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Insurance Coverage & Financial Assistance

Exact Sciences is committed to supporting patient access to the Oncotype DX Genomic Prostate Score (GPS) assay to help your patients make informed decisions about their treatment.

Financial Responsibility Information

Out-of-pocket costs for the Oncotype DX GPS assay, 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. The numbers* cited below are based on historical patient billing data:

84% of Oncotype DX GPS assay patients have $0 financial responsibility
This calculation includes patients with Medicare, Medicare Advantage, Medicaid, Managed Medicaid and commercial insurance. Patient cost-sharing amounts, including deductibles and copays will vary by plan and coverage type. Only your patient’s insurer can confirm if and how the Oncotype DX GPS assay will be covered.
91% of Oncotype DX GPS assay patients have a financial responsibility of <$100
This calculation includes patients with Medicare, Medicare Advantage, Medicaid, Managed Medicaid and commercial insurance. Patients with high-deductible plans may receive a bill for most or all the cost of the Oncotype DX GPS assay if they have not satisfied their deductible.

*The numbers cited are based on historical patient billing data from 1/02/2020 to 12/31/2020. Rates of coverage vary by state and region. Exceptions for coverage may apply. Exact Sciences strongly encourages patients to contact their insurer with questions about Oncotype DX Genomic Prostate Score assay coverage.

Exact Sciences strongly encourages patients to contact their insurer when they have questions about their benefits. Regardless of network status, all commercial insurance coverage is governed by an insurer’s medical policy and patient benefit type.

Patients with fee for service (FFS) Medicare will have $0 financial responsibility if they meet coverage requirements (see below). Patients with Medicare Advantage, which is provided by a commercial insurance company, may have different financial responsibility amounts than patients with FFS Medicare. If your patient’s out-of-pocket amount is $500 or more as determined by the patient’s insurance, 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.

Coverage Information

FFS Medicare, Medicare Advantage plans, and most private insurance carriers cover the Oncotype DX GPS assay for eligible patients with localized risk prostate cancer. 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 DX GPS assay is performed on claims with the unique proprietary laboratory analysis (PLA) code, 0047U.

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.

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: 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.

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

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