Senator Dan Coats (R-IN) www.coats.senate.gov a member of the Senate Finance Committee recently introduced the “Ensuring Patient Access to Critical Breakthrough Products Act” www.congress.gov. The legislation 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 regularly coming up with groundbreaking new treatments for some of our worst illnesses find they encounter government regulations that prevent many patients from receiving potentially life-saving care,” reports Senator Coats. This legislation would streamline the current process to enable Medicare patients to receive new treatments.”
Currently, a new technology may pass the FDA’s www.fda.gov expedited review program, but it then faces up to three years to navigate the coverage and reimbursement process established by CMS www.cms.gov. These regulations create delays and financial uncertainties for companies to invest in new research.
This legislation would also make improvements to the CMS existing but outdated New Technology Add-on Payment (NTAP) program that reduces coverage and payment disincentives and as a result, limits prompt patient access to innovative technologies.
The legislation would grant new treatments approved by FDA a three year temporary coverage period where 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.