Three bills have been introduced to Congress that may improve the prospects for manufacturers of medical devices, two of which would improve the outlook for the entire industry. The Advanced Medical Technology Association (AdvaMed: Washington) expressed its support for all three bills, each of which has bipartisan support on Capitol Hill.
AdvaMed stated that the American Innovation and Jobs Act of 2025 would expand research and development investments
made by small businesses, including small device makers who make up more than 80% of industry. This legislation would restore the ability of small companies to fully deduct their R&D expenditures, which was provided by the Tax Cuts and Jobs Act of 2017. The R&D deductibility policies in the Tax Cuts and Jobs Act of 2017 expired in 2022, however.
The American Innovation and Jobs Act would make permanent the full deductibility policy for R&D expenditures but would also allow companies to retroactively deduct R&D expenditures that were not allowed after 2022. AdvaMed stated that these R&D expensing policies are particularly important for small and emerging medical technology companies. Scott Whitaker, President and CEO of AdvaMed, said, “[w]herever appropriate, the tax code should promote investment in researching and developing the next generation of treatments for patients.”
AdvaMed also supports the Access to Prescription Digital Therapeutics Act of 2025, which has been introduced to both the Senate and the House of Representatives. These bills would amend Section 1861 of the Social Security Act by adding a definition for the term, “prescription digital therapeutic,” and by creating a benefit category for these articles effective Jan. 1, 2026.
Developers of prescription digital therapeutics would be required to report the payment rates provided by private payers, a failure of which would incur a civil monetary penalty of as much as $10,000 per day. The House bill, H.R. 3288, is sponsored by Reps. Kevin Hern (R-Okla.) and Mike Thompson (D-Calif.), while the Senate version, S. 1702, is sponsored by Sens. Shelley Moore Capito (R-W.Va.) and Jeanne Shaheen (D-N.H.).
AdvaMed’s Whitaker said health technology companies “are developing tremendous products to treat chronic diseases and conditions and mental health disorders.” Whitaker said the expanded access would “not only improve patient outcomes but also can help ease the shortage of clinicians in underserved communities.” Shaye Mandle, executive director of the AdvaMed Digital Health Tech division, said passage of these bills would “be a big win for digital health and the patients these technologies serve.”
The Ensuring Patient Access to Critical Breakthrough Products Act has been reintroduced to Congress by Sens. Todd Young (R-Ind.) and Alex Padilla (D-Calif.), a bill that would expand Medicare coverage for devices granted access to the FDA breakthrough devices program. Padilla and Young stated that patients may have to wait 5.7 years to obtain access to novel technologies after the FDA grants the device marketing authorization, citing “bureaucratic red tape” as the reason for these delays.
One important feature of the bill is that it does not exclude in vitro diagnostics, which are currently ineligible for the Transitional Coverage for Emerging Technologies (TCET) program. The device or diagnostic would be eligible for Medicare coverage on the date of the FDA marketing authorization and extend for four years, during which the manufacturer would be required to collect data to support long-term coverage. The Centers for Medicare & Medicaid Services would have six months to respond to an application for coverage under this policy. The legislation also provides the Centers for Medicare & Medicaid Services an annual appropriation of $10 million from 2026 to 2031.
In a recent media appearance, FDA commissioner Marty Makary said he supports a change to the Medicare coverage process for breakthrough devices, a process he described as duplicative of the work done by the FDA. AdvaMed said the legislation, if enacted, “would be a welcome, permanent solution” to the delayed access created by the Medicare coverage process. Whitaker said, “patients shouldn’t have to wait years to benefit from medtech the FDA has already determined to be safe and effective.”
Copyright © 2025 - Medmarc