Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an
Tag: molecular diagnostic tests
CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As many as 20 or more molecular labs operate in California
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer.
The collaboration calls for Sysmex, a major in vitro diagnostics (IVD) manufacturer with expertise in hematology testing, to work with LabCorp. Efforts will center around two assays developed at Sysmex Inostics, called OncoBEAM and Plasma-Sequencing.
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnostics, the organization also told members of Congress that—not only are the prices
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the clinical trial data required to obtain coverage guidelines and
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests while it is determining reimbursement
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts, Claritas Genomics, formerly the molecular lab at Boston Children’s Hospital, is one
CEO SUMMARY: Non-payment of molecular test claims for the first five months of 2013 is not the only financial disruption for labs that perform these tests. Reports are coming in about how Medicare contractors, Medicaid programs, and private payers are declining to pay claims based on rulings that the molecular tests fail to meet medical
CEO SUMMARY: Some payments are beginning to flow for claims submitted under the new molecular test CPT codes. But there is a new issue. Medicare contractors, Medicaid programs, and private health insurers are deeming certain molecular tests to be medically unnecessary. These payers are requesting that labs submit more documentation before they will pay for
CEO SUMMARY: Having gone unpaid since January 1 for the 114 new molecular CPT codes, many clinical labs and pathology groups have stopped running these tests or laid off staff. Some are considering closing their doors. Evidence indicates that certain Medicare contractors are deciding that some molecular tests are not medically necessary. Medicare officials launched