Proposed rules on electronic health information met with early industry approval

Guidance would enable enforcement of information access for patients and provide more pressure on providers to achieve interoperability.


Monday’s release of proposed rules by the Department of Health and Human Services designed to improve healthcare IT interoperability have generated positive reactions from stakeholder groups.

The College of Healthcare Information Management Executives issued a statement that it supports policies ensuring interoperable electronic health information, noting that both the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health IT issued proposed rules simultaneously on Monday that deliver on provisions contained in the 21st Century Cures Act.

“Speeding interoperability and patient access to their records are priorities for our members,” said Liz Johnson, chief innovation officer at Tenet Healthcare and vice chair of the CHIME Policy Steering Committee. “CHIME appreciates that CMS and ONC are tackling these issues and looks forward to reviewing these new policies and responding thoughtfully.”

CMS Administrator Seema Verma said Monday that the two “ground-breaking rules” are part of a “digital data revolution” that will ensure patients have access to their medical records in a digitized format.

“Consumers routinely perform many daily tasks on their mobile phones—banking, shopping, paying bills, scheduling—using secure applications,” observed Verma. “We believe that obtaining their health information should be just as easy, convenient and user-friendly.”

According to Verma, the proposed rules build on CMS’s work over the past year on the MyHealthEData initiative—an effort to put patients in control of their own healthcare information—as well as the launch of Blue Button 2.0 in 2018, which she contends enables nearly 40 million Medicare beneficiaries to share their claims data in an application programming interface (API) format.

“Today, we are doubling down on our commitment to empower patients by requiring health plans to follow our lead in releasing claims data,” added Verma. “We have proposed that by 2020 all health plans doing business in Medicare, Medicaid, and through the federal exchanges be required to share claims and other health information with patients electronically through an API—and, allow those patients to take their information with them when they change plans.”

By requiring health insurers to share their information via an API, Verma estimated that 125 million patients will have access to their medical claims information electronically by 2020.

“We believe the proposed requirements on payers to make information such as claims or provider directories available through standard application programming interfaces has the promise to give patients better information about all of their care,” said Ashley Thompson, the American Hospital Association’s senior vice president for public policy analysis and development.

Matt Eyles, president and CEO of America’s Health Insurance Plans, said that healthcare payers are committed to establishing new, innovative ways to integrate and share data with patients and providers.

“AHIP and our members support seamless access to health information by providers and patients to make better choices about care and treatment,” said Eyles. “At the same time, it is essential that we also protect the privacy and security of patient health information. As we review the proposed rules, we will focus on ensuring it further protects patients, minimizes administrative burdens, and establishes clear data standards and operational protocols to put meaningful information into the hands of patients, providers and insurance providers.”

HHS Deputy Secretary Eric Hargan said the proposed rules from CMS and ONC represent “historic steps forward” which are critical to creating a healthcare system that pays for value instead of volume.

“We cannot build a value-based healthcare system without advanced health IT,” Hargan said.

Also See: Value-based payment impossible without interoperable health IT

“We propose requirements that will enable individual patients to securely and easily access their electronic health information, including by using applications on their smartphones,” added Hargan. “We’re doing this through ONC’s definition of information blocking exceptions, which should allow patients practical and secure access to their data—as well as having the requirements for the use of standards-based APIs. This will allow the developer community to move forward using common international healthcare standards that they understand and can use.”

CMS proposes that entities must conform to the same advanced API standards as those proposed for certified health IT in the ONC proposed rule, as well as including an aligned set of content and vocabulary standards for clinical data classes through the United States Core Data for Interoperability standard.

Don Rucker, MD, National Coordinator for Health IT, commented that ONC’s proposed rule is “highly synchronized” with the proposed CMS rule.

“We are requiring standards-based application programming interfaces—that is the underlying foundation of getting patients their medical records so they control it in a modern app, smartphone kind of way,” said Rucker.

Don Crane, president and CEO of America’s Physician Groups, applauded the release of ONC’s proposed rule on the use and exchange of electronic health information.

“This rule puts power back in the hands of patients by streamlining their ability to access health information literally from the palm of their hand,” said Crane. “Having this information readily accessible can help patients and providers make more informed choices about their care more quickly. And it can help preserve valuable healthcare resources by reducing waste, such as duplicate tests and unnecessary procedures.”

Verma declared during Monday’s conference call that through the two proposed rules HHS is officially putting an end to information blocking in healthcare.

“The days of holding patient data hostage are over,” she emphasized. “Our proposed rule includes a policy to publicly identify doctors, hospitals, and other healthcare providers who engage in information blocking. Simply put, we’re going to expose the bad actors who are purposely trying to keep patients from their own information. Patient data doesn’t belong to the doctor, hospital, or electronic health record. It belongs to the patient.”

Rucker pointed out that the information blocking provisions in the 21st Century Cures Act lay out specific penalties, which have generated a lot of industry interest but without specific exceptions have so far not been enforceable. However, he said that will change with the finalization of ONC’s proposed rule.

“The ONC rule puts in specific provisions for (information blocking) exceptions on privacy, security, and patient harm,” Rucker added.

“At first glance, we are pleased that ONC’s information blocking rule acknowledges in its exceptions the importance of promoting the privacy and security of electronic health information, which is a core tenet of the HIM profession,” said Wylecia Wiggs Harris, CEO of the American Health Information Management Association.

Joel White, executive director of Health IT Now, a coalition of patient groups, provider organizations, employers and payers, said that the proposed rules from HHS are a first step to ending the “shameful business practices” of bad actors blocking information.

“We will review them to ensure they are an honest attempt to end the business practices and technology issues confounding interoperability—but end they must,” said White. “If these rules do not achieve this end, we will be back. The future of healthcare depends on it."

When it comes to improving care coordination across healthcare settings, Verma noted that the CMS proposed rule requires Medicare- and Medicaid-participating hospitals to send patient event notifications (admission, discharge, and transfer) to another healthcare facility or to another community provider.

“The rule would go into effect in 2020,” concluded Verma. “This is a very important step in terms of improving patient safety and quality. When a patient is leaving the hospital, it’s important that their provider has all the necessary information about what happened in the hospital.”

However, Thompson commented that AHA cannot support including electronic event notification as a condition of participation for Medicare and Medicaid.

“We believe that CMS already has better levers to ensure the exchange of appropriate health information for patients,” she said. “We recommend the agency focus on building this exchange infrastructure rather than layering additional requirements on hospitals.”

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