How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Essential
Subscribe today for access to
Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Compliance Alert: 8 New Medicare COVID-19 Test Payment Rules Take Effect on May 12
CMS recently issued long-awaited guidance on post-PHE changes to Medicare coverage of SARS-CoV-2 diagnostic tests.
Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements
An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.
Reimbursement: ABN’s Failure to Include List Prices for Denied Lab Tests Is Not Consumer Fraud
Recent case shows why failing to disclose to individuals the lab test list prices they may need to pay doesn’t count as consumer fraud.
Medicare Expands Coverage of Molecular Cancer Screening Tests
In terms of Medicare coverage, 2023 is shaping up to be a fruitful year—here are five of the most significant approvals so far.
Growth of Medical & Consumer Debt Poses New Challenges for Collections
Increasing medical and consumer debt is likely to get worse, meaning billing and collections may get even tougher for labs.
Hostile Regulatory Environment Further Chills Diagnostics Market
The biggest story in M&A dealmaking continues to be the deal that’s being undone—Illumina’s acquisition of GRAIL.
A Timeline of 2023 Lab Company Layoffs So Far
The wave of layoffs, which began last year with the declines in COVID-19 testing sales, has gathered momentum in 2023.
Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
Lab Companies Team with Nonprofits on Test Development, Access, & Awareness
April was among the busiest months, in recent memory, in terms of both deal volume and significance in the diagnostics industry.
Quiz: Is This Illegal Remuneration Under the AKS?
A recent court case sheds some light on if denying employment can count as illegal remuneration under the Anti-Kickback Statute.
