Dear Patient,

Thank you for your interest in the  CHARITÉ® Artificial Disc - the world's first commercially available artificial disc, a motion preserving technology, for treating select patients. While the CHARITÉ® Artificial Disc is approved by the FDA, getting approval by your individual insurance company may be difficult. Coverage policies may vary by insurer, by individual or even between plans offered by the same insurer. This section of the web site has been designed to help you navigate through the insurer's coverage and/or the appeals process.

To qualify for the CHARITÉ Artificial Disc, your doctor must demonstrate that, among other criteria, you have degenerative disc disease (DDD) at a single level between L4 and S1.  This web page has been designed to assist you in:

• Requesting coverage for the CHARITÉ Artificial Disc from your health insurance plan, and
• Working through the appeal process if your healthcare insurance denies you coverage.

Before moving through the CHARITÉ Artificial Disc Reimbursement web pages, it will help if you familiarize yourself with some terms you will see.

Prior Authorization Request

A request from the physician/surgeon for approval of a specific medical service, typically an elective procedure, that takes place before the services are provided.

Coverage Denials

A response from the insurance company indicating that it will not pay for requested and/or billed service(s).  

Your Right to Appeal

The process by which a patient or his/her representative seeks to overcome a healthcare plan’s denial of insurance coverage.

Keys to a Successful Appeal

Other resources

• He or she drafts a letter of medical necessity describing the medical need and why he/she believes the CHARITÉ Artificial Disc can benefit the patient.
• The payer reviews the letter and decides if it will pay for the implant procedure.
• If the payer decides to cover the procedure, the payer will inform the doctor's office and the procedure is scheduled.
• If the payer decides not to cover the procedure, you have the right to appeal that decision. In the initial authorization process, the role of the patient or family member is minimal. However, there are steps that you can take to help the process along.

• Obtain the name and phone number of the staff person in the doctor's office who is assigned to coordinate and follow up with the prior authorization request made by the doctor on your behalf.
• Have a discussion with that person regarding the process and time expected to secure the prior authorization.
• Consider following up with that individual once every one or two weeks regarding the status of your prior authorization request.
• If the staff person is unaware inform him/her, that DePuy Spine has a reimbursement manager available to provide assistance in the prior authorization or appeal process.

• Whether there is a current positive coverage policy in place for the technology. For a list of positive coverage decisions please click Here>>
  
• Whether you are a Federal Employee with a plan that automatically approves the technology based on FDA approval (October 26, 2004). For federal appeals document please click HERE>>
  
• Whether you are covered under a self-insured plan with benefits defined by the employer.
  

Payers in the US are rapidly developing coverage policies or are rendering positive decisions upon appeal. Although the FDA has determined that the CHARITÉ Artificial Disc is safe and effective, many insurers still consider the CHARITÉ Artificial Disc experimental/investigational. All new devices approved by the FDA require post-approval study for 3 to 5 years to evaluate the long-term safety and effectiveness. Many insurers have rendered negative coverage decisions until the long-term data are published.

As of October 2005, DePuy Spine has evidence that over 110 insurers are covering the CHARITÉ Artificial Disc technology. These insurers have either written a positive coverage decision that generally applies to all members of the plan (assuming the clinical criteria are met) or are rendering a decision on a case-by-case basis. In order to increase the number of positive coverage decisions, patients have the right to pursue to the appeals process. Details of this process are found Here>>. 

Coverage Denials

The prior authorization request may be denied because the payer does not have enough information needed to make a favorable coverage decision.

Your Right to Appeal

If your payer denies coverage for CHARITÉ Artificial Disc, you have a right to appeal. Coverage is sometimes denied because the payer does not understand the CHARITÉ Artificial Disc. Consequently, providing information to them can be helpful. For a bibliography of articles on the CHARITÉ Artificial Disc to enhance your case click Here>>

Be sure to check your policy handbook for instructions on the appeal process offered by your insurance plan.

Appealing a coverage decision can be a lengthy process. Do not get discouraged. There are resources available to assist a patient or family member through an appeal process.


Keys to a Successful Appeal

The appeal process ensures that any critical decision that affects your care (such as whether you will receive CHARITÉ Artificial Disc) is given the consideration it deserves. While the information on this website may be helpful to you, DePuy Spine cannot guarantee your success in gaining coverage. There are four factors that, used together, give you the best chance to overturn a denial of your request for coverage for this procedure:

1. Send a one or two page letter written by you to the payer requesting that the coverage decision be reversed. Your letter should be written within the deadline mentioned in the denial notice, usually 1 - 4 weeks. It should contain relevant information about you, your condition, and the therapy,  to download a Word Document outlining an appeal letter please click Here>>