As the federal Health IT Advisory Committee continues to dig into the recently proposed information blocking rule, industry stakeholders on the committee are wrestling with the fees that should be charged for the delivery of medical records.
The Office of the National Coordinator for Health Information Technology (ONC) unveiled its information blocking rule (PDF) back in February. The proposed rule, mandated by the 21st Century Cures Act, was intended to boost interoperability by defining exceptions to data blocking and fines that may be associated with the practice.
The rule requires that electronic health data be made available at no cost. ONC officials have noted that there were situations where cost was being used as a way to block the flow of information. At the same time, ONC officials also said there are situations where a reasonable cost is incurred for providing interoperability capabilities and acknowledged concerns that prohibiting any fees could stifle innovation. They built in several exceptions as a result.
The proposed rule aims to limit vendors' ability to charge fees for access to certain data. The HITAC's information blocking task force doesn't agree with ONC's language regarding fees, saying it goes too far to enact federal price controls, according to the recommendations the task force presented during a HITAC meeting on Monday.
"While the task force understands the intent of ONC was to address problematic pricing behavior by discouraging rent-seeking behavior and extractive pricing, while providing for market-based pricing to allow innovation, the task force believes the net force of the proposed rule will be to raise prices" by raising compliance burdens, such as accounting controls, pricing controls, and other pricing compliance activities, the task force said in its report.
ONC's language in the rule puts all data-sharing products "under federal price controls," the task force said. It places, for example, standards-based EHR interoperability interfaces, and innovative services, such as patient comparison shopping and bill payment, or AI-based risk scoring on exactly the same footing, the task force said. It sets the price for interoperability that should be built in too high, the task force said.
The debate over fee structures highlights the complexities of developing regulations to drive data sharing in the healthcare industry and the technical and business challenges around interoperability. Former ONC official Genevieve Morris, who served as principal deputy national coordinator for health IT at ONC and who is now a consultant, noted on Twitter the challenges that industry stakeholders face with the recent interoperability regulations.
I think legislators should have to listen to meetings like the HITAC before they continue to regulate. The convos demonstrate how complex and difficult all of this is.— Genevieve Morris (@HITpolicywonk) May 13, 2019
Among its recommendations, the information blocking task force is essentially recommending that ONC distinguish between "basic access" to patient data in the medical records and value-added access. Basic access would include HL7 lab interfaces for lab results, versus value-added access for things like software capabilities that perform decision support or use artificial intelligence or machine learning on the patient data.
For basic access, vendors would be allowed to charge fees to recover costs but not to make a profit, according to the task force's recommendations.
If a vendor supplies a clinical risk scoring service based on patient records, those services would be value-added and offered at market rates. However, if that risk score is used by clinical staff to make clinical decisions, the individual risk score accordingly becomes part of the patient record and is then part of the basic access services, according to the task force recommendations.
"We’re trying to make the appropriate distinction to enable broad-based access while preserving the ability to offer value-added service to the industry," Andrew Truscott, co-chair of the information blocking task force and managing director for health and public service at Accenture, said during the HITAC meeting.
HITAC member Ken Kawamoto, M.D., Ph.D., associate chief medical information officer with the University of Utah Health, said the task force's definition of basic access would put almost every data point about a patient within that category and could, unintentionally, deincentivize health IT innovation.
"My worry there is that the health IT vendors, from their perspective, they are going to be incented to do nothing else than what is minimally required because all the incentive is gone. We have to carefully consider the implications of saying everything should be basically at cost. I would assume that would mean that a lot of the data that we do want access to, those interfaces will never get developed. I think the unintended consequences here could be pretty large," Kawamoto said.
HITAC plans to continue its discussion on the task force's recommendations related to data-sharing fees at its next meeting scheduled for May 22. HITAC will forward all of its final recommendations to ONC. The deadline for the comment period on the ONC and CMS interoperability rules is June 3, after ONC and CMS granted a 30-day extension.