The Cures Act Final Rule’s technical requirements call for radical changes in electronic Patient Health Information Exchange (ePHI). Care providers must adhere to the CoP requirements for patient event notifications (ADT Notifications) and the real-time exchange of ePHI through APIs in 2021. In addition, payer organizations must facilitate the electronic exchange of ePHI between other payers and healthcare providers through a patient access API. They must also provide patients with a list of care providers to choose from for medical services by compiling the provider directory API.
These technical requirements are driven by the CMS’s pursuit of seamless semantic interoperability of healthcare systems and the ONC’s specifications for 2015 requirements of Certified Electronic Health Record Technology. While they affect care providers and payers, health IT developers (HIT vendors) are the catalyst to facilitate the patient centric care.
HIT vendors must swing into action to adhere to their regulatory requirements and enable providers and payers to do so in the process. The stifling competition that is already upon them only lifts the normal for innovation and reflex time. HIT software development requires specialized skill sets and exhaustive processes that escalate costs. In a bid to rein in these costs and adhere to regulatory requirements, HIT developers tend to dilute their competitive edge.
While interoperability has always been one of healthcare’s greatest pain points, the last year or so has emphasized these challenges with the rising demand for data integration and information sharing. The pandemic has required high volumes of data integration, and it’s been difficult for organizations to adapt and respond in an effective and efficient way.
These challenges were further compounded this year with the impending ONC/CMS information blocking rules. With the previous administration’s focus on improving interoperability coinciding with a global health emergency, healthcare organizations had more on their plate than ever. As we look to the future of healthcare in a post-COVID environment, and to the new administration and its healthcare goals, what can healthcare organizations expect?
Healthcare organizations must remain flexible and optimize the organization to be as adaptable as possible. In our interview with Ivan, we explore what healthcare organizations should know about the information blocking rules and the new administration, what is really at the root of the healthcare interoperability problem, and best practices healthcare leaders can employ to set their organizations up for success now and in the future.
How would you define the healthcare interoperability problem?
Interoperability is an evergreen problem across the healthcare industry. As we continue to innovate new capabilities and concepts, we are also constantly expanding our interoperability needs. In a way, interoperability isn’t a problem to be solved. It’s an ongoing practice that has to evolve alongside our other capabilities. For example, there was a time not long ago when social determinants of health (SDoH) were not on anyone’s radar, but as SDoH became more important to healthcare practitioners, it was clear we needed not only to track and store SDoH-related data but also exchange that data across different software systems and organizations. The goal of HL7’s Gravity Project is to build out the standards for exchanging SDOH data using FHIR.
2020 was a tough year in healthcare. The demand for data integration was up, exposing the dire need for better data integration across the healthcare ecosystem. In a world where interoperability wasn’t an issue, how could the pandemic have looked different?
The bad news is that we live in a world where the most reliable COVID vaccination records are stored on paper cards and interoperability is achieved by the patient themselves carrying the card from place to place. In an ideal world, the vaccination would come with an electronic record that the patient could capture on their mobile device and upload to their doctor’s EHR system, their employer’s HR system, and any other third party that needed to see proof of vaccination.
Although we’ve fallen far short of the ideal state, there are some interoperability bright spots to be happy about. For example, we’ve been able to onboard many new sources of lab result data and integrate that into public health departments. This has not always been easy, but because of the ONC’s prior work on the Promoting Interoperability program, we already had agreed-upon standards and an infrastructure in place to move the data from location to location.
Over the course of my career, working in a variety of industries, I have developed certain design patterns when modeling data that guide my approach to tackling a new data domain. One simple example is how I choose the right data type for a given value an application will capture.
While it may sound straightforward, interesting nuances can quickly surface during the data modeling step that necessitate a shared language and vocabulary between the functional experts and the software engineers. In other words, we need to figure out how to work together and speak the same language in order to solve the problem well.
The importance of nuanced semantics may be illustrated with the example of how an anesthesiologist documents the administration of an antibiotic. . The type and timing of antibiotic administration is a key metric that anesthesia providers have historically had to report to Centers for Medicaid and Medicare Services (CMS) since it correlates with both patient outcomes and healthcare costs.
As I analyzed the paper anesthesia record used, I noticed an “antibiotics” checkbox, accompanied by an antibiotic name, an amount, a unit of measure, and the route of administration. These all made sense to me, and I proceeded to incorporate these concepts into my data model. For the antibiotics checkbox, I naively interpreted it as a simple boolean value, and I named it Antibiotics Administered Indicator. In my mind, that simply indicated that the antibiotic denoted on the form was either administered (true), or not administered (false).
During a review of the model, I learned that a clinician interprets this checkbox to mean an “indication for antibiotics”; in other words, antibiotics were or were not determined as a necessary course of action given other clinical conditions. A true value didn’t mean that antibiotics were administered, only that they were indicated, and thus needed to be given. That is obviously a completely different understanding than the one at which I had arrived. Needless to say, this was eye opening for me, even having been down the road of developing a functional understanding of data domains many times before.
The illustration highlights the importance of having both functional (i.e., the doctors) perspectives and technical perspectives present and engaged during software design. A purely technical survey of a subject area will certainly be valuable, and in some cases may provide decent coverage in terms of establishing a foundational understanding of that domain. In most cases, however, a functional perspective will also be required to complete the picture and add the necessary insight required to create an accurate and intuitive user experience.
In fact, healthcare may serve as the poster child for just how challenging, complex, and unforgiving software design can be. Clinician dissatisfaction and fatigue with existing electronic health report software is well documented, and the explanations are plentiful: failed interoperability, difficult user experience, inefficiency with simple tasks, onerous data capture burden, etc. Perhaps the common denominator is a failed understanding of complex and poorly defined clinical workflows being interpreted and standardized in software by technical experts working in isolation. The real issue here is that foundational errors propagate as the software evolves, and there is no easy way to reverse course once construction begins.
By Jerry Rankin, strategy director of healthcare interoperability, Infor.
The unrelenting if unpredictable movement of continental plates builds new mountain ranges and reshapes continents, but for the most part, we do not notice their progress. Such a shift has come to healthcare.
This spring two US Federal agencies, ONC and CMS, announced complimentary Final Rules, signaling tectonic movement in healthcare interoperability. These rules are very consequential for the industry, but while no one can claim that they went unnoticed, the industry has been understandably instead fixated on responding to the COVID-19 pandemic. In response, the federal agencies involved have pushed the implementation timelines back by roughly six months.
The Final Rules
On May 1, 2020, the ONC published a Final Rule implementing provisions of the 2016 21st Century Cures Act. Known in the industry as the “Information Blocking and Health IT Certification” Final Rule, the Provider and EHR focused rule requires developers of Certified Health Information Technology (e.g. EHRs) to make standard APIs available for the delivery of individual and population records, as well as defines the data set and transaction standards of the APIs to be United States Core Data Set for interoperability (USCDI) and FHIR, respectively.
In a parallel action, the CMS issued a ruling implementing provisions of the Cures Act, known as the “Interoperability and Patient Access Rule,” leveraging “Conditions of Participation” in Federal Health programs. The finalized rule requires payers to provide a Patient Access API which gives patients access to certain health data including personal data.
These rules represent an important federal nudge to the industry to move in the next few years to implement and adopt standard, digital friendly APIs for the exchange of key patient information, eliminate policies and practices of health IT vendors, providers and other data holders that constrain the free flow of healthcare data, and, importantly, bring payers and consumers into the interoperability discussion, enabling data to flow across the healthcare ecosystem.
These rules are just the tip of the iceberg, though. The industry has been hard at work for years developing the FHIR API standard, and there are abundant examples of voluntary industry led collaborations working to improve and streamline healthcare leveraging FHIR. For example, the HL7 Da Vinci Project sponsors collaboration among payers, providers and HIT vendors working to define standards-based implementations to improve some of the more costly workflows in the industry. In addition to adoption by traditional HIT vendors, even IT “gorillas” are adopting FHIR. We recently saw this with the launch of Microsoft Cloud for Healthcare which extensively leverages FHIR APIs and data standards.
What to expect for payers and providers?
Payers and providers and their health IT vendors have a great deal of work to do on a tight timeline to meet the requirements put in place and to simply keep up with the pace of change in the industry. Given the massive investment in and footprint of legacy systems, there is a vast amount of work to do to connect systems and data to the emerging FHIR API ecosystem.
In a public health report by the Centers for Disease Control (CDC), the state of the U.S. public health technology was likened to “puttering along the data superhighway in our Model T Ford.”
While the healthcare industry has talked about improving data interoperability with the noble goal of breaking down data silos to better coordinate care and turn data into information, the business of healthcare resisted meaningful change. The status quo that traps data in its silos helped to serve the interests of big, incumbent vendors by locking provider customers into their proprietary tech stacks. In turn, some providers believed they too could protect against patient leakage by holding medical data captive.
Data interoperability is stuck in the past
Even though patients have had, since 1996, a right to access their own information under HIPAA, the healthcare system made it really, really hard to obtain that data. Life Image recently conducted a survey of 1,300 patients and found that 40% of patients had to go to their provider’s office in person to submit requests for medical records. Additionally, 40% received those medical records on a CD, a 1980s technology that is obsolete in the modern consumer world.
In all other industries except healthcare, data requests, collection, storage and exchange are commonplace, and available at your fingertips at any hour and any day of the week. While patient satisfaction and convenience seemed to be worthwhile healthcare goals, they weren’t enough to drive significant, wholesale change and conversion from protectionism, managing resources to optimize the physician rather than the patient, or stubbornly persistent operational practices using CDs.
Nothing happens until something happens
The federal government recognized this inertia and promulgated a lengthy set of interoperability rules in March 2020. Just days later, the force and fury of COVID-19 started hitting the U.S. and created a public health emergency that exposed the significant operational risks and clinical dangers created by the lack of interoperability. Frictionless data sharing was no longer an existential threat. All of a sudden, the hazards became tangible.
The paradox is that COVID-19 has manifested the critical need for exactly what the new federal rules require: advancement of interoperability and digital online access to clinical data and imaging, at scale, for care coordination and infection control. Now more than ever, healthcare needs to be able to digitize, visualize, virtualize, and curate all types of medical data at scale including diagnostic and pathology information without physical exchange. No more CDs, no more faxes, no more film or slides.
Not just data – advanced data
COVID-19 is a respiratory illness with corresponding impacts to the heart, liver, kidney and other organs. People with underlying health conditions such as obesity, diabetes, chronic lung disease and cardiovascular disease appear to be at higher risk for hospitalization and death. Out of the 122,653 U.S. COVID-19 cases reported to CDC, only 5.8% of patients had data available pertaining to underlying health conditions or potential risk factors.
Advanced data such as imaging data are critical to diagnosis, treatment, recovery, and post-care monitoring. The typical structured data found in an electronic health record (EHR) or claims data are easier to access but have limited clinical value. With chronic or complex conditions, advanced data such as medical imaging, pathology and genomics are critical components of the longitudinal patient record that must be easily accessed and shared. However, imaging data has historically been among the most technically challenging to exchange.
While the industry has made some gains in imaging interoperability between large tertiary hospitals and their primary referral sites, patient sharing of digital images online is dismally small.
By Mike Sutten, chief technology officer, and Dr. David Nace, chief medical officer, Innovaccer.
Burdensome documentation and gaps in care have been long-standing challenges in the healthcare industry.
The COVID-19 pandemic has amplified those challenges on a global level, creating a situation in which people have been hesitant to seek care for other medical concerns. As such, healthcare providers are losing revenue, employees are losing their jobs, and those remaining in the workforce are subject to burnout.
In an effort to prevent the spread of COVID-19, many healthcare providers proactively reduced or stopped in-person visits for non-COVID-19 medical needs, ranging from the routine care of a sore throat to treatment of chronic conditions, cancer, and even mental health services.
Additionally, nearly one-third of American adults reported delaying or avoiding medical visits over concerns for possible exposure to the virus, according to an American College of Emergency Physicians and Morning Consult poll. More than half reported worrying about access to their primary care physician or being turned away from the hospital.
As a result, healthcare spending decreased by 18% in the first quarter of 2020, according to the U.S. Bureau of Economic Analysis. Surprisingly, some 1.4 million healthcare workers lost their jobs in April, a sharp increase from the 42,000 reported in March, according to the U.S. Bureau of Labor Statistics.
The global pandemic amplifies the day-to-day challenges of identifying gaps in care, the increased documentation required to track them, and the difficulties associated with determining their effects and responding with appropriate interventions.
The impact of this virus looms over the backdrop of a healthcare environment in which the American Hospital Association (AHA) makes the point is rapidly evolving from a fee-for-service system into a value-based delivery system. As healthcare providers and payers transition to collaborative digital care delivery models, this movement highlights the greater need for a data infrastructure that supports value-based care with sharper and more transparent insights into population health.
Healthcare interoperability and enhanced information sharing continued to improve healthcare quality, safety and cost for U.S. patients and providers, according to the Surescripts 2019 National Progress Report. The nationwide health information network processed 19.15 billion secure transactions in 2019, while connecting 1.78 million healthcare professionals and organizations with actionable patient data for 95% of the U.S. population.
“With the COVID-19 pandemic impacting patients and providers across the globe, a trusted nationwide health information network has never been more critical,” said Tom Skelton, chief executive officer of Surescripts. “In 2019, doctors, nurses, pharmacists and others across the Surescripts Network Alliance made remarkable progress transforming interactions with patients and driving significant improvements in care quality, safety and costs.”
In 2019, healthcare professionals saw the benefits of leveraging actionable patient information to enhance the prescribing process with greater automation, improved workflows, and increased price transparency. For example:
In 2019, prescriber enablement for e-prescribing reached 79%, with 1.79 billion e-prescriptions filled, bringing the rate of e-prescribing to 80% of all prescriptions.
The number of e-prescriptions filled for controlled substances reached 134.2 million, representing 38% of controlled substance prescriptions—up 12% from the year prior, with 49% of prescribers enabled for the technology.
The volume of real-time benefit checks at the point of care increased by 336% with more than 250,000 prescribers using the service (a 233% increase).
Electronic prior authorizations increased by 132%, driven by a 58% increase in provider adoption of the tool.
Further, clinicians accessed actionable patient insights to obtain a more complete picture of their patients’ care histories and make more informed care decisions. For example:
Surescripts delivered 2.18 billion medication histories, a 19% increase, while use of Medication History for Populations increased nearly 200%.
Record Locator & Exchange delivered 333.8 million links to clinical document locations and 143.2 million documents listing where patients had previously received care. Nearly 136,000 clinicians used the service—a 28% increase in 2019.
In 2019, more than 648,000 individuals and organizations sent 37.7 million Clinical Direct Messages (a nearly 20% increase from 2018).
In the midst of this significant progress, Surescripts maintained network-wide uptime of approximately 99.999%, maintained HITRUST CSF Certified status for privacy, security and risk management practices, improved the networkwide Quality Index Score for e-prescription accuracy by 10%, and helped migrate most of the network to the National Council for Prescription Drug Programs’ (NCPDP) new e-prescribing standard (SCRIPT Standard Version 2017071).
As COVID-19 closes in the on U.S., the need for longitudinal health data and interoperability have never been greater. Providers need access to the full picture of every patient they treat, and epidemiologists need to consolidate data from multiple sources to track the spread of the disease and determine where more aggressive containment strategies need to be employed.
For many organizations already overwhelmed, fragmented systems lead to an infrastructure bottleneck, resulting in degraded data quality, gaps in care coordination, medical errors and burdensome workflows. Lack of comprehensive medical data impairs a provider’s ability to know how many people have the virus, the geographical location of confirmed cases, and the effectiveness of treatment.
Even as capacity restrictions force organizations to work without barriers—via drive-thru screenings, make-shift tents or by way of telehealth—real-time access to data can help streamline care management, whether fast tracking admissions or empowering patients at home through online portals.
Here are just five ways data interoperability plays a pivotal role in addressing the epidemic:
Coordination of Care: COVID-19 provides a sobering reminder of just how dire an integrated, scalable and interoperable healthcare infrastructure is. Coordination among first responders, public health officials, labs, acute and post-acute facilities will be critical to efficiently deal with the explosion of cases. Insurers will also be a key player of the care coordination team as to not slow down or hold up prior authorizations and patient discharges. Access to information about hospitalizations and test results among healthcare participants will be vital for enhanced continuity of care across settings and transitions. Real-time data afforded by interoperability bypasses the need for phone calls and faxes, which create delays and information inaccuracies.
Patient Identification: A complete view of one’s medical history can be a matter of life or death in the face of COVID-19. Bringing disparate medical records together into a cohesive story enables those on the frontlines insight into an individual’s pre-existing medical conditions, medications, allergies, etc. to make the most informed decisions under insurmountable circumstances. Patient demographics and data standardization play a huge role. Accurate patient identification ensures data about an individual is correctly linked, updated and shared, for improved clinical decision-making and enhanced care quality and safety. As health officials look to track and predict the spread of the virus. A complete view of the patient population can only be done with a firm understanding of the patient’s identity, and the key relationships the patient has to their next of kin and to their providers of care.
On Mar. 9, 2020, the U.S. Department of Health and Human Services (HHS) finalized “two transformative rules that will give patients unprecedented safe, secure access to their health data.” Issued by the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), the Final Rules implement interoperability and patient access provisions of the 21st Century Cures Act and support President Trump’s MyHealthEData initiative.
In its release announcing the Final Rules, HHS noted that together “these final rules mark the most extensive healthcare data sharing policies the federal government has implemented, requiring both public and private entities to share health information between patients and other parties while keeping that information private and secure, a top priority for the Administration.”
Cures Act Final Rule implements the interoperability provisions of the 21st Century Cures Act, passed by Congress in 2016 to promote patient control over their own health information while still allowing providers to choose the IT tools that let them provide the best care for patients without excessive costs or technical barriers.
Specific to patient matching, the Cures Act Final Rule adopts as standard the first version of the United States Core Data for Interoperability (USCDI v1), making its use a requirement as part of the new application programming interface (API) certification criterion.
According to ONC, adoption of the USCDI standard “supports improved patient matching through the exchange of USCDI and its patient demographic data elements.” The Final Rule integrates additional data elements to the patient demographics data class to improve patient matching:
Phone Number Type
“Any improvement strategy must include data standardization and promote a more consistent, comprehensive collection of patient data at all entry points,” said Karen Proffitt, MHIIM, RHIA, CHP, vice president of industry relations and chief privacy officer, Just Associates. “The Final Rule requirement for adoption of USCDI standards, including historical data and more relevant data elements such as phone number and email address, represents a significant step toward improving interoperability and minimizing MPI errors overall.”
Interoperability and Patient Access Final Rule gives patients access to their health information when they most need it, in a way they can best use it. It is focused on driving interoperability and patient access to health information by leveraging CMS’s regulatory authority over Medicare Advantage, Medicaid, CHIP, QHP issuers and FFEs to free patient data.
Specific to patient matching, which was one of two requests for information included within the proposed rule, CMS noted that while “accurate patient identity management is critical to successfully delivering the right care to the correct patients,” patient matching challenges are beyond the scope of the current rule. However, the comments provided will be taken into consideration for potential future rulemaking.
“As a healthcare community, we must recognize the critical role improved data capture and MPI data quality play in enabling patients to have more comprehensive access to their health information by ensuring complete and accurate data is available for viewing or transmitting,” said Proffitt.
She adds, “any process to incorporate patient verification of data along the way could be very beneficial.”
At the AHIMA19: Health Data and Information Conference, leaders in health information management (HIM) shared innovations in healthcare and addressed issues affecting patient access to their health records including the privacy, accuracy and interoperability of that information.
The annual meeting for the American Health Information Management Association (AHIMA), AHIMA19, also highlighted inspiring stories of perseverance, empowerment and shared details of AHIMA’s global leadership.
Patient advocate Doug Lindsay shared his gripping story of transitioning from a wheelchair to walking again; Alexandra Mugge, deputy chief health informatics officer at the Centers for Medicare & Medicaid Services (CMS), outlined the benefits of interoperability and patient access; healthcare innovators pitched their ideas to a panel of experts for a $5,000 prize; and exhibitors and industry speakers shared their spectrum of knowledge with attendees gathered from across the globe.
Nearly three thousand HIM professionals gathered for the annual conference in September, held at Chicago’s historic McCormick Place, the largest convention center in North America.
Information and Inspiration
Speakers addressed clinical documentation, data ownership, patient access to their medical records, interoperability and cybersecurity. These presentations provided important insights and updates on technology to help HIM professionals continue leading the industry in improving healthcare and changing lives.
Mugge told the crowd that interoperability and greater access to medical data is integral to improving healthcare outcomes for payers, patients, and providers.
“We believe electronic data exchange is the future of healthcare, and interoperability is the foundation of value-based care,” Mugge said. “Patients should know that the way they interact with the healthcare industry is changing. Patients are no longer passive participants in their care, they now have the ability to be empowered consumers of the healthcare industry through access to data that puts them in the driver’s seat to make the best and most informed decision about their health.”
Mugge assured attendees that privacy and security safeguards would remain in place as HIM professionals help shape the landscape of interoperability.
Lindsay found his own way to improve his health, seemingly against all odds. He was bedridden and home-bound for 11 years because of a debilitating illness that forced him to drop out of college at 21 years old.
Although Lindsay’s body was limited, his mind was strong and he was determined to walk again, and to live again.
That determination led Lindsay to create a surgery for what he learned was bilateral adrenal medullary hyperplasia. He then assembled a team of experts to perform the surgery, which eventually led to his recovery.