Meet 3 Cures Act Deadlines with 1 Solution
The 21st Century Cures Act set out the mandates that all 2015 Edition Certified EHRs must comply. These are Conditions of Maintenance (COM) and Conditions of Certification (COC). All 2015 Edition Certified EHRs must provide proof to the ONC Authorized Certification Body with attestations or documentation that they are in compliance to keep their certified status.
To simplify these complex requirements, it would help to think of them as three mandatory updates:
Information Blocking: Provisions to guard against Information Blocking by Apr 5, 2021,*
Real World Testing (RWT): Meet Conditions of Certification (Real World Testing and other recurring requirements) by Dec 15, 2021*
FHIR-Based API: EHR Compliant to all 21st Century Cures Updates by Dec 31, 2022* (FHIR API functionality) and meet all the required COM
*These are end dates. EHRs must complete the compliance activities before these dates.
We are past the Information Blocking deadline, but the Real World Testing deadline is just around the corner. The cut-off dates imposed by the Authorized Certification Bodies (ACB) could range from Oct 1, 2021, to Nov 15, 2021, leaving little wiggle room. Fortunately, there is a solution to help you fulfill the Real World Testing (RWT) requirements in a timely fashion. Let us show you how.
As the Conditions of Certification have inter-related dependencies, we need to start at the beginning to completely cover the Real World Test-plan requirements.
Information Blocking
To avoid being an Information Blocker, your EHR must be capable of bi-directional electronic data Interoperability with limited PHI as of Apr 5, 2021. Your EHR will need to have:
Updated C-CDA data element to the USCDI v1 standard (Transitions of Care, Clinical Reconciliation, Data Export, Patient Portal Clinical Summary, Generation of a C-CDA
Patient API access to full C-CDA
Your EHR must complete the requirements for Information Blocking as these updates flow into the requirements for the Real World Test-plan. If you haven’t fulfilled these requirements yet, we can help you with compliance and dull the impact of impending penalties.
2. Real World Testing: Condition of Certification
Real World Testing is a brand-new annual requirement outlined in the ONC 21st Century Cures Act Final Rule for all Health IT developers. Health IT developers are required to demonstrate the interoperability of their Certified Health IT in real-world scenarios, not just the test environment, and then get it approved by their ONC- Authorized Certification Body (ACB). If your EHR is certified for any criterion covered under RWT by Aug 31, 2021, then you must submit a Real-World Testing plan and receive acceptance from your ACB by Dec 15, 2021*. You will then need to execute the Test Plan throughout 2022, and send the Test-plan results to the ACB to be published on Certified Health IT Product List (CHPL) by Mar 15, 2023, for your EHR to retain your 2015 Edition certification.
*NOTE
Dec 15, 2021, is the drop-dead date. You would need to get the Test-plan to the ACB with a buffer of at least a month (preferably more). It’s in your interest to keep the buffer, or you risk falling out of compliance with negative repercussions for all your EHR users. Check with your ACB regarding the cut-off dates they are imposing. It can range from Oct 1, 2021, to Nov 15, 2021.
This is an annual process and would repeat every year. The frequency of the RWTs would also vary based on the criterion your EHR is certified for.
EHRs would need to submit the RWT for each published version of their EHR.
Without any guidance, this would be an arduous journey to undertake. However, there is an option to ensure a successful and stress-free outcome. Let us share our approach with you.
The Darena Real World Testing Process
Darena offers complete assistance for the Real World Test-plan(s) including the creation of the RWT plan, submission to the ACB, and receiving acceptance notification before the deadline every year. Our RWT assistance service includes:
Conducting a Gap Analysis to determine the required RWT criteria for your EHR and the current state of readiness.
Defining the Setting Types (specialties and points-of-service) regarding the markets of use
Determining the Test frequency required for compliance. It is not a “one and done”.
Identifying Test-plan Participants (3rd Parties and other Providers)
Identifying the targeted user profiles for Test-plan participation
Establishing the criteria metrics and subsequent measurement of success
Planning Test phase milestones
Determining the testing protocol
Creating the Test-plan and submitting it to the ACB
Creating the RWT pathway for the future years
* Pricing will be disclosed upon clarifying the requirements.
Time is of the essence. ACBs will be imposing their own cut-off dates in advance of the deadline to allow for the review and the possible revisions of the RWT. In order to hit all the targets in time to meet the Conditions of Certification, keeping a buffer of up to 1.5 months would be wise.
3. FHIR-APIs and other Mandated 21st Century Cures Updates
The ONC established that all 2015 Edition Certified Health IT developers need to have all the Cures Act updates incorporated into their software by December 31, 2022 deadline. This will include certain new certified capabilities such as:
New standardized API functionality using FHIR-based APIs certified to §170.315(g)(10)
2015 Edition Health IT certification criteria updates as indicated in the ONC final rule
Don’t jeopardize your certification status by waiting too long. When you incorporate development time and the certification process, the timeline to meet the deadline is closer than it appears to be on the calendar. By utilizing the Certified BlueButtonPRO module into your EHR, you would not only meet the FHIR-API requirement but would no longer need to submit the Real World Test-pan for it.
One Solution: BlueButtonPRO
The Conditions of Certifications have related dependencies. By incorporating the 2015 Edition Cures Act Certified BlueButtonPRO Module into your EHR, you can address all the current and future Cures Act Updates required to retain and maintain the 2015 Edition Certification Status of your EHR. BlueButtonPRO fully satisfies the Patient Engagement portion of the Information Blocking rule. The Real World Testing for the API is managed by Darena Solutions, removing it from the developers’ task list.
“Darena Solutions was the first to certify the API application BlueButtonPRO that satisfies the very difficult, multi-phase §170.315 (g)(10) FHIR-Based API criteria. ”
With BlueButtonPRO, EHRs now have an easy option to not only expedite the process to achieving full Cures Act compliance but also to reduce the burden of annual requirements related to Real World Test-plan.
Our next Blog will feature the requirements and development efforts that will be required to meet the Conditions of Certification for this 3rd ONC Cures Act Update. Stay tuned.
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