A bipartisan bill sponsored on July 16 by U.S. Rep. Mike Carey (R-OH) seeks to improve Medicare beneficiary access to new medical technologies that improve healthcare quality and outcomes.
“America is a global leader in medical innovation, and patients’ access to groundbreaking care should not be delayed by arbitrary hurdles that create barriers to treatment,” said Rep. Carey, who introduced the Patient Access to Innovative New Technologies (PAINT) Act, H.R. 4441, with cosponsor U.S. Rep. Danny Davis (D-IL).
If enacted, H.R. 4441 would ensure that breakthrough devices are eligible for conditional approval under the Medicare New Technology Add-On Payment (NTAP) Program, enabling them to be provided without delay to Medicare beneficiaries, according to the bill’s text.
“Our legislation makes it easier for Medicare recipients to take advantage of the newest treatments without bureaucratic delay,” Rep. Carey said. “This bipartisan bill would result in better health outcomes for our seniors and would help the system deliver care more efficiently and in line with its mission.”
Due to bureaucratic rules and regulations, Rep. Carey said that the NTAP Program delays the ability of Medicare beneficiaries to utilize the most modern and advanced medical technologies.
Some new treatments have a U.S. Food and Drug Administration (FDA) approval deadline of May 1 each year, and if not approved by that date, then Medicare recipients must wait until the following year to access an existing treatment, according to information provided by Rep. Carey’s staff.
If enacted, H.R. 4441 would require the Centers for Medicare and Medicaid Services to expand the NTAP conditional approval pathway to include all technologies approved or cleared by the FDA through the Breakthrough Device Program, and create one single deadline for alternative pathway products, the information says.
“This legislative initiative would incentivize manufacturers of diagnostic and medical devices to adopt new medical technologies with a clean pathway to get these products in the hands of patients,” said Rep. Davis.
The measure has been endorsed by AdvaMed, MDMA, and Vantive.