UPDATE: December 13, 2023. THE RULE IS NOW FINAL
For an in depth review of the requirements read: Unveiling Progress—Analyzing The Evolution From The HTI-1 Proposed Rule To Final Rule
The ONC announced the HTI-1 Notice of Proposed Rulemaking back in April 2023, and there is good reason to expect the Final Rule to be issued by the end of 2023. Many of the compliance deadlines are set for 2024. With potentially a year or less to comply with multiple new rules (summarized below), how can developers prepare for a busy compliance year in 2024? In short, start planning now, so you can hit the ground running early next year.
The proposed rule includes 18 new and revised certification criteria across a 600+ page proposal description—it’s daunting. We recommend product developers prioritize understanding the potential impacts the rulemaking will have on their development roadmap, focusing first on the significant deadlines in the first year of the two-year rule change rollout. Let’s take a look at the near-term requirements:
Deadline #1—Upgrade to the USCDI v3 Standard by the End of 2024
The most consistent theme in the new rules is health IT’s move to the USCDI v3 data standard for Health IT. The proposed rule adopts v3 for all certification criteria that currently reference USCDI. The upgrade to this standard will impact capabilities specified in at least nine certification criteria, with many interrelated function updates extending across EHR solutions. The changes to data elements and classes from USCDIv1 to v3 include:
- 47 new elements
- 30 elements with updates to vocabulary standards
- Five new classes
- Five elements moved to different classes
- Two deleted classes
- Three renamed classes
In addition, the ONC announced its move to new Implementation Guides in three areas: the C-CDA Companion Guide, the SMART v2 Guide, and the HL7® FHIR® US Core Guide—all incorporating USCDI v3. The announcement listed these guides’ current versions, all based on USCDI v2. However, the ONC specifically stated in each case that they expect to have guide versions referencing USCDI v3 before the Final Rule is announced. They will adopt these v3 guide updates in the Final Rule, assuming they are available.
Below is an example from the ONC Proposed Rule, which discusses the plan to move to USCDI v3 for the US Core IG standard:
"Based on the annual US Core release cycle, we believe US Core IG v6.0.0 will be published before ONC issues a final rule. Therefore, it is our intent to consider adopting the updated US Core IG v6.0.0 that supports the data elements and data classes in USCDI v3 since we propose to adopt USCDI v3 in this rule. Health IT systems that adopt this version of the US Core IG can provide the latest consensus-based capabilities for providing access to USCDI data classes and elements using a FHIR API."
USCDI v3 also became an approved Standards Version Advancement Process (SVAP) standard, effective September 11, 2023.
In short, USCDI v3 is coming, and it will likely have a December 31, 2024, deadline across the HTI-1 proposed rule changes (Update: On December 13, 2023, the HTI-1 Final Rule officially enforced USCDI v3 to be adopted by December 31, 2025. Read the latest blog on the HTI1-Final Rule here)
–with SVAP already supporting its adoption by developers for certification purposes. Developers should start their development planning and design for this new data standard now.
Deadline #2—Meet New Decision Support Requirements by End of 2024
The new Decision Support Intervention (DSI) rule (b)(11) is proposed to replace the prior Clinical Decision Support (CDS) rule (a)(9), effective January 1, 2025. (Update: The enforcement date of January 1, 2025, was maintained in the HTI-1 Final Rule. Read the latest blog on the HTI1-Final Rule here.) This represents another significant rule change with an end of 2024 deadline. Approximately half of ONC-certified products currently include (a)(9) in their certification, and more may have decision support functionality planned.
There has been much discussion about the new predictive DSI (PDSI) sub-category of (b)(11)–the artificial intelligence (AI) component of the proposed regulation. It would require EHR developers to attest (yes or no) to whether they enable or interface with PDSI. Developers will need to determine in early 2024 whether their current or planned CDS functionality will extend to include PDSI. The proposed definition is as follows:
“Predictive decision support intervention means technology intended to support decision-making based on algorithms or models that derive relationships from training or example data and then are used to produce an output or outputs related to, but not limited to, prediction, classification, recommendation, evaluation, or analysis.”
Answering yes will trigger significant additional requirements, including PDSI risk analysis, mitigation, management, governance program requirements, and public reporting requirements. Since the rule also extends to EHRs that may interface with PDSI, EHRs will need to collaborate on risk management with 3rd-party solution developers, providers, researchers, and others involved in DSI development work. And yet, the proposed rule requires EHR developers to own the risk management program responsibilities.
There is still much to be learned about how risk management factors can be effectively addressed in a programmatic manner among all the players involved with decision support. It is fair to ask whether EHR developers are even the right players to quarterback the PDSI risk management effort, especially if their solutions only interface with PDSI components. The Final Rule should help answer these questions. (Update: The HTI-1 Final Rule clarified that EHR developers will only be responsible for the Predictive DSIs they supply as part of their certified health IT – Read the latest blog on the HTI1-Final Rule here.)
Outside of PDSI, all DSI-certified developers will need to meet new requirements for exposing source attributes in plain language to users for review, including several new data elements driven by USCDI v3, such as Social Determinants of Health (SDoH) data. For PDSI solutions, over a dozen additional source attributes must be exposed for review. Plus, all DSI solutions will need to enable interventions for new data categories, provide bulk export capabilities for source attributes, and enable a feedback loop for users.
Deadline #3—Conduct Real World Testing for Clinical Decision Support During 2024
The ONC proposal to add certified decision support functionality to Real World Testing (RWT) for 2024 is an additional nuance of the decision support requirements. The scope change for RWT would apply to developers currently certified under (a)(9).
This requirement could be revised in the Final Rule since it presents a timing issue for RWT planning. Developers are currently preparing 2024 RWT plans without the Final Rule in place, while the Proposed Rule would apparently bring (a)(9) into scope immediately for the coming RWT plan year.
The ONC will likely issue guidance on how decision support testing should be handled next year if they retain the 2024 requirement in the Final Rule. For now, we advise (a)(9) certified EHRs to plan for (a)(9) testing in their 2024 RWT plans, or at least to note in their plans that they will include decision support in their RWT efforts should the Final Rule require it. (Update: The HTI-1 Final Rule does not require (a)(9) certified decision support functionality to be included in 2024 real-world testing plans, its replacement (b)(11) is included once EHRs achieve this certification by end of 2025. Read the latest blog on the HTI1-Final Rule here.)
Deadline #4—Collect Insights Report Data Starting April 2024 and October 2024
The Insights Condition is a new multi-pronged set of EHR reporting requirements. It is important to note this new Condition only applies to an EHR that “has at least 50 hospital users or 500 clinician users.” The ONC has estimated 52 larger EHRs by market share will have to submit Insights reporting, while smaller EHRs that do not meet the threshold will be exempt.
The ONC’s proposed timeline aligns Insights reporting with current semi-annual ONC attestation deadlines. This may be the trickiest set of deadlines for planning purposes as the reporting period is slated to start a year before the reporting deadline. EHRs subject to the rule must collect data covering multiple interoperability metrics for the six-month period starting April 2024, with a second period commencing in October 2024. (Update: The HTI-1 Final Rule established that the first data collection period will take place from January 1 to December 31 2026, followed by the submission of the first phase of measures and related metrics due in July of 2027. These are annual rather than semi-annual submissions. Read the latest blog on the HTI1-Final Rule here.) There are significant new reporting metrics, some possibly requiring development to enable collection capabilities. EHRs will need to start tracking these metrics just a few months after the rule becomes final should the proposed ONC deadlines remain in the Final Rule.
The first collection period, starting April 2024 would include the following measures: (Update: HTI-1 Final Rule sets the first collection period to begin January 1, 2026 . Read the latest blog on the HTI1-Final Rule here.)
(1) Individuals’ access to electronic health information;
(2) Applications supported through certified health IT;
(3) Immunization administrations electronically submitted to an immunization information system through certified health IT; and
(4) Immunization history and forecasts.
These are rolling 6-month reporting periods for each report, with a new period starting right after the last one ends, unlike the annual reporting for Real World Testing. (Update: The HTI-1 Final Rule now states that the reporting period will cover a full calendar year, with six months provided for collating the data. Insights reports will be due annually in July . Read the latest blog on the HTI1-Final Rule here.) Additionally, in 2025, a second set of reporting requirements will augment the 2024 requirements, beginning with the April – October 2025 reporting period, followed by an expanded report deadline in April 2026. (Update: The HTI-1 Final rule -establishes second and third waves of new reporting requirements commencing January 2028 and January 2029, respectively, with reports due in July of each year. Read the latest blog on the HTI1-Final Rule here.)
A key consideration for EHR development teams going into early 2024 is whether they will already have the capability in place to collect the data required for the first 6-month collection period. Confirming these collection capabilities should be an early milestone in 2024 product roadmaps.
Deadline #5—Update Electronic Case Reporting (f)(5) To New Standards by 12/31/24
The (f)(1) and (f)(5) criteria are MIPS measures required by CMS for clinicians engaged in public health reporting relating to Immunization Registry and Electronic Case Reporting, respectively. HTI-1 would add significant updates to (f)(5), including the addition of required data classes for USCDI v3 compliance.
The proposed rule specifies reporting standards for the first time, referencing HL7 FHIR and CDA Implementation Guides. (Update: The HTI-1 Final Rule maintained this requirement, but shifted the compliance deadline from January 1, 2025 to January 1, 2026. Read the latest blog on the HTI1-Final Rule here.)Reporting trigger codes is a key aspect of the current rule, and have this additional specification in reference to the IGs:
“Consume and process electronic case reporting trigger codes and parameters and identify a reportable patient visit or encounter based on a match from the Reportable Conditions Trigger Code value set in § 170.205(t)(4) contained in the eRSD Specification Library as specified in the HL7 FHIR eCR IG in § 170.205(t)(1).”
Furthermore, the rule would add a required capability to receive, consume, and process case report responses. The response formats must align with FHIR or CDA IG standards.
For the 115 EHR developers currently certified to (f)(5), the multiple standards-based requirements of the new rule mean their product roadmap must incorporate additional development activity in 2024. (Update: After the release of the HTI-1 Final Rule, the enforcement date for these requirements was changed from January 1, 2025, to January 1, 2026. Read the latest blog on the HTI1-Final Rule here.) Since (f)(5) only recently became a required MIPS measure (starting with the 2022 reporting year), developers currently working towards certification should consider integrating the specified standards (if they have not already) into their design/development planning to avoid starting over next year.
Integrating Certification Changes: 2024 Product Roadmap Planning Should Start Now
As we approach 2024, EHR product managers stand on the brink of a challenging yet exciting year. The hurdles in the year ahead are substantial, packed with an array of detailed requirements that demand early focus and meticulous planning. While HTI-1 has more deadlines at the end of 2025 (most notably the enablement of patient-requested restrictions on data access and additional Insights reporting requirements), 2024 will be daunting for many. Milestone tracking and decision coordination will be critical.
We should not lose sight of the bigger picture amidst these challenges. These changes, though demanding, represent a remarkable opportunity for growth, innovation, and EHR technology advancement. This pivotal period requires not just meeting deadlines, but also achieving milestones that pave the way for more dynamic and patient-centric health IT solutions.
At Drummond Advisory, we help EHRs assess changing compliance requirements and develop product roadmaps that incorporate innovation, market, and standards-driven functionality (including changes required to update to the USCDI v3 data standard).
To help you plan for a challenging year ahead, Drummond is pleased to offer a FREE live consultation with a Drummond Expert. Schedule your free consultation today.