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June 2013 Clinical Laboratory News: Volume 39, Number 6


In This Issue...


Presidential Commission Will Study Incidental Findings

The Presidential Commission for the Study of Bioethical Issues announced that in an upcoming report it would focus on the ethical implications of incidental findings resulting from genome sequencing, an area receiving growing attention as sequencing becomes more routine. Incidental findings are data beyond the original aims or goals of testing discovered during sequencing a genome or exome.

In March, the American College of Medical Genetics and Genomics released recommendations for incidental findings, listing 24 conditions and associated genes and variants that should be reported for incidental findings in all patients regardless of age (See CLN, May 2013).

In a recent meeting, presidential commission members discussed several fields in which incidental findings raise serious ethical questions, such as neurology and genetics, in addition to various settings such as clinical and research. The implications of how incidental findings are handled affect research participants, patients, consumers, and healthcare professionals, they noted. In a forthcoming report, the commission plans to cover the importance of what patients and participants are told by healthcare professionals, not only after a procedure or a test is performed, but before as part of the informed consent process.

More information is available online.

USPSTF Releases Final HIV Screening Recommendations

The U.S. Preventive Services Task Force (USPSTF) released its final recommendation statement on screening for HIV, bringing the task force closer in line with recommendations from the Centers for Disease Control and Prevention (CDC). In 2006, CDC recommended that opt-out HIV screening be a part of routine clinical care for American adolescents and adults ages 13–64.

USPSTF now recommends that clinicians screen all people ages 15 to 65, as well as younger adolescents and older adults who are at increased risk for HIV infection. It also recommends that all pregnant women, including those in labor whose HIV status is unknown, be screened.

The task force's grade A recommendation is important because, under the Affordable Care Act, private health insurance policies must offer free preventive services that have been given an A or B recommendation by USPSTF. In addition, Medicaid programs receive financial incentives to follow these recommendations. Many professional societies also base their recommendations on USPSTF decisions.

The task force noted in its report that although there is no cure for HIV infection, treating people with HIV earlier can not only reduce their risk of developing AIDS and delay its onset, but it also decreases the chance that they will pass on the infection to someone else. In addition, treating pregnant women reduces the chances that the virus will be transmitted to their babies.

The recommendations are online in the Annals of Internal Medicine, as well as on the USPSTF website.

Government Rejects Two EHR Systems

The government is sending the message that its electronic healthcare record (EHR) certification requirements have to be taken seriously. Two EHRs previously certified for healthcare providers to use as part of the Medicare and Medicaid Electronic Health Record EHR Incentive Programs have had their certifications revoked. Farzad Mostashari, MD, the national coordinator for health information technology in the Department of Health and Human Services, announced that the products do not meet standards and that providers cannot use these products to meet the requirements of the Medicare and Medicaid EHR Incentive programs.

EHRMagic-Ambulatory and EHRMagic-Inpatient, both developed by EHRMagic Inc. of Santa Fe Springs, Calif., no longer meet the EHR certification requirements. The EHRs must be certified by a certification body authorized by the Office of the National Coordinator for Health IT (ONC) before regaining certification.

More about ONC's certification process for EHR technologies is available online.

PCORI Awards $88.6 Million in Funding for Comparative Effectiveness Research Projects

The Patient-Centered Outcomes Research Institute (PCORI) has approved 51 new awards, totaling $88.6 million over 3 years, to fund comparative clinical effectiveness research (CER) projects under the first four areas of its National Priorities for Research agenda. Established under the Affordable Care Act, PCORI has now awarded nearly $130 million.

The projects approved include studies of how to best care for people with kidney disease, certain cancers, obesity, asthma, diabetes, and various mental health conditions. Other projects will explore ways to support patient decision-making, reduce specific health disparities, and improve healthcare delivery systems.

PCORI's funding announcements consist of three annual cycles and seek proposals for research that will provide patients and those who care for them with the evidence-based information needed to make better-informed health decisions. Twenty of the latest awards address PCORI's national research priority area of assessment of prevention, diagnosis, and treatment options; 13 align with the priority area "improving healthcare systems;" eight address "communication and dissemination research;" and 10 align with "addressing disparities."

More information on the awards is available from the PCORI website.

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