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.
Medicare Fee for Service (FFS) Financial Responsibility*
financial responsibility for Next Generation Sequencing (NGS) test component
*Medicare Advantage, which is provided by commercial insurance companies, may have different financial responsibility compared to Medicare FFS.
co-insurance** for Immunohistochemistry (IHC) test component
**20% co-insurance may be reduced if patient has supplemental insurance coverage. See Medicare FFS coverage example for further details.
Example of Medicare FFS 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
|Medicare FFS Claim Report
||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
||$25 per IHC stain
(5 IHC x $25 = $125)
|Total Financial Responsibility
Assuming no supplemental insurance coverage. Medicare coverage is dependent upon the cancer being recurrent, relapsed, refractory, metastatic, or advanced (stages III or IV).
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
Confirm that the patient has traditional Medicare coverage. If not, an ABN form may not be required.
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.
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.
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
Exact Sciences is committed to compliance with all applicable laws, rules and regulations, including billing regulations promulgated by the Centers for Medicare and Medicaid Services (CMS). When a laboratory test such as Exact Sciences’ Oncotype MAP Pan-Cancer Tissue Test is ordered for a hospital inpatient within 14 days of the patient’s discharge from the hospital, CMS regulations require Exact to bill the hospital directly for that test. This rule is commonly referred to as the “14-day rule.” The 14-day rule is part of CMS’ Date of Service Regulation (42 C.F.R. Section 414.510). As of January 1, 2018, the 14-day rule does not apply to tests ordered for hospital outpatients, and Exact bills Medicare directly for such tests, regardless of their order date.
Exact Sciences processes test orders as they are received from ordering providers. Clinical judgment should be the determining factor regarding when tests are ordered and Exact Sciences does not seek to influence the timing of test orders for any given patient due to billing or other reasons.
Other Coverage and Financial Assistance
Exact Sciences will handle all insurance billing on behalf of the patient. If insurance denies payment, Exact Sciences will pursue appeals on behalf of the patient where appropriate, when insurance information is provided with the order, and if appeal options are available.
A patient’s financial responsibility depends on their specific insurance plan. Plans may include high deductibles (an amount paid by the patient before insurance pays), co-pays (a fixed amount paid per visit or treatment), co-insurance and non-covered charges.
If you are concerned your patient may not have the ability to pay for the test, download the Exact Sciences Genomic Assistance Program (GAP) brochure for financial assistance information.
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.