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
Compliance Alert: Revised Medicare Part B Travel Allowance Rules
What labs need to know to maximize travel allowance reimbursements.
Eight New CLIA-Waived Tests Recognized by CMS
Labs will be able to bill their MACs for the newly recognized tests starting April 1, 2023.
Weekly Enforcement Report: Plenty of Kickbacks
Last week’s cases saw a major false claims-related settlement, as well as many kickback-related schemes.
FY 2022 OIG Enforcement Rebounds—but Recovery Dollars Don’t Show It
The agency’s latest report to Congress shows that while enforcement activity is returning to pre-pandemic levels, recoveries are still down.
The Year in Lab Compliance: The 6 Biggest Stories of 2022
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
New Medicare Part B Lab Specimen Collection Fee Rules Take Effect Jan. 1
What labs need to know to maximize specimen collection fee reimbursements.
Theranos in Court: Balwani Gets Nearly 13 Years in Prison
After being convicted on all charges he faced, the former Theranos COO was sentenced to 12 years, 11 months on Dec. 7.
Weekly Enforcement Report: Jail Time for Diagnostic Testing Facility Owners
Co-owners sentenced to three years each for paying millions in kickbacks for referrals to their Brooklyn-based facilities.
OIG Steps Up Enforcement Activity, but Recovery Numbers Still Lag
While civil actions, criminal actions, and exclusions are up, the increased activity isn’t yet reflected in total recoveries.
Which Blood Tests Are Best at Early Alzheimer’s Detection?
A recent study led by a team at the University of Gothenburg shows that multiple biomarkers could ID the disease even in people with no symptoms.
