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The Five Ws (Why, Who, What, Where, When) of Reimbursement and Regulation for Diagnostics

  • Credit:1.0 ACCENT
  • Duration: 1 hour
  • Date:MAY.12.2022 1:00 p.m. - 02:00 p.m.
  • Level: Intermediate

Price: $0.00

Member Price: $0.00

Rating: Member Average

Register for this webinar to learn about reimbursement and regulation for clinical diagnostics. With your registration, you will have access to the recording on demand through May 31, 2023.


It is critical for any U.S. lab performing clinical diagnostics to thoroughly understand the “ins and out” of the current US Regulatory & Reimbursement systems. Laboratorians and future laboratorians will learn about the latest changes in these processes. This information is instrumental to labs performing EUA tests today to learn what will change when the COVID-19 pandemic ends, or another health emergency occurs. The webinar will also describe the choices that an individual lab or IVD manufacturer has in securing approvals to market their product(s) in the United States.


This activity is designed for physicians, lab supervisors, lab directors (and/or assistant directors), and other laboratory professionals overseeing/conducting within this topic.


At the end of this activity, participants will be able to:

  • Describe the role of the US Food and Drug Administration (FDA) in regulating in vitro diagnostic (IVD) tests and laboratory-developed tests (LDTs)
  • Describe FDA regulations related to IVD tests used for Research Use Only (RUO) and Investigational Use Only (IUO)
  • Describe the role of the Centers for Medicaid and Medicare Services (CMS) in regulating laboratory processes associated with LDTs
  • Understand the use of CPT codes
  • Define the role of a Medicare administrative contractor (MAC)
  • Understand the various options for reimbursement and regulatory strategies


Michael DonovanMichael Donovan, PhD, JD
Lecturer, Arizona State University
Phoenix, AZ, USA

Michael is currently a Lecturer in the biomedical diagnostics program in Arizona State University’s College of Health Solutions. Michael teaches courses related to a variety of diagnostics-related topics, including immunoassays, applied bioethics, regulation of diagnostics, and is a mentor for the BMD program’s applied projects. For the last 11+ years, Michael has been a registered patent attorney (BS – Microbiology; PhD Immunology) specializing in patent prosecution and intellectual-property licensing/commercialization for life sciences-related technologies. After leaving private practice, Michael worked as the Intellectual Property Counsel for The Translational Genomics Research Institute (TGen) and recently served as the System Director for Intellectual Property at CommonSpirit Health. He has protected and commercialized a multitude of different technologies, including medical devices, biomedical diagnostics and therapeutics, among other technologies.

In addition to legal practice, Michael has also served as an adjunct faculty member at both ASU and Grand Canyon University. Michael also serves on the Arizona Supreme Court’s Committee on Examinations.

Marilyn OwensMarilyn Owens, PhD, MBA
Founder and Principal, Medical Laboratory Strategy and Leadership, LLC
Elgin, OR, USA

Marilyn is a senior healthcare executive, with 40 years of experience in establishing and operating esoteric and multi-site clinical laboratories during transformational growth. Her background spans start-up, turnaround, and consolidation activities. She is the Founder and Principal of Medical Laboratory Strategy and Leadership, LLC, providing advisory and consulting services to private laboratories, Academic Medical Centers, In Vitro Diagnostic companies, and various Research Incubators. Dr. Owens is an advisor to several Boards of Directors, for both domestic and international companies, as well as guest lecturer invited to speak on technical and strategic topics.

Mara AspinallMara G. Aspinall, MBA
Managing Director, Health Catalysts Group
Tucson, AZ, USA

Mara is a healthcare industry leader and pioneer committed to active civic involvement. She also heads the Health Catalysts Group, a consulting firm for HIT and Diagnostics, publishing the popular Health Catalysts Diagnostics Year in Review.<

Mara is a member of the Board of Directors of Abcam, Allscripts, Castle Biosciences, OraSure and Blue Cross Blue Shield Arizona. Mara is an advisor to The Rockefeller Foundation on COVID diagnostics. She is co-author on the Foundation’s national reports on COVID testing education and policy recommendations. She is passionate about education on diagnostics, genomics and personalized medicine. To that end, she co-founded the School of Biomedical Diagnostics at Arizona State University, the first school dedicated to Diagnostics as an independent discipline.


AACC is dedicated to ensuring balance, independence, objectivity, and scientific rigor in all educational activities. All participating planning committee members and faculty are required to disclose to the program audience any financial relationships related to the subject matter of this program. Disclosure information is reviewed in advance in order to manage and resolve any possible conflicts of interest. The intent of this disclosure is to provide participants with information on which they can make their own judgments.

The following faculty reported the following relevant financial relationship(s) during the content development process for this activity:

  • Mara G. Aspinall, MBA
    Grant/Research Support: Rockefeller Foundation
    Consultant Fee: Rockefeller Foundation
    Board/Committee Membership/Advisory Board: Abcam, Allscripts, Castle Biosciences, DA32, OraSure, BCBS Arizona
    Stocks/Bonds: Abcam, Allscripts, Castle Biosciences, DA32, OraSure
    Presenter/Speaker: Abbott, ThermoFisher
  • Marilyn Owens, PhD, MBA
    Salary: Medical Laboratory Strategy and Leadership, LLC

The following faculty and reviewers reported no relevant financial relationship:

  • Michael Donovan, PhD, JD


All recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients; AND/OR all scientific research referred to or reported in support or justification of a patient care recommendation conforms to generally accepted standards of experimental design, data collection, and analysis.


This education activity was approved for 1.0 ACCENT credit(s). Activity ID# 4059. This activity was planned in accordance with ACCENT Standards and Policies.


Verification of Participation certificates are provided to registered participants based on completion of the activity, in its entirety, and the activity evaluation. For questions regarding continuing education, please email [email protected].

Sponsored By

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