Diagnostic Development, Approval, and Reimbursement

  • Course Price: $150 USD
  • Course Run Time: 41 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

Diagnostic Development, Approval, and Reimbursement begins by examining the big picture; the roles of U.S. government agencies and their regulatory authority over in vitro diagnostics (IVD) and laboratory-developed tests (LDT). The second section describes the regulatory requirements for Class I, II, and III diagnostic approval pathways. A review of the internationally recognized quality system regulations (QSR), focused on the design and manufacturing QSRs, closes out this section. Diagnostic Developemnt, Approval, and Reimbursement ends by explaining Medicare, Medicaid, hospital, and private payer reimbursement in terms of inpatient DRG codes and outpatient CPT codes. 

Suggested Prerequisites

Diagnostics’ Role in Medicine Today

Takeaways
  1. Compare and contrast the diagnostic regulatory oversight by the FDA and the CMS.
  2. Explain the United States regulatory process for in vitro diagnostics and laboratory-developed tests.
  3. Recognize the regulatory differences between Class I, II, and III diagnostics.
  4. Explain the purpose of quality system regulations (QSR) highlighting the design and manufacturing QSRs.
  5. Discuss the challenges in receiving diagnostic reimbursement in the United States.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Download Agenda
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Trailer
Diagnostics: Regulation of New Clinical Tests
Summarizes the regulatory pathways for different categories of diagnostics and explains the differences in oversight from the Center of Medicare and M...More
Approval Process for Laboratory Developed Tests (LDT)
Compares the regulatory differences between in vitro diagnostics and laboratory developed tests.
Diagnostic Regulatory Pathways
Describes the regulatory burden of Class I, II, and III diagnostics and how to assess a diagnostic's class based on its risk profile. The FDA's 501(k)...More
Quality Control of Diagnostics
Highlights the application of quality system regulations for diagnostics.
European Union Approval Pathways for Diagnostics
Provides a synopsis of the EU's diagnostic approval process.
Reimbursement for Diagnostics
Describes the methodology for economic evaluation and reimbursement of novel diagnostics. Lastly, the US standard reimbursement codes for diagnostics are reviewed.
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent