The Advanced Medical Technology Association released its Congressional agenda Monday, detailing its hopes for medical device tariff exemptions, a modernized Centers for Medicare and Medicaid Services and artificial intelligence policy updates.
With newly imposed tariffs on imports from China, upcoming tariffs on goods from Mexico and Canada and recent job cuts at the Food and Drug Administration, medical device makers face significant challenges this year.
Related: Tariffs on medical devices will raise costs. Here's what to know
Here are the medical device trade group's priorities.
A tariffs exemption
Trump announced Thursday he plans to double tariffs on Chinese goods, which would increase the rate to 20%, and on Tuesday is expected to enact 25% tariffs on goods from Canada and Mexico. AdvaMed wants Congress to provide exemptions for medical technologies.
Tariffs would affect the medtech supply chain so AdvaMed is urging legislators to work with the administration to ensure the industry has access to raw materials, parts and electrical components and enhance trade agreements for supply chain resilience and healthcare prioritization.
A modernized CMS
It typically takes CMS 5.7 years to decide on insurance coverage for medical technology already cleared by the FDA, according to AdvaMed. CMS conducts coverage decisions through its National Coverage Determination process, which involves evidence review, public input and expert consultation, and it typically lasts nine to 12 months, according to the agency.
The group seeks legislation that would require the Health and Human Services secretary to act on national coverage determination applications within 30 days of submission and require Medicare Advantage plans to cover the same technologies traditional Medicare covers.
It also is pushing for bills that establish a timeline for contractors to review local coverage determinations and allow breakthrough devices to receive new technology add-on payments in the first quarter of the year they received FDA approval, clearance or authorization.
AI policy updates
AdvaMed questions whether the Health Insurance Portability and Accountability Act needs updating and wants to see guidelines developed for patient data used to develop AI and address budget neutrality constraints on AI coverage. It also wants a payment pathway for algorithm-based healthcare services and legislation to support digital therapeutics adoption and reimbursement.
A streamlined review process
On Feb. 15, between 230 and 240 employees at the FDA’s Center for Devices and Radiological Health were laid off, according to Scott Whitaker, CEO of AdvaMed. The agency has not confirmed a number. In a statement, he said the FDA was already struggling to keep pace with the tens of thousands of new medical technology applications each year.
The organization is calling on Congress to evaluate how well the FDA is meeting its hiring targets for medical device reviews. It also wants additional resources put in place to streamline the review process.
A more efficient FDA
AdvaMed recommends Congress introduce electronic device labeling to include things like instructions for use and third-party lab testing. It also is seeking transparency and consistency in the de novo pathway, which is the process for classifying and approving novel, low- to moderate-risk medical devices that don't have existing predicate devices for comparison.
Some members of Congress believe that faster communication of device recalls is necessary and have proposed legislation to address this, according to AdvaMed. The Government Accountability Office is investigating the recall system and is expected to issue a report on its findings.
