By Greg Thole (Oracle), Chair, EHR Association Certification Workgroup

In the previous installment of our blog series dissecting the EHR Association’s raft of concerns with ASTP’s Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, we focused on the overarching issues. In this blog, we take a deep dive into the complex web of proposed changes to Insights measures that present specific challenges for certified health IT developers and indirect impacts for the providers that use their solutions. (Our full comments to ASTP are available on our website.)

Insights is a Condition and Maintenance of Certification requirement introduced via statutory directive in the 21st Century Cures Act, which tasked ASTP with creating an EHR reporting program for certified health IT developers. By its nature, Insights poses a difficult value proposition for developers, as it requires the commitment of development time and resources to efforts that do not directly benefit providers. 

For this reason, we believe it’s critical to maintain a low level of complexity for Insights measures, particularly for the initial launch. However, with HTI-2, ASTP proposes both new metrics and changes to preexisting metrics that were initially finalized in HTI-1 rulemaking – changes that impede developers from starting on compliance and, in some cases, may force them to scrap existing plans altogether and return to the drawing board. 

Accordingly, our stance is that ASTP must maintain whatever is finalized in HTI-2 through at least the first year of reporting for each measure to avoid any further re-work by developers.

Accordingly, our stance is that ASTP must maintain whatever is finalized in HTI-2 through at least the first year of reporting for each measure to avoid any further re-work by developers.

The Unique Identifier Conundrum

Sending EHR developers back to the starting blocks with measure development activities is just one of several issues we have with the proposed changes to Insights measures. Of particular concern is the requirement for health IT developers to submit unique identifiers for all the providers whose data is included in measure submissions – providers who are currently anonymous for Insights reporting purposes since developers submit aggregated data across their customer base.

Of particular concern is the requirement for health IT developers to submit unique identifiers for all the providers whose data is included in measure submissions – providers who are currently anonymous for Insights reporting purposes since developers submit aggregated data across their customer base.

To comply, developers would likely need to secure agreements with providers to include their data in measure submissions without the benefit of anonymity. Doing so would inevitably raise significant concerns from the providers themselves, as well as diminish the likelihood they would be willing to participate.

While we understand the desire for and value of this additional data from ASTP’s perspective, requiring submission of unique provider identifiers significantly increases the burden for software developers in preparing to support measurement and reporting capabilities. It also very likely creates additional limitations in EHR developers’ ability to submit data for customers based on contractual obligations.

Furthermore, if identifiers are desired for metrics related to real-world use of certified health IT, our position is that they should be imposed through programs directed at healthcare providers themselves (e.g., CMS’s Promoting interoperability programs) rather than those directed at developers.

We believe that keeping this requirement would be highly misguided. As such, we strongly encourage ASTP to remove it.

Aggressive Additions

As noted previously, the complex nature of Insights requires time and resources to be diverted away from development activities that directly benefit providers. Maintaining overall simplicity in measures – particularly in the introductory years – is key to ensuring Insights does not impose an unnecessary drain on developer resources that may ultimately harm both providers and developers.  

Newly proposed metrics as part of the “C-CDA Reconciliation and Incorporation Through Certified HIT” measure, which involves metrics for certified capabilities that are newly proposed in HTI-2, is a great example of ASTP being too aggressive and complex with Insights measures. 

When introducing new certified capabilities, we strongly recommend that corresponding Insights measures only be considered after they are well established. Specifically, new functional program requirements should be in effect for a minimum of one full calendar year before associated Insights measures are introduced for them.

When introducing new certified capabilities, we strongly recommend that corresponding Insights measures only be considered after they are well established.

Making Our Voices Heard

These concerns notwithstanding, we recognize and appreciate that HTI-2 includes several proposals that respond directly to feedback from the market – and the EHR Association in particular – on measures finalized in HTI-1. The engagement and responsiveness from ASTP to the questions and feedback from the EHR Association since the publication of the initial Insights requirements does not go unnoticed, nor unappreciated.

These concerns notwithstanding, we recognize and appreciate that HTI-2 includes several proposals that respond directly to feedback from the market – and the EHR Association in particular – on measures finalized in HTI-1.

One example is the metric tracking patient access to their EHI via FHIR APIs under the “Individuals Access to EHI via Certified HIT” measure. In HTI-2, ASTP proposes changing the definition of access from a patient obtaining an access token but not necessarily accessing any EHI to when at least one FHIR resource has been returned. This is a subtle but important distinction that more appropriately measures what the metric is meant to track. It also establishes consistency with how access is treated under other measures.

A second is the proposed update to the “Number of Immunization Queries Sent to IISs Overall” metric under the “Immunization History and Forecasts Through Certified HIT” measure to track only the number of queries sent by certified health IT without considering response variables for those queries. We believe this is the correct way to track the defined metric and it aligns with specific feedback provided by the EHR Association after the HTI-1 final rule. 

The bottom line is this: ASTP must consider the burden that the increasing complexity of Insights requirements places on developers and work to maintain simplicity while keeping realistic expectations for what information developers can reasonably obtain (i.e., do not require us to submit provider identifiers, nor other burdensome hospital or clinician-level tracking information).

Read the first installment of this blog series, Huge Scope, Not Enough Time: Concerns with ASTP’s HTI-2 Proposed Rule, here. Our full comment letter to ASTP on HTI-2 is available here.