Patient Support

We will help patients understand and navigate the insurance and billing process for the Precision Oncology portfolio of tests. Our team can assist with prior authorizations, billing insurance, appealing denied claims, and providing flexible payment options when necessary.

Insurance Coverage

The Oncotype® and OncoExTra® tests are covered by Medicare and many commercial insurance plans and available to patients who are enrolled in a Medicaid program. Exact Sciences1 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.

To learn more about Medicare coverage

Billing Process

It starts with you…and we take it from there

1You order an Oncotype DX® or OncoExTra® test

We offer multiple ways to order our tests including Provider Portal and Email/Fax with additional electronic ordering options coming soon. To learn more about the type of ordering available, and specimen retrieval select your test: Oncotype DX Breast Recurrence Score®, Oncotype DX Breast DCIS Score®, Oncotype DX Colon Recurrence Score®, OncoExTra®, and Riskguard™. 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

We verify your patient’s insurance information to determine payor requirements, such as Prior Authorization. If required by the payor, we can assist with Prior Authorizations requests using the completed requisition form and other documentation provided with the order and will contact your office if any additional information is required.

Once testing is complete, we handle insurance billing on behalf of your patients when this option is selected at the time of order. If the claim is denied, we will also pursue appeals on the patient’s behalf if appeal options are available.

3Payment Options

Out-of-pocket (OOP) costs for the test, if any, are determined by the patient's insurance company. Patients with OOP costs may contact us to discuss options.1

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.

Exact Sciences Patient Assistance Program

Exact Sciences believes that everyone should have the opportunity to be as healthy as possible, no matter WHO they are, WHERE they live, or HOW much money they make. A patient may qualify if they:

  • Are an Exact Sciences patient
  • Reside in the United States or its territories AND
  • Have a household income at or below 400% of the Federal Poverty Level (FPL)*

Use the estimator below to assess your eligibility.

Disclaimer: *Exact Sciences uses the Federal Poverty Guidelines for the 48 contiguous states and the District of Columbia, which are subject to updates that may vary from those listed in this resource.

Patient Assistance Estimator

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

Complete the following fields and hit submit.

Patient State or U.S. Territory*
Patient State must be filled in
Household Size*
Household Size must be filled in
Annual Income*
Annual Income must be filled in
Submit

Exact Sciences may change or update its program criteria at anytime, without notice. Eligibility is not guaranteed. Exact Sciences may require that a patient provide proof of financial need if their information is not already available to Exact Sciences. If you have questions please contact help@exactsciences.com or call 866-267-2322

Patient Qualification:

 Qualify for patient 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

Please return the enclosed application with supporting documents to one of the following:
Patient Assistance Program
Mail: ES Labs, 145 E. Badger Road, Madison, WI 53713
Fax: 844-870-8875
Email: help@exactsciences.com
Phone: 866-267-2322

Patient Qualification:

 Do not qualify for patient assistance

Based upon the information provided, the patient 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 888-662-6897, option 2 to discuss further.

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Medicare Information

Oncotype® and OncoExTra® 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 Breast DCIS Score Assay
  • Oncotype DX Breast Recurrence Score Assay
  • Oncotype DX Colon Recurrence Score Assay
  • OncoExTra
Local Coverage Determination (LCD): MolDX: Oncotype DX Breast DCIS Score Assay (Genomic Health) (L36941)

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: Next-Generation Sequencing for Solid Tumors (L38045)

Coverage Indications, Limitations, and/or Medical Necessity

This policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Food and Drug Administration (FDA)-cleared, and FDA-approved clinical laboratory tests utilizing Next-Generation Sequencing (NGS) in cancer as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage. This policy’s scope is specific for solid tumor testing, and is exclusive of hematologic malignancies, circulating tumor DNA testing (ctDNA), and other cancer-related uses of NGS, such as germline testing in/for patients with cancer.

All the following must be present for coverage eligibility:

As per NCD 90.2, this test is reasonable and necessary when:

  • the patient has either:
    • Recurrent cancer;
    • Relapsed cancer;
    • Refractory cancer;
    • Metastatic cancer;
    • Advanced cancer (stages III or IV)
  • AND has not been previously tested by the same test for the same genetic content
  • AND is seeking further treatment

Have a specific billing question?

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

Call 888-662-6897, Option 2