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Personalized medicine or PM is a medical model that proposes the customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.

The use of genetic information has played a major role in certain aspects of PM. and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.

Personalized medicine is not limited to pharmaceutical therapy. Advances in computational power and medical imaging are paving the way for personalized medical treatments that consider a patient’s genetic, anatomical and physiological characteristics.

Several terms, including “precision medicine,” “targeted medicine” and “pharmacogenomics” are sometimes used interchangeably with “personalized medicine.”

According to the FDA, the term is often described as providing ‘the right patient with the right drug at the right dose at the right time.’ More broadly, PM may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.

Advances in genetic and molecular knowledge about different diseases are widely expected to generate more opportunities for PM products and services. Clinical laboratories and pathology groups are continually developing new capabilities in molecular diagnostics, such as the analysis of DNA, RNA, and the human proteome.

Reimbursement policies will have to be redefined to fit the changes that PM will bring to the healthcare system. Some of the factors that will be considered are the level of efficacy of various genetic tests in the general population, cost-effectiveness relative to benefits, how to deal with payment systems for extremely rare conditions, and how to redefine the insurance concept of “shared risk” to incorporate the effect of the newer concept of “individual risk factors.”

Newsmaker Interview: Matthew Hawkins

CEO SUMMARY: By now, most pathologists and clinical laboratory administrators recognize that effective use of information technology will be a critical success factor as healthcare systems transform to do population health management and to use “big data” with value-based payment models. As the provider of laboratory information systems to hundreds of the nation’s major hospitals,

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Investment Bank Bullish On Clinical Labs, Pathology

laboratory request form

CEO SUMMARY: For clinical laboratories and anatomic pathology groups willing to adapt to the evolving needs of the American healthcare system, there are many positive opportunities. That’s the view of a Wall Street investment bank that just published a report on the lab testing sector. The report on healthcare trends includes commentary about developments in cancer care, acceptance of personalized medicine, and the growing activity in direct-to-consumer lab testing.

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Medicare Ends Coverage for Some Pharmacogenomic Testing

pharmacogenomic testing image test tube

CEO SUMMARY: Medicare’s decision to cease covering many pharmacogenomic tests puts as many as 19 million Americans who have genetic variations affecting their response to medications at risk. These medications are commonly prescribed for patients with cardiovascular disease, pain, depression, anxiety, and cancer. Meanwhile, medical centers such as Mayo Clinic are conducting clinical studies to collect evidence that appropriate use of pharmacogenomic tests can improve patient outcomes while also reducing the cost of care.

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Medicare Ends Coverage for Genetic Drug-Sensitivity Tests

pharmacogenomic testing image test tube

CEO SUMMARY: Medicare’s decision to cease covering many pharmacogenomic tests puts as many as 19 million Americans who have genetic variations affecting their response to medications at risk. These medications are commonly prescribed for patients with cardiovascular disease, pain, depression, anxiety, and cancer. Meanwhile, medical centers such as Mayo Clinic are conducting clinical studies to collect evidence that appropriate use of pharmacogenomic tests can improve patient outcomes while also reducing the cost of care.

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Medi-Cal to Cut Lab Pay on July 1 by 25% to 30%

CEO SUMMARY: Since 2011, state officials in California have aggressively cut laboratory testing fees for Medi-Cal, the state’s Medicaid program. Now state officials say they will implement a new methodology next month for determining lab testing fees. The new methodology is based on lab pricing data produced as a result of whistleblower lawsuits against labs that were settled in 2011. Should prices fall below the costs of performing these tests, the Medi-Cal program may see legal challenges from the lab industry.

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New Lab Industry Trends Require Responses by Labs

CEO SUMMARY: One stark difference between the presentations delivered at last year’s Executive War College and this year’s presentations in New Orleans last week was near-unanimous recognition that the era of fee-for-service payment is soon to end! Speaker after speaker urged the audience to accept this marketplace reality. The common recommendation was for lab administrators and pathologists to take immediate steps to help their laboratories respond to this development in effective ways.

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Benchmarking with the Best To Be a World Class Laboratory

laboratory management pyramid levels level 4

CEO SUMMARY : This fourth installment of this special series about the laboratory value pyramid introduces “Level Four: Use Benchmarks to Achieve Best-in-Class.” This is the highest level of the four level pyramid. When a lab organization performs at this level, it will be delivering substantial measurable value to all stakeholders and it will have the metrics to substantiate this value. At the same time, the performance of a level four lab can be validated by its use of recognized third-party benchmarks that show it is performing equal to the best labs in the United States and across the globe. It will also have customer survey data showing it meets and exceeds its customers’ expectations.

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