The U.S. Department of Health and Human Services (HHS) today issued for public comment draft two of the Trusted Exchange Framework and Common Agreement (TEFCA) that will support the full, network-to-network exchange of health information nationally. HHS also released a notice of funding opportunity to engage a non-profit, industry-based organization that will advance nationwide interoperability.
Specifically, the documents being released for comment are: (1) a second draft of the Trusted Exchange Framework (TEF), (2) a second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange, and (3) a first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHINs and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks.
Alex Azar
“The seamless, interoperable exchange of health information is a key piece of building a health system that empowers patients and providers and delivers better care at a lower cost,” said HHS Secretary Alex Azar. “The 21st Century Cures Act took an important step toward this goal by promoting a national framework and common agreement for the trusted exchange of health information. We appreciate the comments and input from stakeholders so far and look forward to continued engagement.”
In developing a TEFCA that meets industry’s needs, HHS’ Office of the National Coordinator for Health Information Technology (ONC) has focused on three high-level goals:
Provide a single “on-ramp” to nationwide connectivity;
Ensure electronic information securely follows you when and where it is needed; and
Support nationwide scalability for network connectivity.
ONC will maintain the TEF, while a non-profit, industry-based organization, known as the Recognized Coordinating Entity (RCE), will be awarded funds to develop, update, implement, and maintain the Common Agreement. Through this effort, ONC will define the minimum required terms and conditions needed to bridge the current differences among data sharing agreements that are preventing the flow of electronic health information. The industry-based RCE will be tasked with developing additional required terms and conditions necessary to operationalize the Common Agreement and meet the interoperability requirements of the 21st Century Cures Act.
The FDA released guidance last year noting that electronic health records (EHRs) have the potential to improve clinical trials, leading to greater safety and efficacy. But tapping that potential, according to the agency, requires interoperability — the ability of two or more products, technologies or systems to 1) exchange information, and 2) to use the information that has been exchanged without special effort on the part of the user.
The healthcare industry, driven by meaningful-use requirements, is focused on wider efforts to promote interoperability. Many of them emphasize technology, including advances such as Fast Healthcare Interoperability Resources (FHIR) tools and Substitutable Medical Applications, Reusable Technologies (SMART) standards. But while the technology is crucial, it is equally as important to recognize the group of stakeholders who could play a critical role in making systems more interoperable, and thus improve the clinical trials process:
The patients themselves.
Interoperability
Interoperability has the potential to help increase care coordination, improve safety, support patients in making the most informed healthcare decisions, reduce costs, and help public health and health promotion efforts. In addition, interoperability can have a role in drug development, as the 21st Century Cures Act mandates that the FDA include Real-World Data (RWD) — data gathered during routine clinical care – in regulatory decision making. This RWD can be in part derived from the EHR-generated data, standardized and shared through the interoperability process.
The growing availability of information (digital health data is increasing by 48 percent each year) creates the potential for better patient care, including improved clinical trials. Unfortunately, despite strides made in interoperability, data in medical records are still too often packaged in ways (i.e., handwritten notes and medical device feeds) that are hard to share or standardized.
On Tuesday, March 26, the Senate health committee will hold a hearing on implementation of the electronic health information provisions in the 21st Century Cures Act.
In the Cures Act, Congress took steps to help improve the exchange of electronic health information. Last month, the Department of Health and Human Services (HHS) released two rules to define information blocking—so it is clear when one system is purposefully not sharing information with another—and to give patients more control over their records and providers more information so they can better treat their patients. This hearing will be about the proposed new rules and efforts to improve electronic health records and make health information more accessible.
Chairman Lamar Alexander (R-Tenn.) said of the new proposed rules: “These proposed rules remove barriers and should make it easier for patients to more quickly access, use, and understand their personal medical information. It should also unleash new ways of helping doctors and other medical providers to make sense of that information in ways that lead to better health care experiences, better outcomes, and lower costs for patients. Our committee will continue careful oversight of these new rules which affect almost every American and are an important result of the bipartisan 21st Century Cures Act.”
The Senate health committee had six hearings in 2015 to explore ways to get our nation’s system of health information technology out of a ditch and make it useful for doctors and patients. The committee then authored the 21st Century Cures Act which directed HHS to make proposals to improve electronic health records.
The 2019 HIMSS Annual Conference may be over, but that doesn’t mean an end to the pressing challenges and trends discussed at Orlando’s Orange County Convention Center. More than 42,500 people attended the conference — the majority of whom were C-suite executives and HIT professionals taking full advantage of the healthcare IT industry’s largest opportunity for networking, product promotions, continuing education and major announcements.
As always, there were a few subjects during HIMSS19 that generated significant buzz. Here are four of those trends that will remain key topics throughout the next year:
Healthcare data exchange
The release of two long-anticipated proposed rules on information blocking came just as HIMSS19 convened. The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) unveiled proposals that would require healthcare providers and plans to implement open data sharing technologies to support transitions of care. The first focuses on standardized application programming interfaces (APIs) and carries forward provisions from the 21st Century Cures Act.
Those associated with Medicaid, the Children’s Health Insurance Program (CHIP), Medicare Advantage and Qualified Health Plans in the federally-facilitated exchanges would have to provide patients with immediate electronic access to medical claims and other health information by 2020. Under a latter proposal, health information exchanges (HIEs), health IT developers and health information networks (HINs) can be penalized up to $1 million per information blocking violation, but providers are not subject to fines.
The goal of the proposals is to consider care across the entire continuum, giving patients greater control and understanding of their health journeys. This is interesting, given that HIMSS attendees who responded to Stoltenberg Consulting’s seventh annual HIT Industry Outlook Survey noted “lack of system interoperability” as one of their biggest operational burdens, and “leveraging meaningful patient data” as the IT team’s most significant hurdle this year. Thus, overcoming these challenges to meet the newly proposed mandates will likely dominate discussions during the remainder of 2019.
The Department of Health and Human Services (HHS) filed its annual year-end report to Congress at the start of 2019. The 22-page report summarized nationwide trends in health information exchange in 2018, including the adoption of EHRs and other technologies that support electronic access to patient information. The most interesting takeaway has to do with the ever-elusive healthcare interoperability.
According to the report, HHS said it heard from stakeholders about several barriers to interoperable access to health information remain, including technical, financial, trust and business practice barriers. “These barriers impede the movement of health information to where it is needed across the care continuum,” the report said. “In addition, burden arising from quality reporting, documentation, administrative, and billing requirements that prescribe how health IT systems are designed also hamper the innovative usability of health IT.”
To better understand these barriers, HHS said it conducted multiple outreach efforts to engage the clinical community and health IT stakeholders to better understand these barriers. Based on these takeaways, HHS said it plans to support, through its policies, and that the health IT community as a whole can take to accelerate progress: Focus on improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate, and move their health information using their smartphones (or other devices) and healthcare providers can easily send, receive, and analyze patient data; increase transparency in data sharing practices and strengthen technical capabilities of health IT so payers can access population-level clinical data to promote economic transparency and operational efficiency to lower the cost of care and administrative costs; and prioritize improving health IT and reducing documentation burden, time inefficiencies, and hassle for health care providers, so they can focus on their patients rather than their computers.
Additionally, HHS said it plans to leverage the 21st Century Cures Act to enhance innovation and promote access and use of electronic health information. The Cures Act includes provisions that can: promote the development and use of upgraded health IT capabilities; establish transparent expectations for data sharing, including through open application programming interfaces (APIs); and improve the health IT end user experience, including by reducing administrative burden.
“Patients, healthcare providers, and payers with appropriate access to health information can use modern computing solutions (e.g., machine learning and artificial intelligence) to benefit from the data,” HHS said in its report. “Improved interoperability can strengthen market competition, result in greater quality, safety and value for patients, payers, and the healthcare system generally, and enable patients, healthcare providers, and payers to experience the promised benefits of health IT.”
Interoperability barriers include:
Technical barriers: These limit interoperability through—for example—a lack of standards development, data quality, and patient and health care provider data matching. Addressing these technical barriers by coordinating to establish the technological foundation for standardizing electronic health information and by promoting exchange of that information can considerably remove these barriers.
Financial barriers: These relate to the costs of developing, implementing, and optimizing health IT to meet frequently changing requirements of health care programs. The cost to adjust health IT to meet these requirements can impact innovation and the timeliness of technical upgrades. Specific barriers include the lack of sufficient incentives for sharing information between health care providers, the need for enhanced business models for secondary uses of data, and the current business models for health systems or health care providers that do not adequately focus on improving data quality.
Trust barriers: Legal and business incentives to keep data from moving present challenges. Health information networks and their participants often treat individuals’ electronic health information as an asset that can be restricted to obtain or maintain competitive advantage.
Elsewhere, the Center for Medical Interoperability, located in Nashville, Tenn., is an organization that is working to promote plug-and-play interoperability. The center’s members include LifePoint Hospitals, Northwestern Memorial Healthcare, Hospital Corporation of America, Cedars-Sinai Health System, Hennepin Healthcare System, Ascension Health, Community Health Systems, Scripps Health, and UNC Health Care System.
Its mission is “to achieve plug-and-play interoperability by unifying healthcare organizations to compel change, building a lab to solve shared technical challenges, and pioneering innovative research and development.” The center stressed that the “lack of plug-and-play interoperability can compromise patient safety, impact care quality and outcomes, contribute to clinician fatigue and waste billions of dollars a year.”
More interoperability barriers identified
In a separate study, “Variation in Interoperability Among U.S. Non-federal Acute Care Hospitals in 2017,” showed additional difficulty integrating information into the EHR was the most common reason reported by hospitals for not using health information received electronically from sources outside their health system. Lack of timely information, unusable formats and difficulty finding specific, relevant information also made the list, according to the 2017 American Hospital Association (AHA) Annual Survey, Information Technology Supplement.
Among the explanations health systems provided for rarely or never using patient health information received electronically from providers or sources outside their health system:
Difficult to integrate information in EHR: 55 percent (percentage of hospitals citing this reason)
Information not always available when needed (e.g. timely): 47 percent
Information not presented in a useful format: 31 percent
Information that is specific and relevant is hard to find: 20 percent
Information available and integrated into the EHR but not part of clinicians’ workflow: 16 percent
Hospitals, when asked to explain their primary inability to send information though an electronic exchange, pointed to: Difficulty locating providers’ addresses. The combined reasons, ranked in order regardless of hospital classification (small, rural, CAH or national) include:
Difficult to find providers’ addresses
Exchange partners’ EHR system lacks capability to receive data
Exchange partners we would like to send data to do not have an EHR or other electronic system to receive data
Many recipients of care summaries report that the information is not useful
Cumbersome workflow to send the information from our EHR system
The complexity of state and federal privacy and security regulations makes it difficult for us to determine whether it is permissible to electronically exchange patient health information
Lack the technical capability to electronically send patient health information to outside providers or other sources
Additional Barriers
The report also details other barriers related to exchanging patient health information, citing the 2017 AHA survey:
Greater challenges exchanging data across different vendor platforms
Paying additional costs to exchange with organizations outside our system
[Need to] develop customized interfaces in order to electronically exchange health information
“Policies aimed at addressing these barriers will be particularly important for improving interoperable exchange in health care,” the report concluded. “The 2015 Edition of the health IT certification criteria includes updated technical requirements that allow for innovation to occur around application programming interfaces (APIs) and interoperability-focused standards such that data are accessible and can be more easily exchanged. The 21st Century Cures Act of 2016 further builds upon this work to improve data sharing by calling for the development of open APIs and a Trusted Exchange Framework and Common Agreement. These efforts, along with many others, should further improvements in interoperability.”
What healthcare leaders are saying about interoperability
While HHS said it conducted outreach efforts to engage health IT stakeholders to better understand these barriers, we did too. To further understand what’s currently going on with healthcare interoperability, read the following perspectives from some of the industry’s leaders. If there’s something more that you think must be done to improve healthcare interoperability, let us know:
Following the release of its proposed new rules designed to improve the interoperability of electronic health information, members of leadership from the Centers for Medicare & Medicaid Services (CMS) hosted a call to provide additional detail about the proposed rule, and to answer questions from the media. The following includes the key takeaways from the officials hosting the call.
Seema Verma
Seema Verma, Administrator, CMS
CMS shares a commitment with patients to obtain and share their health data.
The proposed rules ensure patients have access to their records in digital format.
We are “unleashing” data for research and innovation while tackling what might be the greatest healthcare challenge in our history, including the potential upcoming healthcare cost crisis that could destroy the US economy.
MyHealthEData unleashes innovation and focuses on results.
CMS is doubling down by requiring health plans to release claims data. All health plans in Medicare, Medicaid and that have plans within the federal exchange must allow for information be shared so patients can take their records with them when they move on.
Through these efforts, more than 125 million patients will have access to health information and be able to take information with them.
We are putting an end to information blocking and will publically identify doctors, hospitals and others who engage in information blocking.
Patient data doesn’t belong to doctor, but to the patient.
We’re putting the patient at the center of healthcare data. The time of keeping patients in the dark to trap them in systems so that they can never leave are over.
We are empowering patients to understand their healthcare information.
This rule allows patients to aggregate their data in one place through APIs/apps – putting the data in one place to help them understand it. They can organize the information, create care reminders, take data for the next provider when they go to a new provider.
This allows for aggregation of data in one place; physicians no long need to duplicate tests, for example.
Patients can donate their data for research, if they so desire, possibly opening up new wave of innovation of development.
Don Rucker
Don Rucker, MD, National Coordinator for Health Information Technology (ONC)
Through this rule, ONC has put the technical underpinnings asked for in the 21st Century Cures Act.
Provisions have been made for security and privacy for patients.
Information blocking has not be enforceable until now.
Interoperability is technically there, but pricing strategies were not effective, but this proposed rule changes that.
This strikes a role for transparency – and helps lead toward providing information about what patients are buying and they are getting for a certain cost.
Getting transparency in pricing is very complicated, primarily because of decades of previous regulation.
Eric D. Hargan
Eric Hargan, deputy secretary, HHS Office of the Secretary
These proposals contain a number of historic measures designed so that individual patients can securely access their health records.
We believe empowering patients with this access will build an ecosystem that improves individual care and provides access to healthcare.
This also should reduce the burden on providers.
We can’t built a vale-based healthcare system with these rules.
By John Cunningham, marketing and sales director, myGeoTracking.
John Cunningham
On December 2016, the 21st Century CURES Act was signed into law, resulting in new regulations for the home health industry. The CURES Act mandates the use of electronic visit verification, or EVV, for all Medicaid-funded personal care services. On Jan. 1, 2019, these new federal requirements for EVV went into effect for personal care services.
EVV is a method of utilizing electronic technology to capture point of service information related to the delivery of in-home services, such as:
Type of service performed
Individual receiving the service
Date of the service
Location of service delivery
Individual providing the service
Time the service begins and ends
Types of EVV
There are three ways through which Home Health Care provider companies can comply to the new regulations involving CURES Act. Let’s take a closer look at them.
Biometric recognition
This type of EVV solution uses a dedicated hardware device which is used to record caregiver’s scan of fingerprints or record voice samples to register visits.
Biometric recognition may seem like a good solution to comply with EVV at first, but this system has some drawbacks. These devices are expensive and each care recipient has to have a dedicated biometric device installed on their premises. It can be an inconvenience to both the business and the patient.
Telephony
Telephony method is commonly used in the home setting and don’t require the companies to install or service any devices. To record a visit with this method, the caregiver uses a recipient’s landline phone to dial a toll-free number at the start and completion of service delivery.
Based on a recent National Health Interview Survey (NHIS), it was found that almost half of the US household do not have a landline and are rapidly losing relevance. Smartphones have taken over and landlines are becoming obsolete. The decline of landlines makes this option historical and therefore a weak contender as an effective EVV solution.
Mobile technology (phone and tablets)
The modern EVV solution for all types of caregivers uses the app on the mobile devices, specifically smartphones and tablets. Most modern mobile devices have GPS for location-based Electronic Visit Verification via GPS tracking and geofencing.
Smartphones and tablets are constantly evolving and are becoming more powerful, and with increasing affordability of key technologies like mobile apps, sensors and cloud technology, the mobile technology offers to be the most future-proof EVV option.
Mobile technology EVV solutions go far beyond simple proof of visit. These more comprehensive solutions frequently combine mobile applications with back-office portals, providing additional functionalities:
The Department of Health and Human Services (HHS) filed its annual year-end 
