Systems and Regulatory Issues

Guest Expert Carolyn McAuliffe: Everyone has trouble with insurance denials: here are some answers!

Last Updated: Aug 30, 2012

Insurance issues are a frequent barrier to enrolling patients on a study. Participants at the 2011 CCOP/MBCCOP and Research Base Meeting were energized by the success story of Carolyn McAuliffe, PhD, FNP, Director of Research at Hematology-Oncology Associates of Central New York. We hope you'll find Carolyn's experience empowering.

Carolyn's tools are available for you on AccrualNet: Documenting Allowable Protocal Charges and Tips for Obtaining Insurance Approval. Enjoy reading about Carolyn's success, use the tools and come back to AccrualNet to share your own insurance successes!

Carolyn McAuliffe's Post:

Shortly after the New Year, our practice saw a dramatic increase in denials from insurance companies relative to coverage benefits for services related to clinical trials. From approximately mid-January until the end of February, we received ten denials in a row, thus bringing our accrual to clinical trials to a virtual standstill. To understand the process better, I offered to take on the responsibility for obtaining approval for S9990/1 for any patient interested in participation in a clinical trial. S9990/1 is simply the code for “services related to a clinical trial” and specify coverage benefits for any and all standard of care items that happen to be associated with a clinical trial. I’m guessing many of you have been through a similar process. Believe me, as a clinician and Director of Research, I honestly felt like I was completely out of my league.

The first three inquiries I made were on patients we had previously received denials for. For all three of those patients, we did ultimately receive approval for coverage once I was able to speak to the proper authorities who finally understood I was simply requesting coverage of the standard of care items within the trial with documented assurance that any and all investigational or experimental pieces would be covered by the NCI and/or the sponsoring pharmaceutical company. Have any of you found this to be true for you?

Later that same month, a patient was admitted to our office with Stage III Breast Cancer who wanted to participate in the B-44, BETH trial. The answer to my initial question regarding coverage was the standard: “no, we do not cover investigational treatment”. I tried to explain the situation as well as request to speak to someone with more authority to consider our request without success but was invited to appeal their decision. We initiated a total of three appeals directly with the insurance company itself - however, without success. During this time, we stayed in communications with the patient verifying she wanted us to proceed. Because she needed to recover from surgery before starting her chemotherapy treatment, we did have a modicum of time. After learning of the third “no”, she herself solicited the services of a local lawyer associated with ACS. After a failed attempt to reason with the patient’s insurance company, the lawyer contacted me and we put together an appeal to the NYS Insurance Commission. Our appeal was based on documentation that the treatment option offered via B-44 was medically necessary and a superior treatment option.

We won that case. With that win, I realized with enough time and fortitude, I could most likely garner an approval on any and all inquiries. In a six months time span, I have called on over 65 patients. Of those patients who required pre-determination/authorization or even appeal, all requests for coverage of S9990/1 have been approved.

Has your practice encountered a similar situation? How have you dealt with it? What has helped; what has hindered your approvals?

We feel our battle with the insurance companies over this issue has just begun. The time and cost to our practice and patients remains unacceptable. Therefore, we are attempting to change policy at several levels:

1. With the insurance company itself. I am meeting with Medical Directors simply to inform them of the realities of this code and working with them to change their policy.

2. With employers: most companies are unaware of what this code is and how it effects their employees’ options to choose treatment options.

3. At the State level. The majority of States require insurance companies to follow Medicare regulations relative to this code. However, New York State is not one of them. We are working to change that fact.

We would love to hear how you are handling insurance issues with potential or established research patients. What questions, tips, and concerns do you have that you could share wit

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Originally posted by: Anonymous on the former AccrualNet site on Oct 19, 2010.

Here in Iowa we are dealing with the same headache. The state passed a law that required insurance companies to pay for standard of care items when on a clinical trial. Thinking that was great for our patients, it backed fired big time. Blue Cross/Blue shield responsed back stating all patients need Prior Auth before enrolling in a trial. This has added wait time before a patient can start the needed treatment. This might hurt accural to trials and we are trying to do something about it. I have contacted the Governor with my concern and our doctors are writing letters to insurance companies.

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Originally posted by: cra-pa on the former AccrualNet site on Oct 19, 2010.

First, Christina, thank you for bringing attention to a critical barrier to successful clinical trial accrual. I\'m grateful to have a forum for these types of issues to be addressed.

Here is an explanation of a situation that I encountered when I attempted to enroll a patient on E5103 for triple negative breast cancer.

I am relatively new to clinical trials and my first patient had triple negative breast cancer. We offered her participation on ECOG 5103,A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer. She initially consented to going on trial, but she had some reservations because she was concerned her health plan might not cover her should she suffer a side effect requiring treatment that could be directly related to the study-related drug, Bevacizumab (if, in fact, she was randomized to that arm). When she contacted her insurance plan to discuss the issue, she was preempted by the fact that she found out her prescription drug coverage was merely a discount card. This meant drugs for the side effects of standard therapy weren\'t even covered. At that point she was overwhelmed and decided to forego the study because she had enough to worry about considering her diagnosis.

Our pre-authorization coordinator went to bat for this patient and was able to resolve the prescription drug issue for the standard therapy side effects through coupons and patient assistance. I am currently following up with her health plan, First Priority Health, to determine what exactly their stance is on patient participation in clinical trials. I informed them that the Bevacizumab is paid for by the study should she be randomized to that arm, but I would like to have a written statement on whether or not treatment for side effects directly attributable to the study drug would be covered under her plan. I am still awaiting their response, 3 months later and I don\\\'t expect I\\\'ll be receiving one. This patient has gone on to receive the standard of care therapy for her cancer and did not participate in this trial

Apparently every state\'s insurance commission has its own stance on this issue if they have any at all. It appears that because Pennsylvania is not a state that mandates blanket health insurance coverage for clinical trials (see it is up to the healthcare provider (if so inclined) to assist the patient in navigating their health insurance plan to determine their coverage (see This is a daunting task considering the immediate need to proceed with treatment and considering the patient is overwhelmed by their health let alone its cost. How can we reasonably expect patients to enroll when faced with such bureaucracy?

It would seem appropo in light of the era of National Healthcare that the issue of clinical trial coverage should be at the fore. Clinical trials are a form of translational research that can lead to better and often more cost effective treatments sooner.

Lastly, I found the following article relating to Comparative-Effectiveness Research that provides an excellent understanding of how such problems hold up research success (see Roadblocks to Comparative-Effectiveness Research, N Engl J Med, 363;2, 6/2/2010).

Amanda Downend CRA, Geisinger Medical Center

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