By Stephanie Jamison, Executive Committee Chair and Public Policy Leadership Workgroup Vice Chair, EHR Association.
In the months that have passed since the Office of the National Coordinator for Health Information Technology (ONC) issued the final Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule, the health IT sector has been working diligently to meet the earliest compliance timelines even as it continues an in-depth analysis of the regulatory impact on both developers and the providers who use certified technology.
For the EHR Association, that analysis has given rise to several concerns and ambiguities that need to be addressed to ensure HTI-1, which was published in the Federal Register on Jan. 9, 2024, achieves ONC’s stated goal of advancing patient access, interoperability, and standards.
The new regulations are an important step toward implementing key provisions of the Cures Act and enhancing ONC’s Certification Program. However, there are several aspects of HTI-1 that we believe may have unintended consequences for certified EHR technology (CEHRT) developers and users.
The first deadline is Dec. 31, 2024. That is when CEHRT developers must deliver DSI capabilities to maintain certification. Achieving compliance will necessitate substantial development efforts, including in novel areas for the program like AI/ML for predictive DSIs. Other areas of concern include requirements for:
Developing an end-user feedback function for evidence-based DSIs, including an export capability for machine-readable formatted feedback data.
Developing support for a significantly expanded set of data concepts for which selection of evidence-based DSIs must be available.
Developing support for enabling the selection of predictive DSIs using any data expressed in the USCDI.
Producing nine new source attribute data points for all evidence-based DSIs supplied by developers and more than 30 source attribute data points for all developer-supplied predictive DSIs.
Developing support for customer users to access and modify source attribute information provided by developers for those DSIs they supply.
Developing support for enabling customer users to record and modify their own source attribute entries in the system for DSIs they create or implement on their own.
Developing detailed intervention risk management policies and procedures for ongoing management of predictive DSIs supplied by developers.
Meeting these requirements within the 12-month timeframe presents a formidable challenge for CEHRT developers – a challenge amplified by the lack of a certified companion or other resource guide to support developers with compliant updates. Also coming into play are current CMS requirements governing providers’ use of CEHRT that would force developers to deliver updated technology to their customers well in advance of the ONC deadline.
To alleviate these challenges, we are urging ONC to consider implementing an enforcement discretion period of six to 12 months. This would provide much-needed relief for CEHRT developers and healthcare providers alike, while still ensuring that meaningful progress is made toward real-world implementation of DSI provisions by the 2024 deadline.
By Andrew A. Brooks, M.D., chief medical officer, TigerConnect.
Information is the healthcare industry’s core, from paper to digital record keeping. Healthcare organizations and physicians have relied on charts, treatment plans and other means of records to provide the highest quality of care they can offer. In the 21st century, providers need unrestricted access to holistic data to streamline record-keeping, reduce costs, and better collaborate as treatment teams advance patient care. This access to vital information is becoming more critical as digital healthcare information rises along with the rise in EHR integration.
By current estimates, nearly 30 percent of the world’s data is being generated in healthcare – with no signs of slowing down, this figure is expected to reach 36 percent by 2025. According to a 2019 Centers for Disease Control (CDC) survey, almost 90 percent of office-based physicians responded that they are leveraging EHR systems in their office-based practice. Information availability is only part of the healthcare equation. Data accessibility and interoperability are another.
When roadblocks to information are present, it can create unnecessary challenges for hospitals and treatment teams to do their jobs. These challenges in treatment and care can lead to poor clinical communication and collaboration – reducing the quality of patient care and driving costs upward. In an industry such as healthcare, smooth communications are essential both between providers and patients as they attempt to navigate doctor’s offices, hospitals, and other care facilities. Unfortunately, interoperability and access to information aren’t easy.
Information Blocking and its Impacts on Patient Care
Information blocking often refers to the interference of access, use or exchange of electronic health information. In most cases, information blocking is caused by the use of proprietary technology systems that are unable to interoperate or communicate with one another. When information blocking does occur, patient data necessary for care can be sent or received in an untimely manner or can be transmitted inaccurately. The fact is that most electronic data is still locked in silos across disparate providers. According to a study reported on by the AJMC, nearly 75 percent of physicians feel they lack sufficient information about their patients. The demand for seamless access to healthcare information is one of the driving forces behind the 21st Century Cures Act – which expanded its scope in October.
The 21st Century Cures Act & The Power of Data to Improve Patient Care
When healthcare providers have access to data, they can dramatically improve patient care. This is why many are asking the Department of Health and Human Services (HHS) for additional clarity on new federal information blocking regulations set in motion in October.
The original 21st Century Cures Act held health IT vendors, providers, and health responsible for information exchanges to better provide patient access to health records with 3rd party applications – banning the blocking of health information sharing. But this applied only to a limited set of data. Under the expanded regulations, patients will get electronic access to their records without limitations. So, what do providers and patients need to know, and how can they better align with these new regulations?
The U.S. Department of Health and Human Services (HHS) today finalized two transformative rules that will give patients unprecedented safe, secure access to their health data. Interoperability has been pursued by multiple administrations and numerous laws, and today, these rules finally deliver on giving patients true access to their healthcare data to make informed healthcare decisions anPutting patients in charge of their health records is a key piece of giving patients more control in healthcare, and patient control is at the center of the Trump administration’s work toward a value-based healthcare system.d better manage their care.
The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act) and support President Trump’s MyHealthEData initiative. MyHealthEData is designed to empower patients around a common aim — giving every American access to their medical information so they can make better healthcare decisions.
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.
“President Trump is delivering on his vision for healthcare that is affordable, personalized, and puts patients in control. From the start of our efforts to put patients and value at the center of our healthcare system, we’ve been clear: Patients should have control of their records, period. Now that’s becoming a reality,” said HHS Secretary Alex M. Azar. “These rules are the start of a new chapter in how patients experience American healthcare, opening up countless new opportunities for them to improve their own health, find the providers that meet their needs, and drive quality through greater coordination.”
“Delivering interoperability actually gives patients the ability to manage their healthcare the same way they manage their finances, travel and every other component of their lives. This requires using modern computing standards and APIs that give patients access to their health information and give them the ability to use the tools they want to shop for and coordinate their own care on their smartphones,” said Don Rucker, M.D., national coordinator for health information technology. “A core part of the rule is patients’ control of their electronic health information which will drive a growing patient-facing healthcare IT economy, and allow apps to provide patient-specific price and product transparency.”
“The days of patients being kept in the dark are over,” said CMS Administrator Seema Verma. “In today’s digital age, our health system’s data sharing capacity shouldn’t be mired in the stone age. Unfortunately, data silos continue to fragment care, burden patients, and providers, and drive up costs through repeat tests. Thanks to the leadership of President Trump, these rules begin a new chapter by requiring insurance plans to share health data with their patients in a format suitable for their phones or other device of their choice. We are holding payers to a higher standard while protecting patient privacy through secure access to their health information. Patients can expect improved quality and better outcomes at a lower cost.”
These final rules deliver on the Administration’s promise to put patients at the center of their care by promoting patient access and use of their own health information and spurring the use of and development of new smartphone applications.
Addressing Interoperability and Information Blocking
The ONC Final Rule identifies and finalizes the reasonable and necessary activities that do not constitute information blocking while establishing new rules to prevent “information blocking” practices (e.g., anti-competitive behaviors) by healthcare providers, developers of certified health IT, health information exchanges, and health information networks as required by the Cures Act.
Currently, many EHR contracts contain provisions that either prevent or are perceived to prevent users from sharing information related to the EHRs in use, such as screen shots or video. The ONC final rule updates certification requirements for health IT developers and establishes new provisions to ensure that providers using certified health IT have the ability to communicate about health IT usability, user experience, interoperability, and security including (with limitations) screenshots and video, which are critical forms of visual communication for such issues.
The ONC final rule also requires electronic health records to provide the clinical data necessary, including core data classes and elements, to promote new business models of care. This rule advances common data through the U.S. Core Data for Interoperability (USCDI).
The USCDI is a standardized set of health data classes and data elements that are essential for nationwide, interoperable health information exchange. The USCDI includes “clinical notes,” allergies, and medications among other important clinical data, to help improve the flow of electronic health information and ensure that the information can be effectively understood when it is received. It also includes essential demographic data to support patient matching across care settings.
Unleashing Innovation & Patient Access
ONC’s final rule establishes secure, standards-based application programming interface (API) requirements to support a patient’s access and control of their electronic health information. APIs are the foundation of smartphone applications (apps). As a result of this rule, patients will be able to securely and easily obtain and use their electronic health information from their provider’s medical record for free, using the smartphone app of their choice.
Building on the foundation established by ONC’s final rule, the CMS Interoperability and Patient Access final rule requires health plans in Medicare Advantage, Medicaid, CHIP, and through the federal Exchanges to share claims data electronically with patients.
CMS took the first step towards interoperability by launching Medicare Blue Button 2.0 for Medicare beneficiaries in 2018. Medicare Blue Button 2.0 gives beneficiaries the ability to securely connect their Medicare Part A, Part B and Part D claims and encounter data to apps and other tools developed by innovators. Engagement and partnership with the technology community has involved more than 2,770 developers from over 1,100 organizations working in the Medicare Blue Button 2.0 sandbox to develop innovative apps to benefit Medicare patients.
Currently, 55 organizations have applications in production. Beginning January 1, 2021, Medicare Advantage, Medicaid, CHIP, and, for plan years beginning on or after January 1, 2021, plans on the federal Exchanges will be required to share claims and other health information with patients in a safe, secure, understandable, user-friendly electronic format through the Patient Access API. With more complete data in their hands, patients can be more informed decision makers leading to better informed treatment.
This Patient Access API will allow patients to access their data through any third party application they choose to connect to the API and could also be used to integrate a health plan’s information to a patient’s electronic health record (EHR). By requiring their relevant health information including their claims to be shared with them, patients can take this information with them as they move from plan to plan, and provider to provider throughout the healthcare system.
To further advance the mission of fostering innovation, the CMS final rule establishes a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another healthcare facility or community provider or practitioner when a patient is admitted, discharged, or transferred. These notifications can facilitate better care coordination and improve patient outcomes by allowing a receiving provider, facility, or practitioner to reach out to the patient and deliver appropriate follow-up care in a timely manner.
Additionally, CMS is requiring states to send enrollee data daily beginning April 1, 2022 for beneficiaries enrolled in both Medicare and Medicaid, improving the coordination of care for this population. This ensures beneficiaries are getting access to appropriate services and that these services are billed appropriately the first time, eliminating waste and burden. Beneficiaries will get the right services at the right time at the right cost, with no administrative burden to rebill services.
The American Health Information Management Association (AHIMA) sent a joint letter to Congressional leaders today voicing concerns that certain provisions of the Office of the National Coordinator for Health Information Technology’s (ONC’s) recent 21st Century Cures Act (Cures) proposed rule on information blocking jeopardizes goals to foster a healthcare system that is interoperable, patient-engaged and reduces burdens for those delivering care.
The letter, co-signed by seven organizations representing the nation’s clinicians, hospitals, health systems and experts in health informatics and health information management, outlines several recommendations aimed at furthering the objectives of Cures, while ensuring that the final regulations do not unreasonably increase provider burden or hinder patient care.
“We support the intent of the Cures Act to eradicate practices that unreasonably limit the access, exchange and use of electronic health information for authorized and permitted purposes that have frustrated care coordination and improvements in healthcare quality and efficiency,” said AHIMA CEO Wylecia Wiggs Harris, PhD, CAE. “However, in light of the lessons learned from the meaningful use program, we believe it is crucial that we get this right. We look forward to discussing the details of these recommendations with congressional staff and ONC.”
Recommendations outlined in the letter include:
Additional rulemaking prior to finalization: ONC should seek further input from impacted stakeholders on issues including modifying the information blocking proposal to ensure that the requirements and exceptions are well-defined and understandable, and clinicians, hospitals and health information professionals are not inappropriately penalized if they are unable to provide a patient’s entire electronic health information through an application programming interface (API).
Enhanced privacy and security: The proposed rule does not sufficiently address Cures’ directives to protect patient data privacy and ensure health IT security. It is imperative that the Committee continues its oversight of privacy and security issues that fall outside of the Health Insurance Portability and Accountability Act (HIPAA) regulatory framework. This includes ensuring certified APIs include mechanisms to strengthen patients’ control over their data—including privacy notices, transparency statements and adherence to industry-recognized best practices.
Appropriate implementation timelines: ONC should establish reasonable timelines for any required use of certified health IT (CEHRT). Providers must be given sufficient time to deploy and test these systems, which must take into account competing regulatory mandates.
Revised enforcement: The U.S. Department of Health and Human Services should use discretion in its initial enforcement of the data blocking provisions of the regulation, prioritizing education and corrective action plans over monetary penalties.
For additional information on these recommendations, click here.
Signatories of the letter include:
American Health Information Management Association (AHIMA)
American Medical Association (AMA)
American Medical Informatics Association (AMIA)
College of Healthcare Information Management Executives (CHIME)
Federation of American Hospitals (FAH)
Medical Group Management Association (MGMA)
By Scott E. Rupp, publisher, Electronic Health Reporter.
On March 21 HIMSS representatives vice president of government affairs, Tom Leary, and senior director of federal and state affairs, Jeff Coughlin, hosted a roundtable with members of the media to peel back a few layers of the onion of the newly proposed ONC and HHS rules to explain some of the potential ramifications of the regulations should they be approved.
The CMS proposed regulation is attempting to advance interoperability from the patient perspective, by putting patients at the center of their health care and confirming that they can access their health information electronically without special effort.
ONC’s proposed regulation calls on the healthcare community to adopt standardized application programming interfaces (APIs) and presents seven reasonable and necessary conditions that do not constitute information blocking.
According to HIMSS’s assessment of both proposals there’s room for interpretation of each, but the organization has not yet fully formed a complete response to each as of this writing.
Tom Leary
However, Leary said: “It’s important to emphasize that all sectors of the healthcare ecosystem are included here. The CMS rule focuses on payer world. The ONC rule touches on vendors and providers. All sectors really are touched on by these rules.”
With both, ONC and CMS is trying to use every lever available to it to push interoperability forward and is placing patients at center, Coughlin said. The healthcare sector got a taste of how CMS plans to empower patients through its recent MyHealthEData initiative, but the current proposal places more specifics around the intention of agency. Likewise, the ONC rule is attempting to define the value of the taxpayer’s investment in regard to the EHR incentives invested in the recent meaningful use program.
Key points of the rules
Some key points to consider from the rules: APIs have a role to play in future development of the sector and are seen as a real leveler of the playing field while providing patients more control of their information, Coughlin said.
HHS is focusing on transparency and pricing transparency. For example, there’s movement toward a possibly collecting charge master data from hospitals and, perhaps, publishing negotiated rates between hospitals and payers, which HHS is looking into.
Jeff Coughlin
What happens now that rules are out? According to HIMSS, education members is the first step to understanding it and responding to the federal bodies. “What we’ve done is focus on educating HIMSS members in briefings,” Coughlin said. “Trying to get early feedback and early impressions from members, convening weekly conference calls to address parts of the rule. Once we have critical mass then we work with executive leadership to make sure what we are hearing from membership to is reflected across the membership.”
Looking into the future?
For health systems, the broad exchange of data likely remains a concern. Data exchange within the ONC rule impacts providers and health systems in a number of ways, especially in regard to the costs of compliance to meet all of the proposed requirements.
HIMSS representatives are not currently casting a look into a crystal ball or if they are (they are), they’re not yet ready to tip their hand regarding what the organization intends to pursue through its messaging on behalf of its members.
“We’re not in a place to see where we are going to land,” Coughlin said. “We are hearing from our members about the complexities of rules and what’s included. It’s hard to overestimate how complex this is. ONC and CMS in designing broader exchange of information is something that speaks very well of them, but (this is) complex in interpretation and implementation.”
Information blocking exceptions, the default is broader sharing of information across the spectrum. More information has to be shared and expectations need to be defined, they said. From HIMSS’ perspective, compliance is the primary issue of its members. The question that needs answering is what kind of burden is being placed on health systems and providers. Leary is confident HIMSS will spend a good bit of ink in its response on citing potential concerns over information blocking and what that might mean.
“It will be helpful for the community to have examples and use cases for what’s included especially for exceptions for information blocking,” Coughlin said. “We need examples to clearly define the difference between health information exchange and health information network.”
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 Sequoia Project, a nonprofit dedicated to solving health IT interoperability for the public good, is launching a new workgroup for the Interoperability Matters cooperative focused on information blocking. Launched in October 2018, Interoperability Matters is a public-private cooperative, with member and public events focused on addressing the key remaining issues that hinder nationwide health IT interoperability. The initiative is open to broad private and public sector participation, and this new workgroup will collectively discuss, evaluate and comment on the information blocking requirements and exceptions outlined in the Office of the National Coordinator for Health IT’s (ONC) proposed rule published in the Federal Register on Monday, Mar. 4, 2019.
Mariann Yeager
“We’ve seen a seismic shift towards greater interoperability in the past three years. True, meaningful interoperability is expanding and hospitals and health systems across the country are beginning to share health records at an unprecedented level. But we can’t declare victory yet considering there are still barriers, including the practices that are perceived to impede information sharing,” said Mariann Yeager, CEO of The Sequoia Project. “We’ve reached a tipping point where discussions of interoperability – and the remaining interoperability challenges – are now mainstream and everyone wants a seat at the table. We’re happy to make room for more voices.”
Hundreds of volunteers came forward this winter to offer their expertise from across the entire healthcare continuum, including many organizations that have not previously worked with The Sequoia Project. The expansive interest illustrates the wide impact that the information blocking issue and associated regulations have on health systems, payers, technology vendors and patients.
During her trip to HIMSS19, Center for Medicare & Medicaid Service administrator Seema Verma spoke with registered members of the media to preview her keynote speech and answer questions about her department’s newly released proposed interoperability rule. The rule dictates that data generated by patients while in the scare setting is theirs to own, transfer and share with caregivers. It also would require healthcare providers and plans to implement open data sharing technologies to support transitions of care as patients move between these plan types.
In a statement released prior to her meeting with the media, Verma said that ensuring patients have easy access to their information, and allowing that information to follow them on their healthcare journey “can reduce burden, and eliminate redundant procedures and testing, thus giving clinicians the time to focus on improving care coordination and, ultimately, health outcomes.”
During her meeting with the media at HIMSS, Verma started by discussing CMS’ “why” — why CMS is moving toward enhanced patient empowerment – as well as her and the administration’s focus on the improving the sustainability of the healthcare community.
Patient empowerment remains front and center for the agency, she said. For example, from the patient perspective, everyone has their own experience of going to the healthcare system and not being an empowered patient, she said, and not having access to data decreases patient engagement. CMS is working to change that, now.
When people understand their health and participate in their health, this has the ability to improve care outcomes, she added, and through complete access to their healthcare records, patient care can be more complete. Ultimately, she said, with every detail of a person’s health information in one place — and accessible to the patient — will kick start the digital health data revolution.
On March 21 HIMSS representatives vice president of government affairs, Tom Leary, and senior director of federal and state affairs, Jeff Coughlin, hosted a roundtable with members of the media to peel back a few layers of the onion of the newly proposed ONC and HHS rules to explain some of the potential ramifications of the regulations should they be approved.
