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Dec. 13 — President Barack Obama signed into law the 21st Century Cures Act, a sweeping health package to spur new medical treatments, reform mental health care and provide state grants to curb opioid abuse.
“We are bringing to reality the possibility of new breakthroughs to some of the greatest health challenges of our time,” Obama said in a Dec. 13 bill-signing ceremony.
The Cures law marks the last piece of legislation the Obama administration will enact, Vice President Joe Biden said during the ceremony. “The 21st Century Cures Act is going to harness America’s best minds, science, medicine and technology to tackle some of our biggest and most complex health challenges today,” Biden said. “This bill will literally—not figuratively, literally—save lives. “
The goal of the bill is to allow new drugs and devices to reach patients more quickly by transforming the infrastructures that regulate biomedical research and the innovations it produces. The bill also provides billions of dollars in new research funding. However, there was some concern the bill benefits drug companies by watering down approval standards.
Cures cleared Congress with overwhelming bipartisan support. The House passed the bill Nov. 30 with a vote of 392-26; the Senate followed Dec. 7 with a vote of 94-5.
Cures establishes a new “innovation fund” that will provide $4.8 billion in new funding for the National Institutes of Health over 10 years to boost ongoing work in precision medicine, the cancer “moonshot” effort and brain-related research. The legislation also has $500 million in new funds for the Food and Drug Administration.
The legislative package also folds in several other health-related measures that dominated this Congress’s health agenda, including mental health-care reform, $1 billion in state grants to curb opioid addiction and a provision to exempt more hospitals from Medicare’s controversial site-neutral payment policy.
Site-neutral payments are set to take effect at some hospital outpatient departments Jan. 1, 2017. The payment policy means certain items and services provided by some hospital off-campus outpatient departments will no longer be paid under the hospital outpatient prospective payment system, which has higher reimbursement rates than the Medicare physician fee schedule.
NIH Director Francis S. Collins told Bloomberg BNA he was “thrilled to see 21st Century Cures get across the finish line” with such strong bipartisan support.
“It is by far the most significant piece of legislation for NIH in a decade, probably since our reauthorization,” he said, referring to the NIH reauthorization bill President George W. Bush signed into law in 2007 (Pub. L. 109-48). “It is transformative for us in a whole host of ways.”
In a Dec. 9 interview with Bloomberg BNA, Collins said if he had “any anxiety about the bill,” it’s that the innovation fund only provides additional money for specific research projects.
“The rest of our research effort will still need the regular appropriation process to go forward in order not to be stuck in a holding pattern, and so we’re also very interested in seeing what happens with that appropriation process,” he said.
“Now that the CR is going to be extended to April 28, it will be very important from our perspective to be sure something does happen on April 28,” Collins said. “Otherwise, a yearlong CR would be really very, very difficult for everything else that we’re trying to move forward.”
The continuing resolution (Pub. L. No. 114-254) that keeps the government running through the end of April includes enough money to fund the 21st Century Cures programs through next year, Sen. Lamar Alexander (R-Tenn.) said in a Dec. 13 statement.
The stopgap funding law, which Obama signed Dec. 10, includes $352 million for the NIH, most of which will go toward the cancer moonshot; $500 million for states to respond to the opioid abuse crisis; and $20 million for the FDA in fiscal year 2017, Alexander said.
“This bill is going to pretty quickly send a boost to the front lines of the opioid fight in many states, which will be a big opportunity for Tennessee,” Alexander said. “It shows our commitment to funding the legislation we just passed 94 to 5, and helping find cures for cancer, treating mental illness, and better understanding the brain to prevent diseases like Alzheimer’s.”
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
More information on H.R. 34 is at https://www.congress.gov/bill/114th-congress/house-bill/34/text.
Video of the Cures bill signing ceremony is at https://www.whitehouse.gov/live/president-obama-delivers-remarks-and-signs-21st-century-cures-act.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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