The 21st Century Cures Act is a significant piece of bipartisan legislation meant to advance healthcare innovation and product development passed in December 2016. Despite turning four years old at the end of 2020, many questions remain surrounding the Cures Act, especially from physicians. What are the major components of this Act, and what do they mean for the world of electronic health records (EHR)?
Research FundingOne of the most extensive components of the 21st Century Cures Act is the allocation of ten years' worth of new funding for the National Institutes of Health (NIH) to invest in research for new treatments. The funding represents the "cures" part of the Cures Act, intended to drive medical researchers and doctors to develop groundbreaking treatments for the world's most pressing sicknesses and diseases. The Act includes funding of:
- $2 billion for improved cancer detection and prevention
- $1.5 billion for mapping and a better understanding of how the human brain works to assist with neurological diseases such as epilepsy or Alzheimer's
- $30 million for stem cell research
- $1.5 million for further development of tailored prescriptions designed to fit the unique needs of individual patients
Administrative BurdensAnother integral part of the Cures Act was designed with alleviating administrative hurdles. The legislation includes a request for US federal agencies to review new medical treatment regulations researchers must follow. Once reviewed, determine how much could be scaled back to cut through some of that pesky administrative red tape effectively. This includes a call for federal agencies to examine and simplify disclosure requirements for finance departments as well as a suggestion to improve sub-recipient monitoring. This portion of the Cures Act aims to make medical research easier by reducing the amount of time needed to spend on paperwork and other administrative duties. In turn, the legislation hopes to increase the amount of time spent actually researching.
Opioid CrisisOne of the most urgent crises facing America today is the opioid crisis. The misuse or overuse of prescription painkillers and other medications has been plaguing the nation for many years now. It has had disastrous consequences for our society, the medical world, and the economy. Each unfortunate overdose is a tragedy, and the Cures Act recognizes this and hopes to alleviate some of the more troublesome aspects of the opioid epidemic. Over $1 billion was set aside and split up to each of the 50 states to be spent over a two-year period, to go toward opioid treatment and prescription drug monitoring programs (PDMP), additional training for healthcare professionals on the front lines, and various prevention plans hoping to keep highly addictive opioids away from people who don't need them.
FDA ApprovalsIn addition to easing those administrative burdens mentioned above, the Cures Act also included language designed to modernize and assist the Food and Drug Administration (FDA). Initially founded in 1906, there were many outdated components of the FDA's infrastructure that were in desperate need of an update. The Cures Act designated $500 million a year to the FDA to speed up approving new drugs and medical devices. It also included a detailed outline of the new-and-improved approval process that would hopefully allow lifesaving medicines and technology to get into the hands of medical professionals and patients faster than ever before. One of the most notable examples of this new process is the Cures Act's elimination of the need for full clinical trial results, allowing companies to provide a whole slew of other data to earn their approval instead.
Other smaller victoriesThere's no exaggerating: The Cures Act is a massive piece of legislation with over 300 pages and countless subsections full of new rules and regulations for every corner of the medical field. Nearly $7 billion went into the 21st Century Cares Act, so lawmakers built many different programs into it with new financial or administrative help. Just to list some further examples:
- Assistance for Off-Campus Hospital Outpatient Departments (HOPDs)
- New rules for various infusion drugs and antibiotics
- Mental health reform to help combat the shortcomings of the mental health and psychiatric fields
- Reduced restrictions on things like textbooks, medical journals, and educational courses across the board
The Cures Act: InteroperabilityNow that we've discussed the major parts of the Cures Act, one question remains: What does it all mean for physicians and the world of electronic health records (EHR)? The Cures Act set out to put "interoperability," or the sharing and use of medical information via computers and online software, into understandable legal terms. Once interoperability became more strictly defined, legislation requiring EHR vendors to partake in it reasonably could begin. Additionally, the Cures Act prohibited what is known as information blocking. In simple terms, this is the process of interfering or preventing access to electronic health records (EHR) or electronic medical records (EMR). If someone is found guilty of information blocking, they could be fined up to $1 million per violation according to the Cures Act. In addition to the Cures Act, there are also two additional interoperability regulations released by the US Department of Health and Human Services (HHS) in early March of 2020. The National Coordinator for Health Information Technology (ONC) and Centers for Medicare Medicaid Services (CMS) look to bolster the Cures Act interoperability requirements. The aim is to provide greater health data patient access and transparency. There are new requirements for all healthcare stakeholders: physicians, hospitals, insurers, information networks and exchanges, and health IT companies. The changes required by January 2021 are:
- Hospitals to provide a patient's electronic admission, discharge, and transfer (ADT) messages to other healthcare facilities, primary care doctors, and care team members
- Insurers participating in government marketplaces (Medicare, Medicaid, ACA, & CHIP) to submit patient claims data via application programming interfaces (APIs)
The Cures Act: EHR VendorsIn the ONC's new rule, they defined new requirements for product features & functionality, as well as program business practices that must be adhered to maintain EHR certification. EHR vendors must complete development, certification, and upgrades within 2 years of the Final Rule. The new criteria is requiring the use of an API that meets HL7 FHIR Release 4 (R4) specification. EHR vendors must abide by the following business practice in order to maintain EHR certification:
- Encourage patient information flow by not breaking blocking rules
- Allow electronic exchange, access, and use of health information
- Do not prevent client communications with gag rules
- Abide by API business practices
- Perform real-world product testing annually
- Product attestations twice a year
The TempDev AdvantageRegulations of this magnitude can profoundly affect your practice, particularly if you enter 2021 unprepared. Now is the time to start investigating how you can better participate in interoperability and the Cares Act. TempDev healthcare regulatory consultants are ready to answer any questions you have on the Cures Act and your EHR for these regulatory changes. Contact us here or 888.TEMP.DEV to talk through how to improve interoperability at your practice.
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