Does Insurance Cover the Oncotype DX® Colon Recurrence Score?

Insurance coverage varies by plan for all medical services and benefits. Please check individual coverage policy to verify the extent of coverage as each plan can differ. The Genomic Health® Genomic Assistance Program (GAP) can assist. For more information and for assistance with individual patient coverage, please contact our Customer Service Department at 866-ONCOTYPE (866-662-6897). We are committed to expanding coverage for the Oncotype DX Colon Recurrence Score based on prevailing clinical data to support appropriate use and will work with all plans across the nation to establish coverage policies where they do not exist currently.

The Oncotype DX Colon Recurrence Score Coverage Varies By Policy

It is important to verify benefits directly with the insurer for each beneficiary. Genomic Health works with your office billing staff and your patients throughout the process of determining coverage, billing, and assisting in the appeal of any denial as requested. In most circumstances, Genomic Health, assumes reimbursement assignment except where required to comply with federal billing regulations or policies.

Through our Genomic Access Program (GAP), benefits investigations may be performed to provide your patients information about their specific coverage and potential financial responsibility. Some insurers may require a prior authorization prior to the processing of the patient’s colon cancer specimen. The GAP team can assist you in this process. If coverage is denied, our GAP team can assist patients to appeal this denial. However, in those few cases where all appeals have been exhausted and the claim is not reimbursed, the patient may be responsible for the balance or a portion of the remaining invoice where appropriate policies have been followed and indicate a balance is due. Genomic Health provides a comprehensive Patient Assistance Program for patients with financial hardship and a program for uninsured and underinsured patients based on financial eligibility. The reimbursement professionals at Genomic Health will do their very best to obtain coverage for this test but cannot guarantee success.

Medicare Information

Date of Service Rule (Change Request 5573)* Effective January 1, 2007, the Centers for Medicare and Medicaid Services (CMS) revised the billing rules that apply to laboratory testing performed on stored specimens. Under this regulatory policy, Genomic Health will continue to bill for most testing, but in certain cases (described below), Genomic Health will not be permitted to bill Medicare directly for the test: If Oncotype DX Colon Recurrence Score is ordered within 14 days of the patient’s hospital discharge date (inpatient or outpatient), then the hospital would be required to bill Medicare for the test. Genomic Health is not permitted to bill Medicare for the test under these circumstances; Genomic Health would be required to charge the hospital for the service performed. In that case, the hospital will be paid pursuant to the Medicare policies that guide reimbursement for inpatient or outpatient services. If the test is ordered 14 or more days after discharge, Genomic Health will bill for the service directly to our Medicare contractor. Genomic Health wants to make you aware of this change and let you know that this rule only affects Medicare patients.
*See CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §40.8.

Example of the Medicare Date of Service Rule

Patient is admitted into the hospital on April 1, and undergoes surgical resection. The patient remains in the hospital for post-surgical recovery for five days, and checks out of the hospital on April 6th. If the patient’s physician orders the Oncotype DX Colon Recurrence Score anytime from April 1 to April 20th (within 14 days of discharge), then the hospital must bill for the test. Medicare coverage and payment would be determined by the contractor to whom the hospital submits claims and payment would be based on the Clinical Laboratory Fee Schedule. In this case, Genomic Health is required to charge the hospital for the service. (NOTE: Oncotype DX Colon Recurrence Score is paid for as a clinical lab test; it is not paid under the Outpatient Prospective Payment System of Ambulatory Payment Classification (“APC”) groups, however it is included for inpatient care under the appropriate DRG billed by the hospital. Using this example above, if the service is ordered anytime on or after April 20th, then Genomic Health would assume financial responsibility for billing our Medicare contractor, and the hospital would have no financial obligation. If you have any questions regarding this information please feel free to contact your Genomic Health sales representative or our Customer Service Department at 866-ONCOTYPE (866-662-6897).

As of September 29, 2011, Palmetto GBA, the designated national Medicare contractor for the Oncotype DX Colon Recurrence Score, have established a formal coverage policy for all Medicare patients. The policy covers men and women with Stage II colon cancer. Palmetto's decision is based on the results reported from clinical validation trials performed using tissue from two Phase III randomized trials; QUASAR and CALGB 9581. For more information, please reference the Palmetto GBA coverage policy. Medicare coverage is effective for services performed on or after September 18, 2011.

Next: Case Studies