Enterra Therapy

Introduction

The U.S. Food and Drug Administration (FDA) has designated the Enterra Therapy System as a Humanitarian Use Device (HUD). A Humanitarian Use Device is a medical device intended to treat or diagnose a disease or condition that affects, or is manifest in, fewer than 4,000 individuals per year in the United States.

The FDA has issued a Humanitarian Device Exemption (HDE) approving the sale of Enterra Therapy. A Humanitarian Device Exemption is a determination that a Humanitarian Use Device is safe, has probable benefit, and it is not considered investigational/experimental. Many health plans and insurance companies, referred to as payors, cover the cost of Enterra Therapy. Because of the Humanitarian Device Exemption status of Enterra Therapy, it is highly recommended that your doctor contact the payor to get approval before it can be implanted. This process is called prior authorization.

Prior Authorization Request

Coverage Denials

Your Right to Appeal

Keys to a Successful Appeal

Other resources

Prior Authorization Request

Typically, your doctor makes the initial prior authorization request to your payor for an Enterra System for you.

Your doctor will draft a letter of medical necessity describing the medical need and why they believe Enterra Therapy can benefit the patient.
The payor reviews the letter and decides if they will pay for the implant procedure.
If the payor decides to cover the procedure, the payor will inform the doctor's office and the procedure is scheduled.
If the payor 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 can be taken to help the process.

Tips

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 them, that Medtronic has an insurance specialist available, and ask them to contact Medtronic at 1-800-292-2903 to provide assistance in the prior authorization or appeal process.

Coverage Denials

The prior authorization request may be denied because the payor does not have enough information needed to make a favorable coverage decision. Their letter of denial may give one of the following reasons why the payor will not cover Enterra Therapy.

The therapy is investigational/experimental
The therapy is not medically necessary
The therapy is not a standard of care

Your Right to Appeal

If your payor denies coverage for an Enterra Therapy implant, you have a right to appeal. Coverage is sometimes denied because the payor does not understand the therapy. Consequently, providing information to them can be helpful. 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 Enterra Therapy) is given the consideration it deserves. While the information on this website may be helpful to you, Medtronic cannot guarantee your success in gaining coverage. There are four factors that, used together, give you the best chance to overturn a denial:

1. Send a one or two page letter written by you to the payor requesting that the coverage decision be reversed. Your letter should be written within the deadline mentioned in the denial notice, usually within 1 - 4 weeks. It should contain relevant information about you, your condition, and the therapy.

2. Ask your doctor to call the payor or send a second letter asking the payor to reconsider the decision to deny coverage. For faster results ask your doctor to call the payor. Your doctor should have written a letter requesting coverage. A second letter, written by your doctor, should contain supporting information that may not have been included in the first letter. This could include information about you, your condition, and Enterra Therapy. Ask your doctor for a copy of the second letter to keep for your records.

3. Be persistent. Follow up with the doctor, medical office billing staff, and payor staff. The doctor's office staff is usually quite willing to help out (write letters, make calls, etc.) but you need to be in charge of the process.

4. Write down each contact you make with your doctor, office staff and payor in a notebook. Note the date, contact person, and nature of your discussion. This will help you keep track of the details involved with your interactions.

Other Resources (available after the payor's appeal processes are exhausted)

1. External Review Process: Medicare and many other payors have contracts with independent companies to resolve disputes. If you are a Medicare plus Choice beneficiary and coverage for Enterra^® Therapy is denied, the denial is automatically reviewed by the Center of Health Dispute Resolution (CHDR) for a final coverage decision. You may find additional information on the Medicare appeal process at www.medicareappeal.com. If you have commercial insurance (not Medicare), the initial denial is not automatically forwarded to a dispute resolution company. If dispute resolution service is available, either you or your doctor can request a review. Contact your payor for more information on their external review process/service.

2. Employer Group Assistance: Employers who provide benefits to their employees through non-Medicare payors can often request that "an exception to benefits" be made that allows coverage for Enterra Therapy. Call your Employer's Human Resources Department for benefit information and contacts.

Patient Advocacy Sites

Check the Internet for patient advocacy sites. For example:

Site last updated on November 13, 2007
Version 1.10