Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
FDA Considering Self-Collection Sample Regulation
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FDA Medical Device User Fees Rise as Part of Reauthorization
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New Evidence Shows Genotype-Guided Warfarin Dosing Beneficial
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OPPS 2018: Revised Payment Rates & a New ADLT Date of Service Exemption
From - Laboratory Industry Report
With all of the PAMA commotion, CMS's publication of the 2018 Medicare Hospital and Ambulatory Surgical Outpatient Prospective Payment System (OPPS) final rule has…
PAMA Implementation: PLA Codes for Advanced Dx Tests Are Off to a Flying Start
From - Diagnostic Testing & Emerging Technologies
PAMA implementation is so sweeping that it requires a shift in not just payment paradigm but also CPT codes. This has served as the impetus for…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds charged Mercy Hospital with overbilling Medicare and MaineCare for urinalysis tests. Rather than risk a trial, Mercy has agreed to…
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
Employment Law Update: The Weinstein Edition
By Mike O'Brien bio
Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? Weinstein is…
Outreach Labs Remain Profitable Despite Antiquated Systems & Lack of Exec Respect
From - Laboratory Industry Report
Hidden within the basement of your average hospital is a $24 million business, one that provides a top quality, must-have service and operates at a margin of…
Supreme Court May Take on Its First Health Care Data Breach Case
From - Diagnostic Testing & Emerging Technologies
In a case to watch, CareFirst BlueCross BlueShield will ask the U.S. Supreme Court to consider its first health care data breach case. CareFirst is arguing that the…
