Dynamic Shifts in Regulatory Landscape and Their Impact on Your Organization

At its Health Innovation Summit in October 2023, the National Committee for Quality Assurance (NCQA) announced the establishment of a new Digital Quality Implementers Community. The community will be responsible for testing use cases, developing tools, and agreeing on best practices for implementing NCQA’s clinical quality language (CQL). The initiative is being facilitated by the CARIN Alliance.

b.well is participating in the Digital Quality Implementers Community and plans to contribute its expertise working with CQL, which we have already implemented on the b.well Connected Health Platform. b.well applies CQL in our rules-based engine and machine learning models against real-time streamed health data to surface open care needs. These are based on vetted quality measures from the Health Effectiveness Data and Information Set (HEDIS), the STAR Ratings system, and the U.S. Preventative Task Force Guidelines. 

The b.well Connected Health Platform also links these insights to next best actions like appointment scheduling, which helps eliminate the fragmentation that consumers routinely experience in healthcare, offering opportunities for our customers to improve consumer satisfaction scores.  Customers also gain real time visibility into care gaps and care gap closures of managed populations along with the means to deliver personalized and tailored content through the platform’s consumer digital channels. By showcasing these use cases, we influence the value of open standards that support the consumer shoppable experience which future-proofs customer investments and demonstrates opportunities to drive efficiencies and outcomes in healthcare operations.

Implementer communities are a common way for stakeholders to define open standards and best practices, which make their way into technology specifications and solutions. This particular effort is especially timely because of changes to STAR Ratings in 2022 that increased the weight of consumer satisfaction scores to 4x that of most clinical measures.  Also, because CQL is an extension of the Fast Healthcare Interoperability Resources (FHIR) standard, b.well is able to manage quality-related data in the FHIR R4 standard for customers.  This is important for two reasons: customers can build operational velocity for initiatives that link consumer-centered activities with other quality activities. Additionally, customers can more readily link these initiatives to impact on the quality measures they must start submitting to the Centers for Medicare & Medicaid (CMS) through FHIR APIs, as required by 2026.  (Read more about the announcement of that requirement in our Q3 b.well buzz Newsletter).

November and December are the time of year when different health interoperability communities meet and b.well attends these meetings. As a keynote speaker at these meetings, the National Coordinator for Health IT, Micky Tripathi, is always good for some notable hot-takes. 

One hot-take is that he wants future priorities to go beyond information exchange and to focus on standards for interactive features within and between different health technology systems. His top interactive features include questionnaires, scheduling, FHIR hooks, and FHIR links. 

While these concepts are technical, they mean a lot to b.well and the health technology community more broadly because of how they’re used to build workflows and immersive user experiences.

The great news is the b.well Connected Health Platform already takes advantage of standards-based questionnaires, scheduling, FHIR hooks, and FHIR links. b.well uses the FHIR Questionnaire resource in surveys for collecting patient self-reported data and also as an integral part of b.well’s consumer consent management framework. FHIR Questionnaires are great resources for processing and reporting data in human and computer-readable formats.

We also support FHIR-based scheduling in our integrations with customer scheduling systems. This allows the b.well Connected Health Platform to deliver in-app scheduling and real-time backend data management with our customers’ core scheduling systems. Furthermore, we leverage FHIR hooks and links throughout the user experience to deliver timely, relevant, and real-time personalization in our health journeys. These capabilities leverage our clinical rules engine and machine learning models to surface care gaps and know when they’ve been closed.

We are pleased that Micky Tripathi keeps the industry on its toes with an expansive vision for interoperability that goes beyond information exchange. This broader vision is sorely needed to keep the health technology community energized about the solutions it can build. This kind of energy is exactly what we need to realize a more shoppable healthcare experience for consumers and reduce administrative burdens so the industry can begin to realize benefits in the shift to value.

We were also pleased to hear that the TEFCA community will be launching a new community to incorporate FHIR Questionnaires into its developing privacy and consent framework for interoperability between networks.  b.well has been at the forefront of implementing FHIR Questionnaires this way, and we look forward to participating in the privacy and consent work surrounding TEFCA to bring our learnings into the broader interoperability ecosystem.

At its November 9, 2023 meeting, the Health IT Advisory Council (HITAC) forwarded recommendations to the Office of the National Coordinator for Health Information Technology (ONC) to improve pharmacy interoperability. A key theme in these recommendations is that interoperability must support a broad swath of pharmacy constituents including other healthcare providers, patients, caregivers, PBMs, EMR vendors, and developers of pharmacy information systems.  

Recommendations touch on bi-directional flows of clinical and administrative data between pharmacists and other providers and more data sharing with patients directly. Other recommendations support deeper integration of pharmacists into patients’ care teams, opportunities to help pharmacists offer clinical interventions for polypharmacy patients, and standards that link pharmacy quality measures to actions that pharmacists, patients, and caregivers can take. The task force also tucked in some recommendations for improving lab interoperability.  

Among the notable recommendations include: 

• Standards on pharmacy benefit managers and other third party administrators to support real time benefit checks for patients and providers (Recommendation 10); 
• Support for interactive messaging in pharmacy patient portals (Recommendation 11); 
• Delivery of admission, discharge, and transition (ADT) push notifications to pharmacies (Recommendation 14); 
• Capture and handling of patient-reported data by pharmacies (Recommendation 15); 
• Adoption of an interoperable privacy policy and consent framework to help assure appropriate sharing of health information including clinical data and medication fill administration (Recommendation 16); 
• Addition of RxChange, CancelRx, and RxFill status standards to the USCDI (Recommendation 17); and
• Addition of pharmacies to record location services under TEFCA (Recommendation 20). 

To support lab interoperability, HITAC also recommended efforts that will improve mapping of lab tests and values through the use and exchange of LOINC and SNOMED vocabularies (Recommendation 22). See links to the task force’s presentation and report for more detailed information. 

While not part of the formal recommendations, HITAC members discussed adding interoperability standards for the drug supply chain to address the downstream impacts of drug supply and workforce shortages. Proponents stated that prescribing providers, patients, and caregivers would all have a better experience if they can choose pharmacies with available supplies, and that this additional interoperable capability could also help improve medication adherence.

The recommendations are comprehensive in their understanding of pharmacist, prescribing provider, patient, and caregiver needs. ONC is clearly signaling its intent to target pharmacy interoperability as a near term policy priority.  In consequence, b.well will be helping customers understand the impact of these proposals and how to start implementing them with their partners.  Starting early is a way to influence open standards, tools, and practices as well as  creating market differentiation.  As an implementer, b.well can then help influence standards for open infrastructure which protect your investments, as we’re doing with the NCQA Quality Implementers Community.

Regulators have a way of prioritizing use cases with potential to receive support from many types of stakeholders. This is clearly the case with the pharmacy interoperability recommendations.  We should expect formal rulemaking for pharmacy interoperability in the near-term because of the opportunities to center interoperability investments around clinical and patient experience workflows that are currently delivered through fragmented systems. By streamlining these workflows, the potential payoff includes enhanced prescriber and patient experiences, but also, the potential for pharmacists to participate more seamlessly in patients’ care teams. This could pave the way for pharmacists to practice at the top of their license and spend less of their professional time with dispensing activities. 

ONC’s final “HTI-1” rule was submitted to the federal Office of Management and Budget (OMB)  on October 19, 2023, which is the final stop before publication in the Federal Register. CMS also submitted its final rule to OMB for new payer-to-payer, provider-to-payer, and prior auth APIs on October 25, 2023. This means both final rules could be published in the Federal Register by late December 2023 or early January 2024. We’ll be waiting! Read more about our analysis of these rules as initially proposed in our Q3 b.well buzz Newsletter.

Micky Tripathi told audiences at the season’s industry conferences that ONC’s HTI-2 proposed rule will drop in December 2023.  Besides the obvious focus on public health, he kept mum about what else will be in the proposal. We’ll have to wait and see!

HHS released its long-awaited proposal for program disincentives that could be applied to healthcare providers that violate the Information Blocking Rule. Announcement about the proposal is here. Comments are due January 2, 2024. We are reviewing the proposal and anticipate submitting comments and welcome opportunities to share perspectives so our customers’ interests can be amplified.

TEFCA is not live yet, but the tea leaves point to a partial “Go Live” announcement at ONC’s Annual Meeting on December 14-15, 2023.  We’ll see if “Go Live” means two Qualified Health Information Networks (QHINs), or maybe more.

Despite achieving the “Go Live” milestone, these first connections will be limited to queries for treatment purposes. The emphasis on treatment arises from existing networks having the most experience in supporting it. That means it will take more time before TEFCA goes live with other permitted exchange purposes: Payment, Healthcare Operations, Individual Access, Public Health, and Benefit Determination. 

Meantime, a robust community of committed interoperability stakeholders is shaping up around TEFCA.  For example, Carequality is hosting an individual access early adopter’s program in 2024Q1, which b.well will be participating in. This initiative will be watched closely by regulators and stakeholders within the TEFCA community.  

Significant efforts are underway to ensure that information exchange benefits providers, payers, and most importantly, consumers. This mission is championed by the information usability workgroup.

Plus, a new workgroup is getting started to build out a formal privacy and consent framework across TEFCA. The idea is to leverage FHIR resources and profiles to tag and manage data according to a consensus standard set of policies and consent rules. So, if you query for a treatment purpose there will be an audit trail to see that this purpose was used appropriately.

We’re also seeing TEFCA start to move into FHIR facilitated exchange, but around narrowly defined use cases.  QHIN Candidates, like eHealth Exchange, incentivize collaboration between payers and providers with initiatives like prior auth APIs, even before regulatory mandates are finalized. This approach aims to deliver value to providers, who bear most of the burden of treatment-based interoperability, and simultaneously bring something of value to payers, so they’ll participate in TEFCA and bring their pocketbooks.

Payers seem to be onboard. Some of the largest payers spoke on a panel about getting organized around payer-to-payer APIs through TEFCA.  They are supportive because of the opportunities to improve care transitions post-enrollment and before coverage years begin. We were especially excited that payers understand the need to deliver personalized digital experiences to beneficiaries as soon as they enroll in a new plan and helping them take action to reduce interruptions in their benefits. These are exactly the types of consumer digital experiences where b.well thrives.

We won’t hold our breath on legislative activity in Congress. Even so, we’re keeping an eye on HR 5378 because it includes provisions for ERISA plans to support interoperability through APIs “without special effort.” These are the magic words in the Cures Act that brought us FHIR-based APIs for patient access. We’d love to see more of the 149 million or so people that rely on employment-based coverage have access to their claims data, the same way as consumers with coverage from CMS-regulated payers.