Pharmacogenomics is the study of how genes affect a person’s response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup. Medical professionals and administrators hope this will save lives while also enhancing the practice of personalized medicine, in which drugs and drug combinations are optimized for each individual’s unique genetic makeup.
Many drugs that are currently available are “one size fits all,” but they don’t work the same way for everyone. Whether used to explain a patient’s response or lack thereof to a treatment, or act as a predictive tool, personalized medicine hopes to achieve better treatment outcomes, greater efficacy, minimization of the occurrence of drug toxicities and adverse drug reactions (ADRs). Adverse drug reactions are a significant cause of hospitalizations and deaths in the United States.
With the knowledge gained from the Human Genome Project, researchers are learning how inherited differences in genes affect the body’s response to medications. These genetic differences will be used to predict whether a medication will be effective for a particular person and to help prevent adverse drug reactions.
The field of pharmacogenomics is still in its infancy. Its use is currently quite limited, but new approaches are under study in clinical trials. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma.
The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.
CEO SUMMARY: Management companies using a new generation of potentially fraudulent schemes are targeting hospitals and health systems for arrangements that use questionable means to increase lab test volume and revenue. The management companies often use the term “hospital outpatient department (HOPD) billing model” to describe these arrangements. The scammers want the hospitals, as in-network
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx Reference Lab canceled the lab’s registry and stopped paying most Medicare claims. In the wake
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 and Medicare to reimburse for pharmacogenomic tests, Avera Institute for Human Genetics (AIHG) in
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CEO SUMMARY: One essential element of precision medicine — the wave of the future in
CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the findings to declare payments for thousands of tests over
CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These developments should be a concern to all labs offering pharmacogenomic testing to Medicare patients.
ACROSS THE UNITED STATES, labs that perform pharmacogenomic tests complain that both government and private payers are reluctant to issue coverage guidelines and adequate reimbursement for these assays. Yet, this new class of diagnostic lab tests is the foundation of personalized and precision medicine.
Why are government and private health programs taking this tough stand on
THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health.
Last month, NIH announced this grant to Mayo Clinic. It will establish the world’s largest research-cohort biobank for