Insurance Coverage & Financial Assistance

Exact Sciences is committed to supporting patient access to the Oncotype MAP Pan-Cancer Tissue test to help patients in making informed decisions about their treatment.

Financial Responsibility Information

Out-of-pocket costs for the Oncotype MAP Pan-Cancer Tissue 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.

$0

financial responsibility for Next Generation Sequencing (NGS) test component when Medicare fee for service (FFS) coverage criteria are met

Medicare Advantage, which is provided by commercial insurance companies, may have different financial responsibility compared to Medicare FFS.
20%

co-insurance for Immunohistochemistry (IHC) test component

20% co-insurance may be reduced if patient has supplemental insurance coverage. See FFS Medicare coverage example for further details.

Example of FFS Medicare Coverage

For a Medicare patient requiring an Oncotype MAP Pan-Cancer Tissue test order that includes NGS and 5 IHC stains.

Oncotype MAP Pan Cancer Tissue Test NGS Panel IHC
Medicare FFS Claim Report 1 panel 5 IHC stain units paid at $125 per stain
Medicare Coverage / Patient Co-pay 100% covered / 0% co-pay 80% covered / 20% co-pay
Patient Financial Responsibility $0 $25 per IHC stain
(5 IHC x $25 = $125)
Total Financial Responsibility $0 Est. $125

Assuming no supplemental insurance coverage. Medicare coverage is dependent upon the cancer being recurrent, relapsed, refractory, metastatic, or advanced (stages III or IV).

If your patient’s out-of-pocket amount is $500 or more, they will receive a call from our Exact Sciences’ billing team 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.

Situations that Require a Medicare ABN Form

Medicare requires that providers give their Medicare patients an Advance Beneficiary Notice (ABN) form before they receive any services that are not considered medically necessary under the Medicare program. This is required because the patient will be responsible for paying for the test if he or she still chooses to receive it.

An ABN form is required for the Next Generation Sequencing (NGS) component of the Oncotype MAP test for patients in any of the following situations:

  • The patient does not have recurrent, relapsed, refractory, metastatic, or advanced (stages III or IV) cancer.
  • The patient is not seeking treatment for his or her cancer.
  • The patient has already received NGS testing with Oncotype MAP test for the same primary cancer diagnosis.
Steps for Providing the Medicare ABN Form

STEP 1

Confirm that the patient has traditional Medicare coverage. If not, an ABN form may not be required.

STEP 2

Provide the patient with the ABN form that includes a description of the Oncotype MAP test's NGS component, the reason why Medicare may not pay for the test, and an estimated price to be paid by the patient.

STEP 3

Ask the patient to review the form and select one (1) of the three (3) options available. Once a selection is made, the patient must sign and date the form.

STEP 4

Provide a copy of the signed form to the patient, maintain a copy for your records, and submit a copy along with your order. Submissions can be made by uploading the document to the Physician Portal OR faxing it to 866-444-0640.

If an ABN is required but not submitted with the order, our billing team will need to contact the patient to obtain the form, which may result in a delay in test results. If you or the patient have questions about the ABN form, please call 866-662-6897 and choose option 2 for Billing.

The Medicare 14-Day Rule

FFS Medicare 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.

See Medicare Specific Coverage Criteria

Local Coverage Determination (LCD): MolDX: Next-Generation Sequencing for Solid Tumors (L38119)

See the full LCD

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

The test has satisfactorily completed a technical assessment by MolDX for the stated indications of the test. The assay performed includes at least the minimum genes and genomic positions required for the identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker as well as other biomarkers known to be necessary for clinical decision making for its intended use that can be reasonably detected by the test. Because these genes and variants will change as the literature and drug indications evolve, they are listed separately in associated documents such as the MolDX TA forms.

Coverage Information

FFS Medicare, Medicare Advantage and a growing number of private insurances cover Oncotype MAP Pan-Cancer Tissue test for select solid tumors and clinical indications. Exact Sciences† is an in-network provider with many health plans, including Aetna, Anthem, Cigna, Humana and UnitedHealthcare. Since insurance coverage can vary across the country, it’s a good idea to check with your patient’s carrier or contact the Customer Service team to confirm coverage. The Oncotype MAP Pan-Cancer tissue test is performed by Paradigm Diagnostics and billed by Genomic Health Inc., which are Exact Sciences’ laboratories, and reported on claims with the unique proprietary laboratory analysis (PLA) code, 0244U.

Partnering with You & Your Patients

Genomic Access Program (GAP)

Exact Sciences believes that everyone should have access to the information they need to make confident, informed decisions about their cancer treatments. To advance this mission, we created GAP to help patients navigate and understand the insurance and billing process for the Oncotype tests. The GAP team can:

  • Work with clinicians to get prior authorization from insurance companies (if required).
  • Bill insurance companies directly when possible.
  • Process the claim once the test is complete.
  • With your patient’s consent, assist in the appeal process if a claim is denied.
  • Contact insurance companies on patients’ behalf.

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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. If you do not have an online ordering account, sign up today.

Financial Assistance

Exact Sciences offers financial assistance programs for eligible patients with financial hardship. These programs are based on financial eligibility.

  • 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.
  • Financial assistance is not available if the patient has insurance coverage but elects to be billed directly instead of billing insurance.

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. To learn more, contact our Customer Service by phone at 866-ONCOTYPE (866-662-6897, option 2) or message us for more information.

† Genomic Health, Inc., an Exact Sciences company, is the billing entity for Oncotype tests.

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