Local Coverage Determinations (LCDs) – Revised MM10901

  • Mar 5, 2019

CR 10901 notifies MACs that, in accordance with Section 4009 of H.R. 34-21st Century Cures Act (Public Law No: 114-255), the Centers for Medicare & Medicaid Services (CMS) is updating the “Medicare Program Integrity Manual” with detailed changes to the LCD process. CR# R863PI

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Biocept, Providence Saint Joseph's Health Center Collaborate on CSF Liquid Biopsy Testing

  • Mar 5, 2019

Biocept announced that it has partnered with Providence St. Joseph Health, Southern California, and its affiliates Saint John's Health Center and the John Wayne Cancer Institute, to evaluate usage of cerebral spinal fluid (CSF) in liquid biopsy testing for metastatic cancer. Target Selector liquid biopsy platform to test CSF samples from patients diagnosed with certain types of cancer, including...

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Independent Laboratory Billing of Laboratory Tests for End-Stage Renal Disease (ESRD) Beneficiaries and the Sunset of the CB Modifier CR11061 Feb 05, 2019

  • Mar 5, 2019

Independent Laboratory Billing of Laboratory Tests for End-Stage Renal Disease (ESRD) Beneficiaries and the Sunset of the CB Modifier. MLN Matters Number: MM11061 Related CR Release Date: February 1, 2019 Related CR Transmittal Number: R4227CP Related Change Request (CR) Number: 11061 Effective Date: July 1, 2019 Implementation Date: July 1, 2019 Change Request (CR) 11061 sunsets the...

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Prostate Cancer Patients With Germline Variants Were Often Not Covered by Testing Guidelines

  • Mar 5, 2019

Nearly 20 percent of men with prostate cancer harbor a germline variant that places them at increased risk of developing the disease, according to a new study, but a third of them were not eligible for genetic testing according to guidelines in place at the time. Men with germline mutations in genes like BRCA1 or BRCA2 tend to develop prostate cancer at a younger age and have an increased risk...

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NHGRI Earmarks $7.3M for Human Genome Reference Program Projects

  • Mar 5, 2019

The National Human Genome Research Institute has earmarked nearly $7.3 million to fund a series of research projects over the next several years to advance its recently established Human Genome Reference Program (HGRP), which aims to build a human genome reference that better accounts for genetic diversity than the existing reference. In early 2018, the NHGRI held a meeting of over 65 basic...

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MLN Matters 11135 - Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

  • Mar 5, 2019

CR11135 informs providers and MACs about the new HCPCS codes for 2019 that are subject to and excluded from Clinical Laboratory Improvement Amendments (CLIA) edits. Discontinued Codes as of Dec. 31, 2017 Discontinued Codes as of Sept. 30, 2018 Discontinued Codes as of Dec. 31, 2018 HCPCS codes new for 2019 and are subject to CLIA edits.

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Invitae Partners to Expand Free Epilepsy Genetic Testing Program

  • Mar 5, 2019

Molecular diagnostics company Invitae has partnered with BioMarin, Stoke Therapeutics, and Xenon Pharmaceuticals to expand its free genetic testing program for children with epilepsy. The Behind the Seizure program previously provided no-cost genetic testing for children ages two to four who had an unprovoked seizure. Invitae and its partners are now making free testing under this program...

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Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance

  • Mar 5, 2019

On February 1, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued a Notice of Proposed Rulemaking [CMS-3355-P].  This notice of proposed rulemaking includes the addition and deletion of analytes requiring proficiency testing and updates criteria for acceptable performance under the Clinical Laboratory Improvement...

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