The 21st Century Cures Act: Essentials Every Provider Needs to Know

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If you’re a behavioral healthcare provider, you’ve probably heard the 21st Century Cures Act mentioned a few times. Passed in 2016 and signed by President Barack Obama, the Act includes numerous reforms and changes spanning the entire healthcare landscape across the United States. The Act includes many significant provisions and compliance deadlines that providers must meet. Let’s break down the essentials you need to know, including the Act’s goals, what it means for clients and providers, and how to prepare.

Aims of the 21st Century Cures Act

In the FDA’s own words, the Act “[helps] accelerate medical product development and [brings] new innovations and advances to patients who need them faster and more efficiently.”[1]  The Act bolsters mental health treatment services and expands funding to combat the nation’s opioid epidemic. Biomedical research and medical device design are other areas of focus. The Act also allocates funds to the Food and Drug Administration to promote EHR use, improve telehealth services and simplify medical device and drug approvals.[2]

The ONC Cures Act Final Rule and Electronic Health Information

The Act also outlines many requirements for the healthcare industry regarding client access to electronic health information (EHI). The requirements, which include regulations and compliance deadlines related to information blocking and interoperability as it pertains to Health Information Technology are implemented through the ONC Cures Act Final Rule.

The ONC Cures Act Final Rule speaks to “seamless and secure access, exchange, and use of electronic health information.” The goal is to involve and inform clients in their care, and to help providers coordinate that care more efficiently. Ideally, clients will be able to access their EHI quickly, easily and securely via a third-party smartphone app of their choice. This will offer clients greater transparency as they compare costs and outcomes between providers. Easily accessible EHI also improves care coordination, driving better outcomes for clients and more efficient workflows for providers.[3]

What Does This Mean for Providers?

To offer this access to EHI, to avoid information blocking and to account for future regulatory requirements, providers must ensure that their processes for retrieving and providing client health information are as fast and efficient as possible.

Information blocking includes any interference with access, exchange, or use of electronic health information. Examples include refusing to release EHI upon a client or provider’s request, delaying its release unnecessarily or limiting access to EHI by charging unreasonable fees. These actions are considered forms of information blocking and will be subject to penalties barring certain exceptions.

Providers are affected by the Final Act Rule in four major ways:

  • Providing easy, inexpensive access to EHI data to clients and other providers

Along with numerous technological and workflow requirements to make this efficient data access a reality, any associated charges or fees must be reasonable, consistently applied and proportionate to costs.

  • Accommodating client choice of applications

Providers must accommodate the third-party applications that clients may use to access their EHI.

  • Offering transparency in data requests and access

Providers must avoid information blocking, be open and communicative around their data sharing processes with clients and make them as simple as possible.

  • Protecting client data security and safety

Providers must ensure that their EHR and related data processes keep sensitive information secure. Transparency is encouraged around safety or security concerns.[4]

Exceptions to Information Blocking Rules

Not all EHI requests can be accommodated. Some might be unreasonable or may put data security or client safety at risk. There are eight exceptions to the Information Blocking provisions that account for these kinds of scenarios. These include:

  • preventing harm
  • protecting client privacy
  • protecting data security
  • responding to infeasible requests
  • responding during EHR or health IT downtime
  • licensing considerations
  • charging of reasonable fees
  • capabilities of EHR (content and manner)

For detailed information on the exceptions, be sure to view HealthIT.gov’s summary.[5]

Important Regulatory Dates

The ONC Cures Act Final Rule sets out a timeline of regulatory dates, at which point certain EHI must be available upon a client or provider’s request.[6] Providers do not have to share EHI proactively with those who have not requested it. (Information Blocking FAQs)

  • On April 5, 2021, provisions around Information Blocking, API access and assurances took effect.
  • Starting April 5, 2021, and continuing through October 5, 2022, providers need to offer timely, efficient access to certain forms of client electronic health information (EHI) upon request. During this period, EHI only includes USCDI data.
  • On and after October 6, 2022, providers must offer access to the full scope of EHI – not just USCDI data.
  • By December 31, 2023, providers need to offer full access to all tracked EHI, and need to have the capability to export that EHI data.

All providers are responsible for these provisions, whether or not they are using a certified EHR. These are just a few dates related to information blocking and access. Be sure to view the timeline for more information on key certification dates.

Communication and Technology Strategies to Drive Success

There are two key takeaways for providers. First, communication with clients and other providers is essential. Flexibility and transparency in fulfilling information requests will prevent information blocking, drive coordinated care and lead to more satisfied clients.

Second, providers need the technology to make this data retrieval and sharing quick and secure. An agency’s EHR platform must operate within the requirements and restrictions imposed by the 21st Century Cures Act. In the coming years, an EHR solution that prioritizes interoperability and efficient data management will make all the difference.

Our CareLogic and Credible EHR solutions offer flexible data management tools, interoperability features and easy integrations with third-party systems to make interoperability simple. If you have more questions about what the 21st Century Cures Act means for your agency, or how our EHR solutions can keep you compliant, efficient and profitable moving forward, please contact us today. 

[1] https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424829/

[3] https://www.healthit.gov/curesrule/

[4] https://www.healthit.gov/curesrule/what-it-means-for-me/clinicians

[5] https://www.healthit.gov/topic/information-blocking

[6] https://www.healthit.gov/curesrule/overview/oncs-cures-act-final-rule-highlighted-regulatory-dates

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