Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
CMS Withdraws Memorandum, Seeks Public Comment on Blood Glucose Monitoring
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FDA and CMS Announce Joint Task Force Focusing on LDT Regulation
By Kelly A. Briganti, Editorial Director, G2 Intelligence Asserting that the agencies' regulatory roles are not duplicative, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced formation of a joint task...
Investigators Use Cell Phone Records to Help Prosecute Fraud
By Christopher P. Young, Editor, G2 Compliance Advisor Investigators used cell phone location data in over 800 instances to prove that a physician was not present at El Centro Clinic at the time certain tests were administered, as is required by Medicare...
CDC Says 'Steady' Progress Made in Electronic Reporting of Lab Results
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies National implementation of electronic laboratory reporting (ELR) continues to increase, according to a progress report published April 3 in Morbidity and Mortality Weekly Report. The authors...
Rosetta Genomics Closes Deal to Acquire PersonalizeDx
By Ron Shinkman, Editor, Laboratory Industry Report New Jersey-based Rosetta Genomics has closed a deal to acquire CynoGen, Inc., which does business as PersonalizeDx, for $3.9 million in cash and stock. Rosetta acquired PersonalizeDx from California-based Prelude...
Expedited FDA Approval Process Begins for Diagnostic Devices Addressing Unmet Needs
By Kelly A. Briganti, Editorial Director, G2 Intelligence Starting April 15, the FDA will begin implementing an expedited approval process for devices subject to premarket approval or de novo requests that can satisfy unmet needs for life-threatening or...
EHRs Deficient in Lab Test Result Graphing Capabilities
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Many current commercial electronic health records (EHRs) have "significant limitations" in graphing laboratory test results, according to a study published online March 19 in the Journal...
Cancer Risks Differ by Type of BRCA1 and BRCA2 Mutation, Study Finds
By Stephanie Murg, Managing Director, G2 Intelligence Although an extensive body of research links inherited mutations in the BRCA1 and BRCA2 genes to breast and ovarian cancer, little is known about the relationship between specific mutations and cancer risk—until...
Roche, Foundation Medicine Close Their Strategic Transaction
By Ron Shinkman, Editor, Laboratory Industry Report Foundation Medicine and pharmaceutical giant Roche have closed their $1.03 billion strategic transaction, the two companies have announced this week. Under the terms of the deal, Roche has purchased 15.6 million...
Drug Testing Doctor Gets Jail Sentence For Medicaid Fraud
By Christopher P. Young, Editor, G2 Compliance Advisor A Brookline Massachusetts physician, Dr. Punyamurtula Kishore, and his company Preventive Medicine Associates, Inc. (PMA), pleaded guilty to fraudulently billing Massachusetts's Medicaid program, MassHealth,...