Washington Gathering Discusses Patient Matching At an invite-only event held in Washington this week, CHIME members, federal officials and other health IT stakeholders met at the Bipartisan Policy Center to discuss the issue of patient matching. The briefing was well attended with leading CHIME members, foundation firms and top officials from CMS and ONC looking at various approaches to accurate patient matching. One of the central issues discussed was the appropriate level of federal involvement. A unique patient identifier has long-since been taken off the table, government officials indicated, but there remains a need for common standards and methodologies to match data with the correct patient. The dominant policy question that emerged, centered on the fact that if most care is delivered locally, what kind of national policy would reinforce safety, not hinder it. Examples included forcing more transparency into how false negative / positive error rates are produced and possible standards around how performance data is gathered and presented. Other conversations focused on the need for uniform and consistent intake / registration procedures, to make sure “dirty” data doesn’t complicate matters further.
CHIME Policy Steering Committee members Neal Ganguly and Bill Spooner both made presentations describing how CentraState and Sharp are respectively addressing patient mismatches. While CentraState has a relatively low error rate of false positives and false negatives, there’s a concern about what happens when broader rollout of regional and statewide health information exchange begins, Mr. Ganguly said. Meanwhile, Mr. Spooner’s presentation outlined Sharp’s 20-year “journey” to patient matching.
Ahead of Wednesday’s briefing CHIME did a survey (summary available here and graphs here) finding that many hospitals are using a mix of approaches and technologies; error rates are still high, even with the use of two or more matching strategies; nearly one in five respondents have suffered an adverse event that can be tied to a patient mismatch.
Policy Steering Committee members, Russ Branzell and Randy McCleese also were in attendance.
ONC publishes Request for Information on NwHIN On May 15 ONC published a Request for Information on the topic of the nationwide health information network (NwHIN). The public has 30 days to comment on these “rules of the road” that will “enable secure health information exchange over the internet.” These comments will help ONC develop a proposed rule in the future. The RFI indicates that a national framework or set of rules must be in place for HIE because different sets of regional rules would result in gaps in policies, technological capabilities and other factors that would interfere with data exchange at a broader level beyond direct one-to-one exchange, and ultimately prevent better care coordination. According to ONC, the NwHIN will be a “continually expanding ecosystem of electronic exchange activities for which stakeholders would be able to select the appropriate set of standards, services, and policies to meet their electronic exchange needs.”
CHIME will comment on the RFI and CHIME members who are part of the Advocacy Leadership Team interested in helping develop comments are encouraged to contact Jeff Smith by Tuesday, May 22.
HHS Makes it Easy to Track Healthcare System Progress This week, the Department of Health and Human Services debuted a website called the Health System Measurement Project which “tracks government data on critical U.S. health system indicators.” Aside from national data, the website also presents “population characteristics such as age, sex, income level, and insurance coverage status.” The front page of the website details changes in the healthcare system based on the Affordable Care Act, HITECH under the American Recovery and Reinvestment Act, and Medicare Part D. Some of the data shown illustrate the gap in health insurance offered by small businesses versus large businesses from 2005 to 2009.
Making this data available to the public will help people follow the changes in healthcare as the system adopts electronic health records. It allows the public to see the evolution of the healthcare system including where improvements have been made in the system, and where gaps in care or coverage need to be addressed. Government Health IT reports, “A user can look at data on a given topical area from multiple sources, compare trends across measures and compare national trends with those at the state and regional level.”
FCC Chair Genachowski Advocates for Mobile Body Area Networks The chairman of the Federal Communications Commission, Julius Genachowski spoke in favor of using mobile body area networks (MBAN) at an event at George Washington University on Thursday. He detailed the benefits of the devices including their main use – they allow doctors to remotely monitor patients’ vital signs in real-time. These devices would be an improvement to many tools currently being used because they have wires that are usually attached to monitors or beds and keep the patient from being mobile.
According to the Hill, “The FCC has an agreement with the Food and Drug Administration to help streamline approval processes for medical devices that use wireless spectrum. The two agencies are supposed to collaborate on approving each device, with the FCC handling the technical side and the FDA scrutinizing the medical aspects of the device.” FCC scheduled a vote to approve a plan for MBANs on May 24.
During the briefing at GWU, chairman Genachowski said MBANs are “a cost effective way to monitor every patient in real time in hospitals,” he said. A portion of the spectrum under the proposed rule also will be allocated to wireless devices that patients can wear at home.
Bipartisanship Emerging Over FDA User Fee Bill, Strategy on Mobile Medical Apps Questioned At a time when virtually all meaningful legislation is being held hostage by politics, there is one Ducati motorbike bobbing and weaving through the traffic jam: FDA User Fee legislation. In what has been described by Hill staffers as the only legislation with “legs” the “Food and Drug Administration Safety and Innovation Act,” has passed both House and Senate committees of jurisdiction. The full Senate is looking to pass their version of the bill on Monday with House members looking to vote by the end of the month. While the bulk of the bill is likely to bore segments of the health IT world, there is language in the Senate bill that would be a de facto moratorium on FDA’s mobile medical application guidance. The Senate bill doesn’t put a direct hold on guidance, first issued as a draft last July, but it would require the FDA to undertake a multi-agency report that would lay out a strategy for “an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology.” It would have to produce the report with the FCC and the Office of the National Coordinator for Health Information Technology. This means that “until the report is developed and sent to Congress, all mobile apps that are medical devices will continue to have to meet all applicable FDA requirements,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health wrote in an email to Politico. The resulting report or framework would have eighteen months to be complete – something that provision detractors say will take the full time allotted due to competing agendas and multiple agency involvement. An 18-month moratorium, Mr. Shuren believes, would be a blow to the app industry, forcing FDA to regulate more apps rather than fewer. But others see it as a chance to bring more stakeholders to the table that would result in a stronger regulatory framework.
Congressional leaders on both sides of the isle are looking to pass legislation before a Supreme Court decision on the Affordable Care Act and have a bill to President Obama by July 4.