Six Tips for Coverage Analysis Success

Julie A. Morales


Aegis Compliance and Ethics Center, LLP

Six Tips for Coverage Analysis Success

Coverage Analyses (“CA”s) play a vital role for clinical research trials as well as the companies and facilities that sponsor and hosts such trials. CAs ensure that the clinical research billing process remains compliant with the multiple rules, laws and guidance documents generated by insurance and government organizations (including Medicare) that dictate what services a health care provider can bill to the patients’ insurance and which they cannot. This article describes the basics of CAs and six tips for developing the best CA possible.

What exactly is a Coverage Analysis?

According to the VP for Research and Economic Development at the University at Buffalo, coverage analyses are systematic, objective reviews of clinical trial documents to determine which items or services are billable and to whom. You can also view a CA as a planner if this proves easier. A planner organizes the various tasks and events in your life onto one space where you can easily access and understand it. That’s what a CA essentially does for healthcare providers: it gathers and organizes the different items and services that the providers perform during clinical research trials (i.e., physical exams, MRI, etc.) into an excel grid, or a “planner” so that institutions can see if specific items/services should be billed to the study sponsor or the patient’s insurance. By doing so, healthcare providers have a clearer image of what occurs during a clinical trial.

Why are CAs important? 

Imagine you are writing a huge academic research paper that involves multiple sources of every kind. You find it difficult to keep up with every source and neglect to do so. You write your paper without citing any source hoping your professor will not notice. But she does, reports you to the school and now you face the consequences.

A coverage analysis is like a works cited page. If a clinical research trial includes procedures, tests, and treatments that providers could bill to outside or third-party payors then a provider will find a CA useful if not necessary.  Just as a research paper has outside source references, a CA has items/services that providers must account for. However, instead of academic consequences for neglecting to cite sources, when a research institution improperly bills an item/service to an insurance or government entity the financial and legal consequences are far worse. Research institutions could face millions of dollars of fines and individuals may even face criminal charges depending on the situation.

The American Medical Association describes the various penalties associated with noncompliance and HIPAA Violations. For a HIPPA violation that is unknowingly committed, the minimum penalty is $100 per violation, with an annual maximum of $25,000 for repeat violation. While the maximum penalty is $50,000 per violation, with an annual maximum of $1.5 million, these penalties come from preventable mistakes. Additionally, in 2015 the Medicare Fraud Strike Force found 301 healthcare professionals guilty of both criminal and civil charges for their participation in fraud schemes that resulted in $900 Million in false billing. All in all, noncompliance in healthcare constitutes a very serious offense and can detrimentally impact both the organization and the tax payer dollar.

6 Tips for Building a CA

Therefore, although it may be intimidating learning the nature and the importance of CAs, it is crucial in understanding your role as a CA developer. Here are some helpful tips that can aid in the building process of a CA:

  • A Coverage Analysis is a budgeting and revenue cycle tool.
  • There are essential documents needed to build a CA: an informed consent form (“ICF”), the research study’s protocol, a clinical trial agreement, and a budget. There may be other documents included depending on the study.
  • Begin your CA build by reading the ICF. It describes the study in simple, nonscientific language.
  • When building the CA, we are trying to answer: what is happening to the patient, when is it happening and why.
  • The schedule of events found in the protocol is the skeleton of the CA. However, it does not include everything.
  • Attention to detail is everything when building a CA. The more detail you include in a CA, the easier you make it for the person referencing the CA to determine who to bill for the service.
  • Take your time and be patient with yourself: quality over quantity.


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