BREAKING NEWS: HHS/ONC and CMS Finalize Two Rules Around Interoperability and Information Blocking

March 9, 2020
On Monday morning, senior federal healthcare officials announced the release of two rules around interoperability and information blocking, rules long awaited by the industry

On Monday morning, March 9, senior healthcare officials from the Trump administration announced the release of two rules around interoperability, coming from the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS), and from the Centers for Medicare & Medicaid Services (CMS). In a telephonic press briefing, Alex Azar, Secretary of HHS; Seema Verma, CMS Administrator; and Donald Rucker, M.D., National Coordinator for Health IT, announced the release of the final rules.

They were introduced by Joe Grogan, Assistant to the President, and Director of the Domestic Policy Council, who initiated the telephonic press briefing by stating that the release of these two rules is connected to President Trump’s broader attempt to make the healthcare system more accountable and transparent to consumers. The two new rules clarify issues around information blocking, as defined by the administration, and promote the development of a nationally consistent patient access API (application programming interface) concept, designed to make access to their electronic health records (EHRs) available to all patients through their smartphones.

The rules, which were originally proposed over a year ago, apply to all hospitals, physicians, and health plans that receive any reimbursement through either the Medicare or Medicaid programs. Rucker noted that the feds got more than 2,000 public comments on the rules over the last year.

The press release that was published by HHS as the press briefing was initiated, began thus:

“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 release quoted Rucker as stating that “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. 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,” Rucker said in his statement.

The press release also quoted Administrator Verma as stating that “The days of patients being kept in the dark are over. 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.”

ONC rule specifics

In terms of the specifics, the press release noted that “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.”

It continued, “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.”

Notably, while there were originally seven proposed exceptions to information blocking, as outlined by ONC last year, federal health officials added an eight in its final version—a “Content and Manner Exception,” which according to ONC, “addresses a broad range of comments we received about the required content and manner of an actor’s response to a request to access, exchange, or use EHI. Under the exception, it will not be information blocking for an actor to limit the content of its response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI, provided certain conditions are met. This exception supports innovation and competition by allowing actors to first attempt to reach and maintain market negotiated terms for the access, exchange, and, use of EHI.”

Health care providers, health IT developers of certified health IT, health information exchanges, and health information networks do not have to comply with the information blocking provision until six months after publication of the final rule.

Further, “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.” 

In general, most implementation timelines related to elements such as EHR updates and API-related requirements will go into effect starting in two years from when the rule is published in the Federal Register, which Rucker said will be next week.

The press release goes on to state, “ONC’s final rule establishes secure, standards-based API requirements to support a patient’s access and control of their electronic health information. 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.

The ONC rule in total is more than 1,200 pages in length, and a handy document highlighting the key changes from the proposed to the final version can be seen here.

CMS drops final rule, too

Building on the foundation established by ONC’s final rule, the CMS Interoperability and Patient Access final rule, nearly 500 pages long, requires health plans in Medicare Advantage, Medicaid, CHIP, and through the federal Exchanges to share claims data electronically with patients.

According to agency officials, “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.”

The announcement added, “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.”

And, the press release states, “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 press release notes, “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.”

Following their announcement of the new rules, Azar, Verma and Rucker responded to a number of questions from the press. Some were technical, but one was broader. Andrew Feinberg, a reporter for Breakfast Media, addressing Secretary Azar and Administrator Verma, said, referring to President Trump, “You’re both on the coronavirus taskforce. This morning, the President has blamed the media, trashed [Senate Minority Leader Chuck] Schumer, has been posting tweets on the deep state, on fake news. He seems to be focused on those things and you guys are introducing this rule, which doesn’t take effect until 2022. Meanwhile, the Dow [Jones stock market index] is down 1,900 points now, 17 percent. How should Americans have any confidence that your administration is focusing on this outbreak, while you guys are focusing on this and the president is off tweeting?”

“The Vice President’s leading a whole of government approach,” Azar responded, “and we’ve been very transparent with our efforts.” Among the numerous elements he mentioned were “restrictions on travel and travel advisories, making historic advances on vaccine and other development, a focus on making personal protective equipment” more widely available, and, “we’ve had our healthcare providers alerted from day one on this. We’ve got over 2 million tests” out in the field, he added. “ We’ve unleashed regulatory reform. We are working aggressively on community mitigation efforts in Seattle, in California, and in Florida. And we’ve secured an $8.3 billion emergency supplemental. So this whole of government is enacting response plays the president put in place in 2017. So this is a very serious issue. The risk to any individual American remains low,” he added, “but we’ve been very candid about older Americans or those with compromised immune systems. So, we’ve taken a very aggressive whole of government approach. And the notion that we can’t do our day jobs and focus on this very serious issue is absurd. We’re taking a very serious approach to COVID-19.”

Verma added, “As we are working through this whole of government response…interoperability is very important. Imagine patients affected by this; it helps the doctors and the patients if they have complete medical records,” particularly as patients are released from hospitals. Interoperability “just makes the system work better,” she said.

Initial comments from the field

Some immediate reactions to the release of the two rules were positive. Kenneth Mandl, M.D., lead and chair of the SMART Health IT project run out of Boston Children’s Hospital, tweeted this: “It took a village. New HHS rule ensures an app written once will run anywhere in the healthcare system and  patients can access a computable copy of their medical record.” He added that this journey began more than a decade ago when he and Zac Kohane, M.D., Ph.D., chair of the Department of Biomedical Informatics at Harvard Medical School, proposed a healthcare API in the New England Journal of Medicine.

Meanwhile, the Washington, D.C.-based NAACOS—the National Association of Accountable Care Organizations—released a statement attributed to its president and CEO, Clif Gaus, Sc.D.—that was very positive. “Today’s requirement from CMS that hospitals share electronic notifications of patient’s admission, discharge, and/or transfer is a win for better population health management,” Gaus said. “With this change, ACOs can learn when one of their patients enters or leaves the hospital, allowing that patient’s primary clinician to step in and provide appropriate, well-coordinated care. We are grateful CMS listened to our request to add patient visits to the emergency department as part of its new requirements. For our health system to move to one that rewards value and supports alternative payment models, providers must be given appropriate data about their patients, and this includes alerts on hospitalizations.”

Further, Gaus’s statement added, “NAACOS was a strong supporter of this requirement when CMS proposed it last year and is pleased to see this important rule finalized. NAACOS thanks CMS Administrator Seema Verma, for creating this vital change. While we continue to review the final rules released today, our health system needs better patient-data sharing to help move to a value-based payment system.”

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