Stanford Biodesign Policy Survey Finds Multi-Year Delays in Access to Breakthrough Medical Devices 

Stanford Biodesign Innovation Fellows discuss a new technology project.

Some of the most eagerly anticipated medical technologies in development are those that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions. They are designated “breakthrough” technologies by the US Food and Drug Administration (FDA), which means that either no approved/cleared alternatives exist, or that the breakthrough technology offers significant advantages over existing solutions. [1]

However, breakthrough technologies don’t always get to the patients who need them in a timely manner. Even once a technology is approved by the FDA, it may not become available to Medicare patients for several years due to the time it takes to obtain appropriate coding, coverage, and payment. 84% of Medicare recipients are over 65, and more than a third are over 75.[2]  For those struggling with life-threatening or incapacitating diseases, time matters.

 “The delay in getting important new technologies to Medicare patients with serious health conditions is a well-recognized challenge of our reimbursement system,” said Sandra Waugh Ruggles, assistant director of the Stanford Biodesign Innovation Fellowship and a leader of the group’s new Health Technology Innovation Policy program. “It affects a lot of people who may not have the time to wait.”  More than 61 million Americans, nearly all over the age of 65,[3] rely on Medicare for their health insurance.

Quicker Access For Medicare Patients

In an attempt to remedy this lag, in November of 2020 the Centers for Medicare and Medicaid (CMS) introduced Medicare Coverage of Innovative Technology (MCIT), a coverage pathway intended to help people on Medicare gain quicker access to innovative technologies that provide more effective treatment for life threatening or irreversibly debilitating diseases.[4] The MCIT rule provided for four years of Medicare coverage immediately after FDA authorization.

However, CMS repealed the final rule late last year, before it was ever implemented. “There were some internal procedural issues, as well some important missing elements like a mechanism to determine whether additional clinical data should be collected after FDA authorization,” Ruggles explained.

Today, an amendment to the original MCIT rule is part of the Cures 2.0 Act, a bipartisan bill introduced into the House of Representatives that seeks to speed up the delivery of groundbreaking new cures, treatments, and innovations.

Research Quantifies Delays, Related Issues

To help educate policy makers and the general public on the delays in coverage and benefits of an expedited coverage pathway, and to explore related issues such as the impact of an accelerated pathway on patient care and innovation, Ruggles, Stanford Biodesign director Josh Makower, and other members of the Health Technology Innovation Policy team decided to research the issue.

“While we certainly agree that the original MCIT proposal needed more definition to allow it to be enacted successfully, we believed that it was important to develop data that quantifies the value for patients and the medical innovation ecosystem of an accelerated coverage pathway for breakthrough technologies,” said Makower.

About the Survey

The policy team surveyed 336 healthcare innovators and investors to ask how long, based on their own experience, it took for breakthrough new technologies to achieve Medicare coverage, coding and payment. The survey also asked questions to determine whether a clear path to reimbursement would affect innovation and investment in clinical areas of particular important to Medicare patients, and how innovators thought about continuing to collect safety and efficacy data once a technology was approved. The results are published in the January 25 issue of Health Management, Policy, and Innovation Journal.

Research Highlights

  • Medicare patients often wait years to get access to FDA-authorized technologies. Survey respondents reported that coding and nationwide Medicare coverage for breakthrough products takes an average of 2.6 years and 4.7 years, respectively, following FDA authorization. 
  • A swift, predictable pathway for coverage of breakthrough technologies would encourage innovators and investors to take on high-impact projects in fields that are important to Medicare beneficiaries, such as cardiovascular disease, stroke, and cancers. 
    • Achieving appropriate reimbursement is one of the greatest risks that innovators and the investors who fund them must consider in deciding whether to undertake new projects to improve patient care.
    • 84% of innovators said they were likely to take on a novel or breakthrough product as their next project if there was an accelerated reimbursement pathway in place. 53% said that they were unlikely to do so without such a pathway.
    • Investors agreed. 69% of respondents who made investments in companies developing breakthrough devices said they would be less likely to make those investments again without an expedited pathway.
  • Innovators are committed to evidence generation: The majority of innovators surveyed said that they normally collect real-world evidence of safety and efficacy following FDA authorization of a breakthrough device. 88% of respondents gather real world evidence “always” or “most of the time.”
  • The patient impact and overall healthcare system cost-savings of accelerating patient access to breakthrough technologies is significant. To illustrate this potential, the paper analyzed four FDA-designated breakthrough technologies currently in development that address clinical problems that impact Medicare beneficiaries. One is a device that removes anti-platelet drugs, which could eliminate more than 13,000 major bleeding events each year.

“Based on the data, we believe that a well-designed program that enables coverage while continuing evidence collection, as MCIT was intended, could benefit patients by accelerating access to important health advances and encouraging invention and investment in areas of critically important unmet clinical needs,” said Makower.

Launched in 2021, the Stanford Biodesign Health Technology Innovation Policy Program focuses on understanding the intersection of healthcare, innovation and health policy. The program has three components: research – developing data at the intersection of innovation, healthcare delivery, and patient outcomes; education – graduate-level and post-doctoral fellowship opportunities to learn and research; and engagement – which supports healthcare’s triple aim of improving the individual experience of care, improving the health of populations, and reducing the per-capita costs of care for populations, through engagement with policymakers and the innovation ecosystem.