When the FDA authorizes a new medical device, most people assume patients can get it. For the nearly 70 million Americans on Medicare, that is often not the case. FDA authorization means a company may sell a device, but Medicare makes its own, separate decision about whether to pay for it, and for the most novel technologies that second decision has taken years.
The best evidence on how long comes from a 2023 study in JAMA Health Forum, which followed the medical devices and diagnostics the FDA authorized between 2016 and 2019. Among the truly novel ones, fewer than half had any Medicare coverage by the end of 2022, and the median wait was 5.7 years. The researchers also found no statistically significant link between the strength of a device's evidence and how quickly it was covered, which tells us the wait is not the price of careful review. It is the cost of a slow process, and patients with serious conditions are the ones paying it.
On October 12, Patients Rising filed formal comments with the Centers for Medicare & Medicaid Services (CMS) on a new proposal designed to close that gap. You can read our full letter here. We also joined a coalition letter from patient and provider organizations, and we wrote our own to make sure the patient perspective came through clearly.
In April, CMS and the FDA announced the Regulatory Alignment for Predictable and Immediate Device coverage pathway, known as RAPID, and in August CMS published the details for public comment. The idea is simple and overdue. Instead of the FDA finishing its review and Medicare starting from scratch afterward, the two agencies would work with a device's maker from the beginning of its main clinical study, agreeing in advance on what the study needs to show.
If the study shows that a device improves how Medicare patients feel, function, or survive, CMS would propose national coverage on the same day the FDA authorizes it. The final decision would follow about 60 days later for moderate-risk devices and 90 days later for the highest-risk devices. Measured against a wait of more than five years, that is a transformation, and we told CMS so.
The catch is in who qualifies. RAPID is open only to certain FDA-designated breakthrough devices whose main studies have not started yet. Devices already on the market, devices already in a clinical study, and diagnostic tests are all left out, which means many of the technologies patients are waiting for today would see no change at all.
Our comments start from a simple premise: patients have no say in when a device they need began its clinical study, so they should not lose access because of that timing. CMS asked the public whether it should create a temporary path into RAPID for devices already in a study. We said yes, and asked CMS to keep it open long enough to cover the devices whose studies were underway when RAPID was announced. For devices the FDA has already authorized, we asked CMS to commit to a published timeline for its coverage decisions, so patients and their doctors know when an answer is coming.
We also asked CMS to make room for people with rare and hard-to-treat conditions, including many cancers. RAPID expects studies to show results in Medicare patients specifically, but for a rare disease there may simply not be enough Medicare patients to study. We urged CMS to accept other sound evidence in those cases, such as data pooled across age groups, natural history studies, and patient registries, so that the pathway does not end up least available to the patients with the fewest options.
Three more requests round out our letter. We asked that patients have a voice in choosing the outcomes RAPID measures, since they know best which improvements matter in daily life. We asked that when coverage depends on joining a follow-up study, patients can take part where they already get care, at no added cost, and for a set period rather than indefinitely. And we asked CMS to publish where every device stands in the pathway and to set firm deadlines it reports against, because without deadlines and public reporting, patients have no way to know whether the new system is working.
The comment period closes on October 13. CMS will review the public comments and respond when it publishes a final version of the pathway, and we will report back on what changed. In the meantime, the bigger fix sits with Congress. The bipartisan Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343 in the House, S. 1717 in the Senate) would give breakthrough devices temporary Medicare coverage starting the day the FDA authorizes them, including devices already on the market, and it would write that protection into law so it cannot be paused by the next administration. The House Ways and Means Committee advanced the bill 37 to 3 in September 2025, and it is waiting for a vote.
Here is how you can help.
Ask your representative to cosponsor H.R. 5343 and push for a floor vote, and ask your senators to cosponsor S. 1717. If you or someone you care for has been told that an FDA-authorized device is not covered by Medicare,
Share your story with us, because stories are what turn a statistic like 5.7 years into something lawmakers cannot ignore.
To understand the full issue, including the history of earlier attempts and where every proposal stands, read our Policy Deep Dive on breakthrough device coverage. We keep that page updated as this moves forward.