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Analysis

Health IT Rules of the Road Must Be Clear, Senate Told

By MedPage Today  
   March 27, 2019

A Senate committee examines two proposed rules issued by CMS to make healthcare records more interoperable, including banning information blocking by health IT vendors or healthcare providers.

This article first appeared on Tuesday, March 26, 2019 in MedPage Today.

By Joyce Frieden, News Editor, MedPage Today

WASHINGTON -- The Trump administration should make its interoperability rules more clear and encourage increased use of technologies to improve patient matching in electronic health records, witnesses told a Senate committee Tuesday.

The Senate Health, Education, Labor & Pensions Committee hearing was aimed at discussing two proposed rules issued by the Centers for Medicare & Medicaid Services (CMS) as part of implementing the 21st Century Cures Act.

The rules address ways to make healthcare records more interoperable, including banning information blocking by health IT vendors or healthcare providers.

Committee chairman Lamar Alexander (R-Tenn.) pleaded in his opening statement for advice on enforcing these rules. "I also want to be aware of unintended consequences from these rules: Are we moving too fast?" he asked. "In 2015, I urged the Obama Administration to slow down the Meaningful Use program, which they did not do, and looking back, the results would have been better if it had."

Alexander also wondered whether the rules' standards for data elements were too rigid, and asked, "Is the door still open for bad actors to game the system and continue to information block?"

"I want to ensure these rules will make the problem of information blocking better, not worse," he said.

Christopher Rehm, MD, chief medical informatics officer at Lifepoint Health, a healthcare provider based in Brentwood, Tennessee, noted that one proposed rule "would require hospitals to send electronic notifications when a patient was admitted, discharged, or transferred" as part of the conditions of participation in Medicare and Medicaid.

"In order to comply with conditions of participation, providers must clearly understand the requirement and the objective compliance measure. This proposal lacks both of those elements, which is concerning given the tremendous penalties hospitals face for failing to comply with conditions of participation," he said.

Ben Moscovitch, Project Director for Health Information Technology at The Pew Charitable Trusts here, noted that "interoperability also requires health organizations to know they're communicating about the same person, [what's called] patient matching. When data are exchanged, records may not be matched up to half the time."

A study that Pew did with Indiana University in Indianapolis "revealed that the use of the Postal Service standard for addresses would increase match rates by approximately 3%, a significant improvement," he continued. "One technology developer said it would help their system match an additional tens of thousands of records per day."

"To improve matching, the ONC [Office of the National Coordinator for Health Information Technology] should specify use of the Postal Service standard for addresses and include other routinely collected elements like email addresses, which is already in half of [the] records but not used for matching," Moscovitch said.

Alexander asked the witnesses about data's role in interoperability, specifically, the data collected by medical devices. "The CMS rule focuses on getting patients' claims data, and claims today, for the millions of patients with implants, lack key information -- and that's the device identifier of the implant they have in their body," said Moscovitch. "CMS can close that gap by adding device identifiers to claims."

Mary Grealy, JD, president of the Healthcare Leadership Council, a broad industry coalition, focused on the rule's privacy aspects. "I would note that both proposed rules include changes to how patient health information is used and shared," she said. "These rules incorporate new, innovative products such as third party applications not currently covered by HIPAA [the Health Insurance Portability and Accountability Act]."

"We need to ensure a thoughtful approach on how entities currently subject to HIPAA share information with these new entities to ensure safeguarding of sensitive and valuable personal health information," said Grealy. "Any future legislation or rulemaking that addresses the electronic flow of identifiable health information should engender the same trust that HIPAA has done for these past 20 years."

Grealy also made another request: "Given the significant impact of these rules ... we're requesting ONC and CMS grant a 30-day extension of the comment period for the proposed rules." Alexander seemed sympathetic to that idea. "Your concern -- and it's a concern we share -- is allowing [time] for the implementation of standards," he said. "I think we'll hear from everyone that they'll want a bit more time."

Sen. Mitt Romney (R-Utah) wanted to know the practical effect of making healthcare information more interoperable. "Is the data being used to allow the patient to inform their life choices, so if a record indicates someone looks like they're at risk for developing diabetes, is this flagged by someone; are they seeing that?" he asked. "Are they given instruction on what type of foods they should be eating or what things they should be avoiding?"

Lucia Savage, JD, chief privacy and regulatory officer at Omada Health in San Francisco, said that one diabetes prevention program her company offers through the health plans it contracts with allows patients to use their smartphones to see their weight record, and food intake at any point in order to help them meet their health goals. "So in fact, when you can figure out the business relationship and the data relationships, that magic alchemy occurs," she said.

Sen. Patty Murray (D-Wash.), the committee's ranking member, emphasized the importance of focusing on patients' needs. "As we continue to improve our health IT system, we need to make sure health information is provided in a way that works for patients as well," she said, citing the example of a woman who took a pregnancy test but got her results back in the form of a hormone level, which wasn't helpful to her.

"Our objective should be to make sure technology companies are putting patients in the driver's seat, not the other way around."

“I want to ensure these rules will make the problem of information blocking better, not worse.”


KEY TAKEAWAYS

Lawmakers raise concerns about 'unintended consequences' of proposed rules changes.

Stakeholders say adopting Postal Service standard for addresses would increase patient match rates by 3%.

Senators seemed receptive to a call by stakeholders for a 30-day extension of the comment period.


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