Does insurance cover the Oncotype DX® assay?
Currently, insurance coverage policies are limited to node-negative, estrogen-receptor-positive patients. Some policies also contain a provision for coverage of small tumors micrometastasis (classified as pN1 mic). It is unknown at this time whether node-positive patients will be covered. Genomic Health will continue to work hard to assist you and your patients throughout the process of determining coverage, billing insurance and assisting in the appeals of any denials. We are prepared to take formal assignment of benefits whenever possible and submit insurance claims on behalf of insured patients in the U.S. for the Oncotype DX assay.
We do not expect institutions or healthcare providers to order this assay from Genomic Health and then bill third-party payers on their own, assuming the risks of reimbursement, except where required to comply with billing regulations or policies or pre-existing contractual arrangements.
Genomic Health is pleased that many payers, representing more than 200 million lives covered, have established favorable coverage policies for the Oncotype DX assay in node-negative, estrogen-receptor-positive breast cancer patients. These payers include Medicare (through a local coverage decision developed by the National Heritage Insurance Company which applies to all testing billed by our California facility), United Healthcare, CIGNA*, Aetna*, Kaiser Permanente, Health Net, Humana, Anthem/WellPoint§ and many others. We are committed to expanding coverage for the Oncotype DX assay based on prevailing clinical data to support appropriate use and will continue to work with all major plans across the nation to establish favorable 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 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 cases where all appeals are exhausted and the claim is not fully paid, the patient will ultimately be responsible for any balance remaining on the invoice. Genomic Health provides a comprehensive Financial 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.
*Requires a prior authorization.
§Limited criteria.
Public Payor (Medicare) Update
14 Day Rule and Medicare
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 these new rules, Genomic Health will continue to bill for most testing, but in certain cases (described below), Genomic Health will not be permitted to bill Medicare for the test:
If Oncotype DX is ordered 13 or fewer days after a patient’s hospital discharge (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 usual Medicare rules 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 the Medicare Program. Genomic Health wants to make you aware of this change and let you know that this rule only affects Medicare patients, not patients covered by private payers.
Example of 14 Day Rule
Patient comes into the hospital as a same-day surgery patient. She is admitted in the morning of April 1, and undergoes a lumpectomy. She is discharged later that same day.
If the patient’s physician orders the test at anytime from April 1 to April 14, 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 is paid for as a clinical lab test; it is not paid under the Outpatient Prospective Payment System of Ambulatory Payment Classification (“APC”) groups).
If the service is ordered from April 15th on, then Genomic Health will bill the Medicare Program directly for the test, 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).