myeloid malignancy with an undefined cytopenia for greater than 4 months, and other possible causes have been reasonably excluded, AND
ii. Patient has not previously received or is not currently receiving NGS testing on the specimen for which the test is currently being ordered, AND
iii. Patient has not been tested with the same test for the same genetic content
An ICD-10 diagnosis code list specific to the cancer types for which FoundationOne®Heme is covered by Medicare can be found here.
FoundationOne Tracker is covered by Medicare for monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with all solid tumors. Qualifying Original Medicare beneficiaries have no out-of-pocket costs for FoundationOne Tracker.
Foundation Medicine is committed to doing things the right way in all facets of its business—by providing quality testing for patients, by offering timely and reliable customer service, and by billing for its services responsibly and correctly. Compliance with Medicare rules and regulations is critical to achieving this goal.
One of the more complex Medicare billing rules with which Foundation Medicine, and its customers, must comply, is the so-called 14-day rule. The 14-day rule helps to establish who will be billed for a test provided to a Medicare patient. In some cases, Medicare is billed directly for Foundation Medicine testing. In other cases, the 14-day rule requires that Foundation Medicine bill its hospital customers for testing that is performed on Medicare patients.
The 14-day rule under applicable Medicare rules determines whether or not the clinical laboratory service, is bundled into the diagnosis-related group (DRG) payment made to the hospital for in-patients.
Please view our 14-Day Rule Billing Requirements to determine who is affected.
When patients insured by Original Medicare (i.e., Medicare administered by the federal government; not Medicare Advantage, which is administered by private health plans) have Foundation Medicine testing ordered by a treating physician and do not meet the coverage criteria set forth in an applicable National Coverage Determination (“NCD”) or Local Coverage Determination (“LCD”), the Centers for Medicare & Medicaid Services (“CMS”) requires that patients complete an Advance Beneficiary Notice (“ABN”) prior to receiving non-covered services.
The ABN informs Original Medicare patients that they may have financial responsibility for services ordered by their healthcare providers. If Foundation Medicine determines that a patient with Original Medicare does not meet coverage criteria, we will attempt to contact the patient (and treating physician as necessary) to obtain an ABN if one is not submitted with the Test Requisition Form (“TRF”).
*Foundation Medicine is not currently a Medicaid provider. Foundation Medicine does, in some instances, bill Managed Medicaid plans where permitted to do so.
†Medicare administered by federal government.
‡Medicare administered by private insurers.
§Per the “Decision for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced cancer – CAG-00450R.” (See Appendix B)
¶A “treating physician” is a physician, as defined in §1861(r) of the Social Security Act, who furnishes a consultation or treats a beneficiary for a specific medical problem, and who uses the results of a diagnostic test in the management of the beneficiary’s specific medical problem. More information is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R80BP.pdf.
#National Government Services, the local Medicare Administrative Contractor with jurisdiction over testing performed by Foundation Medicine at its Cambridge, MA laboratory for Original Medicare beneficiaries, does not have a Local Coverage Determination (LCD) for liquid biopsy next generation sequencing >50 genes. Coverage is determined by National Government Services on a case-by-case basis.
**Per the “Local Coverage Determination (LCD):MolDX: NEXT-GENERATION Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies (L38047)”
FoundationOne Heme was developed and its performance characteristics determined by Foundation Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information on this laboratory developed test please see the Technical Specifications at foundationmedicine.com/f1h.
Natera manages all aspects of the billing process including benefits investigations, payer billing, patient outreach, patient billing and the Compassionate Care financial assistance program which supports patients’ access to FoundationOne Tracker. For more information, visit https://www.natera.com/oncology/foundationone-tracker-patientaccess
Important Safety Information
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com
FoundationOne®Tracker is a clinical test performed exclusively as a laboratory service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). FoundationOne Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. Treatment decisions are the responsibility of the treating physician. ctDNA detection sensitivity may be limited if blood collection occurs within two weeks of surgery or while a patient is on therapy. A negative test result does not definitively indicate the absence of cancer. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is designed to detect ctDNA from the assayed tumor only; new primary tumors will not be detected. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.
FoundationOne Liquid CDX
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.