House Looks at CMS Delivery Reforms, No Word on Tavenner Confirmation On Wednesday, the Senate Finance Committee had a hearing on: “Progress in Health Care Delivery: Innovations from the Field.” Senators Max Baucus (D-MT) and Orrin G. Hatch (R-UT) gave statements, and a panel of healthcare executives testified. In his official statement, Sen. Baucus said, “We all have common goals: to reduce healthcare costs and improve healthcare quality. How do we do that? Innovation plays a key role. That’s the focus of our hearing today… The innovation we’re talking about transforms the way providers deliver care to patients. This innovation means patients spend more time with their doctors, rather than talking to insurance companies.” He later said, “Health reform encouraged this innovation, and we must continue to build on this progress.”
Despite this week’s focus on payment and delivery reform at CMS, the agency is still without a Senate-confirmed leader. Acting Administrator Marilyn Tavenner took over for Dr. Donald Berwick at the beginning of the year, but observers note there doesn’t seem to be a push to confirm her, given the political climate in Washington and election season in full swing. “From an operations perspective, she is running the place beautifully,” said Dan Mendelson, who oversaw Medicare, Medicaid and other federal programs as health budget chief during the Clinton administration. “Regulations are getting done without drama, consultation is happening with the private sector and the staff see her as the person in charge.”
Senate Finance Chairman Max Baucus indicated earlier this week his committee has no near-term intensions of beginning the confirmation process.
FCC Approves Spectrum for Wireless Medical Monitoring On Thursday, May 24, the Federal Communications Commission voted to designate 40 MHz of spectrum for mobile body area networks (MBAN). In advance of this vote, the chairman of the FCC, Julius Genachowski spoke in favor of using MBANs at an event at George Washington on May 17. He detailed the benefits of the devices including their main use – they allow doctors to remotely monitor patients’ vital signs (such as blood glucose levels, blood pressure, pulse, respiratory health and temperature) 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.
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. The FCC and the Food and Drug Administration have created a streamlined approval process for medical devices that operate on this spectrum to reduce implementation time. MBANs can improve patient outcomes by detecting changes in patients’ vital signs before they become critical.
ONC Requests Information on Nationwide Health Network; CHIME to Comment On May 15 ONC published a Request for Informationon 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.” 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.”
Senate FDA User Fee Bill Crosses Line with Overwhelming Support 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,” passed the full Senate on Thursday in a vote that was 96-1. Even though the bill has been cooking for eighteen months, it was only within the last few months that momentum started to build. Senate Majority Leader Harry Reid (D-Nev.) said the bill's passage was how all legislation should move through the Senate.
As for the bill’s specifics, there is one piece that should be of interest for the health IT world: a report required to study the intersection of mobile medical applications and how they pertain to device regulation. The Senate bill doesn’t put a direct hold on FDA 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.
The House is looking to pass its version of the bill before the end of the month and congressional leaders have signaled their wishes to have a bill to President Obama by July 4.
Washington Gathering Discusses Patient Matching At an 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.