Three Big Questions for Stage 3 & Patient Engagement

For many, the delay of Stage 3 of the Meaningful Use program evoked a collective sigh of relief, providing a much-needed extra year to focus on the challenging requirements for patient engagement and interoperability. As distant as 2017 may seem however, the preparation for Stage 3 is already underway in Washington; the vendor community and providers will soon be scrambling to follow suit.

Barring further delays, the timeline is as follows: This fall CMS will release the notice of proposed rulemaking (NPRM) for Stage 3 and the corresponding NPRM for the Standards and Certification Criteria. The former is the programmatic framework for what to expect – measures, percentages, reporting requirements, etc., while the latter is the technical product guidelines for software vendors to follow in order to receive ONC certification as a Stage 3 compliant solution that will enable their customers, if properly implemented and used, to collect those sought-after incentive dollars. The final rule is expected to drop sometime in Q1-Q2 of 2015 – just one year away.

But that doesn’t mean there’s a year to put off thinking about it. In a few short weeks, the Health IT Policy Committee (HITPC) is set to deliver an official recommendation on the topic of Stage 3’s patient engagement requirements to the ONC. From all indications, it appears this super-group of wonks will press for inclusion of patient-generated health data (PGHD – yet another #ONCronym for your twitter streams) into electronic health record systems. The technical experts have defined PGHD as follows:

“health-related data—including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information—created, recorded, gathered, or inferred by or from patients or their designees (i.e., care partners or those who assist them) to help address a health concern.”

At first glance, this is a no-brainer, as we’ve been hearing the clarion calls for such inputs for the better part of the last decade. 60 percent of US adults claim to track their weight, diet, or exercise routine, according to the Pew Research Center’s data. Evidence for the positive impact of this data on quality, satisfaction, and in some cases cost is thin but growing.

But as we are learning through the first two stages of this program as well as the early headaches of ACA rollout, reams of sophisticated studies floated down from the ivory tower do not effective policies make. Despite the need for PGHD, when it is wonkified, ONCified, and held to the temple of the nation’s delivery system, there may be a small disaster in waiting. Below are three questions Chilmark is keenly tracking throughout the remainder of 2014:

What Constitutes PGHD?
The language used thus far raises much speculation about what exactly this inclusion will mean when it hits the front lines. The definition provides only a general description, leaving a lot of possibility for interpretation and application down the road. For many, PGHD evokes the notion of datastreams from the vast array of health and wellness devices such as fitbits and jawbones, Bluetooth medical devices, and of course, tracking apps. Yet the definition above makes PGHD seem to carry more of an health risk assessment (HRA)-like utility, where patients fill out a survey and have it sent to their doctors in advance. Yet another angle is the notion of patient-reported outcomes: clinically oriented inputs from patients with regard to their physical and psychosocial health status. Outfits like ATA, HIMSS and others are lobbying for full inclusion of patient-monitoring and home-health data.

Each of these use cases brings with it a unique set of programmatic and technical components. A popular example as of late is with biometric data: If a panel of diabetic patients are all given Bluetooth glucometers that input into respective EHRs, then what – Will someone monitor each of them? Or are HCOs expected to fit those data into an algorithm that alerts and ultimately predicts any aberrance? This has been referred to as providing doctors with ‘insight’ rather than raw data. That sounds snazzy, but can we realistically mandate the creation of insight?

Collecting data such as patient allergies or side effects appears a simpler use case on paper. Yet HITPC is appearing to use everyone’s favorite A+ students – IDN’s like Geisinger, Kaiser Permanente, and Group Health Cooperative among others as the basis for their recommendation. As one example, the report lauds GHC’s eHRA model, which is based on a shared EHR and shared clinical staff for data review. As nicely as that may work, Chilmark is skeptical that it’s reproducible in an average clinical setting. Generally, the innovators in the digital engagement space have been the insurers, not the providers. We understand the need to look at innovators in order to prescribe a path for the rest of the country, but in talking to regular folks at urban hospitals, community clinics, mid-sized IPAs –it’s more likely that fluid data is a byproduct of integrated systems, not the other way around.

How Will the Market Respond?
Despite its unpopularity in the C-suite, meaningful use has forced EHR vendors to pull their heads out of the sand and advance their product features. In addition to giving providers a break, part of the reason behind the Stage 3 delay was for vendors’ benefit: “[to provide] ample time for developers to create and distribute certified EHR technology…and incorporate lessons learned about usability and customization.” The Standards and Certification Criteria 2017 edition will play a big role in the next lurch forward, and one can be sure that those new mandated features will be all the rage at HIMSS 2015.

Yet at the broadest level, the evolution of EHRs (billing >> administration >> clinical) appears to be stalling. In exploring the patient engagement market and the to-date limited functionality of tethered patient portals despite Stage 2’s requirements one thing has become clear: EHR vendors will simply not just add new features for the sake of their customers (forget about patients). With new PGHD functionality emerging, we expect new companies to step up to the plate and seek modular ONC-ATCB certification

An example already underway is 3^rd party data integration. Over the last few years, device manufacturers, startups, and third parties started seeing the value in injecting their data into EHRs. The emergence of middleware companies who provide integration as a service, such as Nanthealth, Corepoint, and Validic, will continue as PGHD requirements develop over the coming months. Similar companies will start (and already are) filling the void for HRA functionality, portal requirements, patient communication, and so on. We expect that this will only exacerbate the headache faced by CIOs & CMIOs with a long list of purchasing options. Startups take note: It should also set off a shopping spree by EHR companies and other enterprise vendors looking to buy rather than build. Allscripts acquisition last year of Jardogs is one such example.

Will Providers be Ready?
In a word, no. The inclusion of PGHD brings with it an avalanche of procedural and programmatic preparation: data review and quality assurance, governance models and new workflows, the prickly issue of data ownership, staff time and training, liability concerns, HIPAA extension of coverage, ever-increasing insurer coordination, clinician accountability, and of course, patient consent, onboarding, and marketing. With the last one, keep in mind that we now live in the post-Snowden era…

Of course, without details of the required measures, further hand-wringing is unwarranted at this point. But suffice to say there’s a small storm-a-comin.’ As the definitions, rules, and standards of patient-generated health data emerge, we look forward to what promises to be a rich commentary and response to the NPRM amidst the broader discussion in the health IT community throughout 2014.