You’ve probably heard all about the Cares Act. But are you also familiar with the latest news regarding the Cures Act? The Cures Act is another law, signed initially back in 2016, that is intended to improve how medical products become available to patients. And as the name implies, new innovations across the entire healthcare ecosystem often lead to better patient care, critical information flows, and therapeutics that save lives. It’s a law that resonates true today with the ongoing efforts to contain the spread and dangers of COVID-19. Today, we’ll take a deeper dive into what the Cures Act can mean for patients, as well as the private sector looking to develop new patient-improvement products. And there is recent news about this law’s intended guidelines.
What the Cures Act Really Does
The law itself, signed on December 13th, 2016, is meant to pave the way for medical innovations to find more efficient channels to the patients who need them. It’s more about an acceleration of the timeline from development to patient administration by means of streamlined data management and implementation. And the idea is to bring legislation and introduce timeline parameters to help speed the process. Private sector companies investing in data technologies, clinical research, production, and distribution will be held to a new standard of efficiency. The idea can enhance the patient experience and, in some examples, improve recovery efforts, as well.
Why the Cures Act Matters So Much More Now than Ever
The Cures Act enacts many advancements. But one primary function of this law is to provide flexibility to the National Institutes of Health (NIH), the largest biomedical research agency worldwide and part of the United States Department of Health and Human Services. The Cures Act will remove roadblocks that tend to stall clinical trials. It makes collaborating among researchers more accessible and enhances data-sharing efforts among those NIH-based researchers. Research volunteers will have more robust protections, and clinical research among more diverse populations is encouraged. In a way, the Cures Act is modernizing how we move new medical developments through the approval process and enhance how quickly new products and medical countermeasures become available. And in today’s pandemic environment, time is of the essence when it comes to getting remedies, therapies, patient information, and medical innovations to the public.
There Are Two Pillars of the Cures Act
There are two primary components to the Cures Act. One addresses the benchmarks for information blocking. The other supports compliance and certification efforts of the Office of the National Coordinator for Health IT (ONC,) a division of the United States Department of Health and Human Services. And more recently, a final rule has been issued by the ONC to comment on an extension for compliance dates. Certification criteria are based on the timelines to meet specific requirements related to information blocking as well as Conditions and Maintenance of Certification (CoC/MoC.)
What is the CMS Final Rule All About?
The Cures Act assigns financial penalties (Civil Monetary Penalties) for those that engage in Information Blocking. Offending developers can be fined up to $1 million for each violation and can also be banned from ONC Certification. The CMS Final Rule outlines policies that impact these stakeholders. CMS also polished the Provider Directory API policies for Medicaid, Medicare Advantage, and the Children’s Health Insurance Program, effective January 1st, 2021. These Final Rule guidelines are designed to improve both interoperability as well as patient access to information.
The Cures Act Final Rule also establishes a few exceptions to its original information blocking provision. And there are newly adopted Health Information Technology (HIT) certification requirements that specifically address the need for patients’ mobile device accessibility. The use of APIs makes this patient flow of information feasible.
Don Rucker, MD, the Health IT national director, pointed out the ONC’s recognition that a need exists to support patient access and clinical coordination with the Final Rule provisions. And those needs have shifted due to the pandemic since patients are looking for more virtual and remote ways of accessing healthcare, patient portals, and data. Rucker wanted to also make it clear; the ONC would not be removing previously the originally outlined guidelines by the Cures Act regarding requirements. But they are offering providers additional time for “everyone in the healthcare ecosystem to focus on COVID-19 response.”
The Final Rule Is a Strategic Balancing Act
The latest ONC Rule was a tough call to make. But ultimately, the idea is to strike a balance between what some see as competing priorities. For example, the primary focus is to maintain privacy for patients while increasing their access capabilities to their Electronic Health Information (EHI.) At the same time, it’s imperative that transparency exists to promote a more robust innovation effort. And there have to be provisions that allow software developers to protect their intellectual property. It’s like wrangling cats when you consider trying to alleviate burdens on providers, make chart requests easier on health systems and physicians, and deliver patient data safely. There is a subtle competition between standardizing versus innovating. Protecting security measures and balancing privacy. And making all the systems of data flow work together is a tall order.
An Explosion of API Implementation
Application programming interfaces (APIs) are game-changers when it comes to interoperability efforts. And while these digital tools have already been solutions to improving the patient journey, more and more platforms are tapping into them today. The seamless flow of medical data and information across a variety of platforms is critical in getting those latest clinical innovations to the providers and patients who need them. The Cures Act provides the standards of operation. The APIs pave the virtual routes to connect all the people to the available data.
The Cures Act will enhance how patients connect with their healthcare providers and their medical information. And those who help facilitate this seamless flow of innovation will have more time to implement their certifications and required standards. To learn more about what the Cures Act may mean for you or to explore your own API solutions, contact the experts at Softheon.