UPDATE: Sept. 23, 2019: On Monday, the provider coalition sent twin letters detailing their concerns around Cures implementation to the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.
- A coalition of seven provider groups aired concerns with the Trump administration's push toward a more interoperable healthcare data ecosystem Tuesday at the September meeting of the Health Information Technology Advisory Committee (HITAC), which advises the government on health IT.
- The brand-new coalition, which includes the American Medical Association, the Federation of American Hospitals and the College of Healthcare Information Management Executives, wants health IT agency ONC to ease provider burden in complying with the data-blocking regulations by clarifying language in the rules, staggering deadlines, updating certification processes, softening rule enforcement and doubling down on data privacy.
- The interoperability proposed rules, released by HHS in February, have been plagued by these concerns from the start. HITAC plans to take the group's comments into consideration as it shapes its annual report to ONC, a representative said.
Providers have a laundry list of concerns around interoperability, and most were reiterated in the coalition's statement Tuesday at the HITAC meeting. The advisory committee welcomed the input, with co-chair and former AMA president Robert Wah calling it a "happy dilemma" to have additional public contributions.
ONC spokesperson Peter Ashkenaz told Healthcare Dive the agency is "aware of the statements made on behalf of a group of stakeholders at the HITAC meeting and continue[s] to thoroughly review the more than 2,000 comments we received on the proposed rule during the public comment period."
The 21st Century Cures Act was passed by Congress in 2016 to further the digitization of healthcare and engage patients in their own healthcare data through the use of application programming interfaces (APIs) that facilitate data sharing between disparate computer systems.
"We appreciate ONC's work to carry out the provisions in Cures and support the work related to supporting standards through the USCDI, open APIs, fostering better access to healthcare data for clinicians and patients and efforts to further patient matching," Mari Savickis, vice president of federal affairs at CHIME and the group's representative, said. "However, we are cognizant of the fact that significant work related to the implementation of Cures continues."
HHS proposed twin rules in February to promote interoperability. ONC's would put into effect the information-blocking provisions of Cures by identifying what does and doesn't constitute data blocking between healthcare companies. It will also put standards in place to enforce the law, force industry to adopt standardized APIs, and give consumers free electronic access to their health data.
Industry groups immediately slammed the fine print of the proposed rules over a slew of perceived concerns, including a too-quick implementation timeline, onerous administrative burdens and worries over patient data privacy. Questions have continued to swirl since on what, if anything, ONC plans to do to ameliorate those concerns, and how it plans to clarify gray areas in the regulation that could inadvertently throw a wrench into the Trump administration's interoperability efforts.
Savickis on Tuesday offered some guidelines for HITAC in its advice to ONC, including issuing a supplemental rule to clarify the definition and scope of electronic health information and health information networks and creating new certification standards for health IT vendors around the data-blocking rule to reduce confusion.
The provider coalition also wants ONC to slow down the implementation timeline by staggering compliance deadlines or pushing them back. As they currently stand, the data-blocking rule deadlines overlap with others set by CMS in its programs, including its interoperability rule and new e-prescribing standards, and could cause confusion.
"The proposed cadence of deadlines under the rule does not account for competing priorities and adequate compliance timeline," Savickis said.
Another oft-cited provider concern also involves compliance. Under Cures, HHS and ONC are required to regulate the flow of healthcare information and punish any bad actors impeding access. They can impose financial penalties of up to $1 million per violation.
That's a substantial fine for something that could easily happen by accident, healthcare companies say, and should be replaced with a less severe option like education or corrective action.
"Given substantial industry shifts associated with this rulemaking and confusion regarding definitions contained in the rule, including the exceptions to the information blocking rule, we believe a more fruitful approach would be one that centers around education and opportunities for corrective action," Savickis said, such as a period of enforcement flexibility where actors could fix their mistakes without affecting their bottom lines.
A perennial concern in the healthcare industry exacerbated by the push toward interoperability centers around privacy and security of highly sensitive patient medical data. The U.S. healthcare system has a history of cybersecurity attacks and employee error and leads all other industries in terms of data breaches. Unsurprisingly, few Americans trust healthcare companies to secure their data.
The rule, as it stands, doesn't "sufficiently address" and could even worsen these issues, Savickis said, calling for continued oversight from the government or other watchdogs as more people take ownership of their healthcare data and a slew of new applications crop up to help them.
However, this is already on ONC's radar. In August, agency head Don Rucker said ONC is in talks with Congress and the White House on regulating the secondary use of healthcare data.
"We are working hard to balance patients' right of access to their records and control of their healthcare with concerns about the secondary use of data," ONC's Ashkenaz said.
This isn't the first time industry groups have banded together to give their comments on the interoperability and data blocking rules additional weight. Earlier this month, the Pew Charitable Trusts, Microsoft, AMIA, AHIMA and the Commonwealth Fund (among others) sent a joint letter to the chairs of the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce lobbying them to support the proposed rule.
Along with FAH, AMA and CHIME, the new provider coalition is composed of health IT professional group the American Health Information Management Association (AHIMA), health informatics nonprofit the American Medical Informatics Association (AMIA), medical group coalition Medical Group Management Association and group purchasing organization Premier Healthcare Alliance, which includes more than 1,700 member hospitals and health systems.
The bloc represents a "vast smattering of the provider community" and plans to do more lobbying and advocacy around health IT in the coming weeks, Savickis told Healthcare Dive.
The next HITAC meeting will be Oct. 16.