LDTs

Health Orgs Seek LDT Oversight

Calling the current regulatory system for laboratory developed tests (LDTs) "inadequate and in urgent need of updating," the American Cancer Society Cancer Action Network and 32 other organizations … [Read more...]

ENFORCEMENT

Health Care Fraud and Abuse Program Faces Declining ROI

The federal government's return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and Abuse … [Read more...]

ENFORCEMENT

Theranos Faces Potential Consumer Fraud Litigation

The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos: state consumer fraud lawsuits. The AGO indicated in its request that it … [Read more...]

HEALTH CARE REFORM

ACA Still Intact for Now, But for How Long?

Now that President Donald Trump has taken office legislative efforts to "repeal and replace" the Affordable Care Act (ACA) have begun in earnest. Both the House of Representatives and the … [Read more...]

PRECISION MEDICINE

Industry Leaders Recommend Standardized Interpretation and Reporting of Somatic Sequence Variants

Acommon refrain within the diagnostics industry is a need for standardization. Rapidly developing technology and testing methods, the call for interoperability, and the vast amount of data and … [Read more...]

HIPAA

Breach Notification Violation Ends in $475,000 Settlement

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Three years ago, a new … [Read more...]

LEGISLATION

Labs Stop VA from Allowing APRNs to Perform Lab Tests

The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advanced practice registered nurses (APRNs) to "perform and supervise" lab testing. … [Read more...]

PRECISION MEDICINE

Coalition Promotes cfDNA-based Noninvasive Prenatal Testing

Five major players in genetic testing have joined forces to promote cellfree DNA (cfDNA)-based noninvasive prenatal testing (NIPT). A newly formed organization, Coalition for Access to Prenatal … [Read more...]

LDTs

FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation

Last December, the U.S. Food and Drug Administration announced that it would not finalize the guidance on agency oversight of laboratory developed tests (LDTs) that it proposed back in 2014— at least … [Read more...]

REIMBURSEMENT

LCDs Demonstrate Evolving Coverage of Molecular Diagnostics

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally … [Read more...]


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