Patients, Manufacturers Plead for Medicare Breakthrough Device Coverage

A group of 67 patient groups and life science organizations has petitioned the Centers for Medicare & Medicaid Services for coverage of breakthrough medical devices. The request comes at a time when these new and unique devices may need six years for payer coverage, a delay the requestors said is inappropriate and a disservice to patients.

The Advanced Medical Technology Association (AdvaMed) posted the letter to CMS administrator Mehmet Oz in an Aug. 20, 2025, press release highlighting the importance of breakthrough medical devices for patient care. The stakeholder letter states that novel medical technologies have trimmed the duration of the average hospital stay by 38% and reduced breast cancer deaths by 43%. Medical devices have also decreased fatalities from stroke and heart disease by nearly 50% while new diagnostics offer a much earlier diagnosis for conditions such as Alzheimer’s and Parkinson’s diseases.

The letter states that despite these advances, many of these technological advances face as much as a six-year delay between FDA approval or clearance and the date on which Medicare covers the device. The letter states that patients should not have to wait more than half a decade to have access to technologies that improve their health and their lives and, in some instances, save their lives.

AdvaMed was just one of many trade associations to sign the letter. Others include state-based life science association such as Biocom California, the Colorado BioScience Association and the Illinois Biotechnology Innovation Organization. Patient advocacy groups such as the Spina Bifida Association, Voices of Alzheimer’s, and the Brem Foundation to Defeat Breast Cancer were also signatories to the letter.

The letter states that the Transitional Coverage of Emerging Technologies (TCET) program is incapable of providing robust and exhaustive coverage of breakthrough devices and diagnostics for several reasons. One of these is that the TCET program is limited to five entries per year and excludes in vitro diagnostics (IVDs). The authors stated that the Medicare Coverage of Innovative Technology (MCIT) program, which CMS proposed in September 2020, is exemplary of an approach that would offer more comprehensive coverage for breakthrough devices than the TCET model, particularly given that the MCIT framework does not bar IVDs.

The letter refers to a bill introduced to the Senate Finance Committee in May 2025, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025. This bill (S. 1717) was introduced by Sen. Todd Young and provides a four-year term of transitional coverage during which the manufacturer must collect data to demonstrate that the device or service meets the Medicare definition of reasonable and necessary. A previous version of the bill was introduced in the 118th Congress but died in committee.

1. 1717 would require that CMS determine whether a device or diagnostic is eligible for breakthrough device coverage within six months of receipt of an application from the manufacturer. CMS would also be required to make a coverage determination regarding the device no later than nine months before the end of the four-year transitional coverage period. This bill would also provide CMS with $10 million per year for five years to cover the cost of administering a breakthrough devices coverage program.

The TCET process currently used by CMS uses a traditional national coverage determination approach and requires that the sponsor of the device enroll studies under the coverage with evidence development mechanism. The process begins with an evidence review by CMS and requires that the manufacturer submit an evidence development plan. However, the TCET program opens two comment periods for the device, the first of which opens upon the issuance of a letter of acceptance to the program.

The second comment period begins when CMS issues a proposed coverage memo. The TCET program does not specifically limit the duration of the CED study, although CMS has stated that it will typically conclude the TCET decision process within six months of acceptance of an application.