Medicare is shifting rapidly to value-based and integrated care. Notably, the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) initiated major changes in Medicare physician payment. In addition to ending the long reviled Sustainable Growth Rate (SGR) used to update Medicare professionals’ payments, MACRA creates two new value-based programs, which will rely on interoperable health IT (HIT). Payments will be affected by these models starting in 2019 (likely based on 2017 performance). The Centers for Medicare and Medicaid Services (CMS) has the lead, with the Office of the National Coordinator for Health Information Technology (ONC) focused on HIT aspects.
The first model is the Merit-Based Incentive Payment System (MIPS), which revises/ replaces the Physician Quality Reporting System (PQRS), Value Modifier (VM), and Medicare Electronic Health Record (EHR) incentive programs, combining them into one new program based on: quality, resource use, clinical practice improvement, and meaningful use of certified EHR technology (CEHRT). MIPS is value-based payment on a fee-for-service foundation.
Second, MACRA creates Alternative Payment Models (APMs), a non-fee-for-service path to payment, and CMS’ desired end state for most services. APMs would use outcomes -focused approaches like Accountable Care Organizations (ACOs), patient centered medical homes, and bundled payment models. Although MIPS retains Meaningful Use, APMs by design do not. Rather, “eligible APM” payments must be made under arrangements in which ‘‘certified EHR technology is used “ with “participants in such model to use certified EHR technology (as defined in subsection (o)(4))”.
The regulatory interpretation of “certified EHR technology” and “use” will determine the future of APMs and of health IT innovation more generally. What did Congress intend and how should CMS and ONC approach these issues? To answer, we should consider the approach Congress took in defining the APM option and how CEHRT is used for Meaningful Use, given MACRA’s reference to HITECH’s definition for CEHRT and the recent CMS and ONC Meaningful Use and certification Final Rules, which emphasized the close CEHRT tie to Meaningful Use.
It is reasonable to conclude that Congress simply intended for APM providers to use EHRs certified by ONC, as for MIPS. There is also no reason to think Congress sought prescriptive “use” requirements nor separate, APM-specific certification criteria, especially if expanded to capabilities not now certified or typically part of an EHR. CMS should, of course, as it suggests in its recent MACRA Request for Information (RFI), narrow the definition of CEHRT if aspects are not needed for APMs.
Unfortunately, CMS and ONC are considering applying certification and “use” to APMs in ways contrary to the intended, less prescriptive operation of these organizations. For example, ONC asked the Advanced Health Models and Meaningful Use Workgroup of the HIT Policy Committee to identify new certification criteria to support APMs. Work on this project draws on a contractor analysis that identified HIT needed to support APMs, market “gaps,” and the likelihood the market will close these gaps by 2019. This study identified several priority capabilities, which seem reasonable, but with many having low predicted probabilities that the market will soon close the gap; the implication being that certification is needed.
Similarly, the CMS RFI asked “What components of certified EHR technology . . . should APM participants be required to use?,” “Should [they] be required to use the same certified EHR technology currently required for the Medicare and Medicaid EHR Incentive Programs or should CMS consider other requirements around certified health IT capabilities?, “Would certification of additional functions or interoperability requirements in health IT products (for example, referral management or population health management . . .) help providers succeed within APMs?,” and “How should CMS define ‘use’ of certified EHR technology . . . for participants in an APM?”
I applaud CMS and ONC for seeking input before writing regulations. Unfortunately, framing policy issues could in this way lead to approaches to APM certification and use contrary to what Congress intended that could hobble these new models and HIT innovation more generally.
The opportunities for MIPS and APMs to advance the shift to value-based, integrated care are exciting. Unfortunately, we risk ignoring key lessons from certification and meaningful use, especially their negative impacts on EHR usability and responsiveness to provider priorities as advisory committees, experts, and regulators have driven product design. Risks from the federal government as product manager are high, especially as we move to newer models of care and payment, with emerging and varied technologies needed, including greater use of cloud and modular approaches.
If I have learned one thing at GE Healthcare and in healthcare technology more generally, it is that developers provide capabilities sought by providers (and policy makers), so long as incentives and market signals are clear (and aligned with policy goals). With the right incentives, time-to-market will be much quicker than forecast by “experts”. For example, while misaligned incentives have slowed the growth of interoperability, APMs are intended to generate aligned incentives that should send developers clear signals on needed capabilities, including interoperability.
I give both no credence and a lot to the ONC contractor’s market responsiveness scores. If customers want these functions and will pay for them, the market will respond, much faster than projected. If not, it won’t. If the market, with all the buzz about these programs, won’t generate these expert-prioritized solutions, there is no guarantee that vendors will certify to and bring to market these solutions on desired timelines (especially with certification modular now), or that APM participants will adopt certified functions or if forced to do so, will use this functionality or be pleased to do so.
Certification was never intended (at least not initially) to force development of new functions that the market did not generate; it was to ensure that incentive dollars for adoption and MU were spent on products meeting government criteria and standards and even then, mostly addressing fairly mature functionality. Where certification did not focus on well-defined and accepted functions ripe for standardization, it has failed or been scaled back (see the arc of Direct clinical summary transport, with various issues emerging, such as lack of users or provider directories or efficient workflow, with CMS no longer requiring use of Direct or other certified data transport in its recent Final Rule).
Although it might seem that expanding certification creates burdens only for vendors, the consequences would be far reaching. It would impose technology obligations on APMs and their providers and prematurely and artificially constrain development of new HIT capabilities and continue to divert vendor resources from what our customers want to what regulators require.
CMS should also take a non-prescriptive view of APM EHR “use,” which Congress clearly distinguished from “meaningful use,” and focus on documented implementation of a certified EHR rather than trying to track specifics of use. APM incentives are for quality and financial outcomes, not technology adoption as with the EHR incentive program, and APMs should make their own decisions on best use of EHRs and other HIT given outcome-focused incentives. Let’s not miss this opportunity to identify and act on the right lessons from recent years.