Compliance Today - July 2020

Kelly M. Willenberg (kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg & Associates in Greenville, SC.

Maintaining revenue integrity is a daunting task if you have a clinical trials program. In order for a site to develop a risk-based revenue compliance plan, you need to appreciate the risk areas that surround billing compliance. In ranking these risks, you must know the universe of research. Evaluating revenue optimization includes a careful review of the entire billing compliance process. Understanding the types of trials taking place while vetting their effect on your program will help you move toward a positive audit plan and review the revenue integrity as you progress. With the slowdown of some studies due to COVID-19, revenue has become increasingly more important to research programs around the country. A word of advice: Do not be intimidated by having to become more stringent in the trials you open. By having a more stringent feasibility study, you can be more successful in realizing revenue. Analyze whether you have a centralized or decentralized practice—having the information can help you be successful at auditing trials. From not knowing what studies are occurring to having no way to review claims prior to their release, missteps can occur. Managing this process can be tricky even in the best circumstances. Arm yourself with knowledge of the risk so you can set yourself up for success as you begin to build a course of action in revenue review and optimization in clinical trials.

Prior to the crisis, there was really no way of knowing how much your program was spending on research without a solid revenue integrity process. Understanding the following risks and how to combat them will help you identify gaps surrounding revenue integrity now and in the future.

1. Know who and where the subjects are coming from, including outside facilities.

2. Ensure the proper use of a complete coverage analysis with backup from the guidelines that are peer reviewed.

3. Review claims prior to release to ensure that you are not double billing, misbilling, or billing research for items that were not budgeted.

4. Validate the completion of claim payment so you are aware if you have denials.

Once the pandemic hit, sites, in some instances, were tasked with assessing their portfolios in an effort to streamline studies that were open, not accruing subjects, or had no in-person visits. Some sites found themselves with many questions and no way to answer them. By knowing all of the studies, patients, and visits, a site knows the schedule and how it must track patient visits. When a site does not know who the clinical trial subjects are, unanticipated consequences can occur in many areas of the revenue cycle, affecting deficits. If a patient is in a clinical trial at an outside physician practice, for example, and the sponsor is paying for a service that is being performed at a hospital, that claim necessitates intervention. Not knowing these patients, especially when you are told to identify all visits that will be occurring, can hinder your success.

The second risk that puts a site into turmoil occurs when it is not performing a complete coverage analysis on every study that has billable charges. Without a coverage analysis, a site will not have success in setting steps for the process to be worry-free. The absolute first step is to know what type of study you are opening. Is it a drug, device, or service? Does it qualify for coverage under the Medicare rules for billing compliance?^[1] Once you have a coverage analysis, you have an intended plan for billing. It is, however, challenging when the coverage analysis is not available—as in the case of the pandemic crisis, when many research teams were working from home but the coverage analysis was located at the office. The coverage analysis is a necessary item in answering claims processing, so access to a thorough one is important.

Once a site knows that claims have been generated, it must review those claims against the coverage analysis and guidelines. Ensuring that Medicare is not billed for items and services that are not medically necessary or otherwise allowable is a must. Creating what-ifs for a sponsor to pay can, in certain circumstances, create noncompliance, unless there are specific criteria (e.g., when a test has to be repeated because it is outside of a required study window at baseline). These billing rules based on a coverage analysis can make the revenue cycle process better.

The third risk of missteps in billing can be tricky for sites, especially when research teams are working remotely without files. It is easier to release a claim if the item or service is a routine cost than have a sponsor pay for that item. The claims processing is automated, so in order to stop claims, a person must review the claim line by line. Sites find the process arduous. This can lead to no claim going out to a payer at all or underbilling. Without closely monitoring billing inquiries of non-charged items, the revenue is lost to the hospital or practice. In reviewing this type of practice, a site may find unbilled revenue. In light of current events, having unbilled revenue can be detrimental to the program.

The fourth risk area is not examining research claim denials, which leads to missed revenue. Put transparent procedures in place to prevent denials from not getting appealed or even reviewed. Using information technology systems, including electronic medical records, clinical trial management systems, e-regulatory systems, and institutional review board systems, should be considered to validate claims are paid by the proper payer. Teamwork can sometimes prevent the claims from being disregarded. A site should ensure that it is following Medicare’s “most favored nation” status,^[2] which means ensuring that one patient (commercial payer) is not provided an item at no cost or free while other patients (government payer) are being charged for the item within the same trial at the same time point. Medicare could potentially view this scenario as if there was a payer (sponsor). This means all government payer patients should always get the best deal regardless of the commercial payer that each of the other patients have.

By designing a process to achieve success in reviewing the revenue integrity with a complete billing process for all clinical trials no matter what the crisis, you will be aware of pending revenue problems or potential outlier costs. Be confident that your coverage analysis is the “source of truth” and that it is done prior to a budget or contract being finalized so you are certain that your costs are always covered. Consider the methodology of how all subjects are identified in your systems and what method is used for stopping the claims. Understand who reviews all claims against the coverage analysis and consent for each patient. Claim review certainty, which includes codes, modifiers, and, when appropriate, items that are added to the claims according to the payer. Strategizing with all stakeholders and administrative team members in maintaining revenue integrity will transform an organization. Developing a program that effectively incorporates analytics to assess billing compliance risks and irregularities will help monitor every situation. Keep revenue optimization at its finest throughout all of the revenue streams at the facility by negating fragmented, disconnected processes that can lead to events that affect the intended revenue, now and in any crisis. Be ready!