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personalized medicine
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.”
Health System Lab Is Genotyping To Identify Best Drugs for Patients
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …
PAMA Economics Drives Merger Of Two Seattle-Area Pathology Groups
CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the comin…
Genetic Testing Lab Finds Payers Respond To Education on Test Utility
CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…
At Executive War College 2016, Two Big Lab Market Trends
CEO SUMMARY: What happens when 100 lab experts interact with an audience of more than 850 lab administrators, pathologists, and IVD executives from across the United States and seven other nations? A consensus of sorts emerges and during this 2016 edition of the Executive War College on L…
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 mode…
Investment Bank Bullish On Clinical Labs, Pathology
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…
Hit by Many New Genetic Tests, Health Insurers Just Say ‘No’
OVERWHELMED WITH REQUESTS TO PAY for new genetic tests, health insurers, particularly smaller and regional insurers, find it easier to simply deny payment for such tests. This is one of the insights shared during a panel discussion involving several managed care executives at the 20th annual Exe…
Medicare Ends Coverage for Genetic Drug-Sensitivity Tests
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…
Medicare Ends Coverage for Some Pharmacogenomic Testing
WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical labor…
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…
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Volume XXXI, No. 5 – April 8, 2024
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