Washington, D.C. – Today, Representatives Mike Carey (R-OH) and Danny K. Davis (D-IL) introduced bipartisan legislation that would simplify regulations to allow Medicare beneficiaries access to breakthrough medical treatments. The Patient Access to Innovative New Technologies Act creates new deadlines to expand the availability of cutting-edge medical treatments that have been approved or cleared by the Food and Drug Administration (FDA) through the Breakthrough Device Program.
“Our bill will increase access to innovative treatment options for Medicare beneficiaries,” said Congressman Carey. “We need to make sure that overcomplicated bureaucracy does not stand in the way of Americans getting the best health care available.”
“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 Congressman Davis (IL-07).
“We thank Congressmen Carey and Davis for recognizing the critical importance of ensuring Medicare beneficiaries have access to novel and innovative technologies through the New Technology Add-On Payment Program,” said AdvaMed President and CEO Scott Whitaker. “NTAP is a critical pathway for ensuring appropriate payment for these devices, and we look forward to working with legislators to advance this legislation.”
“MDMA thanks Congressmen Mike Carey (OH) and Danny Davis (IL) for introducing legislation that would improve CMS’ New Technology Add-on Payment program,” said Mark Leahey, President and CEO of MDMA. “The NTAP program was created by Congress and CMS in 2001 to support access for Medicare beneficiaries to innovative inpatient therapies. By directing CMS to expand its current policy of conditional approval for NTAP applications to include FDA-designated breakthrough medical devices, enactment of this legislation would accelerate access for Medicare beneficiaries to new technologies that provide more effective treatment for life-threatening and debilitating conditions in the inpatient setting.”
“While people across the U.S. benefit from Baxter’s lifesaving chronic and acute therapies, creating equitable and timely access to breakthrough treatments requires collaborative pathways,” said Guillermo Amezcua, Americas general manager, Baxter’s Kidney Care business. “It is essential healthcare innovators and policymakers work together if we are to advance care for all patients.”
The Medicare New Technology Add-on Payment (NTAP) Program was established to allow Medicare beneficiaries to utilize the latest medical technologies without unnecessary delays. Due to antiquated regulations, however, some new treatments have a firm FDA approval deadline of May 1st. If not approved by then, Medicare recipients have to wait another full year.
This strict, but inconsistent, deadline has resulted in important medical treatments being delayed to the detriment of numerous Americans.
Our legislation requires the Centers for Medicare and Medicaid 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. This simplification will prevent disruption in Medicare beneficiaries’ access to innovative devices.
A copy of the bill can be found here.
###