WASHINGTON, D.C. – Today, U.S. Reps. Mike Carey (R-Ohio-15) and Danny K. Davis (D-Ill.-07), both members of the House Ways and Means Committee, reintroduced their bipartisan Patient Access to Innovative New Technologies (PAINT) Act. This legislation aims to simplify regulations and red tape to encourage greater access to innovative, breakthrough treatments for Medicare beneficiaries.
“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,” Rep. Carey said. “Our legislation makes it easier for Medicare recipients to take advantage of the newest treatments without bureaucratic delay. 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. I ask all my colleagues to join us in support of this commonsense legislation.”
“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,” Rep. Davis said.
“For patients with a chronic condition or disease, the worst thing they can hear is that they cannot have access to an FDA-approved medtech solution that could bring them relief,” Scott Whitaker, AdvaMed President and CEO, said. “We thank Congressmen Carey and Davis for recognizing the critical need of improving the payment process for novel and innovative medtech to allow Medicare beneficiaries faster access to the technologies that could improve their health and even save their lives.”
“MDMA thanks Congressmen Mike Carey (OH) and Danny Davis (IL) for their ongoing bipartisan leadership to improve CMS’ New Technology Add-on Payment program,” Mark Leahey, President and CEO of MDMA, said. “This legislation would help accelerate access for Medicare beneficiaries to new technologies that provide more effective treatments for life-threatening and debilitating conditions in the inpatient setting, and would be a strong step forward to achieve our common goal of improving health outcomes for all Americans.”
Timely access to new and innovative breakthrough technologies is essential for patients facing critical healthcare challenges,” Chris Toth, CEO of Vantive, said. “As we work to advance vital organ therapy innovation, this legislation represents an important step toward connecting more patients with new life-saving therapies more efficiently – so patients can get the care they need, when they need it.”
BACKGROUND:
The Medicare New Technology Add-on Payment (NTAP) Program was established to allow Medicare beneficiaries to utilize the most modern and advanced medical technologies without delays. Due to bureaucratic rules and regulations, however, some new treatments have a firm U.S. Food and Drug Administration (FDA) approval deadline of May 1 each year. If not approved by then, Medicare recipients must wait until the following year to access that existing treatment. This means patients face months without care simply because of a arbitrary deadline on a form.
The PAINT Act would require the Centers for Medicare and Medicaid Services (CMS) 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 and will help improve health outcomes by creating greater accessibility to care.
Full text of the bill can be found here.
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