With many clinical research sites facing study start-up delays and backlogs, performing a coverage analysis efficiently and thoroughly is critical to the study start-up process. But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively? In short, a coverage analysis provides a standardized method to identify the appropriate payer for all clinical items or services associated with a trial, but it can be a complex process with many pitfalls if done incorrectly.
In this blog, we will share eight ways clinical research sites can optimize their coverage analysis process in order to improve their study start-up timelines.
1. Understand the Value of Coverage Analysis
Coverage analysis forms a valuable basis for billing compliance, as it helps 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, conducting a coverage analysis can help sites 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 conducting the trial.
2. Clearly Define the Process Before You Begin the Coverage Analysis
What steps can ensure a proper coverage analysis? First, ensure that the research study is a qualifying clinical trial. Then, evaluate the drugs, tests, and procedures – plus the intervals at which these procedures are requested. Next, ask if the cost and the routine procedures are reasonable and necessary for that patient population with that type of disease. Finally, determine the coverage determination.
3. Follow the Correct Clinical Trial Policies
Medicare has three research policies affecting coverage analysis:
- NCD 310.1 defines trial qualification, routine costs, and items 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 that most sites 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 must 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. 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.
4. Start the Coverage Analysis Process as Early as Possible
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.
5. Utilize the Coverage Analysis When Preparing for Budget Negotiations
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 the site and the sponsor.
It’s typical for the site and the sponsor to view routine care determinations differently, leading to budget delays. 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. A phone call helps address complicated situations.
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; acknowledging that everyone wants to get medication to needful patients as quickly as possible speeds the process.
6. Avoid Non-Compliance
Not following proper coverage analysis guidelines can have far-reaching effects. Non-compliance can lead to federal consequences, costs associated with violations, consultant and legal fees, plus additional internal staffing to address the problem.
Sponsors may be hesitant to work with a site that has compliance violations. Further, if the issue becomes public, there can be a negative impact on study enrollment. These are essential motivators to have a solid coverage analysis process in place.
7. Communicate with All Necessary Stakeholders
Beyond the research site staff and administration team, other key stakeholders in this process include pharmacy, nursing, lab, radiology teams, and more. It is important to communicate with these parties so they understand how the coverage analysis and billing will impact their departments.
8. Perform a Review of the Coverage Analysis
Coverage analysis review typically involves a physician, a principal investigator (PI), and a clinical lead. Why? Because, locally, various processes or different insurance plans may be involved. Establish your local guidelines for the review – including whether you will outsource the process or invest in staffing.
For a thorough protocol review, look at inclusionary and exclusionary criteria. Also, consider side effect management and what drugs will be used. Additionally, it is important to institute periodic internal audits to evaluate billing compliance.
- Understand the Value of Coverage Analysis
- Clearly Define the Process Before You Begin the Coverage Analysis
- Follow the Correct Clinical Trial Policies
- Start the Coverage Analysis Process as Early as Possible
- Utilize the Coverage Analysis When Preparing for Budget Negotiations
- Avoid Non-Compliance
- Communicate with All Necessary Stakeholders
- Perform a Review of the Coverage Analysis
Interested in learning more about how WCG can help your site streamline the coverage analysis process? Contact us today to chat with our coverage analysis and billing compliance experts.
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