Policy Program

Publications, Testimony, and Events

Recent Publications and Comments

“Response to Medicare and Medicaid Programs Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly,” January 27, 2025.
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“Regulatory Pathway for Cell and Gene Therapies in the United States: Perspectives from Innovators and Investors” December 4, 2024, Health Management and Policy Innovation.
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“Addressing The Maternal Mortality Crisis By Improving Interoperability,” November 20, 2024, Health Affairs Forefront.
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“The Digitally Enabled Care Framework: Leveraging Technology to Enhance the Physician–Patient Relationship,” September 18, 2024, NEJM Catalyst.
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“Black Maternal Health and HIV/AIDS: Advocacy Lessons Across Movements,” April 18, 2024, TheBodyPro.
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“Current Common Procedural Terminology (CPT®) Coding Process Challenges: Impact on the HealthTech Innovation Ecosystem,” April 12, 2024, Health Management and Policy Innovation.
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"AI Alone Will Not Reduce the Administrative Burden of Health Care," November 16, 2023, JAMA Network.
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“Response to CMS Proposed Transitional Coverage for Emerging Technologies,” August 28, 2023.
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“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," 2022, Health Management and Policy Innovation.
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Recent Testimony

CPT Coding Process
Stanford Biodesign’s director, Josh Makower, joined a panel on Current Procedural Terminology (CPT) volume criteria at the American Medical Association’s CPT/HCPAC Advisory Committee's annual meeting, sharing the ways in which the current criteria for obtaining a Category 1 CPT code pose a challenge to patient access of novel technologies.

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.
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Recent Events

The Digitally Enabled Care Framework
Physicians are experiencing a "crisis of time" in their workflow with increased electronic documentation and an abundance of messages from patients. The Digitally-Enabled Care (DEC) Framework is an innovative idea for primary care delivery that leverages technology to enhance the physician-patient relationship —whether that be in person or remotely, synchronously or asynchronously— in a scalable manner that eases physician’s overload. In this in-depth discussion, speakers examine the technology that underpins it, as well as the payment transformations needed to enable it.
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Accelerated Coverage Breakthrough Medical Technologies
Our panel of experts discussed the similarities and differences of three policies extending Medicare coverage to emerging technologies: MCIT, TCET, and HR1691.
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Health Technology Innovation Policy Conference 2024
The Stanford Biodesign Policy Program’s inaugural convening in Washington, DC brought together healthcare innovators and entrepreneurs, policymakers, researchers, funders, patient advocates, and other thought leaders, to discuss critical policy challenges and opportunities for health technology innovation.
Watch Panel 1: Current Status of Medicare Coverage for Emerging Technologies
Watch Panel 2: From Mandates to Movement: Bridging the Gap in Health Data Interoperability
Watch Panel 3: Artificial Intelligence and Healthcare
Watch Panel 4: Current Policy Challenges Impacting Biotechnology Innovation
Watch Keynote: Artificial Intelligence and the Future of Healthcare

Beyond the Initial Cure: Expanding the Horizons of Orphan Drug Indications
Policy Fellow Erika Modina moderated a discussion on rare disease treatments and how legislative efforts like the Inflation Reduction Act and the Orphan Cures Act could impact the balance required between innovation, affordability, and access.
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The Big Bang of Digital Interoperability: TEFCA
Policy Fellow Rebekah Dailey moderates a conversation on the development, implementation, and limitations of the Trusted Exchange Framework Common Agreement (TEFCA).
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Realizing the Promise of Real World Evidence
Policy Program director Kavita Patel leads a discussion on Real World Evidence - what it is, and its relevance to innovators, clinicians, and regulators.
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Regulation and Reimbursement for Lab Developed Tests: A Critical Policy Update
Policy Program director Kavita Ptael moderated a conversation on the Food and Drug Administration's proposed language on laboratory developed tests (LDTs), and the potential impact on clinicians, patients, and innovators.
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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 Stanford Biodesign.
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Webinar: The Need for Transitional Coverage for Emerging Technologies
Stanford Biodesign and the Duke-Margolis Center for Health Policy 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