With many research sites facing pipeline backlogs, performing coverage analysis quickly and thoroughly can keep the process moving.

This two-part blog offers tips and insights to fuel process enhancements. Our first blog covered the “how and why” of coverage analysis. Next, we’ll delve into the impact on the negotiation process and more.

Prepare for Negotiation

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. 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 II or III 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. 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.

Use Best Practices

How can you mitigate coverage analysis challenges and avoid study start-up delays? Begin the coverage analysis as early as possible to prevent delays. Also, develop coverage analysis standards and have site standard policies on addressing different situations so everyone knows what to expect. Coverage analyses are complicated. The document can be intimidating, with many arms and grids. Work with everyone touching the document to foster understanding of the nuances of each protocol.

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.

Involve All Stakeholders

Beyond the site and research team, stakeholders include pharmacy, nursing, lab, and radiology teams. These parties need communication to understand how the coverage analysis and billing will impact their departments.

Define the Process

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.

Perform a Review

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. Depending upon your institutional review board (IRB), for oncology trials, you may need to indicate everything that is the patient’s responsibility in the informed consent form (ICF).

Recap of Tips for Coverage Analysis Success:

  • Ensure clinical review by PI and clinical lead.
  • Use coverage analysis for budget negotiations.
  • Check if pre-authorization of benefit is needed before consent.
  • Follow the protocol schedule of assessments.
  • Use coverage analysis regarding routine vs. non-routine care.
  • Educate patients regarding responsibility for co-pays.
  • Engage a financial counselor to explain out-of-pocket expenses to patients.
  • Communicate with appropriate departments – billing, nursing, lab, and radiology.
  • Ensure coverage analysis re-evaluation for amendments.
  • Institute periodic internal audits to evaluate billing compliance.

Click here if you missed the first part of this blog.

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.