Jun 8, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Pathologists and clinical laboratory managers will need a strategy for handling incidental findings
When a genetic test for a certain type of cancer provides additional information that could affect the patient’s health, what is the ethical course of action for pathologists and clinical laboratory scientists? Should this information be disclosed to the physician who ordered that cancer test? In turn, should that physician inform his or her patient about these “incidental findings?”
All medical laboratory professionals will soon find themselves regularly dealing with this challenge because of the rapid increase in the number of molecular diagnostic assays and genetic tests that produce large quantities of data about the patient. (more…)
Jan 4, 2012 | Digital Pathology, Laboratory News, Laboratory Pathology
Separate genetic and molecular test registries proposed by the National Institutes of Health and by Palmetto GBA draw detailed public comments from medical lab groups
Registries for genetic tests and molecular diagnostic assays don’t seem to be going over well with clinical laboratories and pathology groups. Two different genetic test registries are drawing criticisms from pathologists and laboratory medicine professionals.
One molecular test registry was proposed last year by the National Institutes of Health (NIH). For different purposes, this fall, Palmetto GBA, the Medicare Carrier based in Columbia, South Carolina, proposed a molecular test registry that would be used by laboratories billing for molecular testing services provided in the Medicare J1 region, which includes California, Hawaii, and Nevada.
This second registry is part of what Palmetto GBA has named the “Molecular Diagnostic Program” (MolDx). Palmetto expects this registry will help resolve problems created by code stacking claims for genetic and molecular tests. (See Dark Daily “Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories,” November 15, 2011.) The MolDx program has already attracted public comments, both positive and negative.
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