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Developments for LDT Regulation and Laboratory Reimbursement: Bill Morice, M.D., Ph.D.

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Manage episode 513979089 series 2908385
Content provided by Mayo Clinic Laboratories. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Mayo Clinic Laboratories or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Published October 16, 2025

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, and William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, discuss recent regulatory and policy developments. Together, they explore:

  • FDA rescinds rule on LDTs (00:48): The FDA has officially withdrawn its rule that would allow oversight of laboratory-developed tests (LDTs) as medical devices. The conversation explores what this decision means and what might come next for LDT regulation.
  • PAMA reform update and new RESULTS Act (05:13): The newly introduced Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act aims to address reimbursement for laboratory tests.
  • Getting engaged (12:37): Why it is important to understand new regulatory policies and help others understand their implications for the industry.

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  continue reading

372 episodes

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iconShare
 
Manage episode 513979089 series 2908385
Content provided by Mayo Clinic Laboratories. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Mayo Clinic Laboratories or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Published October 16, 2025

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, and William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, discuss recent regulatory and policy developments. Together, they explore:

  • FDA rescinds rule on LDTs (00:48): The FDA has officially withdrawn its rule that would allow oversight of laboratory-developed tests (LDTs) as medical devices. The conversation explores what this decision means and what might come next for LDT regulation.
  • PAMA reform update and new RESULTS Act (05:13): The newly introduced Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act aims to address reimbursement for laboratory tests.
  • Getting engaged (12:37): Why it is important to understand new regulatory policies and help others understand their implications for the industry.

Resources

  continue reading

372 episodes

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