LOG IN BACK TO RESOURCES Billing and Reimbursement Support JUMP TO FoundationAccess Program Prior Authorization Support Financial Assistance Medicare Coverage and Compliance ABN Requirements Resources FoundationAccess Program 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. 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. 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 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), 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. Prior Authorization Support 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. PRIOR AUTHORIZATION SUPPORT Prior Authorization 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 Financial Assistance Program Financial assistance is available for qualifying patients in the United States (US) who have out-of-pocket costs associated with Foundation Medicine testing. Financial assistance is based on need and can be applied for at any point during the testing process. Payment plans may also be available. Foundation Medicine's financial assistance program is only available to patients whose tests were ordered within the US and US territories. A financial assistance application (FAA) can be filled out online or by contacting our Client Services team at: Phone: 888.988.3639 Email: client.services@foundationmedicine.com 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. MEDICARE COVERAGE AND COMPLIANCE Medicare Coverage 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) FoundationOne®Heme 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. Medicare Compliance 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. ADVANCE BENEFICIARY NOTICE ABN Requirements 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”). RESOURCES Downloadable Resources Coverage, Billing, and Financial Assistance Overview FoundationAccess FAQs Financial Assistance Application Financial Assistance Application (Español) Medicare ABN (English) Medicare ABN (Español) Medicare ABN (Chinese) ADDITIONAL NOTES *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. 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