ONC, CMS leaders tell Senate HELP Committee: Time is of the essence for new rules
More than a month after its first hearing on the health IT and interoperability provisions of the 21st Century Cures Act, the Senate HELP Committee Hearing reconvened on Tuesday to ask federal policymakers about the way forward for patient and physician data access.
National Coordinator for Health IT Donald Rucker, MD, alongside Kate Goodrich, MD, director of the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services, sat before the committee to answer questions.
They spoke on topics ranging from IT-enabled opioid management, to the health privacy implications of smartphones and consumer genetic testing sites, to the technical challenges of data segmentation of for record sharing.
But the main thrust of the discussion had to do with patient empowerment, interoperability, EHR usability and the prevention of information blocking. Both ONC and CMS have proposed rules aimed at tackling those long-standing challenges, but Committee Chair Sen. Lamar Alexander, R-Tennessee, still urged the agencies to take a slow and deliberate approach.
"My major concern is to remind the administration of the advice my piano teacher used to tell me before a recital: Play it a little slower than you can play it, you're less likely to make a mistake," said Alexander.
Having realized through his work on the 21st Century Cures Act that the meaningful use program had left "our electronic health record system was in a ditch," the senator was nonetheless convinced, he said, that "the best way to get to where you want to go is not to go too far, too fast. We want the fewest possible mistakes and least confusion – we don't need to set a record time to get there."
Still, Alexander's committee colleague, freshman Senator Mike Braun, R-Indiana, took aim at a healthcare industry he said had been foot-dragging for far too long.
"As a conservative, and as a Main Street entrepreneur, I lay the burden not here in the Senate but on the industry itself," said Braun. "When you're making it so difficult to get simple things like interoperability, when you're talking about blocking of information, that is so far out of the mainstream of other industries."
His warning to healthcare: "Get with it. Or you're going to be changed radically by all kinds of approaches that are out there, based upon frustration. You're the only industry out there where the people who buy stuff aren't engaged with it."
That state of affairs, which Braun blamed on the "paternalistic evolution of healthcare," has led to an industry filled with "smart individuals and big corporations who have figured out how to take advantage of it." That's not good for patients, he said, and "has got to change."
For their part, Goodrich and Rucker said CMS and ONC are working in earnest to do just that.
"A core principle for everything we do at CMS is that consumers need to be in the driver's seat," said Goodrich.
Rucker, described ONC's goals with its rulemaking, which envisions a near future where patients are empowered with new tools to combat "asymmetry of information" – where "platforms use raw data to provide consumers with digestible price information through their preferred medium such as an online tool or smartphone app."
The proposed rule "absolutely puts healthcare in a competitive place it hasn't been in 50 years," he said – not least through its repeated emphasis on open APIs, which "have transformed business after business after business" in other sectors of the economy.
"Today, much of American healthcare remains complex and opaque," Rucker conceded, but said that 21st Century Cures, alongside these new advances in computing will "allow us to revisit many assumptions about what medical care can be; ONC's proposed rule and TEFCA serve as major steps to make care more accessible, transparent and affordable."
He cautioned, however, that "the promise of standards-based API technology can only be successful if current business practices that enable information blocking to occur are dismantled."
That's why it's critical – despite Sen. Alexander's caution to slow down a bit – that info blocking rules be put into place as soon as possible.
"To the extent that this is delayed or prevented, the American public is not in charge of their healthcare, they're paying more for their care, they're not getting as good care as they could get, and fundamentally they're not in control of their care," said Rucker.
And that's to say nothing of the needless drag on tech innovation: "We've heard vendors are charging over $1 million to startups to get that data," he said. "That obviously stops innovation in its tracks."
Goodrich said CMS too sees the wide-ranging value of open APIs, and recognized that their potential is only fully realized when they're in as wide use as possible.
That's why the agency has launced the MyHealthEData initiative and its Blue Button 2.0 project, and why it's proposing to require that Medicare Advantage plans, Medicaid fee-for-service and managed care plans, CHIP plans and qualified health plans on the Federal Exchange maintain secure APIs that enable enrollees to easily gain access to their own health information.
"It is critical for patients to have access to their data," she said. "Our proposed rule is to lower the burden and ensure that, for plans that do business with CMS, aggregate that information and make it available through an API. We've seen a lot of interest in this technology, and Medicare beneficiaries wanting to access their data through our Blue Button 2.0. We really hope developers will take our lead and build on that, while maintaining the highest levels of privacy and security."
The hearing also touched upon the continuing uphill battle for better EHR usability, with Sen. Tim Kaine, D-Virginia, citing Dr. Atul Gawande's much-discussed New Yorker article, "Why Doctors Hate Their Computers."
Goodrich pointed to CMS' recent work on reducing physician burden. Too much clinical documentation has been "a big pain point," she admitted.
"We've bundled all kinds of payment and policy into the EMR," Rucker agreed. But that early thinking – "let the EMR take care of it" – has led to those critical clinical systems becoming "a little bit of a wastebasket for various things," he said.
"I went into this business to automate things," said Rucker. "It is a source of personal embarrassment that after 30 years in the field, computers generate more work for me when I practice. I wouldn't have guessed it when I graduated in 1988 from computer science school after my residency. But we have a lot of incentives that are not in the right place."
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