With many research sites facing pipeline backlogs, performing coverage analysis quickly and thoroughly can keep the process moving. Why is coverage analysis so vital? In short, it provides a standardized method to identify the appropriate payer for all clinical items or services associated with a trial.

This two-part blog series offers insights and tips to fuel process enhancements. Let’s begin with the “how and why” of coverage analysis.

Understand Site Challenges

Clinical research has never been busier in the United States. December of 2021 had more study starts than ever before, and 2022 is off to a fast start. With 61% of sites performing coverage analysis for every study start, they face a tremendous task.

The WCG Knowledge Base shows the following indications produce the most labor and time-intensive coverage analysis:

  • Hematology
  • Oncology
  • Neurology
  • Nephrology
  • Infectious Diseases

Our research shows that hematology and oncology coverage analyses take about 60% more time to build than many other indications because these trials often have many different arms with varying treatment schedules. Adding to the site burden, we know that one out of two studies started are in oncology or hematology, meaning that the CAs completed are in therapeutic areas that take the longest.  

Realize Coverage Analysis Value

Coverage analysis forms a valuable basis for billing compliance, helping to prevent double-billing. It also aids research participants in reducing financial stress, as it helps identify non-covered items prior to billing and reduces insurance denials.

For the site, coverage analysis identifies all protocol-required items and services, ensuring that each item is assigned a payer. This process also means that sites get paid for the work performed.

In addition, coverage analysis helps determine the financial feasibility of studies. If most items cannot be billed to insurance and there are no funds to cover those costs, then it’s time to make a decision about the financial feasibility of the study.

Follow Clinical Trial Policy

Medicare has three research policies affecting coverage analysis:

  • NCD 310.1 defines trial qualification and routine costs, plus items that Medicare won’t cover. Medicare first introduced the clinical trial policy NCD 310.1 in 2000 and began covering services for patients in clinical trials. By 2014, the Affordable Care Act stated that virtually all plans must cover routine participation costs in qualified clinical trials.
  • Sites performing device studies should be aware of Medicare Benefit Policy Manual Chapter 14, which includes billing compliance rules for investigational device exemption (IDE) studies. It also defines routine care in an IDE study, which differs from the routine care definition in NCD 310.1.
  • The Coverage with Evidence Development Program allows Medicare to cover certain procedures while collecting additional data to determine their final coverage. For many procedures, Medicare requires

Most sites choose to follow these rules even if they aren’t enrolling Medicare patients in the trial because they form a solid baseline and set of rules across all studies. We also see private insurance companies adopting these policies. In addition, sites follow Medicare’s non-research rules including – national coverage determinations (NCDs) and local coverage determinations (LCDs). These policies include indications and limitations of coverage where Medicare will or will not cover the specific item or service. Any laboratory procedure, from a complete blood count (CBC) to a stem cell transplant, can have an NCD or an LCD. LCDs can differ between states; when negotiating a budget and asking a sponsor to pay for an item not covered based on your LCD, you may need to explain this factor.

Start the Process Early

As studies become more complex, beginning coverage analysis as early as possible can prevent delays down the road. The initial coverage analysis may raise questions for the clinical insight teams (e.g., home health requirements), so the earlier these questions can be addressed, the better.

On your timeline, budget development should only begin once you have a draft coverage analysis available. Why? Any inconsistency between the two documents could lead to double billing. Also, the analysis may identify additional costs you need the sponsor to pay (e.g., items a Medicare policy won’t cover).

Once the study opens, use the document whenever you see a patient on the study. Review charges for visits, tests, and procedures against the coverage analysis to ensure you aren’t billing them for something the sponsor will cover. You can also answer participant questions about study-related billing. Since the cost section of the informed consent form (ICF) may be general and not specify individual tests and procedures billed to their insurance company, participants may ask, “What will be charged to my insurance?” Referencing the coverage analysis will ensure a correct answer. Finally, in the event of a billing audit, you want to have a coverage analysis available.

Note that the coverage analysis and ICF need to be aligned before the study opens. The coverage analysis will also highlight questions for principal investigators (PIs), coordinators, and other research team members (e.g., non-covered hospitalization, home health options, remote visits). These issues impact coverage analysis determinations, insurance billing, and even staffing requirements. Proper coverage analysis will help identify any open issues early in your process, fueling efficiencies down the road.

Read the second part of this blog, where we delve into the impact of a complex coverage analysis on the negotiation process and more!

Interested in learning more about how WCG can help your site navigate the coverage analysis process? Contact us today to chat with our coverage analysis and billing compliance experts.