Visit our website
New America Cypbersecurity Initiative
New America Cypbersecurity Initiative
MIT Technology Review
MIT Technology Review
io9
io9
Techdirt
Techdirt
Knowledge@Wharton
Knowledge@Wharton
Bioscience Technology
Bioscience Technology
redOrbit
redOrbit
Technology & Marketing Law Blog
Technology & Marketing Law Blog
Popular Science Blog
Popular Science Blog
Pew Research Center
Pew Research Center
Genomics Law Report
Genomics Law Report
Science 2.0
Science 2.0
The Guardian Headquarters
The Guardian Headquarters
Genetic Literacy Project
Genetic Literacy Project
Disclaimer

Statements posted on this blog represent the views of individual authors and do not necessarily represent the views of the Center for Law Science & Innovation (which does not take positions on policy issues) or of the Sandra Day O'Connor College of Law or Arizona State University.

LSI Holds 6th Annual Workshop on Regulation and Reimbursement of Molecular Diagnostics

 

By Gary E. Marchant

The Center for Law, Science & Innovation (LSI) convened its 6th Annual Roundtable Workshop on the Regulation and Reimbursement of Molecular Diagnostics on April 12, 2017.  A unique feature of this year’s workshop was that it was co-sponsored by the ASU International School of Biomedical Diagnostics.  As in past years, the LSI workshop was a highly interactive and interdisciplinary discussion of regulatory and reimbursement issues affecting diagnostics, with participants from government, industry, insurers, consulting firms, academia, medicine and patient organizations. It has been an active year on the regulatory front for FDA on diagnostics issues.  The FDA presentation by Alberto Gutierrez and ensuing discussion delved into FDA’s regulatory role for laboratory developed tests, the 21st Century Cures Act, regulation of complex and multiplex tests, next generation sequencing, the Precision Medicine Initiative (aka All of Us), and Parallel Review.  Recent developments with CMS and other payers in the reimbursement of diagnostics, including the clinical laboratory provisions of the Protecting Access to Medicare Act of 2014 (PAMA), were covered in presentations by Louis Jacques and Roger Klein.  Ralph Hall gave a presentation on new draft legislation to be introduced in Congress to create a whole new regulatory approach to molecular diagnostics, which generated an extended and rich discussion.  Other in-depth topics covered in the workshop were regulation of computer software and mHealth devices (David Feigal), reimbursement of cancer diagnostics and experimental exclusions (Kirk Hartley), and the use of whole genome sequencing of pathogen detection (Jeremy Ellis).  Based on the highly engaged discussion, two ideas for group-authored manuscripts on specific diagnostic issues were identified – (i) how to regulate constantly updated algorithm-based diagnostic tests, and (2) developing a more transparent and fair approach to experimental exclusions in coverage.  The 7th Annual Workshop will be held in April 2018.

The agenda and list of participants for the 2017 workshop is posted here: http://conferences.asucollegeoflaw.com/personalizedmedicine/2017-agenda-participants/ and most of the presentations are posted here: http://conferences.asucollegeoflaw.com/personalizedmedicine/2017-presentations/