The 21st Century Cures Act Final Rule Is Here!

Title IV of the 21st Century Cures Act is dedicated to the enablement of easy access to patient health records for care providers, patients, and payers. Interoperability, transparency in reporting, and preventing all efforts directed to blocking access to patient health records a.k.a information blocking make up the nucleus of this section.

With the release of the Cures Act Final Rule, these three pillars that uphold the US government’s vision of seamless Electronic Health Information (EHI) exchange to improve the value of healthcare delivery, receive further reinforcement.

The ONC final rule outlines new policies, requirements, and guidelines for payer organizations, health IT developers, care providers, and Health Information Exchanges (HIE). A concept that is central to all the involved parties is the implementation and maintenance of a Patient Access Application Programming Interface (API).

The API would be developed by certified HIT vendors and is to be used to enable care providers to access patient health information and dispatch the same to other care facilities upon the patient’s request. The patient would also be able to access insurance claims and clinician information using third party mobile solutions.

The Impact on HIT Vendors

The following are the areas through which HIT vendors must adapt to the changes that the final rule introduces:

Information Blocking:

The final rule improves the guidelines introduced in section 4004 of the 21st Century Cures Act by finalizing eight exceptions to information blocking. These exceptions establish the actions and behavior that can be classified as information blocking attempts by care providers, HIT vendors, and Health Information Exchanges (HIE). The exceptions are related to:

  • Prevention of Harm
  • Privacy
  • Security
  • Infeasibility
  • Health IT Performance
  • Content and Manner
  • Fees, and
  • Licensing

EHR Certification Criteria:

The Cures Act Final Rule establishes criteria that HIT vendors specializing in EHR development must conform to. These guidelines define the requirements of Certified EHR technology (CEHRT). The areas where changes await EHR vendors are:

  • Electronic Prescribing
  • Changes to the definition of base CEHRT
  • Clinical Measures Reporting
  • Electronic Health Information (EHI) Exporting
  • API Development
  • Requirements for use of the FHIR standard in EHR systems
  • USCDI Standards for HIE initiatives
  • Privacy, Security, Audits, and Documentation

Health IT Certification Program:

Besides establishing standards for the development of certified APIs, the final rule introduces changes to the HL7 standards for HIT vendors to develop Health IT software platforms. These changes come through the ONC’s Health IT Certification Program and affect the following areas of the program

  • Conditions of Certification
  • Technology Testing
  • Communications About Usability and Security of Applications

Takeaways for Payers and Care Providers

The CMS introduces significant changes to the conditions of participation (CoPs) of direct care providers, including Critical Access hospitals (CAHs). These changes pertain to the dispatch of event notifications of a patient’s admission, discharge, and/or transfer to another healthcare facility or community provider or practitioner. The final rule also establishes deadlines for care providers to update their digital contact information in the National Plan and Provider Enumeration System (NPPES).

CMS-regulated payers are required to exchange certain patient clinical data at the patient’s request. This mandate enables a patient to access their healthcare information seamlessly as they move from payer to payer over time to help create a cumulative health record with their current payer.

This would require payers to maintain a process for the electronic exchange of data classes and elements included in the United States Core Data for Interoperability (USCDI) standard via payer-to-payer data exchange.

The impacted payers are required to incorporate the data they receive into the enrolee’s record. With the approval and at the direction of a current or former enrollee, a payer must send the defined information set to other payers of the patient’s choice.

Parting Words

The final rule comes with strict timelines for HIT vendors. While achieving successful compliance can be a daunting task, it can be made easier with assistance from an experienced partner.

With over 20+ successful MU certifications to our name for some of the biggest names in HIT development, our knowledge of healthcare standards and regulations has been thoroughly tested.

Learn more about the impact of the Cures Act Final rule on the HIT development from our recent webinar. View the video to know what you missed!


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Puneeth Salian

Puneeth Salian

A writer in Healthcare domain, who is also a science and technology enthusiast. Enjoys creating interesting pieces that elucidate the latest Healthcare IT trends and advancements.
Puneeth Salian

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