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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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
Turning Whistleblower Lemons into Compliance Lemonade
A False Claims Act whistleblower lawsuit can do significant damage to your lab and its reputation, even if the case lacks truth and merit.
FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
Lab Owner Charged in Latest COVID-19 Fraud Crackdown
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
How Could Cheaper Genomic Sequencing Affect the Clinical Testing Industry?
Recently released NGS systems will be helpful to researchers but are unlikely to immediately impact diagnostics, expert says.
It’s Decision Day for Makers of FDA-Approved COVID-19 Tests
COVID-19 test makers will either have to get full marketing approval, or take the product off the market.
Compliance Alert: Start Using New ABN Form on June 30
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
AACC Offers New Guidance for HPV and Cervical Cancer Screening
New document aims to help clinicians navigate screening guidelines, choose testing strategies, and analyze test results.
The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
New Device Predicts the Efficacy of Hypnosis Treatment for Pain
The inexpensive POC device is a biosensor that performs COMT genotyping as a biomarker for hypnotizability.
Medicaid Fraud Recoveries Drop Significantly in 2022
At $1.1 billion, total recoveries in 2022 did exceed $1 billion for the fourth year in a row, but dropped from $1.7 billion in FY 2021
