June 2012 - American Association for Clinical Chemistry

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new icD-10 Transition Deadline announced The Department of Health and Human Services (HHS) announced that the nation’s transition to the ICD-10 medical coding set will be delayed for a second time until October 1, 2014. The most recent deadline was October 1, 2013, a 2-year deferral from the original 2011 date. ICD-10 will introduce more than 100,000 new diagnostic and procedure codes, affecting everything from medical research to reimbursement. Physician groups had turned up the pressure in recent months to delay implementation, criticizing HHS for requiring too much from providers in a short timeframe, such as the transition to electronic health records. In addition, some in the lab community had warned that payers were not prepared for ICD-10, and that labs could be stuck between physicians and payers, both of whom appeared equally illprepared for the transition to a new coding scheme. More information about ICD-10 is available from the government’s ICD-10 website, www.cms.gov/Medicare/Coding/ ICD10. medicare long-Term health at risk report from the Medicare Trustees a shows that the Hospital Insurance (HI) trust fund may run out of money in 2024. In 2011, the HI trust fund expenditures were lower than expected. However, HI expenditures have exceeded income annually since 2008 and are projected to continue doing so under current law in all future years. The trust fund’s assets are projected to cover annual deficits through 2023, with asset depletion in 2024. At this point, if Con- Assays for the Next Generation TM reguLatory Methotrexate Assay ARK introduces its homogeneous enzyme immunoassay for methotrexate. Liquid, stable, ready-to-use formulations deliver convenience for routine use. 1190 Bordeaux Drive, Sunnyvale, CA 94089 877.869.2320 24 CliniCal laboratory news June 2012 p r o f i L e s p r o f i L e s gress were to take no further action, projected revenue would be adequate to cover 87% of estimated expenditures in 2024 and 67% of projected costs in 2050. In practice, Congress has never allowed a Medicare trust fund to exhaust its assets. Medicare has bought some time due to the Affordable Care Act, which cut some payments. Without this law, the trust fund would expire 8 years earlier, in 2016. The full report is available from the Centers for Medicare and Medicaid Services website, www.cms.gov. Proposed Payment rule for hospitals Pushes Quality metrics The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies and rates for inpatient stays. According to CMS, the proposed rule is a continuation of efforts to promote improvements in care designed to produce better patient outcomes while slowing healthcare cost growth. The rule implements elements of the Affordable Care Act, including value-based purchasing programs and the hospital readmissions reduction program. It also lays groundwork for expanding Medicare’s quality reporting requirements. These programs will adjust hospital payments beginning in 2013 and annually thereafter based on how well they perform or improve their performance on a set of quality measures. Beginning in 2015, the value-based purchasing program would include all Part A and Part B payments from 3 days prior to an inpatient hospital admission through 30 days post-discharge, with certain exclusions. The proposed measure would be risk-adjusted for the beneficiary’s age and severity of illness. In addition, the Hospital Readmissions Now Available FDA Cleared ARK produces assays of choice – high-quality, rapid and reliable – for precise results on automated clinical chemistry analyzers. Call or email today. Also available, AED assays: Levetiracetam Topiramate Zonisamide Lamotrigine Gabapentin customersupport@ark-tdm.com www.ark-tdm.com Reduction Program will reduce payments to certain hospitals that have excess readmissions for three selected conditions: heart attack, heart failure, and pneumonia. The proposed rule includes a methodology and the payment adjustment factors to account for excess readmissions for these three conditions. Overall, CMS estimates that under the proposed rule, rates to general acute care hospitals will increase by 2.3% in 2013. The 2.3% is a net update after inflation, improvements in productivity, a statutory adjustment factor, and adjustments for hospital documentation and coding changes. CMS will accept comments on the proposed rule until June 25. The proposed rule can be downloaded from the Federal Register, https://federalregister.gov. report: more oversight needed of ehr Program The Centers for Medicare and Medicaid Services (CMS) should improve its process for verifying that healthcare providers qualify for incentive payments through the meaningful use program of electronic healthcare records (EHR), according to a K-ASSAY ® report by the Government Accountability Office (GAO). Under the 2009 federal economic stimulus package, healthcare providers who demonstrate meaningful use of EHRs can qualify for incentive payments from CMS. After 2015, providers will face cuts to reimbursement if they fail to implement EHRs. GAO found that CMS has implemented proper systems to verify whether providers have met eligibility requirements before any incentive payments are processed. However, GAO noted serious problems with how exceptions are handled. CMS allows providers to exempt themselves from reporting certain measures if they report that the measures are not relevant to their patients or practices. However, GAO found that among participants in the first year of the Medicare EHR program, the majority of providers chose to exempt themselves from reporting on at least one meaningful use measure. In addition, many providers reported at least one clinical quality measure based on less than seven patients. GAO recommended that CMS collect more detailed information about providers. The full report is available from the GAO website, www.gao.gov. The Assay You Can Trust... Immunoassay Reagents for Chemistry Analyzers • Insulin Now it is possible to run quantitative insulin assays on your existing chemistry analyzer without the hazardous radioactivity of RIAs or the high cost of ELISAs. The insulin assay is highly specific and features liquidstable reagents requiring no dilution or mixing. Assay Range: 1 - 100 µIU/mL Sample Type: serum or plasma • α-1 Microglobulin Assay Range: 1.0 - 137 mg/L (serum / plasma) 0.2 - 34 mg/L (urine) • Fructosamine Colorimetric assay. Includes calibrator. Assay Range: 1 - 10 mmol/L • Direct Hemoglobin A1c Non-enzymic assay. No patient fasting required. On-board lysis step on many analyzers. Assay Range: 2 - 16% Adaptable to most chemistry analyzers (including Abbott Aeroset ® , Bayer Advia ® , Beckman Synchron CX ® and LX ® , Dade Dimension ® , Roche / Hitachi, Olympus ® AU ) For in vitro diagnostic use. KAMIYA BIOMEDICAL COMPANY 12779 Gateway Drive, Seattle, WA 98168 800-526-4925 206-575-8068 FAX: 206-575-8094 www.k-assay.com 2011.09 CLN Insulin.indd 1 8/5/2011 5:19:18 PM
abbott acquires Prostate cancer biomarkers for mDx Test abbott obtained an exclusive license from Stanford University for several novel prostate cancer biomarkers that it intends to use in developing molecular diagnostics tests that will differentiate aggressive from nonaggressive prostate cancer. The molecular assay will be based on Abbott’s fluorescence in situ hybridization technology and will be designed to detect rearrangements of the ERG and ETV1 genes, as well as loss of the PTEN gene. roche Will not extend offer for illumina after months of negotiations, Roche decided not to extend its tender offer for Illumina, ending its hostile bid for the Swiss pharmaceuticals and diagnostics firm. “We continue to hold Illumina and its management in very high regard, but with access only to public information about Illumina’s business and prospects, we do not believe that a price above Roche’s offer for Illumina of $51.00 per share would be in the interest of Roche’s shareholders,” said Severin Schwan, CEO of Roche. In January, Roche commenced a tender offer to acquire all outstanding shares of Illumina for $44.50 per share in cash and increased its offer in March to $51.00 per share in cash. genmark Diagnostics and advanced liquid logic ink ivD Deal genMark Diagnostics, Inc., and Advanced Liquid Logic, Inc., (ALL) forged a collaborative deal to develop an all-electronic, fully integrated in-vitro diagnostic platform combining ALL’s proprietary electrowetting technology and GenMark’s proprietary electrochemical detection. According to GenMark President and CEO Hany Massarany, the collaboration will focus on multiplex molecular testing, followed by efforts in other diagnostic areas including protein detection and point-of-care testing. roche licenses Pcr Technologies To life Technologies roche and Life Technologies Corporation signed two licensing deals allowing Life Tech access to polymerase chain reaction (PCR) technologies. Under the terms of the deal, Roche is granting Life Tech an in vitro diagnostic product license to all of its PCR patents for real-time PCR and other PCR-related technology in the diagnostic field. “Roche has a broad, active out-licensing program for its PCR-based intellectual property portfolio. By continuing to out-license this technology, we contribute to the development of well-validated techniques within the diagnostics field,” said Paul Brown, head of Roche Molecular Diagnostics. iNdustry p r o f i L e s p r o f i L e s hologic to acquire gen-Probe hologic announced that it is purchasing Gen-Probe for approximately $3.7 billion, creating what company officials are calling the largest diagnostics company concentrated on women’s health. The purchase allows Hologic to combine Gen-Probe’s automated Tigris and Panther platforms and Use in combination with our web based inter-laboratory program 24•7 for optimum performance and gain access to peer group data from laboratories worldwide. Peer group data is uniquely updated every 24 hours giving you access to the most up to date information available. associated menu of sexually transmitted disease tests, including the Aptima chlamydia/ gonorrhea, human papillomavirus, and Trichomonas products, with its own menu of women’s health testing platforms. “This transaction combines best-in-class technology with strong market presence and global distribution to target the rapidly growing molecular diagnostics market,” said Rob Cascella, president and CEO of Hologic. The deal is expected to close in the second half of 2012. The deal comes a year after Gen-Probe hired Morgan Stanley to seek a buyer for the firm. Though reports suggested that several companies were interested, none of them went through with a deal to acquire Gen-Probe. SAVE MONEY rapid Pathogen screening awarded contract to Develop Dx Test u .S. Department of Homeland Security’s Chemical and Biological Defense Division awarded Rapid Pathogen Screening, Inc. a contract to develop and manufacture a rapid, point-of-care diagnostic test to help in diagnosis in the event of biological attacks or pandemic events. According to the company, an emerging developer of point-of-care diagnostic tests, the test is innovative in its ability to accurately confirm and differentiate a viral infection from a bacterial infection using a finger stick of blood. CONSOLIDATE YOUR IMMUNOASSAY CONTROLS WITH RANDOX Randox Acusera Immunoassay Premium Plus is the only control to combine routine tumor markers, therapeutic drugs, thyroid hormones, fertility hormones, proteins, intact PTH and Vitamin D in a single immunoassay control. Covering 54 analytes in total, laboratories can dramatically consolidate their control use while ultimately saving money. High Quality • 100% human serum providing a matrix consistent with patient samples • Third party control • Reconstituted stability of seven days at +2-8oC or four weeks at -20oC Clinically Relevant Concentrations • Three levels available spanning the clinical range • Ferritin and Vitamin B12 present at levels suitable for anemia monitoring • Ultra low TSH levels in the level 1 control Randox Laboratories US Limited 515 Industrial Boulevard, Kearneysville, West Virginia Virginia 25430, USA T +1 304 728 2890 Toll Free 8664 Randox F +1 304 728 1890 Toll Free 8664 Randox1 E marketing@randox.com I www.randox.com/qc Scan for a rep to contact you about saving money CliniCal laboratory news June 2012 25
Page 1 and 2: news brief RepoRt Details U.s. NUtR
Page 3 and 4: Screening Tests Spark Controversy S
Page 5 and 6: I want to think about - Uptime inst
Page 7 and 8: Moving toward a better future... ID
Page 9 and 10: urine Drug Testing cutoffs standard
Page 11 and 12: figure 1 steps for achieving accura
Page 13 and 14: BD Biosciences Solutions for CD4 Mo
Page 15 and 16: Meet the 2012 Annual Meeting Chair
Page 17 and 18: See the Largest Clinical Laboratory
Page 19 and 20: Accreditation Proficiency Testing C
Page 21 and 22: oth the group of four patients who
Page 23: Our point is to change the thinking
Page 27 and 28: news from the fda Clearance for Sie

June 2012 - American Association for Clinical Chemistry

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