Tips for Obtaining Approval for Insurance Coverage for Standard of Care

This document describes a procedure to initiate authorization with a patient’s insurance company for participation in clinical trials.

The specific aim is to verify coverage of code S9990 or S9991 which specifies coverage of “services related to clinical trial”:

S9990 addresses phase II research
S9991 addresses phase III research

Sometimes, the policy clearly states coverage of this code. Many more times, the policy and request for coverage requires evaluation by the insurance company’s department of utilization management utilization review, or case management. Typically, they label this process: pre-determination or pre-authorization. The purpose of this evaluation is to determine medical necessity and/or the compliance with the insurance company’s corporate policy on clinical trials.

This is a process that requires adequate and appropriate documentation to answer these questions. When initiating this process, it will be necessary to ask whom exactly the request should be addressed to. It is also helpful to indicate the urgency of your request and to ask how to expedite the process as well as to obtain a reference number of your conversation/request to include in your letter and cover sheet. Once those details are secured, the request for pre-authorization or pre-determination can be compiled.

Therefore, the following is suggested (with the caveat the more complete the information, the more quickly an answer can be given):

Cover letter stating specific request
Name of patient with specific diagnosis
Study specifics
Design
Basic rationale for the study
Number of sites accruing to trial
Number of needed subjects with current number enrolled
Credentials of site to conduct research
List of items included in request (appendices to letter)
Clear statement of what claims will include: i.e., the request is only for coverage of diagnostics, intervention, etc within protocol that are considered standard of care versus anything “experimental” or “investigational”
How to contact patient’s physician or author of letter for further questions
Summary of study from clinicaltrials.gov
Cover sheet of protocol to provide evidence of sponsorship
Documentation of IRB approval (original and current approval)
Table of allowable charges (it is extremely helpful to separate out what will be covered or provided by study and what will be billed to insurance as standard of care)
Fax cover sheet: mark urgent, provide reference number and contact information
If the request is marked urgent, most of the decisions are made within three days
Some representatives will warn you of longer time frames for their process of review.
In this circumstance, it is helpful to obtain a contact name and number of someone to keep checking in with.

Additional Considerations

It would be very surprising that any of the CCOP studies would not meet an insurance company’s corporate policy and/or be deemed medically necessary simply based on the inclusion/exclusion criteria used. More times than not, if a decision is made that the insurance company will not provide coverage of S9990 or S9991, it is simply because the request has not been given adequate review or as a third party payer, the company does not have the authority to determine a change in coverage policy. In those instances, it is helpful to try several or all of the following:

Contact the employer who the insurance policy is through. As the purchaser of the company policy, they are allowed to grant exceptions. Most if not all employers, once they understand the situation, will grant the waiver. To initiate this conversation with the employer, it is helpful to start with the policy administrator who is usually situated within the HR or administration departments.
Appeal the decision. Particularly for situations that involve lack of attention to your request (i.e., the decision states surgery is denied when you were asking for coverage of participation in an adjuvant, chemotherapy study), an appeal can be effective. In this case, it is helpful to send the request with additional supportive documentation to the Medical Director. Specifically, including published research speaking to the rationale and importance of the study can be very persuasive and effective in convincing the Medical Director the study is medically superior to other treatment options.
Contact legal advice from legal services. Most ACS organizations provide listings of legal service aid to oncology patients. Many of these organizations’ aim is to protect cancer patients’ rights to self determination and ethical care. Infringement of patients’ rights to choose what is best for them is an area that legal aid services are aimed to protect. The arsenal of legal help will vary, however most will provide counsel to you and your patient relative to what other options might be explored.
Contact your State Attorney General. Counsel as well as advocacy is available when the complaint is legitimate. Infringement of patients’ rights and access to best care is considered legitimate.
Appeal the case to your State’s Insurance Commission. It is helpful to have legal assistance with this last step; however, it can be done by any individual – patient or provider.
Once approval for participation in the trial is obtained, be sure to request the decision in writing as well as to document internally the name of the person stating the approval with their company’s reference number of the conversation.