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
Roche Alzheimer’s Early Detection Tests Get FDA Green Light
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
Huge Decline in Medicare Laboratory Testing Due to COVID-19
According to a recent OIG report, fewer Medicare Part B beneficiaries received lab tests during the first 10 months of the pandemic.
The Promise of State-of-the-Art Sequencing Technologies for Cancer Screening
Circulating tumor DNA sequencing technologies are tackling the challenges of early cancer detection.
How the Use of MALDI-TOF MS Is Expanding in Clinical Diagnostics
Advances in MALDI time-of-flight mass spectrometry have significantly expanded its use in high-throughput diagnostic labs.
Recent Discovery Could Lead to a Better Lyme Disease Test
Researchers have identified 35 genes found in high expression in people with long-term Lyme disease, which could lead to earlier detection.
Improving the Chances of Early Breast Cancer Detection in High-Risk Patients
A new test targeting changes in serum proteins can detect breast cancer up to two years before the condition would normally be diagnosed.
New Payment Rules for Lab Specimen Collection & Travel Allowances
Here’s a look at what labs need to know about the new rules that take effect on Jan. 1 as part of the 2023 Medicare Physician Fee Schedule.
Hospital Workplace Violence Prevention to Face Greater Scrutiny
CMS has instructed state surveyors to crack down on hospitals that don’t implement adequate workplace violence protections.
CMS Recognizes 8 New CLIA-Waived Tests
Labs will be able to bill Medicare and Medicaid for these new CLIA-waived tests, starting on April 1, 2023.
Compliance Alert: Revised Medicare Part B Travel Allowance Rules
What labs need to know to maximize travel allowance reimbursements.
