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AdvaMed’s Innovation Agenda Highlights Patient Access, FDA Regulation

AdvaMedThe Advanced Medical Technology Association (AdvaMed) has developed an innovation agenda for the 118th Congress, which emphasizes nine top priorities, such as the reinstatement of expensing for research and development costs. AdvaMed said also that it will continue to support passage of legislation for Medicare coverage of novel devices and for improved access to diagnostic testing, just two of several other essential considerations for the next two years.

Advances in medical technology have played a critical role in the five-year increase in life expectancy between 1980 and 2019, and cancer screening helped reduce breast cancer deaths by 43% compared to 1989. Scott Whitaker, AdvaMed President and CEO, said the nine priorities outlined in the innovation agenda will have both an immediate and a long-term impact on patient care, and that achievement of all nine priorities would “unleash a new era of life-changing innovation for patients.”

There are two means by which Medicare patient access to advanced technologies could be secured, including passage of legislation that would be similar to the Ensuring Patient Access to Critical Breakthrough Products Act, which was introduced to the 117th Congress. AdvaMed will continue to work with the Centers for Medicare and Medicaid Services (CMS) on its Transitional Coverage of Emerging Technologies (TCET) draft rule, which is also intended to provide faster access to medical devices that are part of the FDA breakthrough devices program.

AdvaMed has several policy objectives with regard to access to diagnostic testing, including a revision of CMS’s approach to the diagnostic test rate reset called for by the Protecting Access to Medicare Act. Congress has interceded to prevent cuts of as much as 15% to many tests that are paid under the Medicare program, but the threat of cuts has been stayed, not eliminated, by congressional action. AdvaMed also supports passage of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would modernize the FDA’s authorities for regulating diagnostic testing, including lab-developed tests.

State and federal government policies in connection with the use of ethylene oxide (EtO) as a sterilizer agent for medical devices is another crucial part of the AdvaMed agenda for 2023. AdvaMed staff will continue to communicate with state officials regarding the safety of EtO and the critical role it plays in ensuring patient access to medical devices, surgical supplies and surgical instruments, such as duodenoscopes and other products that reduce the invasiveness of surgeries. At least half of all medical devices and instruments used in the U.S. are sterilized with EtO, and for many of these products, there is no currently available alternative.

The global supply chain is a continuing source of concern for the medical device industry, a problem that predated the COVID-19 pandemic, but which the pandemic highlighted and amplified. AdvaMed had supported passage of the CHIPS and Science Act of 2022 as a measure that would ensure long-term availability of semiconductor products that are used in a wide range of medical devices, but also will continue to advise policymakers on the importance of ensuring that medical devices are prioritized in the ongoing shortage of semiconductors.

In addition to concerns over semiconductors, AdvaMed will emphasize the need to ensure a steady supply of plastics that are used in medical devices and in medical device packaging. There will also be ongoing communication with Congress regarding trade agreements that will help ensure that the supply chain for medical devices and equipment is steady and reliable in the years ahead.

Market access is another key policy for AdvaMed, such as requesting that Congress take steps to help ensure that products made in the U.S. do not encounter unfair trading policies in China. Best international regulatory practices and regulatory harmonization are two essential priorities for the medical device industry as well, and AdvaMed will continue to communicate with Congress and other stakeholders about the problems encountered in the European Union in connection with the Medical Device Regulation and the In Vitro Diagnostic Regulation.

AdvaMed will urge Congress to reinstate the immediate expending of R&D costs, a policy that was implemented after passage of the Tax Cuts and Jobs Act of 2017. The discontinuation of that policy creates a disincentive for investment among medical device manufacturers, and makes doing business in the U.S. less attractive for investors, AdvaMed stated.


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