By Sasha TerMaat
Co-Chair, EHRA Executive Committee

The final 2019 IPPS rule included changes to the Promoting Interoperability/ Meaningful Use program beginning January 1, 2019. Disappointingly, with only six weeks between the close of the public comment period for the proposed rule in late June and the publication of the final rule in early August, CMS’ rushed process and failure to fully consider stakeholder comments (including EHRA’s) led to a rule filled with measures that will be unworkable, inefficient, and onerous.

In a previous blog we delved into PDMP query as just one of the measures where EHR developers anticipate challenges. In that case it’s due to differing levels of PDMP integration with CEHRT and inconsistent references within the rule about whether the query needs to be made via CEHRT, along with other areas in which the measure is ambiguous.  

In this blog post, let’s look at the reasons we’re concerned about a different measure, this one related to opioid treatment agreements.

Verify Opioid Treatment Agreement

While we noted in our comments several studies that found no significant patient improvement by having an agreement in place, we defer to clinicians and patients as to the inherent value of opioid treatment agreements in the hospital or emergency department setting.

However, CMS has proposed a measure which is not possible to accurately measure in an EHR.

First, there’s general misunderstandings about the standards possible to use in this measure. Second, CMS has defined a denominator which cannot be accurately determined. Finally, the numerator is an action which cannot be measured in an EHR.

No Standards for Opioid Treatment Agreements

CMS has a misunderstanding of standards for this area.

As noted in the proposed rule (83 FR 20529), there are a number of
ways certified health IT may be able to support the electronic 
exchange of opioid abuse related treatment data, such as use of 
the C-CDA care plan template that is currently optional in CEHRT. 
This template contains information on health concerns, goals,
intervention, health status evaluation & outcomes sections that
could support the development of an opioid treatment agreement. 
(2000)

C-CDA care plans are not commonly used for opioid treatment agreements, and even if they are, there is no method to distinguish a care plan about opioids from a care plan about any other topics, so it is not clear how one would “seek to identify” that one exists programmatically. If CMS intends that any query for a care plan should be considering “seeking” an opioid treatment agreement, that should be clarified. However, we think querying for a care plan is an unlikely workflow for seeking an opioid treatment agreement.

Problems with the Measure Denominator

CMS requires EHRs to use a denominator based on a data from external systems that are not required to provide the EHR with sufficient structure to perform the calculation.

Comment: A few commenters stated that this measure may not be
possible to calculate as the NCPDP 10.6 Medication History query 
does not contain a field for prescription days and relies on third
party data that may not be discrete. 

Response: We recognize that the capabilities to which health IT
must be certified in order for it to meet the minimum requirements
for CEHRT under this program do not include the ability to
automatically track prescriber behaviors addressed by this measure.
However, we disagree that this measure cannot be implemented at
this time, and believe that some health care providers are
currently verifying if there is an opioid treatment agreement in
place before they prescribe. As we noted that in the proposed rule
(83 FR 20529), the adoption of the NCPDP 10.6 standard does not 
preclude developers from also incorporating and using technology
standards or services not required by regulation in their health IT
product which could result in development of a workflow which more
closely resembles types that health care provider are currently
using. However we do understand the limitations for those health
care providers that have chosen not to implement such standards and
functionalities beyond the minimum to which their CEHRT is require
to be certified to meet the requirements of this program. (2003)

On page 2003 CMS again misunderstands standards and ignores key public comments about the impossibility of their measurement. CMS seems to imply that an EHR can go above and beyond the standards to calculate a lookback period based on data from other systems. This is mathematically impossible. If the EHR must perform this calculation based on external data then the ability to perform the calculation is outside the EHR’s control.

There will be challenges in several ways:

1. Some state PDMPs do not permit EHRs to incorporate PDMP data, which will mean the medication history is not able to be used for this calculation.
2. Other sources for medication history, such as pharmacy networks, might have incomplete data sets based on only e-prescriptions, for example.
3. Gathering data from many sources might introduce duplicates, and the process for how reconciliation plays into the calculation is unclear.

Because of the historical poor quality of data received through these sources, we anticipate that the calculation used for the denominator of CMS’ measure will not be very accurate. CMS may not care if the denominator is inaccurate, but clinicians will need to be trained not to make clinical determinations based on whether a patient is included in the denominator, given the unreliability.

Problems with the Measure Numerator

The numerator is also impossible to measure, because it is about an ambition, not an action. The numerator is met if the EH “seeks to identify” a signed opioid treatment agreement, which is not an EHR action.

Possible actual actions:

1. Another user has already included a signed opioid treatment agreement in the EHR. This can be measured by data in the EHR.
2. Providers open a signed opioid treatment agreement in the EHR. This can be measured by the EHR.
3. Providers add/create a new opioid treatment agreement in the EHR. This can be measured by the EHR.
4. Providers do something non-discrete within the EHR, or outside the EHR, and manually track that they “sought to identify” an agreement. This cannot be measured by the EHR.

How would providers count action number four as meeting this measure, when CMS says they must use CEHRT to perform this action? Is it not supposed to be measured?

We need further clarification on what action is expected to be tracked.

CMS seems to recognize the challenge, because they expect low adoption of this measure and have made it optional:

We also recognize that a provider’s attempt to verify whether a
treatment agreement is in place may be difficult to capture in an
automated fashion in cases where a machine readable treatment
agreement cannot be queried. While we believe some providers do
currently have the ability to query for an electronic treatment 
agreement, which could support machine capture of this data, we 
recognize that for most health care providers this will require
additional workflow steps. 

As a result of these issues, we are also finalizing this measure 
as optional for CYs 2019 and 2020, and expect this measure is 
likely to be adopted by a limited set of providers in treatment
arrangements that already possess the infrastructure to support
capture and calculation of this measure.  We intend to revisit 
this measure along with the necessary data elements in future
rulemaking. (2003-4)

Does this mean that EHR developers should hold off on trying to create a function to capture this measure? Why would EHRs divert development resources from new features users have requested to create a report to measure something that is impossible to measure accurately with a burdensome workflow?

As we explained in our comments on the IPPS rule: 

“The use of the Medication History transaction seems a poor fit for supporting a measure denominator for the Opioid Treatment measure, as the transaction does not really support the concept of prescription days but uses a duration which has no start or stop date needed to reconcile overlap given the denominator definition.”

Health information and technology provide a wide array of tools to support provider and public health efforts to address the opioid crisis. That’s why EHRA formed an Opioid Crisis Task Force to look at how EHRs can be optimized in the fight against opioid abuse. But cloudy government mandates that can’t be supported by current standards isn’t the way forward.