Publications, Testimony, and Events

Recent Publications and Comments

“Response to CMS Proposed Transitional Coverage for Emerging Technologies,” August 28, 2023.
Read the letter

“Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies,” August 4, 2023, JAMA Health Forum.
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"The Need for Accelerated Medicare Coverage of Innovative Technologies: Impact on Patient Access and the Innovation Ecosystem," Health Management and Policy Innovation, 2022
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Recent Testimony

Breakthrough Device Coverage
Stanford Biodesign’s director, Josh Makower, testified before the health subcommittee of the House Committee on Ways and Means on the ‘valley of death’ increasingly confronting medical technology innovators - where their technologies have received FDA authorization, but often no insurance coverage exists to allow patients to gain access to them for many years, if ever.
Watch the recording

Recent Events

Drug Supply, Demand and Pricing
Policy Program director Kavita Patel moderated a discussion on how to balance innovation and cost, and other important policy issues on drug pricing.
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Policy Implications for Artificial Intelligence in Healthcare: Beyond the Hype
Policy Program director Kavita Patel moderated a discussion on the promise of AI in healthcare, and the questions it raises.
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Time from FDA Authorization to Medicare Coverage for Novel Medical Technologies
Stanford Biodesign researchers recently published results from a cross-sectional study of 64 novel technologies, observing a several-year period to establish at least nominal Medicare coverage after FDA authorization. Senior members of the research team discuss the results of the study with other leaders in the medical technology community. 
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Impact of Changing IP Policy on the Innovation Ecosystem
In a dialog with Eb Bright, our policy program’s director for IP, and Suzanne Harrison, founder of Percipience LLP, two former directors of the USPTO, Andrei Icanu and David Kappos, shared thoughts on the role IP law and policy play in supporting innovation and technological disruption.
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From the Innovator’s Workbench: Anna Eshoo
US Representative Anna Eshoo, whose district includes Stanford, stressed the importance of policy and regulation for healthcare innovation in a conversation with Kavita Patel of the Stanford Byers Center for Biodesign.
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Webinar: The Need for Transitional Coverage for Emerging Technologies
The Duke-Margolis Center for Health Policy and the Stanford Byers Center for Biodesign co-hosted a public webinar on March 28, 2022, that focused on the need for a well-designed coverage program that could accelerate patient access to critical new medical innovations. The webinar highlighted stakeholder perspectives, including those of CMS, innovators, and policymakers.
Read the meeting summary
View the presentation slides
Watch the recording

Webinar: CPT Codes and Innovation
One of the keys to a successful invention is understanding how a new device or procedure fits into the current procedural code (CPT) landscape. We organized this American Medical Association webinar in September 2021 to help physician innovators understand how the CPT process works, how to engage with the CPT Editorial Panel, and when to apply for a new code. Co-sponsored by Fogarty Innovation with MDMA, Wilson Sonsini Goodrich & Rosati, Silicon Valley Bank, MedTech Strategist, and AdvaMed.
View the presentation slides
Watch the recording

Prior Publications

A Comprehensive Analysis of the FDA 510(k) Process, 2011

FDA Impact on US Medical Technology Innovation, 2010

Stanford Researchers Publish Comprehensive Model for Medical Device Development, 2009