oCtoBeR 2010 - American Association for Clinical Chemistry

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slow progress on electronic health records The federal government’s push for widespread implementation of electronic health records (EHR) has so far not led to swift adoption by U.S. hospitals, although a new government effort to help hospitals choose EHR systems that meet govern- reguLatory 20 CliniCal laboratory news oCtoBeR 2010 p r o f i L e s p r o f i L e s ment standards is on track. A new study released by Health Affairs found that while the number of U.S. hospitals that have adopted either basic or comprehensive EHRs rose modestly between 2008 and 2009, from 8.7% to 11.9%, only 2% of the country’s hospitals reported having records that would meet the federal government’s meaningful use criteria and be eligible for extra Medicare and Medicaid incentive payments. The authors of the study went on to note that “policy makers need to consider ways to make it easier for hospitals to adopt EHRs and meet the criteria for their meaningful use—especially in the case of smaller, rural, and public hospitals… to ensure that all Americans, regardless of where they receive care, derive the benefits that health IT has to offer.” On the other hand, the federal government recently announced two EHR certification bodies that will be authorized to test and certify EHR systems for compliance with the standards and certification criteria that were issued by the U.S. Department of Health and Human Services earlier this year. The Certification Commission for Health Information Technology (CCHIT), Chicago, Ill. and the Drummond Group Inc. (DGI), Austin, Texas, were named by the Office of the National Coordinator for Health Information Technology (ONC) as the first such technology review bodies. Announcement of these ONC-authorized testing and certification bodies (ONC-ATCBs) means that EHR vendors can now begin to have their products certified as meeting criteria to support meaningful use, which ONC described as a key step in the national initiative to encourage adoption and effective use of EHRs. More about the ONC-ATCBs is available at www.cchit.org and www.drummondgroup.com. More information about the ONC certification programs is available at http://healthit.hhs.gov/certification. fda, cms to Work more closely on post-market research The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) announced a plan to improve their collaboration on post-market research, a move that lab industry observers hope can cut the time between FDA approval of a device and a CMS decision to pay for it. The Memorandum of Understanding (MOU), published in the Federal Register, aims to enhance knowledge and efficiency, and sharing of information and expertise between the two agencies. The goals of the collaboration are to explore ways to: further enhance information sharing efforts through more efficient and robust interagency activities; promote efficient utilization of tools and expertise for product analysis, validation, and risk identification; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices. Unless terminated before by FDA or CMS, the MOU will remain in effect for 5 years. The MOU is available from the Federal Register, www.gpoaccess.gov/fr/. cms cuts hospital inpatient payments cMS announced it will cut Medicare inpatient payments to hospitals in 2011 by $440 million compared to 2010, nearly $300 million more than the agency estimated in April in a proposed rule. The cuts mean an overall 0.4% reduction in reimbursement rates to acute care hospitals for inpatient stays. This reduction reflects the balance of a range of adjustments, mainly a positive 2.4% update for inflation coupled with a 2.9% cut aimed at recouping payments in 2008 and 2009 that CMS says did not accurately reflect the severity of patients’ illness. CMS has replaced its Diagnosis-Related Group (DRG) system with the new Medicare Severity DRGs (MS-DRGs), which indicate the severity of a patient’s illness in addition to the diagnosis. However, CMS believes it got a bad deal on payments it made while this change was being rolled out, and has determined that a 5.9% adjustment is needed to recover overpayments. Part of this adjustment is coming out of the 2011 payment system rule, with more cuts expected for 2012. CMS published the final Inpatient Prospective Payment System rule in the Federal Register, www.gpoaccess.gov/fr/. productivity cuts imperil future of medicare in a recent report, the Medicare Board of Trustees admitted that CMS productivity cuts, expanded by healthcare reform to include cuts to the lab fee schedule, could eventually make it difficult for providers to offer care to Medicare beneficiaries as costs to providers rise faster than payment increases. The board raised concerns that, in the long run, these cuts could result in lower provider participation, less access to care, and reduced quality of services. Statutory changes to correct this problem would require congressional action. Because the productivity adjustments are tied to the over-all economy, the ensuing cuts to providers do not take into account the unique factors in each area of medicine, the report explained. “Since the provision of health services tends to be labor-intensive and is often customized to match individuals’ specific needs, most categories of health providers have not been able to improve their productivity to the same extent as the economy at large,” the board wrote. “Overtime, the productivity adjustments mean that the prices paid for health services by Medicare will grow about 1.1 percent per year more slowly than the increase in prices that providers must pay to purchase the goods and services they use to provide health care services. Unless providers could reduce their cost per service correspondingly, through productivity improvements or other steps, they would eventually become unwilling or unable to treat Medicare beneficiaries.” It is possible that providers could reduce waste and take other steps to keep their cost growth within the boundaries imposed by the Medicare payment limitations, the board suggested. “Similarly, the implementation of payment and delivery system reforms…could help constrain cost growth to a level consistent with the lower Medicare payments. These outcomes are far from certain, however.” The Board of Trustees report is available on the CMS website, www.cms.gov/.
labcorp to purchase genzyme genetics for $925m laboratory Corporation of American Holdings announced it will acquire Genzyme Genetics for $925 million. The acquisition is aimed at expanding the firm’s capabilities in several testing areas, including reproductive, genetic, and hematologyoncology. According to David King, chairman and CEO of LabCorp, the purchase of Genzyme Genetics will also increase the company’s ability to perform clinical trials as a central laboratory. beckman coulter’s ceo resigns scott Garrett, chairman, president, and chief executive officer of Beckman Coulter, announced his resignation, effective September 6, 2010. Garrett had been with the company since 2005 and had recently led the integration of Olympus labbased diagnostics business into Beckman Coulter. J. Robert Hurley has been named interim president and CEO until the firm finds a permanent successor to Garrett. salk, sanford-burnham to use $21m grant for hiv effort salk Institute of Biological Studies and the Sanford-Burnham Medical Research Institute have announced that they will conduct systems biology-based studies of the earliest immune system responses to HIV infection with a $21 million grant from the National Institutes of Health. The multi-center research project will include DNA sequencing, expression analysis, RNAi analysis, and mass spectrometry, designed to discover the cellular protein mechanisms that protect against HIV. nih awards rheonix grant to develop poc Test for uTis rheonix, a microfluidics firm, has received a $233,044 supplemental grant from the National Institutes of Health, which will be used to develop a point-ofcare test for urinary tract infections (UTI). According to the firm, the test will allow all components of a multiplex molecular diagnostic to be integrated onto a 1-mm thick, palm-sized polystyrene chip. The grant supplements an earlier NIH award to develop a fully automated molecular diagnostic for identifying sexually transmitted infections and increases the scope of the work to include the molecular detection of UTI. nih to fund neurobiological assay research The National Institutes of Health announced that beginning in 2011 it will provide as much as $5 million in grants to develop molecular and cellular assays that can measure and analyze changes iNdustry p r o f i L e s p r o f i L e s in the function of brain cells. According to NIH, this grant program will fund research projects that seek to develop new technologies that can optimize, automate, standardize, and validate measures of molecular and cellular events that are relevant to brain function. These highthroughput tools should enable efficient screening of small molecules, peptides, or genetic perturbations. mlc dx to Target biomarkers nih to fund sigma-aldrich’s With dna Technologies cardiovascular disease research m s LC Dx, a San Francisco-based mo- igma-Aldrich has signed an agreement lecular diagnostics firm, has raised with the National Heart, Lung, and almost $6 million in private financing, it Blood Institute (NHLBI) of the National disclosed in a document filed with the U.S. Institutes of Health, and Boston University Securities and Exchange Commission. Ac- (BU) to develop methods to measure sevcording to the firm, it currently has a pateral potential biomarkers of atherosclerotic ent application for a method that uses cardiovascular disease (CVD) using plasma DNA sequencing technology to identify samples from NHLBI’s Framingham Heart biomarkers of autoimmune disorders and Study. Sigma-Aldrich will work with NHLother diseases. The method includes isolat- BI and BU to provide analysis of plasma ing samples from a subject, one or more samples from 7,000 participants that will rounds of nucleic acid amplification, spa- examine 180 potential biomarkers for CVD. tially isolating individual nucleic acids, and The project will be funded by NHLBI under sequencing nucleic acids. a research subaward agreement with BU. Presents a Conference Practical Applications of Mass Spectrometry In the Clinical Laboratory November 15, 2010 Johns Hopkins Medical Institution’s Owens Auditorium Baltimore, MD Mass spectrometry is fast becoming the analytical method of choice for many clinical assays. This program will tackle and attempt to demystify some of the issues that have arisen as this technology evolves into a routine laboratory tool. Lab professionals often describe “mass spec” as a complimentary method to immunoassay, but no one doubts it has technological advantages over immunoassay for certain applications. Attend this conference to � nd out if mass spec has a place in your lab, and learn about clinical applications where it is now routinely used. Leading clinical mass spec experts will show you: • Advantages and challenges of mass spec • Basics of MS method evaluation • Pros and cons of mass spec vs. immunoassay In addition, conference faculty will examine some current applications in the clinical lab, including: • Therapeutic drug monitoring • Toxicology screening and con� rmation • Steroid and vitamin D analyses • Thyroid, thyroglobulin, and catecholamine testing For more information or to register, please visit the AACC web site at www.aacc.org. This educational event is supported, in part, by a generous educational grant from Thermo Fisher Scienti� c. CliniCal laboratory news oCtoBeR 2010 21
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