The U.S. Senate approved the 21st Century Cures Act
December 7, 2016
The U.S. Senate today approved the 21st Century Cures Act, bipartisan, comprehensive legislation aimed at fast-tracking the development of new medicine and treatments, tackling opioid addiction, and improving mental health programs. Senator Cory Gardner, a member of the U.S. Senate serving Colorado, authored language that was included in the 21st Century Cures Act to preserve Medicare funding for Craig Hospital as well as a provision that enhances access to life-saving medical devices for patients with rare diseases.
Prior to the passage of the 21st Century Cures Act, Craig Hospital was at risk of losing its Long Term Care Hospital (LTCH) designation due to new LTCH Medicare payment system rules that fail to capture the severity of patients' needs at Craig Hospital. Gardner recently visited Craig Hospital in September to meet with hospital leadership to discuss the hospital's challenges in light of the new LTCH payment rules, and has worked hard to ensure that Craig Hospital maintains its LTCH designation so that the Medicare patients it serves can continue to receive treatment. Gardner successfully secured language in the 21st Century Cures Act that temporarily preserves Craig Hospital's LTCH designation and requires language be submitted by 2018 demonstrating the need for Craig Hospital to remain a LTCH.
"Medicare patients at Craig Hospital were at risk of losing access to care under new payment system rules," said Gardner.
"I'm proud I was able to secure language in the 21st Century Cures Act that will enable Craig Hospital to continue providing treatment to Medicare patients, and I'll continue to work with Craig Hospital and other health care facilities throughout Colorado to address their challenges to improving health care delivery."
The 21st Century Cures Act also included the Rare Disease Innovation Act, a bill Gardner authored that streamlines and expedites the Federal Drug Administration's (FDA) approval of medical devices used to treat patients with rare diseases, including ALS, cerebral palsy, Hodgkin's lymphoma, mesothelioma, and tuberculosis. Currently, FDA has a simplified approval process for medical devices intended to treat or diagnose rare diseases that are present in 4,000 patients or fewer in the U.S. annually. Gardner's language increases the threshold from 4,000 to 8,000 patient cases for medical devices that qualify for expedited approval, creating an incentive for manufacturers to develop medical devices for rare conditions that meet the new criteria.
"Streamlining the FDA's approval process, particularly for medical devices used to treat rare conditions, is essential to enhancing the quality of care and improving the quality of life for those suffering from rare conditions. The 21st Century Cures Act recognizes that there needs to be more attention placed on developing devices for rare diseases, and therefore incentivizes innovation where it may not have otherwise occurred," said Gardner.
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The 21st Century Cures Act is designed to reduce regulatory hurdles and spur the development of treatments for diseases such as Alzheimer's and Parkinson's and cures for cancer by supporting the National Institute for Health's (NIH) efforts to map one million genomes. This legislation includes funding for the "Cancer Moonshot" effort to speed research as well as the Precision Medicine Initiative. Furthermore, this legislation addresses the country's mental health crisis by enhancing coordination between federal agencies and departments that treat mental illness, ensuring federal dollars are more effectively spent, encouraging new approaches to care, and improving access to mental health care for veterans, women, and children.
"The 21st Century Cures Act is an acknowledgment that federal policy related to improving the quality of health care in our country must be updated to keep pace with science and innovation. The bill breaks down barriers to research and development, encouraging medicine's brightest minds to move forward with breakthrough discoveries and cures. The 21st Century Cures Act is the product of an overwhelming bipartisan, bicameral effort, and evidence of the progress Congress can make when we work together to move this country forward."
The 21st Century Cures Act previously overwhelmingly passed the House of Representatives, and President Obama recently urged its passage.