FOR IMMEDIATE RELEASE
March 9, 2020
March 9, 2020
Contact: HHS Press
Office
202-690-6343
media@hhs.gov
202-690-6343
media@hhs.gov
HHS Finalizes Historic Rules to Provide
Patients More Control of Their Health Data
Final rules require access to health
information, spur innovation and aim to end information blocking
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 and better manage their care. Putting
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.
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.
For more information on the ONC final rule,
please visit: https://healthit.gov/curesrule.
For more information on the CMS final rule,
please visit: https://www.cms.gov/newsroom/fact-sheets/interoperability-and-patient-access-fact-sheet.
To view the CMS final rule, please visit: https://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index.
To view the ONC final rule, please visit: https://healthit.gov/curesrule.
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Last revised: March 9, 2020
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Last revised: March 9, 2020
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