Coverage Analysis Kelly Willenberg

In this episode, we tackle another important aspect of clinical research finance, specifically, coverage analysis for US based clinical trials.

At the beginning of any clinical trial, coverage analysis is generally required.

The process of performing coverage analysis can be rather overwhelming for someone performing this activity for the first time or not as frequently. 

To get us introduced to the concept of coverage analysis and what it entails, I invited Kelly Willenberg (LinkedIn) to the show.

Kelly is currently the owner of Kelly Willenberg, LLC. 

Prior to starting her firm in 2009, Kelly worked for over 12 years at Vanderbilt University Medical Center where she established the enterprise wide billing compliance program and served as the first Director of Billing Compliance.

She also served as the Director of the Clinical Trials Office for the Cancer Center managing a Community Oncology Research Program.

She was the Managing Editor of the 3rd Edition of the Research Compliance Professional’s Handbook for Healthcare Compliance Association (HCCA). She served as an editor for the 3rd Edition of the Manual for Clinical Trials Nurses for ONS. She has a bi-monthly column in Compliance Today titled “Research Reflections”.

Kelly is also a frequent presenter and speaker and has nearly 35 years of experience in clinical trials management and research compliance, including all aspects of clinical trial billing compliance. 

She is a Certified Clinical Research Professional (CCRP), Certified as a Healthcare Research Compliance Professional (CHRC) and Certified in Healthcare Compliance (CHC) and has a Bachelor’s Degree in Nursing, a Masters and a Doctorate in Business Administration. 

Please join me in welcoming Kelly on the Clinical Trial Podcast.


This podcast is brought to you by Florence Healthcare. To learn more, visit

Show Notes:

[4:15] Components of Clinical Research (Trial) Compliance 

  1. Billing Compliance including Coverage Analysis
  2. Grants Management
  3. Scientific Misconduct
  4. Animal Research
  5. FDA record keeping 

[4:55] Clinical research compliance applies not only to Industry Sponsored Studies but also National Institute of Health (NIH) funded research, Investigator Initiated Studies, Department of Defense projects 

[5:17] Clinical Trial Billing Compliance 

  1. Budgeting
  2. Claims Processing
  3. Coverage Analysis
  4. Coding

[6:03] Ensure the following documents synced up and say the same thing

  1. Budget & contract
  2. Informed consent
  3. Coverage analysis 
  4. Investigational Drug/ Device Brochure

[7:04] Coverage analysis is a key documentation that must occur in order for you to have the backup of being able to submit a claim to a payor

[8:20] Example of studies that do not generally require coverage analysis include:

  1. Observational studies
  2. Quality of Life study
  3. Behavioral study

[8:52] A coverage analysis needs to be completed on any study that is going to have a charge flow through a system

[13:02] How long does it take to perform coverage analysis?

  • Outsourced vs. insourced (via centralized clinical trial billing program)
  • Average is 4.5 hours, can be 8-10 hours per study, does not include Phase 1 and multi-arm studies 
  • Specialized role (dedicated coverage analysis personnel) vs. generalized role (ex: research coordinator) 
  • Managed via CTMS 

[15:31]   If protocol is amended, coverage analysis probably needs to be re-done – updated and validated

[16:21] Can performing coverage analysis delay site start-up? 

[17:51] What is coding? 

  • When you have a procedure in a clinical trial study calendar, it’s getting down to the level of what is the CPT code? Or what are the ranges of codes that need to be assigned to this particular item or service?

[19:26] How do set-up coverage analysis? 

  1. Take a look at the study calendar and beyond. Review from the time the patient is consented to patient goes off study, including unscheduled visits 
  2. Consider rules for every payor 

[21:51] Is Coverage Analysis limited to trials with patients that are 65 and older?

[22:56] Do sites need to perform coverage analysis taking into consideration multiple private payers? 

  • Depends on the site
  • Depends on type of study
  • Depends on site’s risk tolerance 

[27:21] Does the study phase (I, II, III, IV) impact the type of coverage analysis needed?

  • Phase I studies need coverage analysis even if the sponsor is paying for everything

[28:10] Before you bill or consent a patient, know the answers to the following questions:

  • Do you have a drug, a device or another type of study? 
  • Or is it a coverage of an evidence development trial or registry? 
  • And if it is a drug? Is it a deemed and qualifying trial? 
  • And if it’s a device? Is a Category A or B? And is it listed on the CMS website?

[30:07] What does it mean to say, “Medicare gets the best deal?” and why is this important

  • They’re the most favored nation. They want to make sure that you’re not giving another patient on the same trial a better deal than they’re getting
  • Is it research or is it billable? This needs to be clear

[32:44] How do you validate a coverage analysis tool?

  • When the PI looks at the coverage analysis and signs off on it and agrees with it and says yes, “I understand what we’re doing here” or sometimes asks questions i.e. Is the test medically necessary? If not, then it is a research 
  • Final check for consistency across study documents 

[34:31] Who develops and reviews the coverage analysis?

  1. Research coordinator
  2. Facility personnel develops the coverage analysis, and research team validates it
  3. Research team takes a study calendar and circles everything on it that they think is their Standard of Care (SoC) and then someone on the coverage analysis team is reviewing it
  4. Coverage, budget analyst, contract analyst

[36:08] Audits & Coverage Analysis 

[37:28] Training for Coverage Analysis

  • Clinical background or support is important 
  • What does the coverage analysis do to help the front end to be correct? And flow through to the backend?
  • What are the study documents that you need to validate and make sure that they’re all the same? 
  • Do you have a Phase I policy for your institution?
  • What are some of your business rules for how you do your coverage analysis? 
  • How do your PI’s function? How do they give feedback? Are they part of the process?
  • How does this coverage analysis help you build a better budget?
  • What’s in the contract? And how does that function with what is in your coverage analysis? 
  • What about subject injury? 
  • What about payments that are invoiceable?
  • What does the sponsor say that they will pay for?

[45:03] Coverage Analysis is US centric, it gets complicated when Out of US Sponsors (international) bring studies into the US 

[46:22] Phase I Therapeutic Content Policy 

  • Is there a Phase I committee?
  • Do you have a way to validate?
  • If you have a Phase I study that is non-qualifying, are you going to have the sponsor pay for everything? Or research related services? 

Resources Mentioned:

Kelly Willenberg LLC





GE Centricity Centers for Medicare & Medicaid Services

National coverage determinations (NCDs)

Local Coverage Determinations

Research Cadet – 8 Week Live Coverage Analysis Training

NCCN Guidelines

NCCN Drugs & Biologics Compendium

Evicore Clinical Guidelines

Momentum Events – Research Billing Compliance Summit

Research Compliance Academy

Health Care Compliance Association (HCCA)

Society of Clinical Research Association (SoCRA)

Association of Clinical Research Professionals (ACRP)

Healthcare Compliance Manual

Research Compliance Professional’s Handbook, 3rd Edition

1 Thought on "Introduction to Coverage Analysis with Kelly Willenberg"

  1. Gayle Turi
    August 15, 2022

    This information that Kelly presented was so informative and very helpful! I appreciate the opportunity to have her insight, it was great. Thank you for providing such an interesting podcast with this vital information.

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