September 18, 2025, Energy & Commerce Subcommittee on Health
Chairman Griffith, Ranking Member DeGette, Chairman Guthrie, Ranking Member Pallone, and distinguished members of the Committee, thank you for the invitation to testify. I’m Dr. Diana Zuckerman, president of the National Center for Health Research (NCHR), a nonprofit think tank that uses research to improve the quality of medical care in the United States.
I was previously a faculty member at Vassar and Yale, a research director at Harvard, and most important, a Committee staffer in the House and Senate.
Both the Breakthrough Devices Act and the Nancy Gardner Sewell Act require Medicare coverage for specific medical devices. Keep in mind that the standard for Medicare coverage is “reasonable and necessary” for Medicare patients. FDA safety and effectiveness standards are not specific to Medicare-age patients.
FDA requires prescription drugs be proven safe and effective, almost always based on patients in clinical trials. In contrast, FDA requires less than 5% of medical devices to be tested in clinical trials, while more than 95% go through a less stringent review called the 510(k) pathway. Those devices are cleared for market if the device is “substantially equivalent” to a device that’s already on the market, even though that older device also wasn’t required to be proven safe or effective in a clinical trial.
Medicare almost always pays for prescription drugs approved by FDA. It does not pay for all medical devices, especially if there are no clinical trials or evidence that they are safe or effective for Medicare patients.
When I served on CMS’ Advisory Committee that recommends whether products should be covered by Medicare, I saw many devices were not covered because they had never been studied on Medicare-age patients. Age is important for implants and many other devices because the older we are, the more likely we are to have chronic health conditions that make surgery, anesthesia, and other treatments riskier.
Devices are designated as breakthrough before scientific evidence is available, based on the FDA’s belief that the device will be more effective than any other available devices. But if completed studies show the device is not more effective than other devices, it will still be sold as breakthrough devices.
Most of the 160 breakthrough devices available in the U.S. are therapeutic devices to treat a disease or condition. Thirty-eight percent of these treatment devices cleared the 510(k) review as substantially equivalent to devices already on the market. Of the 34 distinct 510(k) devices that are relevant to patients 65 and over, 10 (29%) were studied in clinical trials that were listed in ClinicalTrials.gov, although the law requires these types of studies to be listed on that website.
Most of those 10 devices have not yet publicly reported whether any of the patients studied were 65 and older. It is impossible to determine how many of those 10 devices included studies of sufficient numbers of patients ages 65 and older to be able to conclude that they would be considered reasonable and necessary for Medicare coverage.
The other 55% of breakthrough 510(k) devices either had nonclinical data such as animal or mechanical data or had some kind of clinical data that was not a clinical trial. While some of those studies may provide very useful information, it will not be possible to conclude the data are relevant to patients over 65, who often have greater risks and fewer benefits from medical interventions.
59 other breakthrough treatment devices went through the more stringent PMA or De Novo reviews and many were studied in clinical trials. However, numerous studies were small and had no placebo or comparison group. Many studies did not include Medicare-aged patients or have not yet publicly reported the number of patients studied who were 65 or older.
Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
As a cancer survivor, I appreciate that the goal of the Nancy Gardner Sewell Screening bill is to save lives. Multi-cancer early detection tests are promising, but they’re not ready for prime time. The most recent research has concluded that the existing tests are subject to bias, miss most early cancers in people who do not have symptoms, and may provide false positives to most patients.[2] In one of the tests, a test result indicating cancer was correct only 4% of the time.
A test with many false positives, where most patients who are told they may have cancer do not have cancer, causes anxiety and results in additional testing that may be painful, harmful, expensive, time-consuming, and stressful. A test with many false negatives, in which patients are told they do not have cancer when they actually do, is likely to result in patients who ignore signs and symptoms of cancer, thus delaying needed treatment.
NCI recently launched the Vanguard Study of 24,000 people ages 45-75. The goals are to determine how accurate these tests are and whether any of the tests save lives. As stated in the study in Annals of Internal Medicine, it is unclear whether MCED tests “detect cancer types at later, untreatable stages or whether they detect very early-stage precancerous lesions that might never have developed into cancer.”
If in the future these tests are proven to have benefits that outweigh the risks for Medicare patients, then I strongly urge that the age restrictions be deleted from the bill. Age restrictions set a dangerous precedent for Medicare coverage decisions and would cause an uproar among patients who are excluded from coverage for reasons that are not scientific and will be perceived as unfair.
Conclusions
Both these bills are intended to help Medicare patients by increasing their access to medical devices. However, in both cases there is a lack of evidence that determines which of these devices have benefits that outweigh the risks for Medicare patients. The goals are wonderful but requiring Medicare to pay for devices not proven to help its beneficiaries is not the best way to help patients.
- Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices, JAMA Internal Medicine, 174(11): 1781-1787.
- Kahwati, L. C., Avenarius, M., Brouwer, L., Crossnohere, N. L., Doubeni, C. A., Miller, C., Siddiqui, M., Voisin, C., Wines, R. C., & Jonas, D. E. (2025). Multicancer Detection Tests for Screening. Annals of Internal Medicine. https://doi.org/10.7326/ANNALS-25-01877