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hhs announces Proposed changes to hiPaa Privacy rule under a rule proposed by the U.S. Department of Health and Human Services Office for Civil Rights, individuals would be given the right to get a report on who has electronically accessed their protected health information. The proposed rule is a change to the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). With this change, people could obtain this information by requesting an electronic access report that would document the particular persons who electronically accessed and viewed their protected health information. Although covered entities, including physicians, hospitals, labs, health plans, and other healthcare organizations, are currently required by the HIPAA Security Rule to track access to electronic reguLatory Automate with Confidence Medicon, a brand of Optima Life Science, has brought the latest innovations to the well-coating process. Modularly built, the Medicon ImmuCoat® machine is positioned to be everything you need it to be. Including in-line drying and pouch packaging capabilities. Scale and reconfigure the modules to expertly fit your needs, offering you the utmost in flexibility. OPTIMA Machinery Corporation Green Bay, WI · USA 44 CliniCal laboratory news July 2011 p r o f i L e s p r o f i L e s protected health information, they are not required to share this information. The proposed rule also requires an accounting of more detailed information for certain disclosures that are most likely to affect a person’s rights or interests. To effect the change, all healthcare organizations will be required to update their privacy notices under HIPAA to educate patients about requesting access reports. The new rule will take effect January 1, 2013, if adopted. Comments on the proposed rule will be accepted through August 1, 2011. To read the proposed rule or submit a comment, go to www.regulations.gov. reform to net $120 billion in savings for medicare an analysis issued by the Centers for Medicare and Medicaid Services (CMS) www.optima-usa.com More information / sign in: www.immucoat.com Meet us at AACC, Atlanta, July 26–28, 2011 booth no. 1953 outlines $120 billion in 5-year projected savings resulting from improvements to the Medicare program, including implementation of many provisions in the Affordable Care Act. The report summed up projected savings from several sources, including new tools to combat fraud, waste, and abuse in the Medicare system, as well as delivery system reforms, such as those that deter hospital readmissions. The report looked at five general areas of projected savings: reforming provider payments to reward quality of care, $55 billion; lowering hospital readmission and hospital-acquired infections, $10 billion; fraud and abuse prevention, $1.8 billion; improvements in durable medical equipment purchasing, $2.9 billion; reducing payments to insurance companies, $50 billion. The full report is available from the CMS website, www.cms.gov/apps/files/ medicare-savings-report.pdf. sured. Most uninsured people have virtually no savings, and the median per-family financial assets for uninsured families are just $20. Even among higher-income families, assets are low: half of families with income at 400% of the Federal Poverty Level, or $89,400 a year for a family of four in 2011, have financial assets below $4,100. The report is available from the HHS website, https://aspe.hhs.gov/health/reports /2011/ValueofInsurance/rb.shtml. hhs begins broad battle over Payment advisory board continues The Affordable Care Act established a 15-member Independent Payment Advisory Board (IPAB) charged with making cuts to Medicare in years that spending exceeds a target growth rate. Under the Act, IPAB recommendations will automatically become law unless blocked by both Congress and the President. The Congressional Budget Office (CBO) recently estimated that repealing IPAB would inevitably mean stronger spending growth, adding up to regulatory review $2.4 billion between 2018 and 2021. The U.S. Department of Health and Hu- The CBO report is bad news for House man Services (HHS) released its pre- Republicans who have targeted IPAB in liminary plan for retrospective review of their effort to defund or repeal healthcare existing rules based on a comprehensive reform provisions. This year Representative inventory of each of its agencies’ existing Phil Roe (R-Tenn.) introduced legislation, regulations. The plan highlights regulations H.R.452, the “Medicare Decisions Account- already being modified or streamlined and ability Act,” to abolish IPAB. The projected identifies additional candidates for further costs of doing away with IPAB means that review. the bill would also need to offset these costs Earlier this year, President Obama out- somewhere else in the budget. lined his plan for ongoing review of regula- Beginning April 2013, the Affordable tions in the federal government with the in- Care Act requires the chief actuary of the tention of culling rules that are out-of-date, Centers for Medicare and Medicaid Servic- unnecessary, excessively burdensome, or in es to project whether Medicare per capita conflict with other rules. spending exceeds the average Consumer The HHS plan outlined several areas Price Index, based on a 5-year period. If for improvement, including conflicting so, beginning January 15, 2014, IPAB must requirements between Medicaid and Medi- submit recommendations to cut Medicare care; reviewing the criteria used to define spending. The board must also submit rec- health professional shortages and mediommendations every other year to slow the cally underserved areas; and using more growth in national private health expendi- cost-effective technologies like electronic tures while preserving quality of care. The signatures and document storage. threshold target will then change begin- The full regulatory review plan for the ning in 2018, when it becomes Medicare agency is available on www.whitehouse. per capita spending that exceeds gross do- gov. mestic product per capita plus 1%. The law specifically prohibits IPAB from submitting proposals that would ration care, increase report: most uninsured revenues, or change benefits, eligibility, or can’t Pay bills Medicare beneficiary cost sharing. new report released by the U.S. De- More information is available from the a partment of Health and Human Ser- CBO website, www.cbo.gov. vices (HHS) shows that few families without health insurance have the financial assets to pay potential hospital bills. On average, uninsured families can only afford to pay in full for approximately 12% next in CLN of hospital stays they may experience, and even higher-income uninsured families are unable to pay for most potential hospitalizations, the report found. Hospital stays for which the uninsured cannot pay in full account for 95% of the total amount hospitals bill the uninsured. Platelet function Testing The idea that people without heath insurance can get care with little or no problem is an enduring myth, said HHS Secretary Kathleen Sebelius. According to the new report, approximately 50 million Americans are unin- 30 years of hiv Testing
iNdustry p r o f i L e s p r o f i L e s Quest completes in pre-clinical development for advanced non-small cell lung cancer (NSCLC) pa- acquisition of celera tients, will run on Roche’s Cobas 4800 sys- Quest Diagnostics has successfully tem and is intended for the identification completed acquisition of Celera Cor- of mutations, including the EGFR T790M poration for approximately $671 million. mutation, in patients with NSCLC. “Our According to Quest, the deal was com- agreement with Clovis Oncology strengthpleted through a short-form merger, after ens our position as the partner of choice for its tender offer expired. Quest announced the development of companion diagnos- plans to purchase Celera in March in an eftics. Roche hopes that through this collabofort to strengthen its molecular diagnostics ration we will be able to advance oncology portfolio. diagnostic testing and drug therapy for the benefit of many patients worldwide,” said Paul Brown, head of Roche Molecular Di- danaher extends offer agnostics. for beckman coulter danaher has extended for a third time its cash tender offer to acquire all of Thermo fisher signs deal to the outstanding shares of Beckman Coulter, Inc. for $83.50 per share in cash. All other terms and conditions of the offer expand specialty dx Portfolio Thermo Fisher Scientific has inked a definitive deal to acquire Phadia, an al- remain unchanged. Danaher continues to lergy and autoimmunity diagnostics firm. anticipate completing the acquisition in The deal is designed to significantly expand 2011. The deal is valued at approximately Thermo Fisher’s specialty diagnostics port- $6.8 billion. folio. Currently, Thermo Fisher’s diagnostics business focuses on tissue-based cancer diagnostics, microbiology technologies for myriad Genetics licenses cancer detecting pathogens in food and infectious diagnostic Technology from chronix diseases, and specialty assays, such as drugs- myriad Genetics has licensed the of-abuse testing and its biomarker business. rights to technology for early detec- “Phadia is a strong fit strategically with our tion of cancer from Chronix Biomedical. existing specialty diagnostic platform, sig- Under the terms of the deal, Myriad has nificantly increasing our penetration of a the rights to commercialize tests derived high-growth market,” said Thermo Fisher from the technology for the early detection of breast, colon, and prostate cancers in North America, South America, president and CEO, Marc Casper. and Europe. Myriad Genetics will pay nestle health science acquires upfront fees, milestone payments, and royalty payments in exchange for access to Chronix Biomedical’s technology. Prometheus laboratories nestle Health Science has finalized an agreement to buy Prometheus Labo- “The technology we have licensed from ratories for an undisclosed amount. The Chronix Biomedical has the potential to deal is aimed at moving the company into revolutionize the early detection of cancer the gastrointestinal diagnostics sector. Nes- through the analysis of unique DNA setle Health Science is a wholly owned subsidquences in blood samples,” said Mark Caiary of Nestle and is focused on developing pone, president of Myriad Genetics. science-based nutritional solutions for personalized medicine. Joseph Limber, president and CEO of Prometheus, said that as metabolon moves into the a result of the acquisition, his company will diagnostics business “accelerate the development of our innova- metabolon will expand its offerings by tive diagnostics platforms for gastroenterol- moving into the diagnostics market. ogy and oncology and potentially into ad- The metabolomics firm anticipates the launch of its first test for insulin resistance, called Quantose. The company will focus ditional important therapeutic areas.” its attention on developing metabolomics- labcorp Purchases clearstone based diagnostics. Two tests for prostate cancer are also planned, as well as tests for determining the aggressiveness of cancers central laboratories laboratory Corporation of America has signed a definitive deal to buy central and for assessing tolerance to chemothera- laboratory service provider Clearstone pies, directed at bladder and kidney cancers. Central Laboratories in an effort to bolster the company’s companion diagnostics business. According to LabCorp, the deal roche and clovis collaborate on will provide it with a global network of cen- companion dx for eGfr mutations tral laboratories and access to Clearstone’s roche and Clovis Oncology have part- clinical trials management system, Apollo nered to develop an in vitro PCR- CLPM, which offers real-time access to based companion diagnostic test. The as- global data. The deal is expected to close say for CO-1686, a compound currently this summer. myriad Genetics finalizes rules-based medicine Purchase myriad Genetics has completed its purchase of Rules-Based Medicine for $80 million. According to Myriad, Rules- Based Medicine will continue its collaborations with pharmaceutical partners in companion diagnostics discovery. The deal is expected to further develop Myriad’s companion diagnostics franchise. In addition, the acquisition will help expand the company’s product portfolio into new disease areas including psychiatric disorders, infectious diseases, and inflammatory conditions. siemens signs agreements to strengthen microbiology Portfolio siemens Healthcare Diagnostics has signed a strategic partnership with Copan and a co-marketing agreement with Bruker Corporation in an effort to strengthen the analytical workflow and molecular identification functionality of its microbiology portfolio. The new agreements grant laboratories access to enhanced analytical workflow efficiency and advanced mass spectrometric identification, designed to support their microbiology testing needs. neoGenomics laboratories inks distribution deal with signal Genetics Laboratories has signed neoGenomics a deal to distribute Signal Genetics’s new gene expression profile test for multiple myeloma to pathologists and hospital-based hematologists and oncologists nationwide. Under the terms of the deal, Signal Genetics’s Myeloma Prognostic Risk Signature test (MyPRS) will be performed at its CLIA-certified laboratory in Little Rock, Ark. The MyPRS test analyzes a defined number of relevant genes to determine the gene expression profile associated with a patient’s condition, giving physicians a predictive view of the patient’s progress and enabling personalized treatment decisions. NeoGenomics has also obtained the right of first negotiation to market any genomic and transcriptomic-based diagnostic test developed and/or launched by Signal Genetics in the future. Coagulation Reagents for Chemistry Analyzers K-ASSAY The Assay You Can Trust... ® Coagulation / Hemostasis assays can now be performed on most chemistry analyzers ! ! (including Abbott Aeroset ® , Bayer Advia ® , Beckman AU series, Synchron CX ® and LX ® , Dade Dimension ® , Roche / Hitachi, and many others) • Anti-Thrombin III 9-35 mg/dL • D-Dimer 0.5-30 µg/mL • Fibrinogen 100-900 mg/dL • Plasminogen 3-14 mg/dL For in vitro diagnostic use. • Factor XIII (plasma) 2.3%-140% • FDP (serum) 0.2-80 µg/mL • FDP (urine) 0.02-3.2 µg/mL • P-FDP (plasma) 2-80 µg/mL • FDP-E (serum) 22-1,920 ng/mL • FDP-E (urine) 6-192 ng/mL For research use only. Not for use in diagnostic procedures. KAMIYA BIOMEDICAL COMPANY 12779 Gateway Drive, Seattle, WA 98168 800-526-4925 206-575-8068 FAX: 206-575-8094 www.kamiyabiomedical.com see us at the 2011 clin lab expo, booth no. 2220 Coagulation CLN 05-2011.indd 1 3/28/2011 1:42:51 PM CliniCal laboratory news July 2011 45
Page 1 and 2: news brief Forecast: robust Market
Page 3 and 4: Most Adults Check Online for Health
Page 5 and 6: visitors and the hundreds of thousa
Page 7 and 8: Bio-Rad Laboratories HEMOGLOBIN TES
Page 9 and 10: IGF-I Automated Assay Now Available
Page 11 and 12: care. Unfortunately, most laborator
Page 13 and 14: The point of our demonstration is a
Page 15 and 16: checklist for structured handoffs a
Page 17 and 18: Being Prepared Hickson urges labora
Page 19 and 20: See what we see. At Phadia, we see
Page 21 and 22: itC ...............................
Page 23 and 24: See us at the 2011 Clin Lab Expo, B
Page 25 and 26: 2 0 11 N E w P r o d U c T s r E v
Page 43: Expand Your Expertise. Validate You
Page 47 and 48: news from the fda Pcr-based hepatit

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