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AMP Releases Tools to Calculate Cost, Demonstrate Value of Genome SequencingBy Stephanie Murg, Managing Director of Conferences and Events, G2 Intelligence
No discussion of next-generation sequencing (NGS) is complete without a reference to the swiftly plummeting cost of the technology, and yet little effort has made to put a dollar figure on the value of this type of analysis. The Association for Molecular Pathology (AMP) is seeking to change that. On March 4, the organization released cost analysis results and health economic evaluation models for several genomic sequencing procedure CPT codes as well as a micro-costing analysis template that molecular diagnostic laboratories can use to calculate the cost of the NGS assays they use to perform these procedures.
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Annual Physician Fee Schedule Game Begins
By Christopher P. Young, Editor, G2 Compliance Advisor
The Medicare physician fee schedule (MPFS) will be adjusted to reflect a 21.2 percent negative update effective April 1 unless Congress acts to override or delay the cut as has been the case in previous years. According to the Centers for Medicare and Medicaid Services (CMS) program transmittal R3205CP issued on Feb. 27, Medicare administrative contractors (MACs) were instructed to retrieve the files and use them to update their systems. The transmittal has an effective date of Jan. 1 with an implementation date of April 6. Congress has a little more than 3 weeks to stop the reductions. So, here we are again with CMS, MACs, laboratories and other providers having to act at the last minute to avoid a claims filing nightmare depending on what Congress does. The 21.2 percent negative update to the fee schedule translates to a $7.53 reduction in the conversion factor..
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Castle Biosciences Study Reaffirms Efficacy of Predictive Melanoma Test
By Ron Shinkman, Editor, Laboratory Industry Report
A new clinical study conducted in conjunction with the Texas-based Castle Biosciences, Inc. suggests that its molecular assay for melanoma patients can assist in determining whether their particular cancer will spread.
The test focuses on the gene expression profile of each patient's melanoma. The clinical study focused on the efficacy of Castle's test, known as DecisionDx-Melanoma, in comparison with the biopsy of lymph nodes, which is the accepted method for predicting whether the melanoma will spread to other parts of the body. A total of 217 patients were included in the study.
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Oncotype DX Use Consistent With Guidelines, Study Finds
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Oncotype DX assay (Genomic Health; Redwood City, Calif.), to assess a patient's risk of recurrence, was adopted quickly in clinical practice after Medicare's positive coverage decision, according to a study published online March 5 in JAMA Oncology. The authors further found that adoption appears to be consistent with clinical guidelines and equitable across geographic and racial groups. However, despite the assay's goal to identify patients most likely to benefit from adjuvant chemotherapy, chemotherapy rates did not change as assay use increased, a finding the authors say warrants further investigation.
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HHS Declares Enterovirus D68 Significant Potential for Public Health Emergency
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence
The U.S. Department of Health and Human Services Secretary issued a notice declaring the enterovirus D68 (EV-D68) poses a "significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad." Thus, based on that determination, the Secretary also announced that these circumstances justify authorization of emergency use of new in vitro diagnostics to detect EV-D68.
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