Safe and effective medical technologies can improve people’s lives only when they are accessible. As a physician and inventor, I am acutely aware that the more treatment options available to a provider, the better equipped they are to alleviate suffering and save lives.
In 2016, Congress sought to help enlarge the therapeutic toolkit with the passage of the 21st Century Cures Act. It codified the Food and Drug Administration’s breakthrough program for medical devices to prioritize the review of new treatments that addressed critical gaps in patient care for serious or life-threatening conditions. Breakthrough-designated technologies are required to meet the same statutory standard of safety and efficacy as every other medical device under review by the agency. Breakthrough-designated devices are also offered additional FDA scientific experts, oversight, and, when scientifically appropriate, more flexible clinical trial structures to help accelerate the review of a technology.
Despite the goal of the FDA’s breakthrough program to help accelerate the development and introduction of new therapeutic and diagnostic technologies, millions of patients in the United States who suffer from serious conditions tragically continue to have limited options. This is because even if a product is authorized and deemed safe and effective by the FDA, that does not mean that Medicare will cover it. If it is not covered, it is not accessible to many physicians or their patients.
The process for coverage — by Medicare or any other insurance — for novel technologies is long, complex, and difficult, and the challenge is disincentivizing the development of cures and technologies we need now. A study my colleagues and I conducted at the Stanford Mussallem Center for Biodesign demonstrated that on average it takes 5.7 years after a breakthrough technology is authorized by the FDA to gain even the most nominal level of coverage under Medicare.
Innovators refer to this gap as the “valley of death,” and it leads to needless suffering for Medicare beneficiaries. In an increasingly competitive global marketplace, this also results in a looming crisis for our nation’s leadership in medical technology innovation.
Congress can accelerate patient access for the narrow but clinically important category of breakthrough medical technologies that come to market without existing Medicare coverage. Over the years, numerous bipartisan bills have been introduced to close that gap. That goal now seems within reach: Last year, legislation focused on this issue secured an overwhelming 37-3 vote in the House Committee on Ways and Means. The corresponding bill in the Senate is still in consideration for a future vote.
Critics of the legislation are working hard to keep it from passing, but their most common allegations don’t hold water.
Some mistakenly argue that accelerating coverage for breakthroughs could lead to significant increases in health care costs. Nothing could be further from the truth.
They typically point to the wrong numbers when they characterize the impact. While it is true that the FDA has enrolled more than 1,000 breakthrough devices and diagnostics in this program, only 160 have been authorized in the last decade. This fact is evidence of the high standard the FDA applies to reviewing these technologies before authorizing them.
Further, only a very small percentage of these products would be eligible for coverage under proposed bills being consideration by Congress. The study my colleagues and I conducted reviewing novel and breakthrough technologies authorized by the FDA found only 64 technologies from 2016 to 2019 matched existing Medicare benefit categories and required new coverage. Despite what some critics claim, 16 technologies per year would in no way threaten the Medicare Trust Fund.
Even this extremely small number of novel technologies has tremendous potential to dramatically improve patient care for Medicare beneficiaries. If Congress and CMS can work to narrow the “valley of death” that these and other future technologies endure before reaching patients and providers, this small number of technologies could make a meaningful impact on many lives.
There have also been several incorrect assumptions about cost. The Congressional Budget Office estimated in November 2025 that it would cost $100 million a year over 10 years. The current CMS budget for fiscal year 2025 is over $1.5 trillion, and breakthrough legislation would represent an infinitesimal amount of that budget. Those numbers also do not take into account the clinical benefits and cost savings of getting patients back to leading productive lives, with fewer complications, and less days in the health care delivery system.
There is a reason that this legislative proposal has garnered such broad, bipartisan support in numerous sessions of Congress, and it is because policymakers have taken a very balanced approach to solving a serious problem. The legislation under consideration does not confer “automatic” coverage of all FDA authorized breakthrough technologies. Instead, a technology must first be applicable to the program by falling within an established benefit category, and it must pass a CMS review of the product and provide related clinical data to ensure it does not present an undue risk of harm that outweighs clinical benefits. It is also important to note that the breakthrough legislation currently under consideration in Congress does not create new benefit categories.
Further, once CMS coverage is approved, it would be temporary for four years during which time additional data would be collected. If CMS has concerns about the technology, the temporary coverage can be suspended. The breakthrough program, and the legislative efforts to address the “valley of death,” are not only powerful attempts to help expedite the access of safe and effective medical technologies for patients, they are also targeted policies that would expand the toolkit for health care providers.
It would be a travesty if we don’t act soon to solve this pressing problem for patients and providers, and the health technology ecosystem that creates these technologies. Leaving things as-is would also weaken our leadership position in medical technology manufacturing, something the United States’ competitors, like China, would happily welcome. Do we really want to have a system that encourages innovators to choose incremental technologies to be able to get to market faster, or do we want to incentivize those that take on important unmet patient needs, and reward those that deliver safe and effective technologies to do so?
At a time of so much partisanship in Congress, especially related to health care, breakthrough legislation is a shining example of how commonsense policies that support patient care and innovation can achieve broad support. I urge Congress to get this legislation across the finish line this year. America’s seniors and innovators have waited long enough.
Josh Makower, M.D., is the Yock family professor of medicine and bioengineering at the Stanford Schools of Medicine and Engineering, and the Byers family director and co-founder of the Stanford Mussallem Center for Biodesign, a center dedicated to training the next generation of medical technology innovators to advance patient health outcomes and access.
