Legislation Introduced to Ensure Patient Access to Medical Breakthroughs

U.S. Sen. Dan Coats (R-Ind.), a member of the Senate Finance Committee, has introduced legislation to streamline decision-making for innovative medical technologies.
 
The Ensuring Patient Access to Critical Breakthrough Products Act would establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.
 
“Researchers and entrepreneurs, including many in Indiana, regularly come up with groundbreaking new treatments for some of our worst illnesses, only to encounter government regulations that prevent many patients from receiving potentially life-saving care,” said Coats. “This legislation would streamline the current process, allowing Medicare patients to receive new treatments while also ensuring proper safety and quality regulations are met.”
 
Currently, a new technology may pass the U.S. Food and Drug Administration’s (FDA) expedited review program, but it then faces an up to three-year process of navigating the coverage and reimbursement process established by the Centers for Medicare and Medicaid Services (CMS). This means that years could pass before Medicare beneficiaries are able to access these approved medical breakthroughs. These regulations also create a financial uncertainty that discourages investment in new, groundbreaking research. The legislation would make improvements to the outdated new technology add-on payment program, so barriers that limit patient access to valuable technologies would be removed.
 
This legislation would grant new treatments approved by the FDA a three-year temporary coverage period during which the therapy would receive a guaranteed level of payment, and CMS could specify what additional data would be needed to continue coverage after the three-year period under its statutory “reasonable and necessary” standard.
 
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), praised the bill (S. 2998), claiming the legislation could potential stimulate development of devices and diagnostics.
 
“The Ensuring Patient Access to Critical Breakthrough Products Act will help bridge a gap between FDA and CMS and improve patient access to breakthrough medical technologies for serious illnesses. Currently, FDA has an established process to provide priority review to breakthrough technologies. We support reforms to that process in other pending legislation. However, there is no similar process at CMS to ensure patients have access to these devices and diagnostics in a timely manner,” he said.

“So, after FDA determines a breakthrough technology is safe and effective, sometimes it is years later before patients have access to it because of coverage and reimbursement delays at CMS. Medicare beneficiaries deserve better. AdvaMed commends Sen. Coats for introducing legislation which will address this issue, allowing patients and physicians to benefit sooner from such breakthrough medical technologies,” Whitaker continued.
 
“These CMS reforms would both stimulate development of important new devices and diagnostics and assure more timely patient access to new treatment options. We look forward to working with members of Congress, CMS and other key stakeholders to move this legislation forward,” he concluded.