Navigating New Healthcare Regulatory Changes and their Impact on Interoperability

There are many intricacies in the healthcare regulatory landscape and its impact on interoperability. Inspired by an education session at ViVE 2024, hosted by Jill DeGraff, Senior Vice President at b.well Connected Health, we’re here to decode the regulatory landscape and chart a course for a unified healthcare ecosystem with regulations as waypoints. In considering our journey towards interoperability, the focus is on meeting consumers’ desires for a more seamless and personalized healthcare experience, reducing fragmentation and frustration. The aim is to emulate the personalized experiences found in other aspects of life, such as e-commerce,  banking, and even social media.

Healthcare leaders must not only acknowledge impending regulations  but also turn mandates into business opportunities. This requires intentional strategies that account for both current and future regulations. The solution? An adaptable infrastructure built to evolve and scale.

Understanding the Healthcare Regulatory Terrain

Healthcare regulations can span hundreds of pages filled with complex language. Understanding their nuances is essential for anyone wanting to compete in the market and meet consumer needs.

When looking at the current healthcare regulatory landscape, four major themes emerge:

  1. First, starting with regulations that support a consumer-centric healthcare model. This involves adapting to the presence of new, tech-savvy market entrants who are reshaping workflows and engaging consumers effectively. Healthcare organizations that are using legacy platforms must strategize on how to compete in this evolving landscape.
  2. Secondly, the regulatory agenda is driving towards a connected health ecosystem, emphasizing the importance of integration and collaboration within the healthcare sector. 
  3. The third key theme revolves around managing the potential risk of data overload that comes with interoperability. It’s crucial to not just transfer data but also to convert it into actionable insights, turning information into knowledge that drives meaningful actions. Achieving personalization extends beyond consumer-facing solutions to encompass business-to-business interactions. This personalized approach enhances not only consumer experiences but also facilitates efficient operations within the healthcare industry.
  4. The fourth, and final key theme involves adopting a platform approach that allows organizations to cultivate their internal ecosystems while fostering connections with external ecosystems. This aligns with regulatory objectives, emphasizing collaboration and interoperability across the healthcare landscape, “At the end of the day, this is really what the regulators want you to do.” – Jill DeGraff, SVP of Regulatory at b.well

In essence, behind these regulations lies a concerted effort by regulators to leverage policy levers to prioritize interoperability, often setting timelines and signaling market priorities. These efforts aim to drive standards that support longitudinal health records and place consumers at the forefront of healthcare initiatives.

Key Healthcare Regulatory Initiatives Shaping the Future

The Health Information Technology Advisory Committee (HITAC), an advisory committee of the The Office of the National Coordinator for Health Information Technology (ONC), released 34 recommendations in November aimed at integrating pharmacy interoperability standards into healthcare systems. This move addresses the lack of certified APIs for pharmacy data exchange, highlighting the importance of leveraging pharmacies for improved accessibility to care. The recommendations emphasize empowering pharmacists to operate at their full capacity within clinical teams, enabling real-time benefit checks for consumers, and facilitating seamless redirection of prescriptions to maximize value. Below are several key recent regulations.

Implementation of TEFCA

TEFCA (Trusted Exchange Framework and Common Agreement) went live in December, focusing primarily on query-based information exchange for treatment purposes. Although TEFCA’s initial phase has limitations, such as repetitive querying and processing burdens, its rollout marks a significant milestone towards network-based data exchange. Notably, the introduction of digital IDs under TEFCA enables individual access services, promoting patient-centered health information exchange and reducing the need for multiple logins across various APIs, eliminating “portalitis”.

ONC HTI-1 Final Rule Enhancements

The ONC final rule includes provisions to combat information blocking and promote API-based exchange on standardized platforms. Under these enhancements, data holders must offer API-based exchange methods compliant with ONC standards, fostering an evolving ecosystem centered around interoperability. DeGraff stated, “We’re always going to see this continued evolution of an API-based ecosystem, which is important for all of us, and it also puts an onus on any of the information actors to make sure that they have the data behind an API to support that transmission.” 

TEFCA Common Agreement v.2 Proposal

In January, we saw version 2 of TEFCA which represents a commitment made three years ago to initiate fire-based exchange over networks within TEFCA, although it’s not yet finalized. Alongside addressing numerous ecosystem enablers, such as record locator services and dynamic registration for API connectors, these developments mark significant milestones for advancing a connected health ecosystem reliant on interconnected applications through APIs. 

California Data Exchange Framework Mandate

The California Data Exchange Framework, now mandatory for healthcare organizations in the state, presents an intriguing comparison to TEFCA’s voluntary approach. As California often sets precedents for national standards, this mandatory framework could influence future regulatory developments. Similar to other statewide initiatives, such as the California Consumer Privacy Act, this framework may catalyze broader adoption of network-based data exchange practices, shaping the future of healthcare interoperability.

CMS Electronic Prior Authorization Rule

The CMS Electronic Prior Authorization Rule introduces mandatory provisions for provider access APIs and pair-to-pair APIs, building upon previous regulations regarding patient access to claims data. This initiative aims to alleviate administrative burdens, enhance efficiency, and reduce costs within the healthcare system. By streamlining prior authorization processes, CMS anticipates significant cost savings of potentially over $15 billion dollars, while benefiting providers, consumers, and payers alike.

Proactive Strategies of Market Leaders: Embracing Change Ahead of Regulation

Regulatory mandates serve as guiding beacons, urging stakeholders to navigate the complexities of healthcare interoperability. While timelines are provided for compliance, proactive engagement with established standards is encouraged to ensure seamless integration and alignment with evolving regulatory frameworks.

Learning from real-world examples can provide invaluable insights into the power of regulatory compliance. Take MultiCare, for instance, a healthcare organization that proactively implemented electronic prior authorization (prior auth) using open standards. By acting as early adopters, they achieved significant savings of $22 per prior auth on the provider side and $17 per auth on the payer side. Moreover, their throughput increased nearly tenfold, with at least 85% of requests approved within hours. This success story underscores the potential benefits of embracing change and implementing innovative solutions.

Another example of proactive strategy is evident in Utah’s OneUtah Health Collaborative, spearheaded by Spencer Cox, the governor of Utah. This initiative brings together stakeholders from across the healthcare industry to focus on improving affordability and health outcomes for Utahns. By fostering collaboration and shared goals, such initiatives demonstrate the power of collective action in driving positive change, “Are those the important values that you want to see move forward? It does take a village, in our case. Sometimes those villages can be established on a statewide basis. So I encourage you to all think about how you could pull your stakeholders in a region together to perhaps move these priorities forward,” said DeGraff. Utah’s collaborative effort extends beyond electronic prior auth, encompassing initiatives such as clinical data exchange, digital ID implementation, and public health interoperability. By prioritizing innovation and leveraging existing standards, Utah is not only meeting regulatory requirements but also laying the groundwork for future advancements in healthcare delivery and patient experience.

Having a Consumer-Centric Approach to Healthcare Regulatory

Market leaders recognize the importance of meeting consumer needs and preferences. At the heart of our journey towards healthcare interoperability lies a simple truth: consumers crave seamless, personalized healthcare experiences. Whether it’s accessing critical information or managing their health journey, consumers deserve a system that works for them, not against them. 

“Consumers don’t think of themselves as sick people. They don’t think of themselves as patients. They think of themselves as humans, and they want their fragmented experience with healthcare to end. So if you give them an exchange of value, they will contribute their data. Give them an opportunity to do that, not just in the health system, but beyond in their real life.” – Jill DeGraff

Take, for instance, the imminent enforcement by CMS on reducing long wait times, signaling a clear directive for healthcare providers to optimize their scheduling processes. Incorporating scheduling APIs into mandatory frameworks is not a distant possibility but a looming reality, demanding proactive adaptation.

In addition, recent initiatives like the Power for the Patients ad during the Super Bowl underscore the growing importance of price transparency and affordability in healthcare. Recognizing that a significant portion of the workforce, including gig economy workers, prioritize accessibility and pricing, emphasizes the urgent need for healthcare organizations to address these concerns. Legislative efforts with bipartisan support echo the necessity for action in this domain.

In light of these developments, let’s consider four actionable principles:

  1. Maximize Data Utilization: Interoperability isn’t just about pulling in data; it’s about leveraging robust infrastructure to enrich and utilize that information effectively. Establish systems that not only gather data but also analyze and enrich it to inform strategic decisions comprehensively.
  2. Prioritize Consumer-Centric Strategies: Consumers are at the heart of healthcare. Develop strategies that prioritize their needs and preferences, recognizing them not merely as patients but as individuals seeking seamless experiences. Engage with consumers proactively, offering personalized solutions that resonate with their expectations.
  3. Stay Ahead of Regulatory Mandates: Regulatory compliance is essential, but it shouldn’t be the sole driving force behind organizational initiatives. Anticipate future mandates and trends, positioning your organization as a proactive leader rather than a reactive follower. Embrace change and innovation to stay ahead of the curve.
  4. Forge Collaborative Partnerships: In the journey towards interoperability and consumer-centric healthcare, collaboration is key. Identify and engage with stakeholders across the healthcare ecosystem, forming alliances that foster innovation and drive progress. Whether through initiatives like OneUtah or other stakeholder communities, find your allies and work together towards shared goals.

By embracing these principles, organizations can navigate the evolving healthcare landscape with confidence, driving positive change and ultimately improving outcomes for consumers. The road ahead may present challenges, but with proactive strategies and collaborative efforts, we can build a healthcare ecosystem that truly serves the needs of all.

Navigating Healthcare Regulatory Waters Towards Interoperability with b.well

Mastering healthcare regulation is not merely about compliance; it’s about seizing the opportunities embedded within regulatory mandates to foster innovation and drive growth. By reframing regulations as guiding markers rather than obstacles, organizations can proactively shape their strategies to align with regulatory requirements while anticipating forthcoming trends. From the ongoing push towards shoppable healthcare to the continuous evolution of connected health ecosystems, regulatory signals serve as invaluable insights into the trajectory of healthcare. By prioritizing consumer needs, fortifying infrastructure, and embracing regulatory shifts, we can steer towards a future where healthcare is not only accessible but also truly transformative for all. 

Join us as we navigate the regulatory seas, propelled by a shared vision of a healthcare landscape that is connected, consumer-centric, and relentlessly innovative. Contact us today

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