Payer and provider organizations say the Department of Health and Human Services' (HHS') timelines to implement interoperability regulations are "troubling" and not realistic given the current evolving pandemic.
Most industry groups and stakeholders continue to parse through the combined 1,700 pages of the two interoperability rules HHS dropped Monday.
Overall, industry groups are supportive of the Trump administration's overarching goal to advance patients' access to their health information through mobile apps. The details are outlined in the new rules from the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC).
But stakeholders have deep concerns about six-month and nine-month timelines for getting into compliance, especially given the coronavirus pandemic. Many groups hope that federal policymakers will make changes to give hospitals and health plans more time and to ease compliance burdens
CMS' Interoperability and Patient Access final rule will require, among other things, that Medicaid, the Children’s Health Insurance Program (CHIP), Medicare Advantage (MA) plans and qualified health plans make enrollee data immediately accessible and do so in nine months, by January 2021. Plans will have to do this by developing a secure, standards-based (HL7 FHIR Release 4.0.1) API, or application programming interface, that allows patients to easily access their claims and encounter information, including cost, through a third-party app of their choice.
"The timeline was overly ambitious in the first place. Add everyone's response to the pandemic and the timeline is more difficult to meet," Danielle Lloyd, senior vice president of quality and private market at America’s Health Insurance Plans (AHIP), told FierceHealthcare.
Plans have to put out a request for proposal and acquire a vendor, Lloyd said, noting that many plan executives had planned to talk with vendors during the Health Information Management and Systems Society (HIMSS) conference, which was canceled due to the coronavirus outbreak.
"Plans then have to build the technology itself and go through extensive testing of that technology to make sure the patients' information is going to the apps that they selected," she said.
That testing process is important as evidenced by CMS' problems with its Blue Button 2.0 data-sharing tool. The agency had temporarily shut down access to its Blue Button 2.0 data-sharing tool in December after discovering a bug that may have exposed some beneficiary information. CMS suspended access to the Blue Button 2.0 API after a third-party app developer reported a "data anomaly," Kaiser Health News reported.
Lloyd also noted that the standards needed to build these API capabilities are not fully mature, which adds to the challenge for health plans.
"Health insurance providers are committed to giving consumers the information they need and harnessing technology to do that and we look forward to working with the Administration to remove the barriers to accomplish that," Lloyd said.
Claudia Williams, CEO of Manifest MedEx, a large health information exchange (HIE) serving California, said smaller health plans will be challenged to meet CMS' January 2021 deadline to provide patient access APIs.
"In the California market, the small plans that serve the Medi-Cal market don’t have a lot of technical capability. They have slim teams and are focused on their mission of being a non-profit health plan," she said.
Williams recommends that health plans work with partners such as HIEs and technology vendors to take on the technology workload of developing APIs and interfacing with app developers. She also suggests that health plans collaborate with each other to meet the deadline.
As part of the CMS rule, hospitals have to begin doing patient event notifications in about six months. CMS has said the policy goes into effect six months after publication of the rule, which can take several weeks. Those electronic admission, discharge and/or transfer notifications will be required as a condition of participation in Medicare, per the rule.
Meryl Bloomrosen, senior director of federal affairs for the Premier health alliance, said the six-month timeline is "potentially troubling" for providers, which includes hospitals and clinics. Premier is a healthcare improvement company representing about 4,000 U.S. hospitals and health systems and more than 175,000 other providers and organizations.
"Given the public health crisis with coronavirus, a six-month timeline is extremely aggressive. We are optimistic there will be opportunities to revisit that," she said. "CMS seems to assume that it’s going to be relatively easy to meet that requirement by turning on a switch. They may have underestimated the ramp-up time needed for that. That timeline is not realistic, in our opinion."
Premier also is concerned that ONC is maintaining a two-year implementation timeline for updates to electronic health records (EHRs) for APIs. As part of its interoperability and information blocking rule (PDF), ONC is requiring vendor development and provider adoption all within a two-year window.
If EHR vendors use that entire two-year window to update their systems, that will leave no time for hospitals to test the updated systems and that adds to the compliance burden for providers, Bloomrosen noted.
In response to a request for comment about the rule timelines, an ONC official said it's "premature" to discuss any changes, because the rule is not yet officially published.
ONC has submitted the final rule for publication, and it can take several weeks for the Office of the Federal Register to set a publication date. Once the final rule is officially published it has a 60-day delayed effective date, ONC said.
Speaking with reporters, CMS Administrator Seema Verma said she believed CMS developed fair and realistic timelines for payers and hospitals to implement the rules.
"Patients can't wait for their health information. This is a matter of life and death. We're seeing this with the situation with coronavirus and patients coming into a hospital and providers are stressed with dealing with sick patients and they have no time to gather patient information to have a complete medical record. These rules will make a difference to help provide safe and high-quality care all across the country," she said.
Williams agrees that the current public health crisis only highlights the urgent need for efficient healthcare data sharing.
"It's a great use case for why we need interoperability so desperately. The message I’m taking away is that interoperability is a key national infrastructure to support crisis response for any public health event. We have to do the hard work before the next crisis hits. The current situation underscores that interoperability can’t wait," she said.