The Office of the National Coordinator for Health IT is still in the process of defining information blocking, a key provision of the 21st Century Cures Act, but it’s unclear when they will complete that rulemaking process that paves the way for enforcement.
In a hearing before the Senate Committee on Health Education Labor and Pensions Committee to review the implementation of the 21st Century Cures Act, ONC’s Deputy National Coordinator for Health IT Jon White, M.D., said ONC is working with stakeholders and other government agencies to identify information blocking exemptions. But he declined to provide lawmakers with a timeline for when that effort will be finalized, at one point telling lawmakers that ONC’s counsel had advised against discussing the rulemaking process while it is still in its early stages.
Sen. Lamar Alexander, R-Tenn., pushed back on that response, arguing that he wasn't aware of any law that prohibited ONC from sharing the status of a rule with the committee.
“Go back to your counsel and say, in a bipartisan way, we'd like to know when you’re going to start and when you’re going to finish,” Alexander replied. “And if there’s some law or rule that prohibits our knowing that, we’d like to know.”
A law is not worth the paper it’s printed on if it is not implemented properly. I intend to ensure #Cures is implemented properly— Sen. Lamar Alexander (@SenAlexander) October 31, 2017
For its part, the Office of the Inspector General is ready to enforce information blocking once the ONC finalizes its work. James Cannatti, senior counsel for health information technology at the OIG, said the agency will not issue penalties until ONC’s rulemaking is complete, but it has already begun investigating some complaints and referrals. White acknowledged that information blocking does occur and that the ONC is concerned about it, but there is a delicate balance when it comes to enforcement.
Information blocking was just one of several health IT topics addressed in a hearing that covered a range of requirements under Cures. Some highlights:
- Pointing to a 2016 study from the American Medical Association that showed physicians spend two hours with EHRs for every one hour with patients, Alexander urged officials at ONC and CMS to work with providers and AMA to get EHRs "out of the ditch." He suggested the agencies start by establishing a specific goal that reduces the amount time spent on EHRs. “What I’m urging to you do is set a number,” Alexander said. “If they think two-thirds of their time is spent on [EHRs], pick another number and say let’s get to that goal.”
- White said he would take Alexander's advice back to ONC. Earlier in the hearing, he said ONC was focused on four areas to reduce the time-suck of EHRs: federal reporting requirements, federal documentation requirements tied to billing, platform usability and state-level requirements.
- In a letter (PDF) to the Senate committee, the American Hospital Association again called for lawmakers to cancel Meaningful Use Stage 3. Alexander noted that one hospital told him Stage 3 is “terrifying.”
- In response to concerns from Sen. Patty Murphy, D-Wash., about a proposed 37% reduction to ONC’s 2018 budget, White said ONC would be able to implement all the requirements of 21st Century Cures except for the EHR reporting program. That provision required the HHS secretary to convene a group of stakeholders to develop reporting criteria including security, usability and conformance to certification testing.
- Several lawmakers raised concerns about patient matching problems within EHRs. White said ONC is leaning on the private sector to develop modernized solutions. He said ONC was watching the College of Healthcare Information Management Executives’ (CHIME) national patient ID challenge “with great interest” and predicted there will be some “good approaches on the near horizon.”
Kate Goodrich, M.D., director of the Center for Clinical Standards and the chief medical officer at CMS, added that in her time as clinicians, she has been “witness actual harm to a patient” due to misidentification.
- White said ONC plans to release a draft of its Trusted Exchange Framework and Common Agreement by the end of the year. ONC is coordinating its efforts with a variety of existing exchange frameworks to resolve issues like user authorization. White said ONC sees itself as a “neutral coordinator of industry efforts.”
- He added that the framework will be voluntary, just as many organizations have called for, to provide developers room to innovate.
New acronym we're using for those who keep track: Trusted Exchange Framework and Common Agreement or TEFCA which = interoperability for all.— Genevieve Morris (@HITpolicywonk) October 31, 2017
- Sen. Bill Cassidy, R-La., raised concerns about copy and paste functionality within EHRs, both in terms of patient harm and as a potential conduit for Medicare fraud. Goodwin acknowledged that she has seen firsthand the bloated clinical notes from clinicians copying and pasting patient information, which muddles the medical record. While most of the focus around copy and past has been around patient safety, she said Medicare fraud is “something we definitely need to keep an eye on.”