Does insurance cover the Oncotype DX® assay?
Insurance coverage varies by plan for all medical services and benefits. Oncotype Dx is validated in ER positive, lymph node negative and lymph node positive, early stage breast cancer patients. Oncotype Dx is covered by over 92% of private insures and is also a covered benefit for Medicare beneficiaries and Medicaid beneficiaries (state dependent). Please check your individual coverage policy to verify the extent of coverage as each plan can differ.
Coverage variation by policy:
It is important to verify benefits directly with the insurer for each beneficiary. A typical policy will cover Oncotype Dx when used to aid in guiding treatment decisions for early stage breast cancer patients, estrogen receptor positive disease with nodal status being an additional factor for coverage consideration. Some policies limit coverage to node negative disease while many others contain a provision for coverage of micrometastasis (small tumors classified as pN1 mic) and node positive disease (1-3 positive lymph nodes) based on recent validation studies.
Genomic Health, in most circumstances, assumes reimbursement assignment except where required to comply with federal billing regulations or policies. We continue to work hard to assist you and your patients throughout the process of determining coverage, billing insurance and assisting in the appeal of any denial.
Payors representing more than 200 million lives cover Oncotype Dx and have established favorable coverage policies for this groundbreaking technology. These payers include but are not limited to: United Healthcare, CIGNA*, Aetna*, Kaiser Permanente, Health Net, Humana, Anthem/WellPoint§ and Medicare (through a local coverage decision with Palmetto GBA listed on the Medicare Coverage Database website:
http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=28287&lcd_version=18&show=all
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 plans across the nation to establish coverage policies where they do not exist currently.
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 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 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.
Medicare Update
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 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, not patients covered by private payers.
*See CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §40.8.
Example of the Date of Service 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, 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 15th, 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).