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.
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.
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.
“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.
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, 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, MD, National Coordinator for Health Information Technology (ONC)
Guest post by Abhinav Shashank, CEO and co-founder, Innovaccer.
P.J. Carter in a blog explained how the lack of interoperability resulted in extreme physical pain to his father who had to go into an eye surgery for the repair of a detached retina. His father was told by his eye specialist that and an urgent operation had to carried out. The operation began, but doctors could not access the past medical record of his father. Since doctors were unaware of the medical history, they had to carry out a painful operation of the eye without anesthesia! His father was awake the whole time and had to endure the pain.
Healthcare industry is lagging the most when it comes to advancements. There have been innovations, but equal implementation has been lacking. The cost of care has risen to over $10,000 per person in the US because there is huge expenditure on various digital infrastructures, but not for the meaningful use of them.
Interoperability and Its Types
Interoperability is a term that has no single definition. In broad terms, interoperability is the ability of systems and devices to exchange vital information and interpret it. For healthcare, interoperability is the ability of computer systems in hospitals to communicate, share critical information and put it to use to achieve quality health services delivery.
There are three levels of health information technology interoperability:
1) Foundational: This is the most basic level of interoperability. In this tier, the health information systems are equipped to transmit and receive data, but the HIT system on the receiving end may not be decked up to interpret that information.
2) Structural: The middle level, structural interoperability defines how the data exchange will take place. Structural interoperability is all about how data should be presented in pre-described message standards. This tier is critical to interoperability as it allows a uniform movement of health information from one system to another, avoiding the alteration and promoting the security of data.
3) Semantic: Semantic interoperability is the third tier, and at the top of the communications pyramid. The highest level of interoperability, it provides the systems the ability to exchange data and make use of the information. The message is received in an encoded format and which is later normalized. This normalization of data pushes health IT systems to close in on the technology gaps and create a common platform for secure, uninterrupted machine-to-machine communication.
Scope of Interoperability
There has been a dramatic increase in population, and with that came the need to manage population health. The amount of information increased exponentially with the use of EMRs. They helped in storing the increasing information, but sharing was still doubtful.
In 2005, only about 30 percent of the entire group of office-based physicians and hospitals used basic EHRs which increased to 75 percent for hospitals by the end of 2011. The state of Indiana now connects more than 10 million patients across 80 hospitals, and about 18,000 physicians use this data.
How long until 100 percent interoperability?
It has been accepted that health care, as a single entity, faces challenges in the exchange of information. Even the pioneer EHR vendors admit that although they have some complex connections established, not all of them were successful. According to a report, less than half the providers were satisfied with the way their information exchange was taking place. Stakeholders involved have always been concerned that EHRs, even the ones for Meaningful Use 2, are unable to share data effectively.
In the latest ONC report, it was mentioned that if all the providers were to come down to a common consensus, there happen to be two barriers on the road to complete interoperability. One, discord on how data should be transmitted. Second, a lack of proper infrastructure which is equipped enough to transmit data nationwide. It is very critical that the technology being used is updated and standardized to ease the flow of patients’ vital information to avoid any probable mishap.
Persisting Problems in the Path of Interoperability
1) Inadequate Standards
More often than not even after collecting patients’ data, it cannot be passed on to the members of the healthcare community because of lack of the appropriate standards. Most of the times it happens that two systems trying to exchange data are using a different version of standards. This is because there are varying standards and numerous version for which providers aren’t equipped.