As we dive into 2021, its clear practices and billing companies are adjusting to the fastest pace of change ever. One area that’s on track to change is ONC Health IT certification. In 2020 the Office of the National Coordinator (ONC) launched a new set of Health IT “Conditions of Certification” (requirements). The new requirements are part of the 21st Century Cures Act and are designed to make data more accessible to patients, providers, and 3rd party applications, as well as to increase security, and offer transparency into care quality and costs. Let’s dig into the rule, requirements, and timing. We’ll also highlight MicroMD’s commitment to ensuring that you’ll continue to have certified technology, assurances for attesting to the new Information Blocking requirements, as well as confirming the data fields and methods that you have to share today.
The 21st Century Cures Act
In 2016, Congress passed the 21st Century Cures Act to drive the electronic access, exchange, and use of health information. The ONC Cures Act Final Rule implements the interoperability provisions of the Cures Act to promote patient control over their own health information. Essentially, the Cures Act Final Rule fosters innovation in health care to deliver better information, more conveniently, to patients and their providers. As the ONC implements the Cures Act Final Rule requirements, over time patients will begin to get on-demand access to certain information within their medical records, specifically the United States Core Data for Interoperability (USCDI), which includes clinical notes, test results, and medications and be required to be provided by certified EHRs before December 2022.
Current Requirements and Compliance Dates
As typically occurring during CMS and ONC rulemaking processes, the Final Rule dates and requirements, termed the Conditions of Certification (CoC), have been updated from the first issuance in May 2020. The ONC extended a six month reprieve for most requirements due to the pandemic, with compliance now required for some of the CoCs by April 5th. The CoCs required by April 5th are already in place for MicroMD EMR. We have submitted our Information Blocking attestation to our certification body Drummond, ensured our current CDA and Open API are updated to current standards, and will be issuing formal communications to clients that outline our assurances that we will not take actions that constitute information blocking or that inhibit access, exchange, or use of electronic health information according to the current requirements and exceptions.
Upcoming April 5th ONC Cures Act Interim Final Rule Compliance Dates
| Provision | Final Rule | Interim Final Rule |
| Condition of Certification (CoC) – Information Blocking – (§170.401) | November 2, 2020 | April 5, 2021 |
| CoC – Assurances – (§ 170.402(a)(1)) – Will not take any action that constitutes information blocking or actions that inhibit access, exchange, and use or electronic health information (EHI) | November 2, 2020 | April 5, 2021 |
| CoC – Assurances – (§ 170.402(a)(2) and (3), and (b)(1)) – Other | Effective date: June 30, 2020 |
April 5, 2021 |
| CoC – Communications – (§ 170.403) – Communications requirements, except for § 170.403(b)(1) where we removed the notice requirement for 2020 | Effective date: June 30, 2020 |
April 5, 2021 |
| CoC – API – (§ 170.404(b)(4)) – Compliance for current API criteria | November 2, 2020 | April 5, 2021 |
View all the provisions and deadlines in place for the ONC Cures Act Interim Final Rule:
https://www.healthit.gov/cures/sites/default/files/cures/2020-10/IFC_FactSheet_Certification.pdf
Information Blocking & Exceptions
Despite still being called “2015 Edition CEHRT”, compliance with and certification of the new requirements kicks off in 2020 and stretches through to the end of 2022. Compliance with simpler items and initial steps of larger compliance items are required this year. Larger lift requirements, including the USCDI data set, FHIR API, and Real World Testing, have longer compliance timeframes and offer some exceptions for information blocking compliance as developers work to transition to the new USCDI data set. While the compliance requirements to offer a certified FHIR API and USCDI data set aren’t due until December 2022, that doesn’t mean that health IT vendors can sit back and wait until 2022 to plan, develop, test, certify, and launch. These are significant and costly development projects that health IT vendors should already have in the works.
On a positive note, there are eight Information Blocking exceptions that allow providers and developers some flexibility in what data is required to be accessible and shared, as well as how and when. One question we’ve received is whether it is considered information blocking if the FHIR API or the new USCDI Version 1 data points aren’t all yet available. The answer is no. As the FHIR API and USCDI Version 1 are not required until December 2022, some health IT vendors may not have the full functionality available until then. Under the “Content and Manner” Information Blocking Exception providers have some flexibility. As long as a provider is able to share requested data in another “Manner” (i.e. Posting CDA documents to a secure patient portal, 3rd party tie into MicroMD’s OpenAPI, upload documents to an FTP site for secure access by patients or a 3rd party, or set up a data interface to export requested data from your EMR), they would be considered compliant. The MicroMD CDA and OpenAPI includes the current required USCDI data elements, which is a “Manner” in which providers can electronically share data until we launch the certified USCDI and FHIR API that will include the new data fields required by December 2022.
Your MicroMD teams are actively working behind the scenes on development initiatives to launch FHIR API and USCDI data access with MicroMD EMR Version 19 this year. Keep an eye out for future updates as we get closer to certification and launch – or as requirements change, which is frequent with ONC and CMS rules.
View all the current Information Blocking Exceptions:
https://www.healthit.gov/sites/default/files/cures/2020-03/InformationBlockingExceptions.pdf
Our Certification Commitment
Your MicroMD teams have consistently focused on evolving your EMR software to ensure ongoing ONC certification. When the last round of significant EMR certification changes were launched, we were the 12th EMR/EHR developer and the 21st EMR/EHR product to achieve 2015 Edition CEHRT out of more than 600 EMR/EHRs in the ambulatory space at the time. This differentiator and commitment to achieving certification well in advance of deadlines is a sense of pride and what we strive for each time new requirements are launched (or change). We continue with that unwavering commitment to these new ONC certification requirements to ensure you have the newest certified tools in advance of compliance deadlines.
In 2021, we’ll be updating our API and CDA files to include the new USCDI data elements, including:
- Clinical Notes: Consultation Note, Discharge Summary Note, History & Physical, Imaging Narrative, Laboratory Report Narrative, Pathology Report Narrative, Procedure Note, Progress Note
- Patient Demographics: Previous Name, Middle Name, Suffix, Previous Address, Email Address
- Vital Signs: Weight-for-length Percentile (Birth – 35 Months), Head Occipital-frontal Circumference Percentil (Birth – 36 Months)
- Provenance: Author Time Stamp, Author Organization
In the meantime, here are the MicroMD Data Fields available in the current compliant CDA and OpenAPI
| MicroMD CDA (Human Readable HTML File) |
MicroMD OpenAPI (For Authorized 3rd Parties to Pull Patient Data from MicroMD) |
| Patient Name DOB Race Address Primary/Home Phone Mobile Phone Work Phone Language Sex Ethnicity Patient ID Providers Payers Allergies/Reactions Medications Problems Encounters Assessment Review of Systems Reason for Visit/Chief Complaint Reason for Referral Medications Administered Instructions & Education Plan of Treatment Immunizations Vital Signs Family History Social History Procedures Implantable Devices Lab Results Functional & Mental Status Goals Health Concerns |
SSN Last Name First Name DOB Address Zip Phone Patient ID CDA Payers Problems Allergies Medications Immunizations Lab Results Vitals Fam History Soc History Procedures Encounters Assessment Review Of System Reason For Visit Reason For Referral Meds Administered Instructions Functional Status Care Team Members UDI (Implantable Devices) Goals Health Concerns |
If you have any additional questions on MicroMD’s ONC Cures Act compliance and timing or if you have questions on how to share the current compliant CDA data set with a patient or 3rd party, please contact Client Support at 330.758.8832 option 2 or hsms.support@henryschein.com
About the author,
Kristen Heffernan
Kristen is the general manager of Henry Schein MicroMD. She leads the operational teams that conceive, develop, launch, sell, implement, train and support the simple yet powerful MicroMD solutions.
Learn more about
Kristen here.
