Billing and Reimbursement Support
Overview
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.
Foundation Medicine accepts all health insurance plans, and we are committed to helping patients access our testing services.
Depending on the medical criteria within the policy or in-network status, a patient’s financial responsibility may vary.
Foundation Medicine has coverage for CGP testing for solid tumors with all major insurers, including Aetna, Anthem, United Healthcare and the majority of Blue Cross Blue Shield plans.
Regardless of network status, all commercial health plan coverage is pursuant to the applicable health plan’s medical policy and specific patient benefit levels.
Learn more about patient protections against surprise billing.
FoundationAccess Program
FoundationAccess Program
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.
Patient Outreach
We reach out to all patients with expected out of pocket costs
Prior Authorizations
We help obtain prior authorizations (PAs) when we are aware one is required
Appeals Support
We bill the patient’s health plan for the test and appeal denials as necessary and with the patient's consent
How does the FoundationAccess Program Work?
Patient Outreach
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), the patient will receive a letter informing them that we expect them to have no out-of-pocket costs for their Foundation Medicine CGP testing.
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 will need to apply for financial assistance to see if they qualify.
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.
Applying is easy. Complete an online form or this PDF application. Or talk to a Client Services team member at:
Phone: 888.988.3639
Email: client.services@foundationmedicine.com
*Financial assistance is only available for tests ordered within the U.S. and its territories.
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.
Changes for Coverage Information and Financial Resources Website page. https://www.foundationmedicine.com/patient/financial-support-resources
Coverage information and financial resources
FoundationAccess® program
Giving you access to insurance, billing, and financial assistance is a top priority at Foundation Medicine—and FoundationAccess® is here to help.
Changes for Patient FAQ Website Page. https://www.foundationmedicine.com/faq/patient-faqs
Does insurance cover my Foundation Medicine comprehensive genomic profiling test?
Foundation Medicine accepts all insurance plans. More than 80 health plans cover one or more of Foundation Medicine’s tests including Original Medicare and Medicare Advantage. Qualifying Original Medicare beneficiaries have no out-of-pocket costs for Foundation Medicine NGS testing.†
Our FoundationAccess® program reviews your benefit information and contacts you if we expect you’ll incur out-of-pocket costs. If there is a cost and you can’t afford it, financial assistance is available for those who qualify.* You can apply anytime to see if you qualify. If you do qualify, you’ll pay no more than $100 in out-of-pocket costs. Financial assistance isn’t available for patients who have insurance and choose to be self pay.
Applying is easy. Complete an online form or this PDF application. Or talk to a Client Services team member at:
Phone: 888.988.3639
Email: client.services@foundationmedicine.com
†For FoundationOne®CDx and FoundationOne®Liquid CDx, see “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer,” CAG-00450R. For FoundationOne®Heme, see Local Coverage Determination, “Next Generation Sequencing for Solid Tumors L38158.” For FoundationOne®RNA, see Local Coverage Determination, "Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms L37810.”
*Financial assistance is only available for tests ordered within the U.S. and its territories.
Additional Notes
*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.
Changes for Coverage Information and Financial Resources Website page. https://www.foundationmedicine.com/patient/financial-support-resources
Need More Details?
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.
Important Safety Information
FoundationOne CDx and FoundationOne Liquid CDx
FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures. FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may benefit from treatment with specific therapies in accordance with the 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 tests 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 testing with FoundationOne CDx when archival tissue is not available which may pose a risk. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are tested with FoundationOne Liquid CDx and 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 important risk information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.
FoundationOne CDx and FoundationOne Liquid CDx
FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures. FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may benefit from treatment with specific therapies in accordance with the 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 tests 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 testing with FoundationOne CDx when archival tissue is not available which may pose a risk. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are tested with FoundationOne Liquid CDx and 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 important risk information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.