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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Tool: Model PHI Amendment Denial Letter
There are two things you must do to lawfully deny a patient’s request to amend his/her own PHI: i. Have a legal basis for the denial, i.e., at least one of four circumstances described in the main article must be present; and ii. You must put the denial in writing and ensure it meets the criteria for a denial notice in the HIPAA privacy regulations.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
Quest Pays $88.7K to Settle Specimen Collection Fee Kickback Charges Against Its Subsidiary
Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million
New Jersey Lab Hit with $144.6K Settlement Tab for Improper Billing of Nerve Conduction Studies
Industry Buzz: Cologuard’s Wild September Ride
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Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
After a brief summer lull, strategic deal making ramped up in September, especially in alliance making where volume nearly doubled last month’s levels. Here’s an overview of the long-term trends and key deals from late August through the third week of September.
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
From - Laboratory Industry Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…
Newly Proposed CMS Hospital Transparency Rules & their Impact on Labs
From - National Intelligence Report
It's an all too common occurrence. You or a loved one require an in-hospital procedure, but you have no idea of what the…
Enforcement Trends: New Emphasis on MD Practices Puts Labs at Growing Risk of Antitrust Enforcement
From - Lab Compliance Advisor
In addition to the usual Medicare and Medicaid anti-fraud laws, labs have a new liability risk to contend with…
