Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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...
Patient Test Requests Not Driving Health Care Costs
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Physicians' perceptions of the "demanding patient" may not be based in reality. According to a new study, published online Feb. 12 in JAMA Oncology, patients make demands for additional cancer...
LifeCode Obtains CAP Laboratory Accreditation Raises $20.5 Million
By Ron Shinkman, Editor, Laboratory Industry Report LifeCode, the California-based laboratory firm that focuses on next-generation sequencing assays, has obtained laboratory accreditation from the College of American Pathologists and raised $20.5 million from a...
Claritas Genomics Raises $15 Million to Expand Operations, Test Menu
By Stephanie Murg, Managing Director, G2 Intelligence Genetic diagnostic testing company Claritas Genomics (Cambridge, Mass.) has secured $15 million to fund expansion of its commercial operations and launch novel next generation sequencing-based tests for...