North Columbus News

Representatives Mike Carey (R-OH) and Danny K. Davis (D-IL) introduced bipartisan legislation aimed at simplifying regulations to provide Medicare beneficiaries with access to breakthrough medical treatments. The Patient Access to Innovative New Technologies Act sets new deadlines to enhance the availability of advanced medical treatments 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,” stated Congressman Davis.

AdvaMed President and CEO Scott Whitaker expressed support, saying, “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. NTAP is a critical pathway for ensuring appropriate payment for these devices, and we look forward to working with legislators to advance this legislation.”

Mark Leahey, President and CEO of MDMA, added, “MDMA thanks Congressmen Mike Carey and Danny Davis for introducing legislation that would improve CMS’ New Technology Add-on Payment program. 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.”

Guillermo Amezcua, Americas general manager of Baxter’s Kidney Care business, commented on the collaborative nature required: “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. 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 timely use of the latest medical technologies without unnecessary delays. However, due to outdated regulations, some new treatments face an FDA approval deadline of May 1st; if not met, Medicare recipients must wait another full year.

This rigid deadline has led to significant delays in important medical treatments affecting numerous Americans adversely.

The proposed legislation mandates that the Centers for Medicare & Medicaid Services expand the NTAP conditional approval pathway to encompass all technologies approved or cleared by the FDA through its Breakthrough Device Program while establishing a single deadline for alternative pathway products. This measure aims at preventing disruptions in Medicare beneficiaries' access to innovative devices.

A copy of the bill can be found here.