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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Urine Biomarker Test Promises Early Detection of Kidney Cancer
By Stephanie Murg, Managing Director, G2 Intelligence A noninvasive screening method may hold the promise of improved outcomes for patients with kidney cancer, which affects approximately 65,000 people each year in the United States. The key is early diagnosis: If...
MEDCAC Meeting Set for Molecular Pathology Testing
By Christopher P. Young, Editor, G2 Compliance Advisor The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) is meeting on March 24 to consider evidence about the prognostic capability of certain molecular pathology tests that may have...
Exact Sciences Lands Major Payer Coverage for Cologuard Test
By Ron Shinkman, Editor, Laboratory Industry Report Exact Sciences, the Wisconsin-based molecular laboratory, has added an impressive list of names to its roster that are providing some form of coverage or support to its colon cancer assay. Anthem, one of the...
Personal Genome Diagnostics, VA Partner for Precision Oncology Program
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Personal Genome Diagnostics' CancerSelect targeted gene profiling panel has been selected for use in all newly-diagnosed lung cancer patients in the U.S. Department of Veterans Affairs (VA) New...
At Lab Revolution Conference, a Peek Inside Quest’s ‘Lab of the Future’
By Stephanie Murg, Managing Director, G2 Intelligence What does the lab of the future look like? This question was addressed by a broad range of experts at G2 Intelligence’s Lab Revolution 2015 conference, held March 11-13 in Orlando, Florida. Among the speakers...
Coverage for Electron Microscopy Left to MACs
By Christopher P. Young, Editor, G2 Compliance Advisor The Centers for Medicare and Medicaid Services (CMS) has removed the national coverage determination (NCD) for electron microscopy (EM) from the Medicare National Coverage Determinations Internet only manual...