It is important that every patient read and understand the full Next Generation Sequencing (“NGS”) Affordability Program (also referred to as the “Program”) Terms and Conditions.

The NGS Affordability Co-Pay program is a one-time offer for coverage of a single NGS laboratory biomarker test that specifically tests for the KRAS G12C gene mutation and may only be used once per patient per lifetime.

PROGRAM ELIGIBILITY

The Program is only open to commercially or privately insured patients diagnosed with stage IV Non-Small Cell Lung Cancer (NSCLC), whose healthcare provider has ordered an NGS biomarker laboratory test that specifically tests for the KRAS G12C gene mutation. Patients with insurance plan coverage available through state and federal healthcare exchanges are eligible for the Program. Eligible patients are reimbursed for their NGS biomarker test costs covered by the Program once the patient has satisfied the reimbursement requirements detailed in these Terms and Conditions.

The program is not valid for patients whose NGS laboratory test is paid for in whole or in part by any federal, state or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TriCare. It is not valid for cash paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for an NGS test or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of an NGS test.

Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility.

PROGRAM BENEFITS:

• The NGS Affordability Program may help lower your NGS test out-of-pocket costs. NGS Affordability Program patients pay as little as $0 out-of-pocket for their NGS laboratory biomarker test that specifically tests for the KRAS G12C gene mutation up to the NGS Affordability Program Maximum Program Benefit of $1,000.
• NGS Affordability program patients are responsible for all amounts that exceed this limit.
• Out-of-pocket costs covered by the Program include co-payment, co-insurance, and deductible out-of-pocket costs for the eligible patient’s NGS biomarker laboratory test.
• The NGS Affordability Program does not cover any other costs such as those related to patient office visits, biopsy or related procedures.
• The NGS Affordability Co-Pay program is a one-time offer for coverage of a single NGS laboratory biomarker test and may only be used once per patient per lifetime.

Please ask a Biomarker Assist representative to help you understand eligibility for the NGS Affordability Program, including whether your particular insurance coverage is likely to result in your exceeding the Maximum Program Benefit amount by calling 1(866) AMG-ASST (1-866-264-2778).

PROGRAM DETAILS:

For all eligible patients the NGS Affordability Program offers:

• A program benefit that covers the patient’s eligible out-of-pocket costs (co-pay, deductible, or co-insurance) for a one-time NGS biomarker laboratory test that specifically tests for the KRAS G12C gene mutation on behalf of the patient, up to a Maximum Program Benefit. The NGS Affordability Program does not cover any other costs related to office visits or biopsy and is limited to one test per eligible patient per the patient’s lifetime.
• NGS Affordability program patients pay as little as $0 out-of-pocket for their applicable NGS laboratory biomarker test. Amgen will pay on behalf of the patient the remaining eligible out-of-pocket NGS test costs up to the Maximum Program Benefit.
• NGS Affordability program patients are responsible for all amounts that exceed the Maximum Program Benefit limit.

Service Verification and Patient Reimbursement/Direct Payment to Laboratory Requirements:

• Program coverage is contingent on the submission of the required Explanation of Benefits (EOB) and valid verification of payment by the patient of their out-of-pocket obligation for their applicable NGS test. Note, as explained below, if the patient has not yet paid the laboratory for their out-of-pocket portion, Amgen will pay the laboratory directly provided all the required information is submitted within the specified timeframes.
• The EOB must:
• list the patient’s name and date of service for the participating NGS laboratory biomarker test that specifically tests for the KRAS G12C gene mutation; and
• list CPT (current procedural terminology) or PLA (proprietary laboratory analyses) code which specifies testing for the KRAS G12C gene mutation (Please contact Biomarker Assist at (866) AMG-ASST (1-866-264-2778) for a list of reimbursable codes); and,
• list the date of service for the NGS laboratory as no later than December 31, 2023; and
• be submitted to the program by the patient, healthcare provider’s office or the pathology lab that conducted the test within 180 days of the date of service and never later than June 29, 2024; and,
• list the itemized patient out-of-pocket cost for their NGS laboratory biomarker test that is not covered by their insurance – this is the patient’s portion of the payment for the NGS test; and,
  be submitted with valid verification of payment to:
  • By mail
    Biomarker Assist – NGS Affordability Program
    PO Box 2355
    Morristown, NJ 07962
    
  • Or by fax to 1-866-671-9373
• Valid Verification of Payment/Bill Showing Payment Due – WITH THE EOB, the patient must submit:
• The receipt/invoice/bill from the laboratory that conducted the test that specifically lists the patient’s name, address, and service date of the NGS laboratory biomarker test (note the service date must match the date listed on the valid EOB and must be on or before December 31, 2023) and the out-of-pocket amount owed to the laboratory once the patient’s insurance has covered its portion in full; and, ONE OF THE FOLLOWING:
• Receipt/paid invoice/paid bill from the laboratory that shows the patient has paid in full their portion of their out-of-pocket cost for the NGS biomarker test;
  OR
• A cancelled check or credit card statement/receipt paid to the laboratory evidencing the patient’s paid portion of their out-of-pocket cost for the NGS biomarker test;
  OR
• If payment has not yet been made to the laboratory, the patient must submit the laboratory bill showing the patient’s outstanding out-of-pocket amount owed to the laboratory once the patient’s insurance has paid its portion in full. This is required where the patient has requested payment be made directly to the laboratory as marked on the enrollment form.

Limitation of Third-Party Reimbursement:

• Patients may not seek reimbursement for the value received from the NGS Affordability Program from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure your insurance provider may have regarding your participation in the NGS Affordability Program. Restrictions may apply. Offer subject to change or discontinuation without notice.

Maximum Program Benefit May Change, End or Vary:

• The program provides up to a Maximum Program Benefit of $1,000 assistance to reduce a patient’s out-of-pocket NGS laboratory biomarker test costs that Amgen will provide to an eligible patient once per lifetime which must be applied to the patient’s out-of-pocket costs (co-pay, deductible, or co-insurance) for such NGS test. Each patient is responsible for costs above the Maximum Program Benefit amounts. Please ask your NGS Affordability representative to help you understand whether your particular insurance coverage is likely to result in your exceeding the Maximum Program Benefit amount by calling (866) AMG - ASST (1-866-264-2778).

The NGS Affordability Program is not health insurance. The NGS Affordability Program is valid through 12/31/2023 and only covers tests completed on or before 12/31/2023. Submissions for reimbursement must be received no later than 6/29/2024. Amgen reserves the right to change, vary or end the Program at any time without prior notice .