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: $139 per person


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Physicians

AMA PRA Category 1 Credit

3 credits
(4 CE Certified Modules)
$60

15 November 2019
14 November 2022

Psychologists

CE Credit/Hour

3 credits
(4 CE Certified Modules)
$60

15 November 2019
14 November 2022

Other Participants

Certificate of Participation

3 Credits
(4 CE certified modules)
$50

15 November 2019
14 November 2022


Course 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

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

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

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

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

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