Overturning of Molecular Test Coverage Denials Varies Widely, According to UCSF Study
Research into independent medical review data in four states show payers’ internal policies affect rates of overturns
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Articles and Reports
FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
CMS Ends Paper CLIA Certificates and Coupons Effective March 1
Laboratories must register for email-only communications and submit all CLIA fees electronically
Up Next for Labs: PAMA Reporting Window Opens May 1
Cuts to reimbursement rates under PAMA have been pushed back again by Congress, this time to January 2027
PAMA Delay Proposed Until 2027 Under a New Federal Spending Bill
However, attorney Danielle Sloane urges labs to be proactive about potential PAMA reporting requirements on Jan. 31 if the bill doesn’t pass quickly
FDA Watch: Truvian Health Receives Initial FDA Clearance for 34-Test Platform
San Diego-based healthcare diagnostics company is trying to succeed where Theranos failed
ACLA Head Pushes RESULTS Act Passage During House Subcommittee Testimony
Better clinical laboratory test data reporting would allow ‘Medicare rates to be more appropriately set,’ says Susan Van Meter
FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS' proposal
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
