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
Blood-Based Alzheimer’s Tests Have Officially Arrived
Recent developments suggest that we are on the precipice of a new age offering expanded options for Alzheimer’s diagnosis.
Telehealth Encounters Lead to More Follow-Ups than In-Person Visits
Recent study suggests those being treated for acute conditions are likelier to schedule follow-up appointments after telehealth visits.
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
Does Race Affect Interpretation of Alzheimer’s Blood Test Results?
Researchers find that three out of four blood tests produced different results depending on if they were used for White or Black people.
HHS Tabs OraSure Technologies for COVID-19 School Testing
HHS will distribute OraSure’s InteliSwab COVID-19 rapid at-home antigen test kits to schools across the nation.
Could a Pacifier Replace Blood Draws for Babies in the NICU?
A recently developed bioelectronic tool could make health monitoring less invasive for babies in newborn intensive care units.
CMS Proposes Modest Increase to Hospital IPPS Rates
Unsurprisingly, the American Hospital Association and other industry groups don’t think that increase is anywhere near adequate.
AI Algorithm Gets FDA Breakthrough Device Designation
The algorithm, designed to help diagnose pulmonary hypertension earlier, aims to ensure patients get treatment sooner.
What Happens to COVID Tests After Public Health Emergency Ends?
The FDA will almost certainly keep EUA tests on the market after the PHE expires.
Labs in Court Weekly Roundup
Settlements for False Claims Act allegations the theme in recent enforcement actions involving the healthcare industry.
