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Clinical Trial Billing Compliance (CTBC)

This course focuses on developing the knowledge and skills necessary to maintain compliance and best practices associated with clinical research billing.

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About this Course


Clinical Trial Billing Compliance (CTBC) provides individuals with training on clinical research billing compliance and best practices. This includes research staff, department administrators, registration staff, billing/coding staff, and others involved in the process or who are interested in working in research billing compliance.

This course was authored by Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC of Kelly Willenberg & Associates and peer-reviewed by experts.

Language Availability: English

Suggested Audiences: Billing/Coding Staff, Department Administrators, Registration Staff, Research Staff

Organizational Subscription Price: $500 per year/per site
Independent Learner Price: $137.50 per person


Course Content


Toggle Content Before the National Coverage Determination/The Clinical Trial Policy and Its Meaning

Discusses the impact of billing compliance on patients, sites, physicians, sponsors, and payers. It provides a brief history of clinical trials billing compliance including the implementation of the Clinical Trial Policy (CTP), National Coverage Determination (NCD 310.1), as well as a discussion of the CTP and its limitations, the concept of a coverage analysis, and the different requirements for Medicare coverage.

Recommended Use: Required
ID (Language): 17061 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates

Toggle Content Understanding the Term "Qualifying Clinical Trial" for Investigational Drugs and Devices

Focuses on the concept of “qualifying,” which is an important first step in assessing whether a clinical trial’s items and services are billable to payers. It covers where to locate Medicare benefit categories, therapeutic intent, qualifying versus non-qualifying clinical trials, U.S. Food and Drug Administration (FDA) device rules, Category A and Category B devices, and Medicare coverage for drugs and devices.

Recommended Use: Required
ID (Language): 17062 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates

Toggle Content Implementing a Clinical Trial Billing Compliance Program

Provides an understanding of the operational challenges, troubleshooting steps, and recommendations, to achieve compliant and sustainable clinical research billing operational practices, with a particular focus on the appropriate billing of routine costs.

Recommended Use: Required
ID (Language): 17063 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates

Toggle Content Study Document Synchronization

Reviews study and regulatory documents involved in clinical trials billing compliance. It explains why the documents are important to the billing compliance continuum, the importance of study document synchronization, and the role of the payers in the process.

Recommended Use: Required
ID (Language): 17064 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates

Toggle Content Using a Coverage Analysis to Enhance Billing Accuracy and Claims Processing

Focuses on the use of a coverage analysis to validate billing for items and services related to a clinical trial. It describes the coverage analysis and how it aids in billing compliance, the claim submission process, and proper coding.

Recommended Use: Required
ID (Language): 17065 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates

Toggle Content Coding Clinical Trial Activity Through the Insurance Claim

Discusses the meaning and application of the specific diagnosis codes, modifiers, condition codes, and national clinical trial numbers required on a claim for items or services related to a clinical trial. A thorough understanding of this topic allows billing and coding staff to streamline the claims submission process while remaining in compliance with clinical billing policies, regulations, and laws

Recommended Use: Required
ID (Language): 17066 (English)
Author(s): Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC - Kelly Willenberg & Associates


FAQs


Toggle ContentWhat is the importance of Clinical Trial Billing Compliance (CTBC)?

CTBC is a key concern for any research or healthcare organization, as services and items provided as part of a clinical trial must be correctly billed to the appropriate payer. Compliance with clinical billing regulations and best practices reaps many benefits, such as reduced errors, consistent billing practices, increased revenues, improved budget negotiations, and effective informed consent. It also helps avoid issues like double-billing, billing for non-qualifying items or services, and billing for services offered for free in the informed consent.

Toggle ContentWhen should individuals consider taking the CTBC course?

This course is suitable for learners who need a resource that provides comprehensive education on CTBC regulations and best practices. There is no uniform standard for how frequently CTBC training should occur. For a retraining (refresher) cycle, organizations and independent learners should designate the frequency of CTBC retraining. Unlike other CITI Program courses, there is no “refresher” version available at this time, but learners can retake the CTBC course or complete whatever subset of content their organization has selected for them.

Toggle ContentHow is the CTBC course structured?

It consists of modules that contain detailed content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace.

Toggle ContentWhat regulations and topics does CITI Program's CTBC series cover?

The CTBC series discusses compliance with the Clinical Trial Policy (CTP), National Coverage Determination (NCD 310.1). It also covers:

  • “Qualifying” a clinical trial for investigational drugs and devices
  • Implementing an effective CTBC program that addresses operational challenges, troubleshooting steps, and best practices
  • Synchronizing study and regulatory documents
  • Using a coverage analysis to validate billing for items and services related to a clinical trial
  • Applying specific diagnosis codes, modifiers, condition codes, and national clinical trial numbers to streamline claims submissions

Toggle ContentWhat are the standard recommendations for setting up a CTBC learner group?

CITI Program allows organizations to customize their learner groups, which means they can choose the modules their learners need to complete. We will work with your CITI Program designated administrator to determine the learner groups that best fit your organizational needs.

The standard recommendation for CTBC is to designate each module as required in a learner group. This helps to ensure a complete training for the learner. However, organizations may also elect to present certain modules as supplemental, particularly when the organizations provide specific training on the topics.

Toggle ContentWhat are the advantages of the CTBC course?

This course was developed and reviewed by industry experts to help organizations and individuals achieve clinical trial billing compliance. The author has over 30 years of clinical research experience and 25 years of billing compliance experience. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for all individuals working in clinical trial billing compliance.