Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
AI and Wearable Devices Offer Promise as an Early COVID-19 ID Method
While still in its infancy, recent research shows the combination of AI and wearables can accurately detect early SARS-CoV-2 infection.
Diagnostic Lab to Pay Nearly $10 Million to Settle FCA Allegations
BioReference Health LLC and its parent company have agreed to pay $9.85 million to resolve alleged violations of the False Claims Act.
NCCN Recommends Molecular Testing for Pediatric Cancer Treatment
The new guidelines will likely prove highly influential with oncologists and payors.
CDC, Major Laboratory Companies Launch New Tests for Monkeypox
As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.
Lesion Samples Are Best When It Comes to Monkeypox Testing
Recent FDA Safety Communication warns of the potential of false results from other sample types when testing for the monkeypox virus.
GAO to FDA: Create Emergency Powers Policy to Avoid COVID Mistakes
The agency needs a plan on use of EUA authority to get lab tests to market during the next public health emergency, says the GAO.
OIG Calls Out MA Plans for Wrongfully Denying Reimbursement
The new report could be a turning point in the battle to curb payor abuse of preauthorization requirements.
Labs Figure Prominently in New OIG Enforcement Report
While the report’s most significant findings involved labs and lab testing, it wasn’t just the usual finger pointing this time.
Theranos in Court: Jury Finds Balwani Guilty on All 12 Counts
Federal San Jose jury finds ex-Theranos COO guilty of all 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
The 6 Changes Labs Need to Know About the 2023 Physicians Fee Schedule
Here are the aspects of the proposed rule most likely to have an impact on labs and the businesses that own them.
