About Reimbursement

This section describes your choices for obtaining reimbursement, as well as step-by-step guidelines for what you can do in working with your health insurance plan. We will continue to provide coverage updates as Focused Ultrasound becomes a more widely available option for fibroid relief.

Although Focused Ultrasound was approved by the Federal Food and Drug Administration (FDA) in October 2004 broad insurance coverage for anew technology, like Focused Ultrasound, takes time.

You should check with your employer to see if Focused Ultrasound is a covered benefit. Because this treatment enables patients to return to work quickly, it is often beneficial for an employer to provide this as a benefit. Furthermore, State or Federal laws may dictate that your employer must provide this as a covered benefit.

If it is not, you may want to try to get it approved on a case by case basis, by showing the medical necessity of the treatment.

In order for payers to approve , or provide prior authorization on a case-by-case basis they generally request the insurance claim form as well as additional supporting documentation. Supplemental documents may include:

• Letter of Medical Necessity from the physician
• FDA approval documentation
• Focused Ultrasound peer reviewed published clinical literature
• Detailed documentation regarding how the procedure is performed

The medical provider who is providing the Focused Ultrasound treatment should be able to help you.

If you decide, in consultation with your physician, that Focused Ultrasound is the preferred treatment for your uterine fibroids, your health insurance plan may ask for information regarding the procedure or the treatment.

Determine | Contact | Request | Follow-Up | Appeal

As a patient, you have rights to the treatment you feel is most appropriate for you clinically and financially. If your insurance company does not approve the Focused Ultrasound procedure upon the first request, ask the health plan the appropriate steps to appeal the coverage decision. Every insurer has a patient grievance process that requires the insurance plan to reconsider the health care coverage for the procedure.

The following steps may help to increase the coverage for Focused Ultrasound by your health insurance plan:

1) Determine if you are a good candidate for Focused Ultrasound treatment for uterine fibroids.

Pre-screening diagnostic tests may also require pre-authorization. Once you have been evaluated, your physician or the facility where you plan to receive treatment will generally initiate the prior authorization process.

2) Contact your health plan to confirm that Focused Ultrasound is a covered benefit.

Your health plan may request the CPT procedure codes that describe the procedure. If requested by the plan, the appropriate CPT codes for Focused Ultrasound are T 0071T and 0072T. If Focused Ultrasound is an approved procedure, ask if prior authorization is required. If prior authorization is required, ask for the prior authorization processand determine how long a prior authorization request will take. Generally 2-4
weeks is reasonable for determination on a prior authorization request. If Focused Ultrasound is not a covered procedure; ask your health plan why it is not covered. Ask what documentation would be required by the plan to consider coverage for the Focused Ultrasound procedure. Keep records regarding each contact with your insurance plan. Make a note of the time, date and the individual you spoke with (first and last
name) and document the discussion.

3) IF it is not covered - Request prior authorization by your health plan for Focused Ultrasound treatment.

The Focused Ultrasound treatment center or hospital where you plan to be treated can assist with efforts to obtain health plan prior authorization. A prior authorization request will most likely require the following information included in a medical necessity letter prepared by your physician:

a) your medical history and condition (diagnosis and related symptoms)

b) the medical necessity for the procedure

c) a description of the procedure

d) the health problems that may result if you do not have Focused Ultrasound

e) other treatments you have received for fibroids, and why they did or did
not work

f) why Focused Ultrasound is the most appropriate treatment for your uterine fibroids

4) Follow-up after submitting the prior authorization request

Follow up with the health plan weekly to determine the status of the prior authorization request. Again, document the calls to the plan, the name of the reviewer and the status of your prior authorization request. Your health plan should provide a written determination and if the procedure is approved or denied. In most cases, if the request is denied, information regarding the appeal process will be included with the determination letter within a section title ‘your rights to appeal’. If this information is not included with the letter, contact the plan and request a copy of the appeal and patient grievance process.

5) Appeal procedure

The first response of your insurance plan is not necessarily the final decision. Request the denial in writing, with reasons provided, so you can respond to specific issues outlined by your plan. If your health plan is self-funded, federal law applies and the Department of Labor has jurisdiction. If you have commercial insurance, state laws apply under the Division of Insurance.

a) Telephone Reconsideration of denial will involve a telephone review between
the plan and the patient. The health plan will generally provide written guidelines
for your telephone review. Follow the telephone review with a formal letter
and include the following points:

· Your medical history and the reason why Focused Ultrasound is the best treatment
option for you;

· A brief review of the request for the appeal and what you have done
to date to gain coverage by the plan;

· Based upon the reason for denial by the plan information should be
provided to address the medical necessity, FDA approval, published clinical
documentation and other information specific to the reason for denial.

b) A written appeal is a more formal response to denial of the informal appeal.
Your physician should prepare a response to the denial. Submit the written
appeal immediately after receiving the denial of your informal appeal. In
the written appeal, include a request for a physician to physician telephone
call to discuss your case. This would be a telephone call between the patient’s
physician and the plan medical director. The Medical Director at the plan
generally has the authority to review and approve prior authorization appeals
based upon the patient’s medical necessity. This written appeal process generally
takes 30-60 days.

c) A second appeal can be submitted if the first written appeal is denied.
Obtain a copy of the formal denial in writing, and ask the plan where a second
appeal may be submitted. Answer all objections and resubmit your appeal. This
level appeal generally takes 30-45 days.

d) The final option is generally the external independent review. This is
an appeal that includes one to three external physicians who will review the
procedure, documentation provided by your physician and the prior appeal letters
to determine if they are in agreement with the plan decision or not. It generally
involves three physicians, with approval required by 2 of 3 to overturn the
decision. In many cases the external physicians will be permitted to speak
with your physician to discuss your treatment decision. Generally this request
must be submitted within 15-30 days after the second appeal decision is made.
The external review must be completed within 21 days through the State Department
of Insurance or the State Insurance Commissioner’s office. The State office
is required to notify you of the decision within 5 days after the 21 day review.
This final decision is binding on the patient and the health plan.

Is It Really Worth the Trouble?

Not all patients will have to go to this extreme to gain coverage for Focused Ultrasound by their insurance plan. You do have every right to pursue the medical treatment that you and your physician consider best suited to your medical condition, lifestyle, age, and economic situation. And every woman who pursues this course will smooth the path for those who follow.

Dr. Gina Hesley, a Mayo Clinic physician who has been involved with Focused Ultrasound treatment of uterine fibroids since the first clinical trials in 2002, commented in a recent interview:

“If patients are interested, we always encourage them to go through the process. I think the more times we talk with the insurers and have that dialogue, and show them the information, and the more patients that are interested, the more likely they are to cover the procedure. And the more likely they will be, in time at least, to consider covering it outright, versus having the individual appeals process”.