Maria is a 70-year old woman in your practice with a new diagnosis of advanced non-small cell lung cancer (NSCLC). You plan to test a biopsy specimen for a handful of recommended genes, but what you’d really like to do is order a large scale genomic tumor test (GTT) that includes these plus hundreds of other genes. While this test has been covered by insurance for some of your patients, it is difficult to identify a consistent set of factors that led to coverage. Conversations with patients about the benefits and costs of large scale GTT get uncomfortable, as you don't understand why GTT may or may not be covered for an individual patient. Instead, you talk about testing in general terms and forge ahead, indicating on the test requisition that the results “will be used for treatment decisions.” A week later you receive a letter from the patient’s insurance company that the test has been denied covered. Where do you go from here?
GTT is ushering in an age of precision oncology, tailoring treatments to pathways identified by the results. But a concern among some providers and patients is that genomic testing, which can provide hope to patients facing advanced or metastatic disease like Maria, may be out of reach financially.
The cost of GTT varies widely, starting around $300 for targeted testing. Larger panels typically cost $1000-$3000, and may run over $10,000 (American Cancer Society 2019). Cost of precision treatments can run upwards of $100,000 per year (Tran 2018). An increasing concern in the medical community and among patient advocacy organizations is the downstream negative effect of out of pocket costs, or financial toxicity.
Despite these concerns, currently, only 25% of oncologists are discussing the cost of GTT with their patients (Yabroff 2020). Likely, this is due to the complex and sometimes uncomfortable nature of these conversations. In addition, there is a lack of transparency in pricing of tests, insurance companies using the process of utilization management to make coverage decisions, and widely variable patient responsibilities in regard to deductibles, co-pays and co-insurance.
Understanding how coverage decisions are made can help facilitate discussions with patients about GTT costs. To learn what clinicians need to know, we spoke with Carla McGruder, a utilization management expert, who shed some light on these issues. She indicated that GTT is often determined to be medically necessary, but there are other barriers within the system that come into play and may lead to a denial of coverage.
Carla is one of a growing number of genetic counselors taking an active role in utilization management (UM) in oncology care. Her role at eviCore Healthcare is to inform coverage decisions for GTT in the specific context of the patient. She has seen that managing costs and providing optimum care can go hand-in-hand.
Initially a cost-cutting measure in the context of managed care, UM has evolved to encompass value-based care, relying on evidence-based guidelines and current literature to make recommendations for coverage. UM is typically a part of a patient’s health insurance plan. Carla says the trend, and what payers are asking for, is for UM to be more involved in genomic tumor testing decisions, and consequently she has seen this role grow considerably in the past two years.
Her team develops coverage recommendations, such as one she is currently developing on RNA-based tumor testing, which they share with different payers including Medicare and Medicaid. While each payer may tweak these recommendations when establishing policies, providing these recommendations is an important part of the relationship between UM and the payers.
Providers may view the review process as a black box. They often think there is a computer algorithm spitting out decisions, or that the UM company employs reviewers without the experience or education needed to make an informed decision. Carla says this isn’t true, that expert clinicians such as genetic counselors examine evidence individually for each patient. And they are thorough - her organization has hundreds of specific coverage policies.
Many oncologists and genetic counselors involved in ordering GTT are overwhelmed, Carla says. They may want to throw up their hands and say, “I don’t know how this test is billed, I’ve no idea what the CPT codes even means, I just know I want the test.” She sees her role as promoting understanding of this complicated process among the key players: providers, labs, insurers, and central to it all, the patient.
Although the goal is to set uniform policies in coverage, the ways in which labs submit codes for billing are extremely variable. This is where most of the challenges arise for oncology providers. Partly, this is due to the labs not having complete information from the providers, but also because billing personnel will employ all sorts of strategies in attempts to get coverage. Below are some general tips that can help providers smooth the way.
Understanding the relevant CPT codes and including them on the requisition can streamline the process and increase the chance for approval. “We try to educate the providers and the billing personnel who are submitting the billing (CPT) codes,” Carla says. She encourages providers to communicate with the lab’s medical science liaison or salesperson, who often times can provide the necessary billing codes directly to the provider.
Listing the specific drugs the clinician is interested in assessing as candidates for treatment may help demonstrate medical necessity.
Carla strongly encourages providers to fully read the coverage determination letters. Often, the letter is reviewed by office staff who then verbally communicate only that the test was denied. Information in her letters about changing the billing codes can be overlooked, and that may be all it would take to get the test approved. The letter will indicate when GTT is deemed medically necessary, but has to be billed differently to obtain coverage. These coverage determination letters can increase understanding of the reasons a test may be denied, and help in completing requisitions in the future.
UM will provide a contact phone number and, when available, information on how to appeal a decision, which can be different for each patient.
Carla concludes on a note of encouragement. She says. “If you want to reach out for an appeal with a peer-to-peer, we love talking to providers. We are always happy to educate offices on billing.”
What can you do if coverage is denied, despite careful attention to billing codes and UM communications? You may ask the lab about patient assistance programs to help defray costs. Look into patient advocacy organizations or within your own organization, where assistance is funded by charitable giving and may include assistance with deductibles, copays and coinsurance. If you are interested in helping your patient access a treatment targeted to a specific biological pathway, look into whether a research study may include genomic tumor testing. Also, don't overlook your cancer center’s social work department. Often, they can facilitate obtaining or adjusting insurance coverage to make GTT and targeted treatments accessible. If the cancer center team includes genetic counselor, they may have familiarity with the labs’ financial assistance programs and can be a resource for you as well.
Your patient, Maria, agrees to proceed with genomic tumor testing. In addition to indicating on the test requisition that the results “will be used for treatment decisions,” you elaborate how certain genes on the panel will influence treatment decisions. You include the billing (CPT) codes recommended by your practice’s medical science liaison and as much clinical information as possible on the test requisition. Testing is fully covered, and in three weeks, the report is available and it identifies an FDA-approved targeted therapy. After shared decision-making, including a discussion about goals of treatment and resources to help defray some of the associated costs, Maria starts targeted treatment feeling empowered and hopeful.
For assistance in understanding the complicated process among labs, insurance and utilization management, contact Carla.McGruder@evicore.com