The Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the HHS Office of Inspector General (OIG) announced a policy of enforcement discretion to allow compliance flexibilities regarding the implementation of the interoperability final rules announced on Mar. 9, 2020, in response to the coronavirus disease (COVID-19) public health emergency. ONC, CMS, and OIG will continue to monitor the implementation landscape to determine if further action is needed.
“ONC remains committed to ensuring that patients and providers can access electronic health information, when and where it matters most. During this critical time, we understand that resources need to be focused on fighting the COVID-19 pandemic. To support that important work and the information sharing efforts we are already seeing, ONC intends to exercise enforcement discretion for 3 months at the end of certain ONC Health IT Certification Program compliance dates associated with the ONC Cures Act Final Rule to provide flexibility while ensuring the goals of the rule remain on track.” – Don Rucker, MD, National Coordinator for Health Information Technology.
“Today’s action follows the extensive steps CMS has taken to ease burden on the healthcare industry as it fights COVID-19. Now more than ever, patients need secure access to their healthcare data. Hospitals should be doing everything in their power to ensure that patients get appropriate follow-up care. Nevertheless, in a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19. Our action today will provide hospitals an additional 6 months to implement the new requirements.” – Seema Verma, CMS Administrator
This report describes examples of electronic health record (EHR) related burden, as well as strategies and recommendations that HHS and other stakeholders can use to help clinicians focus their attention on patients rather than paperwork, when they use health information technology (health IT).
“Usable, interoperable health IT is essential to a healthcare system that puts the patient at the center, like President Trump has promised,” said HHS Secretary Alex Azar. “We received feedback from hundreds of organizations and healthcare providers on this new burden-reduction strategy, and the input made clear that there are plenty of steps still necessary to make IT more usable for providers and maximize the promise of electronic health records.”
The development of the report, required under the 21st Century Cures Act, was led by the HHS Office of the National Coordinator for Health Information Technology (ONC) in conjunction with the Centers for Medicare & Medicaid Services (CMS). The initial draft, issued in November 2018, represented HHS’s assessment and response to feedback heard from a wide variety of health IT stakeholders, from practicing clinicians to health IT developers.
The report released today reflects additional input from the more than 200 comments submitted in response to the draft strategy and recommendations. The report outlines three primary goals and offers recommendations to:
Reduce the effort and time required to record information in EHRs for health care providers when they are seeing patients;
Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and
Improve the functionality and intuitiveness (ease of use) of EHRs.
“The strategy we are releasing today takes a hard look at ways that the federal government and stakeholders can work together to reduce the administrative and technological burdens experienced by healthcare providers,” said Don Rucker, M.D., national coordinator for health IT. “Patients will benefit from these efforts because their physicians will spend more time focused on them instead of their keyboards.”
Specifically, ONC and CMS looked at four key areas and offered strategies to address each area:
Clinical documentation
Health IT usability (or ease of use of health IT tools and systems)
Federal health IT and EHR reporting requirements
Public health reporting (including coordination with prescription drug reporting programs and electronic prescribing of controlled substances).
Seema Verma
“The taxpayers made a massive investment in EHRs with the expectation that it would solve the many issues that plagued paper-bound health records,” said CMS Administrator Seema Verma. “Unfortunately – as this report shows – in all too many cases, the cure has been worse than the disease. Twenty years into the 21st century, it’s unacceptable that the application of Health IT still struggles to provide ready access to medical records – access that might mean the difference between life and death. The report’s recommendations provide valuable guidance on how to minimize EHR burden as we seek to fulfill the promise of an interoperable health system.”
The report explains that different types of administrative burden can affect different healthcare providers, but is focused on those healthcare providers that are directly involved in delivery of patient care. Those may include physicians, nurses, and other clinical staff; practice managers and other administrators immediately engaged in the management of care delivery; and care delivery institutions, such as hospitals.
The U.S. Department of Health and Human Services (HHS) released the draft 2020-2025 Federal Health IT Strategic Plan for public comment. The draft plan outlines federal health information technology (health IT) goals and objectives to ensure that individuals have access to their electronic health information to help enable them to manage their health and shop for care. The strategic plan was developed by the HHS Office for the National Coordinator for Health Information Technology (ONC) in collaboration with more than 25 federal organizations.
“The draft federal strategic plan supports the provisions in the 21st Century Cures Act that will help to bring electronic health information into the hands of patients through smartphone applications,” said Don Rucker, M.D. “We look forward to public comment to help guide the federal government’s strategy to have a more connected health system that better serves patients.”
The federal agencies that helped to create the draft strategic plan regulate, purchase, develop, and use health IT to help deliver care and improve patient health. Through these efforts, stakeholders such as providers, payers, and researchers are increasingly using health IT tools and systems that can provide individual patients access to their health information, provide for tracking and managing of their health care treatments, and allow for interactions with their healthcare providers. These can include the use of:
Electronic health records and patient portals through programs like Medicare and Medicaid at CMS, and health service programs at the Indian Health Service, Veterans Administration, and the Department of Defense,
Data systems to help monitor and pay for health care services, and
Health IT systems used for public health surveillance and research.
“The Federal Health IT Strategic Plan represents the work being done, collectively and individually, to help ensure that patients and their providers can electronically access the health information they need to help them manage their care,” said Lauren Thompson, interoperability director for the Federal Electronic Health Record Modernization Program Office. “We are looking for public comment about ways to expand the use of health IT to help improve the quality of care for people, so that those currently serving in or retired from the armed forces can benefit from a great care delivery experience, along with all other Americans.”
The final 2020-2025 strategic plan will serve as a roadmap for federal agencies and drive private sector alignment. Agency officials will use it to prioritize resources, align and coordinate efforts across agencies, signal priorities to the private sector, and benchmark and assess change over time.
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.
DirectTrust announces that it has received accreditation by the American National Standards Institute (ANSI) to develop DirectTrust Standards to enhance healthcare interoperability and identity using Direct exchange and trust frameworks. DirectTrust also issued a call for industry stakeholders to participate in the development of DirectTrust Standards.
DirectTrust is a non-profit health care industry alliance created to advance the electronic sharing of protected health information (PHI) between provider organizations, and between providers and patients, for the purpose of improved transitions of care, care efficiency and coordination, patient satisfaction and reducing healthcare cost. ANSI coordinates, facilitates and promotes the development of voluntary consensus standards that are relied upon by the industry, government agencies and consumers across the United States and around the world. DirectTrust began the ANSI application process in 2018 and received notice of accreditation on March 26, 2019.
Scott Stuewe, DirectTrust president and CEO said, “DirectTrust and the Direct Project have always had a consensus approach to standards development. We’re thrilled to achieve this milestone of ANSI accreditation to ensure standards we establish to foster interoperability are consistent with the ANSI goals of transparency and balance.”
National Coordinator for Health Information Technology, Don Rucker, M.D., added, “In 2010 the Office of the National Coordinator for Health IT initiated the Direct Project as a new option for the secure exchange of electronic health information. DirectTrust’s accreditation by ANSI is an important step forward for this decade-long public-private effort to advance interoperability nationwide.”
The DirectTrust Standards mission – to develop standards and specifications that enable and promote healthcare interoperability using Direct exchange and trust frameworks – grew from voluntary discussions and workgroup meetings that began in 2011 among stakeholders eager to develop standards suitable for the growth such an exchange approach. From its inception, the Direct Project was structured as a consensus-based standards development organization with participation from and the sanction of the Health and Human Service Office of the National Coordinator but with no affiliation with an accrediting authority. More information about DirectTrust Standards can be found at www.DirectTrust.org through selection of the Standards menu.
Call for Participation
DirectTrust also issued a “call for participation” for the Direct Standard Consensus Body, a group of industry stakeholders that will be created to develop standards while conducting discussions in according with ANSI requirements. Participation in DirectTrust Standards is open to any person or company that has a direct and material interest within the respective scope of the work of Standards development. DirectTrust membership includes eligibility for participation in Standards activities. Non-members interested in participation can visit bit.ly/DTParticipateStandards to complete an application.
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.
As part of the ongoing efforts to strengthen the relationship between patients and their doctors, the U.S. Department of Health and Human Services (HHS) issued the 
DirectTrust announces that it has received accreditation by the American National Standards Institute (ANSI) to develop DirectTrust Standards to enhance healthcare interoperability and identity using Direct exchange and trust frameworks. DirectTrust also issued a call for industry stakeholders to participate in the development of DirectTrust Standards.
