WASHINGTON -- Patients would have access to their electronic health records free of charge and would be able to transfer them more easily from one provider to another under rules proposed Monday by the Department of Health and Human Services (HHS).
"These proposed rules strive to bring the nation's healthcare system one step closer to a point where patients and clinicians have the access they need to all of a patient's health information, helping them in making better choices about care and treatment," HHS Secretary Alex Azar said in a statement. "By outlining specific requirements about electronic health information, we will be able to help patients, their caregivers, and providers securely access and share health information. These steps forward for health IT are essential to building a healthcare system that pays for value rather than procedures, especially through empowering patients as consumers."
The rules were issued jointly by the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS). "For the first time, CMS is now proposing requirements that Medicaid, the Children's Health Insurance Program, Medicare Advantage plans and Qualified Health Plans in the federally facilitated exchanges must provide enrollees with immediate electronic access to medical claims and other health information electronically by 2020," the agency noted.
Although the proposed rule on record-sharing focuses on Medicare Advantage plans, Medicaid managed care plans, and health insurers who are offering plans through the Affordable Care Act's health insurance exchanges, "there is nothing that prohibits private insurers to allow this sharing of data for their private patients as well," CMS Administrator Seema Verma told MedPage Today. "And we feel like, because they're building it for these three very significant programs which [serve] 125 million patients overall, that this is going to have such a large impact -- and they're already going to be making the investment -- so they should be able to offer this to their privately insured patients as well."
Plans also would have to use "open data-sharing technologies" to help patients maintain access to their records when they change insurers. "By ensuring patients have easy access to their information, and that information follows them on their healthcare journey, we can reduce burden, and eliminate redundant procedures and testing thus giving clinicians the time to focus on improving care coordination and, ultimately, health outcomes," the statement noted.
CMS also plans to publicly report providers and hospitals that participate in "information blocking" -- not releasing health records or other information to providers who don't use the same electronic health record system. "The days of holding data hostage are over," CMS administrator Seema Verma said on a phone call with reporters. "Data doesn't belong to doctors, hospitals, or electronic health records. It belongs to patients."
Under the proposed rules, providers would have to attest to whether they are information-blocking or not, Verma explained. "They're answering a Yes or No question on this, and if they answer Yes ... we will be publishing that data." In addition, those who do block information will be subject to penalties already delineated under the 21st Century Cures Act, including civil monetary penalties and CMS payment penalties, said Don Rucker, MD, who heads the ONC. He noted that the information-blocking rules would apply to all providers using electronic health records, not just those reimbursed by public programs like Medicare and Medicaid.
To further encourage sharing of patient health records, the proposed rules ask the healthcare industry to adopt standardized application programming interfaces (APIs), which will help patients to get their health information using smartphones and other mobile devices. "Consumers routinely perform many daily tasks on their mobile phones using secure applications" for things like banking and shopping, Verma said. "We believe obtaining health information should be just as easy and consumer-friendly."
The rules would also require health plans to make provider directories available via an API, including timely updates to that data, for most plans covered by CMS programs, Verma said.
The ability to maintain their records through multiple providers will help both patients and clinicians, Verma said.
"Today, some providers make information available through a patient portal, but if you're going to multiple providers, you're essentially consulting with multiple patient portals. What this allows the patient to do is to aggregate all that data; because it's going to be in API format, they can take that information and potentially aggregate that into one place ... They can also take that data when they go see the next doctor, and say, 'Here's my entire healthcare record,'" so doctors will have a more complete patient history and won't have to duplicate tests, she said.
HHS "put in a lot of provisions to ensure security and privacy for patients, in that work to get it on the smartphone," said Rucker. "The ONC rule puts in specific provisions or exceptions [to account] for privacy, security, and patient harm, but importantly makes pricing of this a reasonable set of pricing structures. We've heard a lot of concerns that interoperability is technically there, but because of pricing strategies and shutting down market competition, those APIs are not effectively available. This proposed rule will stop that."
In addition, "the administration is extremely interested in transparency here," he added. "We think both of our rules will strike a blow to get transparency for the American public. There are two kinds of transparency to think about; one is transparency on the product, the care you're getting ... that's one part of shopping. The other part is pricing information. In our interoperability proposed rule, we have a [request for information] ... It turns out that getting pricing information transparent is very complicated and has a huge structure to it from decades of regulation, and we are exploring how to unlock that information and empower the American public on that."
HHS is also issuing requests for information in two areas: how patient identity and patient-matching can be improved, and how to better improve health information technology adoption in post-acute care settings.
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