ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
OIG Report on Lab Testing Should Prompt Compliance Review
Genetic testing now accounts for 43 percent of all Medicare Part B laboratory spending
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
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
