Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
FDA to Hold Public Workshop on Next Generation Sequencing
By Kelly A. Briganti, Editorial Director, G2 Intelligence Next Generation Sequencing (NGS) diagnostic tests bring incredible opportunities for patient care, yet at the same time present significant challenges for oversight. Recognizing these challenges and...
CMS Says More Data On the Way
By Christopher P. Young, Editor, G2 Compliance Advisor In spite of objections from the American Medical Association (AMA), a Centers for Medicare and Medicaid Services (CMS) spokesperson told a Wall Street Journal (WSJ) reporter that it intends to publish annual...
Laboratory Medicine Shifting Away from Academic Orientation
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Increasingly, the practice of laboratory medicine is burdened by administrative responsibilities leaving less time for research among academic clinical chemists (laboratory physicians and...
Guilty Pleas In Biodiagnostic Case Reach 35
By Ron Shinkman, Editor, Laboratory Industry Report A Jersey City, NJ physician has become the latest person to plead guilty for his part in a kickback scheme involving Parsippany, NJ-based Biodiagnostic Laboratory Services. Anthony DelPiano, M.D., admitted in...
FY 2016 Budgets Target Diagnostic Testing and Compliance Issues
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence Government agencies that impact the laboratory industry have submitted budgets for fiscal year 2016 that will fund efforts to reduce healthcare spending, focus on quality of care rather than quantity,...
MetaStat Enters Into Tissue Deal With Kaiser Hospitals
By Ron Shinkman, Editor, Laboratory Industry Report MetaStat, the Boston-based molecular laboratory startup, has entered into an agreement to obtain a large cache of both tissue samples and deidentified patient data. Under the terms of the deal, Kaiser Foundation...
Thermo Fisher, Cynvenio Partner as Liquid Biopsy Technology Expands
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Thermo Fisher Scientific (Carlsbad, Calif.) and Cynvenio Biosystems (Westlake Village, Calif.) have signed a distribution agreement for the LiquidBiopsy platform. The combination of Cynvenio’s...
Medicare Announces Timeline for Shifting from Volume to Value Based Reimbursement
By Kelly A. Briganti, JD, Editorial Director G2 Intelligence There has been much discussion about moving away from fee for service reimbursement and the need to tie reimbursement to the value provided, rather than the amount of care provided. That discussion takes...
The New 59 X(EPSU) Modifiers, X’d For Now
By Christopher P. Young, Editor, G2 Compliance Advisor The latest communication from the Centers for Medicare and Medicaid Services (CMS) concerning new modifiers, referred to as X(EPSU), intended to replace the 59 modifier, says that while the new modifiers are...
FDA Authorizes Marketing of 23andMe Direct-to-Consumer Genetic Screening Test
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence Only a little more than a year after receiving an FDA warning letter telling 23andMe to stop marketing its direct-to-consumer Personal Genome Service, the company finally has a bit of good news. The FDA...