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HFES Bulletin

February 2014
Volume 57, Number 2

Public Policy Matters

Congress Approves Omnibus Appropriations Bill

By Lewis-Burke Associates LLC

On January 13, the House and Senate Appropriations Committees released an omnibus appropriations bill for fiscal year (FY) 2014. Both the House and Senate passed the bill, on January 15 and January 16, respectively. The omnibus bill will provide a needed boost for federal research, education, and health-care programs important to universities and nonprofit research institutions. Somewhat surprisingly, the omnibus includes all 12 of the annual spending bills.

The more controversial appropriations bills—including Labor, Health and Human Services, Education, and Interior and Environment—were expected to require continuing resolutions (CRs) to fund programs at current levels for the remainder of FY 2014, particularly after a stalemate over issues such as funding for the health-care reform law caused a halt in appropriations negotiations and a shutdown of the federal government in October 2013. Reaching agreement on all 12 bills is a victory for appropriators who have seen their influence decline in recent years as gridlock on major funding issues, coupled with increased partisanship, made CRs commonplace.

As drafted, the sprawling omnibus bill adheres to the $1.012 trillion topline spending level established by the Ryan-Murray budget agreement approved by Congress last month. House Appropriations Committee Chairman Hal Rogers (R-KY) and Senate Appropriations Chairwoman Barbara Mikulski (D-MD) were able to negotiate a package that contains concessions for both parties and is free of many of the divisive policy riders that threatened to derail progress. Because the House and Senate approved the bill, the omnibus will avert the threat of another government shutdown and represents a reassertion of congressional power to set spending priorities across the federal government.

With some relief from sequestration for two years and support for new initiatives in the omnibus, many federal research agencies and programs fare well in the agreement. The Department of Energy Office of Science, National Science Foundation, National Institutes of Health, and science and technology programs at the Department of Defense are among those slated to receive increases above FY 2013 levels (post-sequestration). As evidenced by the omnibus, research and development—and particularly basic research—remains a bipartisan priority for members of Congress despite constrained total spending levels. Guidance for each agency is included in the explanatory statement that accompanies the omnibus bill. Of interest to HFES, the Army included the language on user interfaces to improve warfighter performance as follows:

The Army is performing research and conducting exercises aimed at closing the gap between the difficulty in operating traditional military equipment and the ease of operating modern handheld devices. The Secretary of the Army is encouraged to accelerate these ongoing technology development efforts and update equipment user interfaces to improve warfighter performance.

The full Lewis-Burke analysis of the FY 2014 omnibus bill is available here.

Issues Related to Federal Agency Travel Spending
On Tuesday, January 14, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled "Examining Conference and Travel Spending Across the Federal Government." At the hearing, Senator Coburn (R-OK) and a few others expressed a desire to pass legislation that would codify the current Office of Management and Budget (OMB) guidance. The OMB guidance was issued in a memorandum to the heads of executive departments and agencies in May 2012 as part of an effort to promote efficient spending across the federal government. The memo stated that each agency must reduce their travel expenses for FY 2013 by 30 percent under FY 2010 levels and maintain this reduction each year through FY 2016 Some senators seemed worried that agencies will become less diligent in oversight as more time passes, as media attention decreases on the issue, and as the administration changes. The OMB witness, Beth Cobert, was reluctant to endorse the idea of legislation, highlighting the importance of flexibility given changing technology and other factors. Senator Carper (D-DE) and Cobert did note the value of face-to-face interaction to accomplish agencies' missions, and they highlighted scientific societies' annual meetings as an example. HFES will be submitting testimony on this issue to be included in the congressional record.

In addition to the hearing, the FY 2014 omnibus included some new policies related to federal agency officials' travel to conferences. These new policies are in addition to existing Obama Administration policies that limit travel to conferences but should not affect HFES conference attendance. The two policies included in the omnibus would require agency-hosted conferences to explain the costs and contracting procedures for events that cost more than $100,000. The second policy restricts travel to a single conference outside the United States to no more than 50 federal employees from a federal agency, unless it is law-enforcement related.

Although there has been a lot of momentum from scientific societies recommending that scientific conferences should be exempted from these restrictions, the Obama Administration likely sees those current restrictions as both a way to save money in a time of tight budgets and also avoid any potential further scandal. Lewis-Burke will continue to lobby Congress on this important issue.

National Research Council Releases Prepublication Report on Common Rule
On January 14, the National Research Council (NRC) committee released a prepublication of the report "Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Science." The final publication is expected to be released in March. The report examines the prospective revisions to the Common Rule (45 CFR 46) to inform the Department of Health and Human Services' current efforts to reassess the federal policy and to update the federal rule (last revised in 1991) for the protection of human research participants relevant to the behavioral and social sciences.

The study was to be conducted in two phases. This report is Phase II and is a result of Phase I, a public workshop held March 2013 to inform the efforts of the federal government in revising the regulations that govern the protection of human participants in research. The Department of Health and Human Services (HHS) put forth several proposals in its July 2011 Advance Notice of Proposed Rulemaking (ANPRM).

The NRC committee recommends revising the Common Rule in other ways and amending specific proposals in the ANPRM to more effectively respond to the current research and methods, and to clarify the definition of "human subjects research" and "minimal risk." The NRC report addresses the current research landscape to provide guidance for Institutional Review Boards (IRB) in the context of upholding the ethics of human subjects research and maintaining the effectiveness and processes of social and behavioral science research. Since the last update of the Common Rule, technology has drastically advanced, as has the volume of data on human participants; thus, the report provides best practices for IRBs to implement new human research protections and assess the effectiveness of the rule.

On Thursday, January 30, an open public forum was held at which the committee presented the recommendations of the report and discussed it with an audience of representatives of federal agencies, research institutions, and professional and advocacy associations, as well as other stakeholders. Lewis-Burke attended this meeting on behalf of HFES.

More information about the NRC study is available here.

Usability of Electronic Health Records
On January 15, the Office of the National Coordinator for Health Information Technology (ONC) released Safety Assurance Factors for EHR Resilience (SAFER) guides to help practitioners use health information technology more safely. The SAFER guides are an important component of DHHS' July 2013 Health IT Patient Safety Action and Surveillance Plan. The guides have been developed by health IT safety and informatics researchers and cover the following areas: High Priority Practices, Organizational Responsibilities, Patient Identification, Computerized Physician Order Entry (CPOE) with Decision Support, Test Results Review and Follow-Up, Clinician Communication, Contingency Planning, System Interfaces, and System Configuration.

Additionally, on January 6, Jacob Reider, MD, director of the Office of the Chief Medical Officer at ONC, published an article on the usability of electronic health records. In the article, Reider raised concerns that many usability challenges remain unresolved. Lewis-Burke has engaged with the National Institute of Standards and Technology on this topic, and we encourage HFES members to provide comments and to offer expertise. Any comments should be posted at the bottom of the online article.

Lewis-Burke Associates LLC, a leading Washington, D.C.–based government relations and consulting firm, represents the public policy interests of scientific societies and institutions of higher education. Lewis-Burke's staff of about 20 government relations professionals work to promote the federal research and policy goals of HFES and the HF/E community.

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