What You Need to Know about the 21st Century Cures Act

What You Need to Know about the 21st Century Cures Act

House of Representatives
Image by Kim Ahlström | Flickr

A recent bill widely supported by legislators on both sides of the aisle is poised to transform and advance healthcare in America. H.R. 6, more commonly known as the 21st Century Cures Act, is aimed at solving some of the most pressing healthcare challenges facing the modern world.

It will accomplish this by speeding up the “discovery, development, and delivery” of new medical interventions, while at the same time allowing for the more efficient delivery of existing treatments. The act provides increased funding for biomedical research and streamlines the approval process for new drugs and medical devices.

In addition to spurring healthcare innovation, the Cures Act also includes provisions designed to improve the availability and quality of mental health care and curb opioid abuse.

The 21st Century Cures Act is a sweeping piece of legislation that impacts nearly every aspect of the American healthcare sector. It provides much-needed funding for researchers seeking cures for AIDS, cancer, Alzheimer’s, and other life-threatening diseases. Additionally, it represents a targeted effort to improve the health and wellbeing of not only Americans, but individuals around the world.

A Bipartisan Effort

Described by Senate majority leader Mitch McConnell as “the most significant legislation passed by this Congress,” the Cures Act was an impressive display of bipartisan cooperation on issues affecting virtually every American. Michigan representative Fred Upton, a republican and chairman of the House Committee on Energy and Commerce, introduced the bill to the House of Representatives in May 2015 after working diligently to draft legislation that would please both parties.

Upton’s collaborators included Senator Lamar Alexander, a fellow republican from Tennessee; democratic representative Diana Degette of Colorado, who served as a co-sponsor on the bill; and democratic senator Patty Murray of Washington. Throughout the drafting process, the bill sponsors and stakeholders traveled across the United States to hold hearings, visit hospitals, and speak directly to patients battling the very diseases that the Cures Act seeks to combat.

The results of this bipartisan cooperation paid off on November 30, when the House of Representatives voted in favor of the 21st Century Cures Act 392 to 26. The bill passed the Senate with a 94 to 5 vote a week later on December 7. On December 13, 2016, President Obama signed the groundbreaking legislation into law.

A Boon for Modern Medicine

Dr. Collins
Dr. Collins | Image by IU School of Medicine | Flickr

The Cures Act received an outpouring of support from various American medical organizations. Its key supporters included National Institutes of Health (NIH) director, Dr. Francis S. Collins.

Dr. Collins worked tirelessly to advocate for the bill’s passage by introducing lawmakers to the vast possibilities it presented. Dr. Collins drew legislators’ attention to potential medical advancements such as artificial organs, stem cell repair for heart tissue, and a vaccine for AIDS. These examples helped to illustrate the enormous positive impact that the bill could have on patients’ lives.

Other organizations, including the American Society for Biochemistry and Molecular Biology, praised the bill for its demonstration of bipartisan cooperation. It also called for similar collaborative efforts in the future.

Dr. Otis Brawley, chief medical officer of the American Cancer Society, specifically praised provisions of the bill aimed at speeding up the delivery of life-saving medical treatments. However, he noted the need for continued efforts to ensure medical care for all Americans.

Changes to Current Healthcare Infrastructure

Several elements of the 21st Century Cures Act introduce revisions to the Federal Food, Drug and Cosmetic Act, particularly regarding the drug approval process. The bill provides an extra $550 million in funding to assist the Food and Drug Administration in implementing a number of changes.

For example, under the Cures Act, the FDA will permit patient experience data, as well as related data from separate studies, to inform the development and assessment of new drugs. The bill also requires the FDA to assess new drug development tools and establish a new, streamlined data review and drug approval process.

Additionally, the 21st Century Cures Act increases funding for the NIH over the next five years, equaling a total investment of $8.75 billion. These funds will allow for the creation of an NIH Cures innovation Fund dedicated to groundbreaking biomedical research.

The funds will also support President Obama’s Precision Medicine Initiative, which is aimed at advancing personalized medicine and genomics. Finally, the funds will spur forward additional governmental efforts to increase the efficiency and efficacy of healthcare.

According to Congressional representative and Cures Act sponsor Fred Upton, the Cures Act will enable life-saving progress to be made in the biopharmaceutical and medical device industry. Additionally, it will generate new jobs and permit the United States to remain a significant contributor to global medical research efforts.

Impact on Ambulatory Care Sector

Another noteworthy medical organization that offered praise for the 21st Century Cures Act was the Ambulatory Surgery Center Association (ASCA). The organization specifically lauded two provisions, Section 4012 and Section 16003, which help to streamline interactions between the Medicare system and ambulatory care centers (ASC).

The former requires the department of Health and Human Services (HHS) to create a website where Medicare beneficiaries can compare out-of-pocket expenses for ASC and hospital outpatient procedures. The latter outlines protections for ASC physicians against penalties under the Medicare Meaningful Use Program.

The Meaningful Use Program is intended to promote the implementation of certified electronic health record (EHR) technologies in hospital settings. However, such technologies are not currently available for ambulatory care environments, thus introducing unavoidable financial penalties for some physicians. The 21st Century Cures Act will help to rectify this, in addition to authorizing HHS to approve EHR technologies for use in ambulatory care centers.

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