Genomic Access Program

To advance this mission, we created the Genomic Access Program (GAP) to help patients navigate and understand the insurance and billing process for the Precision Oncology portfolio of tests. GAP assists with obtaining prior authorizations, billing insurance, appealing denied claims and providing flexible payment options when necessary.

Learn more

Insurance Coverage

The Oncotype® tests are covered by Medicare and many commercial insurance plans and available to patients who are enrolled in a Medicaid program. Exact Sciences* is an in-network provider with many health plans, including Aetna, Anthem, Cigna, Humana and UnitedHealthcare. Exact Sciences performs the services ordered and deemed medically necessary, regardless of network-provider status.

In network means that Exact Sciences has contracted with the insurer to be part of their preferred lab network.

Financial Assistance Estimator

See if your patient could be eligible for testing at no cost with the Financial Assistance Estimator.

Complete the following fields and hit submit.

Patient State*
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Household Size*
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Annual Income*
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Exact Sciences may modify or terminate its Genomic Access Program (GAP) and/or financial assistance options at any time. If your patient lives in American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, or the US Virgin Islands, please contact Customer Service at 866-ONCOTYPE (866-662-6897), option 2 to discuss available financial resources.

Patient Qualification:

 Qualify for financial assistance

Based upon the information provided you could have no out-of-pocket costs for this test.

Please note that additional information is required to apply:

 

1

Download the Financial Assistance Disclosure and Application Form
Download application in Spanish

2

Complete and submit the form along with required supporting documentation

3

Exact Sciences will review your completed application and confirm eligibility

Download the Application

Patient Qualification:

 Do not qualify for financial assistance

Based upon the information provided, the financial assistance criteria have not been met.

However, Exact Sciences offers flexible payment options and can discuss any extenuating circumstances the patient may have.

Contact Customer Service at 888-ONCOTYPE (888-662-6897), option 2 to discuss further.

Contact Customer Support

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Genomic Access Program

It starts with you…and we take it from there

1You order an Oncotype test

Ordering a Test

Ordering a test and receiving the results is a straightforward process.

Online Ordering

For faster results, complete your requisition form online on the Physician Portal, as insurance can be verified and most required forms can be pre-filled and completed online.

Necessary Information

Be sure to include a copy of your patient’s insurance card and the primary ICD-10 code selection supporting medical necessity. When ordering for your Medicare patients, please include the Specimen Collection Date and Patient Hospital Status to streamline the process.

2We verify and bill insurance

Verify & Bill Insurance

The billing process starts with performing insurance verification for each patient using the insurance information provided when the test is ordered.

Prior Authorizations

We obtain prior authorizations, when required by the payer, using the documentation provided by your office on the completed requisition form. The insurance information you provide helps us determine whether prior authorization or other forms are required by the insurance company. We will contact your office with instructions if the payer requires that the physician initiate the Prior Authorization or asks for additional documentation from your office.

Explanation of Benefits

Once Oncotype testing is complete, we handle insurance billing on behalf of your patients when this option is selected on the requisition form. Patients may receive one or more Explanation of Benefits (EOB) from their insurance company. Even though this is not a bill, we are here to answer any questions patients may have.

3We offer financial assistance

Assistance with Appeals

If the claim is denied, we will pursue appeals on the patient’s behalf if appeal options are available. This process can take several months.

Out-of-Pocket Payment Options

Out-of-pocket (OOP) costs for the test, if any, are determined by the insurance company. Patients may have financial responsibility for a co-pay, co-insurance, deductible or non-covered charges as determined by their insurance plan once available appeal options are completed. If your patient’s out-of-pocket amount exceeds $500, they will receive a call to discuss payment options. We will also submit secondary or supplemental insurance claims on your patient’s behalf if the necessary information was submitted with the order. If your patient receives a bill and is not sure if a claim was submitted to their secondary or supplemental insurance, please have your patient contact us.

Financial Assistance

Financial assistance is available for eligible patients who are uninsured and may be available for insured patients unable to pay the out-of-pocket amount determined by their insurance.

  • Eligibility is based on Federal poverty guidelines, and we proactively contact all uninsured patients to determine eligibility for financial assistance. Payment plans may also be available.
  • Patients may also contact us before the test is ordered or during the testing process to review available payment terms or to be pre-screened† for financial assistance.
  • Financial assistance is not available if a patient has insurance coverage but elects to be billed directly instead of billing insurance.

Because insurance coverage varies across the country and is based on medical policy and benefit design, it is sometimes difficult for patients to understand costs associated with testing. We strongly encourage patients to contact their insurer when they have questions about their plan design and benefits.

Medicare Information

Oncotype tests are covered by Medicare Fee for Service (FFS) for patients meeting coverage criteria. Patients who meet clinical criteria for coverage have zero financial responsibility.

See the specific coverage criteria for each test

Advance Beneficiary Notice (ABN) Requirements

Medicare FFS requires that providers give their Medicare patients an ABN form before they receive any services not considered medically necessary under the Medicare FFS program. This is required because the patient will be responsible for paying for the test if they still choose to receive it.

The 14-Day Rule

Medicare FFS has specific date of service reporting requirements for laboratory tests, and the technical component of physician pathology services, ordered for Medicare patients (commonly known as the “14-Day Rule”). The 14-Day Rule determines whether the laboratory performing the test bills Medicare directly or bills the hospital where the specimen was collected.

In general, Medicare requires that laboratories bill the hospital when the test is ordered less than 14 days following a patient’s inpatient or outpatient hospital stay (when the specimen was collected). However, as of January 1, 2018, the 14-day rule does not apply to molecular pathology tests when the specimen is collected from a hospital outpatient, regardless of order date.

We process test orders as they are received from providers. Clinical judgment should be the determining factor for test ordering.

Download 14-Day Rule Provider Guide

Resources

Helpful documents to download

Medicare Coverage Criteria for Each Test

  • Oncotype DX AR-V7 Nucleus Detect Assay
  • Oncotype DX Breast DCIS Score Assay
  • Oncotype DX Breast Recurrence Score Assay
  • Oncotype DX Colon Recurrence Score Assay
  • Oncotype DX Genomic Prostate Score Assay
Local Coverage Determination (LCD): MolDX: Androgen Receptor Variant (AR-V7) Protein Test (L37701)

See the full LCD

Coverage Indications, Limitations, and/or Medical Necessity

This contractor will provide limited coverage for an Androgen Receptor splice variant 7 messenger RNA protein test (AR-V7) to help determine which patients with metastatic castrate resistant prostate cancer or other androgen receptor containing tumors may benefit from androgen receptor signaling inhibitor therapy and which may benefit from chemotherapy.

AR-V7 is covered as follows:

  • Patients will have progressive mCRPC as defined by the Prostate Cancer Working Group 2 guidelines (a minimum of 2 rising prostate-specific antigen (PSA) levels 1 or more weeks apart, new lesions by bone scintigraphy, and/or new or enlarging soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI)).
  • Patients will have failed one ARSi, (presently Enzalutamide (Xtandi), Apalutamide (Erleada), or Abiraterone (Zytiga) and future similar class drugs approved by the FDA) .
  • Patients will be considered appropriate for treatment by their treating physician for the alternative ARSi as a single agent.
  • Circulating tumor cells (CTC) with nuclear expression of AR-V7 protein will be assessed prior to initiation of therapy.
  • Decision impact analysis: We expect that < 15% of nuclear AR-V7-positive patients will receive an ARSi.
  • Efficacy analysis: Nuclear AR-V7-negative patients who receive an ARSi will have similar or better time on therapy than untested mCRPC patients (meeting above criteria) receiving an ARSi.
  • Other Androgen Receptor variant tests that demonstrate an equivalent analytical validity and clinical validity will be considered reasonable and necessary for similar diagnoses and criteria listed below indications. Analytical and clinical validity will be assessed as part of a thorough and comprehensive technical assessment (TA) by the MolDx program and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.
Local Coverage Determination (LCD): MolDX: Oncotype DX Breast DCIS Score Assay (Genomic Health) (L36941)

See the full LCD

The Oncotype DX Breast DCIS Score assay is covered only when the following clinical conditions are met:

  • Pathology (excisional or core biopsy) reveals ductal carcinoma in situ of the BREAST (no pathological evidence of invasive disease), and
  • FFPE specimen with at least 0.5 mm of DCIS length, and
  • Patient is a candidate for and is considering BREAST conserving surgery alone as well as BREAST conserving surgery combined with adjuvant radiation therapy, and
  • Test result will be used to determine treatment choice between surgery alone vs. surgery with radiation therapy, and
  • Patient has not received and is not planning on receiving a mastectomy.
Local Coverage Article: Billing and Coding: MolDX: Oncotype DX Breast Recurrence Score Cancer Assay (A54480)

Oncotype DX Breast Recurrence Score test was developed for patients with the following findings:

  • Estrogen receptor-positive, node-negative carcinoma of the BREAST
  • Estrogen receptor-positive micrometastases of carcinoma of the BREAST, and
  • Estrogen receptor-positive BREAST carcinoma with 1-3 positive nodes
Local Coverage Article: Billing and Coding: MolDX: Oncotype DX Colon Recurrence Score Assay (A54484)

The Oncotype DX Colon Recurrence Score test, developed to predict the recurrence risk for patients with Stage II COLON CANCER.

Local Coverage Determination (LCD): MOLDX: Prostate Cancer Genomic Classifier Assay for Men With Localized Disease (L38339)

See the full LCD

Coverage Indications, Limitations, and/or Medical Necessity

This is a limited coverage policy for Genomic derived tests that assess risk in localized (non-metastatic) prostate cancer. The test is considered reasonable and necessary to help identify men with localized Prostate Cancer and a life expectancy of at least 10 years who are good candidates for active surveillance according to the most recent National Comprehensive Cancer Network (NCCN) guidelines.

Covered for men with prostate cancer:

With localized or biochemically recurrent adenocarcinoma of the prostate (i.e., no clinical evidence of metastasis) who have a life expectancy of greater than or equal to 10 years if they are a candidate for and are considering (or being considered for) at least 1 of the following:

  • Conservative management and yet would be eligible for definitive therapy (radical prostatectomy (RP), radiation or brachytherapy), or;
  • Radiation therapy and yet would be eligible for the addition of a brachytherapy boost, or;
  • Radiation therapy and yet would be eligible for the addition of short-term androgen deprivation therapy (ADT), or;
  • Radiation therapy with short-term ADT yet would be eligible for the use of long-term ADT, or;
  • Radiation with standard ADT yet would be eligible for systemic therapy intensification using next generation androgen signaling inhibitors or chemotherapy, or;
  • Observation post-prostatectomy yet would be eligible for the addition of post-operative adjuvant radiotherapy, or;
  • Salvage radiotherapy post-prostatectomy yet would be eligible for the addition of ADT.

The following criteria must also be met for coverage:

  • The assay is performed on formalin-fixed paraffin embedded (FFPE) prostate biopsy tissue with at least 0.5 mm of linear tumor diameter or FFPE tissue from a prostate resection specimen, and;
  • Result will be used to determine treatment according to established practice guidelines, and;
  • Patient has not received pelvic radiation or ADT prior to the biopsy or prostate resection specimen, and;
  • Patient is monitored for disease progression according to established standards of care.

Other genomic tests that demonstrate an equivalent analytical validity and clinical validity will be considered reasonable and necessary for the same indications. Analytical and clinical validity will be assessed as part of a thorough and comprehensive technical assessment (TA) by the MolDX program and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.

Have a specific billing question?

Contact us to learn more about billing and coverage for our tests.

Call 888-662-6897, Option 2