The TomoTherapy® System was cleared by the U.S. Food and Drug Administration (FDA) in 2002 and the Radixact™ System in 2016 to treat lesions and tumors anywhere in the body. With its ability to deliver radiation with extreme precision, the TomoTherapy System has been used around the world to treat a wide variety of lesions, and primary and metastatic tumors, including those in the brain, spine, lung, breast, prostate, pancreas, liver and kidney.
In general, reimbursement exists in the U.S. and other countries for standard applications of 3D and intensity modulated radiation therapy (IMRT) by both Medicare and commercial payers. Reimbursement typically aligns with evidence-based standards of care resulting from hundreds of published studies over the last decade to validate clinical effectiveness, reductions in treatment related side-effects, and improvements in a patient’s quality of life. In the U.S., TomoTherapy treatment is supported by the leading professional society for radiation oncology, the American Society for Radiation Oncology (ASTRO), and is included as a treatment option in multiple treatment guidelines developed by the National Comprehensive Cancer Network and the National Cancer Institute.
Physicians continue to study new applications for the Systems, either as a stand-alone therapy or in combination with other treatments to determine how it can be used most effectively.
Because every patient is unique, the System may be appropriate in the treatment of less common indications or when an unusual aspect of their tumor, tumor location or overall health status may preclude other treatments. In cases where insurance coverage is not available, but the physician and patient think that the TomoTherapy System may be the best option, an insurance appeal may be necessary.
Treatment charges are not set by Accuray. The center you have selected for your treatment has the best information on reimbursement coverage for your particular condition, the process for approval and the amount of your out-of-pocket expense for co-pays.
The following information defines the typical process for reimbursement in the U.S. It may provide a baseline for questions to centers in other geographies.
Prior to starting treatment, the doctor or reimbursement administrator will investigate whether treatment is covered.
If the patient is covered by a private payer or Medicare Advantage plan, the Center may seek a prior authorization.
If the patient is covered by traditional Medicare Parts A or B, prior authorization is not required and coverage is generally provided for a broader range of indications. Nonetheless, treatment usually follows guidelines or a published coverage policy found on the Medicare Administrative Contractor website.
If no policy exists or the policy has been retired, the center may make treatment decisions based on medical necessity.
During this part of the process, your role is minimal. If the center determines you are eligible for coverage, your center will contact you for scheduling to initiate treatment.
If your insurance carrier is not one with which the center is familiar, you may be asked to contact your carrier directly to assess whether your condition is covered for TomoTherapy or Radixact treatment.
If the treatment is denied, the doctor will typically engage in a peer-to-peer conversation or draft a letter to the payer, which describes why the treatment is appropriate and medically necessary in your specific case. The payer may review the letter and decide to authorize payment for the treatment, informing the doctor’s office or reimbursement administrator of the approval. Or, the payer could again deny your eligibility, after which you have the right to appeal the decision.
If a payer still denies coverage for treatment, you have the right to appeal. Coverage is sometimes denied because payer policies have not kept pace with medical practice, or the payer does not understand the therapy or its application and benefit in your case. Therefore, providing comprehensive information to them can be very helpful. You should check your policy to better understand the appeal process.
Often insurers offer two rounds of internal appeals and then the right to an external appeal. Medicare and many other payers have contracts with independent companies to assist in resolving disputes. You can find additional information on the Medicare appeal process at www.medicareappeal.com.
Your role in the appeal is critical because insurers expect to hear from the patient themselves. Clarify with your center whether you will need to shepherd the appeal or not.
The appeal process is designed to ensure that all critical decisions affecting your care – including whether you receive TomoTherapy or Radixact treatment – is given the consideration it deserves. There are five steps that can be taken to give you the best chance to overturn a denial.
Understand the Payer’s Reason for Denial – Understanding the payer’s reasoning for denial is very important because it will help you and your doctor develop an appropriate approach for a successful appeal and gather the necessary supporting documentation. In cases where coverage is still denied, their letter of denial may give one or more of the following reasons why the payer will not cover your treatment such as:
Appeal in writing – You must send a letter to the payer requesting that the coverage decision be reversed. The letter should be written within the deadline mentioned in the denial notice, typically within one to four weeks, and it should contain relevant information about you, your condition and the treatment.
Get Your Doctor Involved – You can ask your doctor to call the payer or send a second letter seeking reconsideration of the denial. Sometimes there will be a faster response when a doctor personally calls the medical director of the insurance plan. Also, the doctor can send a formal letter requesting coverage approval and submit supporting documentation on the medical necessity of the treatment. The letter should contain information that may not have been included in your letter, such as medical details and clinical efficacy of the treatment.
Be Persistent – You should be persistent and follow-up with the doctor, reimbursement administrator and payer staff on all correspondence and progress. Often, the doctor’s staff is willing to help, but it is important for you to be in charge of the process and take responsibility to keep it moving along.
Keep Good Records – You should maintain proper records and documentation, and ask the doctor for copies of any correspondence that he or the office staff presented to the payer. You also should keep track of each contact you make with the doctor, office staff and payer. It’s important to note the date, contact person and nature of the discussion. This will help you keep track of the details involved with the interactions, such as requests, follow-ups and promises with all parties.
If you’ve unsuccessfully exhausted the appeal process, there are other resources to consider:
Employer Group Assistance – Employers that provide benefits to their employees through non-Medicare payers can often request that "an exception to benefits" be made to enable coverage for TomoTherapy treatments. The human resources department can assist in explaining benefit information and provide contact information.
State Department of Insurance – Every citizen has a right in their own state to appeal a healthcare denial to their State Department of Insurance. There is a health insurance appeal form and a complaint form on the state websites. You also may be able to find other services available in your state.
Legal Assistance – Contact attorneys that specialize in healthcare.
Patient Advocacy Organizations – There are many patient advocacy organizations that offer financial and or legal assistance. These websites are good examples of resources that are available on the Internet:
And finally, while Accuray cannot guarantee reimbursement from any third-party payer, we can serve as a resource to those patients who experience challenges throughout the payer approval process. For more information, please contact:
Accuray Patient Relations at [email protected], or call 1.888.522.3740 ext 4301 or +1.408.789.4301.