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