Regulation & Reimbursement
Sixth Annual Roundtable Workshop
the Center for Law, Science & Innovation at ASU’s Sandra Day O’Connor College of Law
the ASU International School of Biomedical Diagnostics
April 12, 2017
Skysong Innovation Center, Scottsdale, AZ
The Center for Law, Science & Innovation convened its Sixth 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 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, and 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, 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.