21st Century Cures Act passes through Senate: 6 healthcare leaders react

The Senate on Dec. 7 passed the 21st Century Cures Act, a complex legislation that was years in the making, in a 94-5 vote, according to The New York Times.

President Barack Obama, who has supported the bill despite opposition from some liberal Democrats and consumer advocates, indicated he will sign the bill when it arrives on his desk.

The $6.3 billion 21st Century Cures Act would provide the NIH with up to $4.8 billion in additional funding over 10 years. Over the same time period, it would also provide $500 million in new funding for the FDA and $1 billion in grants to states to deal with the opioid crisis and improve mental healthcare.

Here are six reactions from healthcare leaders to the passage of the bill in the Senate.

Bruce Siegel, MD, president and CEO of America's Essential Hospitals.
"America's Essential Hospitals thanks the Senate for its vote today to protect vulnerable patients and underserved communities by helping their hospitals keep urgently needed resources to improve care and expand access.

With their vote, senators have helped level the playing field for essential hospitals, the backbone of the nation's safety net. By risk adjusting readmissions measures that unfairly penalize hospitals for factors outside their control, the Cures Act will help preserve vital services in at-risk communities.

Likewise, the Senate's approval of partial relief from damaging cuts to hospital outpatient department payments will ease the threat to healthcare access for many people. We urge lawmakers to consider additional steps to stop these cuts from eroding access in the nation's healthcare deserts, where vulnerable people already face a severe shortage of services.

Vulnerable patients struggle with daily hardships — homelessness, hunger, financial instability, lack of family support, and others — that can hinder recovery after a hospital encounter. Essential hospitals lead efforts to help them overcome these challenges and avoid readmissions, and the Cures Act will support their success.

We look forward to the president signing this milestone legislation. We also thank our House and Senate champions for their commitment to equity and their tireless work since 2014 to bring risk adjustment to the Hospital Readmissions Reduction Program: Reps. Jim Renacci, R-Ohio, and Eliot Engel, D-N.Y., and Sens. Joe Manchin, D-W.V., and Rob Portman, R-Ohio."

Allan Coukell, senior director of health programs at The Pew Charitable Trusts.
"This legislation makes important progress on pressing public health issues: the growing global threat of antibiotic resistance and the devastating epidemic of prescription drug overdoses that takes the lives of dozens of Americans every day. It also shines a spotlight on patient safety in the implementation of health information technology.

States don't have the financial resources to provide treatment for the millions of people struggling with opioid use disorders. The $1 billion in funding in the Cures legislation will give more people access to the care they need and help states begin to address this epidemic, though Congress must appropriate the funds as quickly as possible.

The bill also authorizes a new approval pathway that will advance the development of new antibiotics. The limited-population antibacterial drug, or LPAD, pathway would allow antibiotics for resistant infections to come to market through streamlined clinical trials and would help ensure that these products aren't used inappropriately in more general populations that can be treated with existing medicines.

The legislation also provides for better data to guide antibiotic selection by allowing for more frequent and timely updating of information about bacterial sensitivities. This will aid in choosing the right drug for patients and will help reduce inappropriate use that can lead to resistance."

Todd Ebert, president and CEO of the Healthcare Supply Chain Association.
"The Healthcare Supply Chain Association and its group purchasing organization members applaud Congress for bipartisan efforts to pass 21st Century Cures legislation and for its commitment to improving patient outcomes and reducing costs across the entire healthcare system. We urge the president to swiftly sign the legislation.

The 21st Century Cures legislation passed today by the Senate includes critical health information technology interoperability requirements that will help healthcare stakeholders safely exchange data and collaborate across different IT systems. Advances in HIT, including data interoperability and electronic health records, are driving a revolution in patient care. For healthcare providers to administer first-class patient care — and for patients to effectively engage in their own care — they must have access to vital patient and device data that are currently locked in system silos across the healthcare supply chain. Comprehensive EHRs with data that are accessible and interoperable across systems — and operating under appropriate privacy safeguards — will allow providers and patients to see a complete patient health picture and have access to all applicable information when making critical care decisions.

We hope that Congress will explore additional common-sense policy solutions to help increase competition in the generic drug market and address the significant price spikes for some generic drugs that are jeopardizing patient access to care. Specifically, we encourage Congress to pass the bipartisan 'Increasing Competition in Pharmaceuticals Act' (S.2615), and to consider mandating priority review for generic injectable drugs with two or fewer manufacturers or in instances where there has already been a significant price spike." 

William G. Powderly, MD, president of the Infectious Diseases Society of America.
"The Infectious Diseases Society of America applauds the Senate for passing the 21st Century Cures Act earlier today. The soon-to-be law makes regulatory changes and new investments that will undoubtedly save lives in the years ahead. IDSA is particularly pleased that the legislation contains provisions that help combat antibiotic resistance as well as the opioid epidemic that is spurring a surge in new HIV and hepatitis C infections. The bill also recognizes that our ability to address future public health threats is enhanced by acting now to support young biomedical researchers.

Antibiotic resistance is one of the critically important public health threats addressed by the 21stCentury Cures Act. Across the globe, at least 700,000 individuals die annually from drug-resistant infections. Increased research and development for new antibiotics is a central part of the broader strategy to combat drug resistance. 

IDSA has long advocated for the creation of a limited population approval pathway at the FDA for antibacterials and antifungals that treat serious or life-threatening infections with an unmet medical need. The new pathway is essential to reinvigorating R&D in this area as the population of individuals who have a specific antibiotic-resistant infection at any given time is relatively small, which is often an obstacle to populating a traditional large-scale clinical trial. We are pleased that the Cures Act creates this approval pathway and gives hope to future patients suffering from antibiotic-resistant infections.

IDSA also commends Congress for creating the Next Generation Researchers Initiative within the National Institutes of Health as part of the Cures Act. This new effort joined with an increase in the NIH loan repayment maximum, also included in Cures, will help make certain that we have the workforce necessary to combat existing and emerging infectious diseases.

While the next Congress will need to build on the 21st Century Cures Act to realize its goals, the new law is a tremendous contribution to public health and national security."

Matt Zone, president and Cleveland councilmember of the National League of Cities.
"The National League of Cities applauds the passage of the 21st Century Cures Act, which is set to help cities combat the growing opioid crisis that is gripping our nation. As local officials, we are on the frontlines of this health pandemic — one that leads to more deaths than car accidents. We have seen far too many lives lost and families torn apart, and we must put an end to it.

While we are working tirelessly to reverse the trend of substance use disorders, we know that the only way to effectively stop the spread of this crisis is to work in collaboration with our counterparts at the state and federal level. The Cures Act goes a long way to lay the groundwork for strong partnerships at every level of government, and it is our hope that before the 114th Congress adjourns, it will appropriate the necessary funding authorized in the legislation. We look forward to working with Congress and the administration to strengthen the health and safety of our communities."

Behshad Sheldon, CEO of Braeburn Pharmaceuticals.
"Braeburn Pharmaceuticals commends Congress for passing the 21st Century Cures Act. Allocating funds that increase patient access to evidence-based treatment for opioid use disorder is of the utmost importance as America works to reduce the opioid overdose and heroin epidemic. It is also our hope that a more streamlined regulatory drug approval process will jumpstart the development of innovative treatments for people with serious health conditions in need of more treatment options. Braeburn remains committed to this effort and looks forward to continued collaboration with FDA to bring long-acting, safe and effective treatments to patients with opioid use disorder, pain and schizophrenia as quickly as possible."

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