Final IPPS Rule Ignores EHR Developer Concerns–Includes Impossible Measures, Will Lead to Increased Clinician Burden

By Sasha TerMaat
EHRA Vice Chair

IPPS blogOn August 2, 2018, CMS published the 2600-page pre-publication version of the 2019 IPPS Final Rule. EHRA members have begun digging into the Promoting Interoperability/Meaningful Use program, hoping to see changes based on their public comments on the proposed rule released in May. While we’re glad to see the requirement for 2015 CEHRT in 2019 confirmed, overall we’re disappointed that CMS failed to respond to many of EHRA’s comments as well as other stakeholder feedback.

In releasing the final rule less than six weeks after the public comment period closed (during which it received 1,058 comments), CMS appears to have rushed what should have been a thoughtful process. Several measures will be infeasible to program. Other measures will result in additional burden on clinicians, solely for the purpose of measurement rather than improved patient care.

Let’s review just one of the measures where we foresee problems.

Query of Prescription Drug Monitoring Program (PDMP)

Checking a PDMP prior to placing a prescription for an opioid is important for patient safety, and EHRA members have worked with states and their PDMPs on standards and policies to promote this integration in ways that are convenient for clinicians, within their EHR workflow.

Many state PDMPs do not support EHR integration, and some even prohibit incorporation of PDMP data into EHRs.

There seems to be confusion about the meaning of EHR-PDMP integration, so we will clarify what we mean. In our view, an integrated and interoperable PDMP includes capabilities using existing NCPDP standards for:

  1. Receiving electronic submission of prescriptions for inclusion
  2. Accepting electronic queries for a patient’s medication history
  3. Returning discrete data with the patient’s medication history to a query
  4. Permits incorporation and reconciliation of this data into the EHR for a complete medication list

There are several non-integrated and non-interoperable workflows for PDMPs. For example, in some cases a clinician must leave their EHR and open a separate web portal; log in with separate credentials; search and find the patient of interest in the PDMP portal; and view the information about the patient’s medication history in that portal. If they want to reference any of that information in the EHR they would need to manually copy it–if the PDMP allows that (not all permit inclusion of their information in EHRs).  This is clearly a lack of interoperability.

There are other methods–short of full integration–of improving the workflow for checking a PDMP. For example, the SMART on FHIR standard permits context-sensitive launch of a PDMP web portal within an EHR, which at least saves a clinician from having to login separately and perform another patient search. However, it doesn’t allow for discrete incorporation or reconciliation of the PDMP data into the EHR, so it will not facilitate a complete medication list. Workflow improvements such as these are preferable to a completely separate portal, but are not as desirable as true interoperability.

EHRA’s Opioid Crisis Task Force has put together a state landscape showing the variances across the country in technical capabilities and policy. Only 28 states were identified in the landscape as having EHR integration initiatives, and not all of those initiatives have reached full integration as described above. This means that  that hospitals in at least 22 states will all be forced to manually track their use of the PDMP to meet CMS’ new requirement.

In this excerpt from the final rule, CMS seems to acknowledge the workflow burden they are adding for clinicians whose PDMPs do not permit integration with an EHR, but they clearly misunderstand the feedback they have received:

CMS (page 1975): We understand that the Query of PDMP and Verify Opioid Treatment Agreement measures could require eligible hospitals and CAHs to incur additional burden due to workflow changes at the point of care. In addition, we understand eligible hospitals and CAHs that have integrated PDMPs within an EHR may be required to manually calculate the measure, as automated functionality for this measure is not currently supported through certification criteria for Health IT Modules. However, we also stated in the proposed rule that health care providers would have the flexibility to query the PDMP in any manner allowed under their State law (83 FR 20527). This would include using relevant included capabilities of their CEHRT, such as those required by the 2015 Edition electronic prescribing criterion at 45 CFR 170.315(b)(3).

The opposite is true. EHs and CAHs who are able to integrate PDMP data into their EHR can reasonably expect to report on whether a PDMP is checked from their EHR. It is EHs and CAHs who are unable to integrate PDMP data into their EHR who will need to manually calculate their rates of querying a PDMP. Obviously if the query does not happen in the EHR, the EHR cannot report on whether it happened.

A couple of pages later, CMS uses confusing language on whether the query must come from the EHR or can take any form. Sometimes, the language indicates any format of querying the PDMP is acceptable:

As previously stated, health care providers would have the flexibility to query the PDMP in any manner allowed as legal and practicable under their State law (83 FR 20527) which we believe provides more flexibility for health care providers to successfully demonstrate meaningful use and be able to report on this measure beginning in CY 2020. (1977)

Sometimes, the language indicates the query should come from an EHR (which would make sense for an EHR incentive program), as in these two examples:

We proposed that the query of the PDMP for prescription drug history must be conducted prior to the electronic transmission of the Schedule II opioid prescription and that eligible hospitals and CAHs would have flexibility to query the PDMP using CEHRT in any manner allowed under their State law. (1979)

 

We also proposed that in order to meet this measure, an eligible hospital or CAH must use the capabilities and standards as defined for CEHRT at 45 CFR 170.315(b)(3) and 170.315(a)(10)(ii). (1982)

On pages 1985-6, CMS further discusses how CEHRT must be used for this measure. They do not address the fact that while CEHRT includes the capabilities to perform ePrescribing (eRx) transactions, most state PDMPs do not use the same transactions.

In fact, even though commenters pointed this out, CMS proposes no solutions for those hospitals whose state PDMP capabilities are limited:

Comment: One commenter requested an additional exclusion for the Query of PDMP measure specific to States that do not have a Statewide PDMP. Another commenter requested exclusion criteria for hospitals whose States do not allow direct integration with an API as workflows that are not interoperable will increase reporting burden.
Response: We decline to finalize additional exclusion criteria, as recommended by the commenters.We stated that health care providers may query the PDMP in any manner that is allowed by their State, which we believe would reduce the burden of instituting new workflows.In addition, we are adopting exclusion criteria below for hospitals not able to report on this measure in accordance with applicable law when the measure is required beginning in CY 2020. We will continue to monitor health care provider use and querying of PDMPs and consider whether additional exclusion criteria are necessary in future rulemaking, as the measure is optional for CY 2019. (1987-8)

How does permitting a hospital to use any workflow their state supports “reduce the burden of instituting new workflows” if the only workflow their state supports is a completely separate portal that has no integration with their EHR?

CMS is effectively requiring hospitals to complete a burdensome workflow. And, by requiring whatever workflow the state currently supports, CMS has removed incentives for states to adopt new electronic workflows that would actually “promote interoperability.”

Readers are left confused as to what is intended to be measured and how that is possible. If “any method” is permissible, then manual tallying of queries completely outside the EHR would seem reasonable to meet the measure.

If use of CEHRT is required but not certain standards, then perhaps launching of a single-sign-on session is able to count as a ‘query’ even if discrete data is not returned to the EHR with full integration.

Or if use of the e-prescribing standards is expected (p 1982), then perhaps only full integration is to be measured, and launching a single-sign-on session or logging into a separate portal is not sufficient.

There is too much ambiguity to be able to program this measure effectively.

Summary

To summarize, EHRA has identified several problems with CMS’ discussion of this new measure:

  1. Inconsistent references to whether the query must happen using CEHRT, or if a query can happen using any means.
  2. At least half of hospitals will not be able to query from their CEHRT–because of limitations in their state PDMP systems–and will have to report through manual tracking of when queries take place, or based on reports from the PMDP.
  3. There is no incentive for PDMP systems to support true EHR integration using the same standards to which EHRs have already been certified.
  4. Based on the ambiguity above and the discussion that continues through page 1992, it’s unclear what hospitals should do. If their state does not permit EHR integration, should they encourage the state to do so? Or should they implement manual counting processes based on their state’s unintegrated workflow? Or do they rely on the vague exclusion of “EHs…that could not report on this measure?”
  5. EHRs will only be able to measure the numerator of this measure if the query happens from the CEHRT.

EHR developers continue to work to improve EHR usability, and we support CMS’ efforts to streamline regulations and reduce provider burden. But required measurements must take into account the variety of capabilities and state rules affecting providers, and they must be real-world based.

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