Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
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.
False Billing of UDTs Remains a Prime Target for Enforcement
UDT false billing cases seem to be on the rise again, accounting for a trio of recent multimillion dollar settlements.
OIG Issues First Positive Advisory Opinion for Free Genetic Testing
On April 11, the OIG approved a proposed arrangement involving the offering of free genetic tests and counseling services.
FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
