Foundation Medicine is committed to helping patients access our testing services. Depending on the specific test, patients may already have coverage through Medicare or private insurance. We also offer Financial Assistance if a patient is uninsured or concerned about their ability to pay for the out-of-pocket cost of testing.
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.
Prior Authorization Support
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.
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.
Medicare Coverage and Compliance
Foundation Medicine’s tests may be covered by Original Medicare1 and Medicare Advantage2.
FoundationOne®CDx and FoundationOne®Liquid CDx
Covered3 if all 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.4 Patients who are insured by Original Medicare1 and meet clinical criteria for coverage have no out-of-pocket costs.
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)
Covered5 if all 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.4 Patients who are insured by Original Medicare1 and meet clinical criteria for coverage have no out-of-pocket costs.
Patient Coverage Criteria6
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.
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 “Date of Service 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.
Advance Beneficiary Notice
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”).
Financial Assistance Program
If a patient is uninsured or concerned about their ability to pay for the out-of-pocket cost of testing, they can fill out a financial assistance application (FAA) online or by contacting our Care Team at:
Phone: 888.988.3639 Email: email@example.com
Patients may apply for financial assistance before, during, and after the testing process. Payment plans may also be available.
Patients who apply for Foundation Medicine’s financial assistance program may be approved for anywhere between 0% and 100% of their final balance due. For example, if a patient’s final balance is $1,000 and they are approved for 60% financial assistance, their final bill will be reduced to $400.
If a patient experiences a change in their financial status or extenuating circumstances, they can re-apply by updating their financial assistance application form and/or by submitting additional documents documenting the changes or new information.
Patients who are covered by a State-managed Medicaid program automatically receive 100% financial assistance for testing under our financial assistance program. Patients who have Managed Medicaid plans will still need to fill out a financial assistance application form.*
*Foundation Medicine is not currently a Medicaid provider. Foundation Medicine does, in some instances, bill Managed Medicaid plans where permitted to do so.
Patients with Insurance Who Request to be Billed as Self Pay:
Foundation Medicine will not apply a financial assistance award to a patient’s bill if the patient has insurance but elects to not have their insurance billed and requests to be billed as a self-pay patient.
Foundation Medicine’s financial assistance program is not intended to be used for promotional purposes.
Each Financial Assistance Application is reviewed individually for patient-specific details, including extenuating circumstances, and is based on an individualized determination of genuine patient financial need or hardship.
1Medicare administered by federal government.
2Medicare administered by private insurers.
3Per the “Decision for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced cancer – CAG-00450R.” (See Appendix B)
4A “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.
5National 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.
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.
Need More Details?
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Important Safety Information
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced 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 Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced 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. Patients who are negative for 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.