This monthly feature presents questions from clinical trial professionals with answers from WCG’s expert staff. This month features insights from Quality and Development Manager Amanda Miller.

Question: At what point in the planning process should a site conduct a detailed coverage analysis? If we are scrambling to restart delayed trials, what’s the most efficient way to work in coverage analysis?

Answer: With many research sites facing pipeline backlogs, performing coverage analysis quickly and thoroughly can keep the process moving. It provides a standardized method to identify the appropriate payer for all clinical items or services associated with a trial.

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 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. 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).

Note that the coverage analysis and informed consent form (ICF) need to be aligned before the study opens. The coverage analysis will also highlight questions for principal investigators, coordinators and other research team members (e.g., noncovered 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.

Question: When should site staff refer to the coverage analysis document during a trial?

Answer: Once the study opens, use the document whenever you interact with a trial participant. 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 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.

Question: Are there any specific coverage analysis policies a site should follow?

Answer: Medicare has three research policies affecting coverage analysis. Most sites choose to follow these rules even if they aren’t enrolling Medicare participants in the trial because they form a solid baseline and set of rules across all studies:

Section 310.1 of the National Coverage Determinations (NCD) manual defines trial qualification and routine costs plus items that Medicare won’t cover. The program first introduced the clinical trial policy in 2000 and began covering services for participants 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 Chapter 14 of the Medicare Benefit Policy Manual, 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.

In addition, sites follow Medicare’s nonresearch rules, including NCDs and local coverage determinations (LCD). 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 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.

Question: How can coverage analysis help budget negotiations when sites are dealing with larger, more complex trials, such as what we’re increasingly seeing in oncology?

Answer: A complex or large protocol will likely entail complicated routine care determinations in the coverage analysis. This challenge leads to an equally complicated budget, impacting negotiations for both site and sponsor.

It’s typical for the site and the sponsor to view routine care determinations differently, leading to budget delays. For example, a sponsor might expect a first-in-human oncology study to follow the same pattern as other oncology budgets. However, the site may not be comfortable treating a first-in-human study budget the same as a phase 2 or 3 study budget.

Coverage analysis justification can aid negotiations. Have detailed explanations of why you’re asking the sponsor to pay for services and be prepared to explain your stance.

Finally, set expectations early with the site team and the sponsor. Communicate regarding budget edits and let the study teams know timeline impacts. Remember, both site and sponsor are working toward the same goal.