Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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 Perspectives: California Case Illustrates Lab’s Liability Risks for “Causing” MDs to Submit False Claims
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LabCorp Must Go to Trial to Defend against Deceptive Trade Practices Charges
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Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold
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The DX Pipeline: A Roundup of the Month’s Key New Product Launches
Here's a summary of the key product launches announced from late August through the third week of September, 2019:
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
Kickbacks: Medical Practices and Doctors Settlements for Accepting Millennium Freebies
In 2016, Millennium Health settled one of the largest lab kickback schemes ever concocted for $256 million. In September 2017, federal enforcers turned their attention to the practices that accepted bribes from Millennium in the form of...
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
You Make the Call: Does Lab Manager Have a Valid Claim for Age Discrimination?
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