Patient Access to ESRD New Innovative Devices Act

Patient Access to ESRD New Innovative Devices Act

This bill requires the Centers for Medicare & Medicaid Services (CMS) to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must provide for a three-year temporary add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD. (CMS regulations currently provide a two-year temporary add-on payment adjustment.)

Bill 117 HR 4809, also known as the Patient Access to ESRD New Innovative Devices Act, is a piece of legislation currently being considered by the US Congress. The bill aims to improve access to innovative medical devices for patients with End-Stage Renal Disease (ESRD).

ESRD is a serious and often life-threatening condition that requires ongoing treatment, such as dialysis or kidney transplantation. Patients with ESRD rely on medical devices to manage their condition and improve their quality of life. However, the current regulatory process for approving new devices can be lengthy and cumbersome, leading to delays in patients' access to potentially life-saving technology.

The Patient Access to ESRD New Innovative Devices Act seeks to streamline the approval process for new medical devices specifically designed for ESRD patients. By expediting the review and approval of these devices, the bill aims to ensure that patients have timely access to the latest advancements in medical technology. In addition to improving access to innovative devices, the bill also includes provisions to enhance patient safety and ensure that new devices meet high standards of quality and effectiveness. This includes requirements for post-market surveillance and monitoring of device performance, as well as measures to address any safety concerns that may arise. Overall, the Patient Access to ESRD New Innovative Devices Act is aimed at improving outcomes for patients with ESRD by facilitating access to cutting-edge medical technology. The bill has garnered bipartisan support in Congress and is currently under review in committee. If passed, it has the potential to make a significant impact on the lives of ESRD patients across the country.