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
- Updates on changes to regulations
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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
ACA: DOJ Won’t Defend Individual Mandate in Court—But 16+ States Will
From - National Intelligence Report
One of the DOJ's principal roles is to defend the federal laws in court cases challenging their constitutionality. But the agency has made it known that…
Feds Target Providers Who Took Free Test Cup Kickbacks from Millennium Labs
From - G2 Compliance Advisor
Free point-of-care test cups from Millennium Labs have become radioactive. So far, at least six different providers have agreed to fork over…
Should You Contract with The Blues?
By Sean McSweeney bio
Should you contract with the Blues? Many BCBS insurers around the country are opening up to paneling laboratories where previously that had not often been possible. They are offering…
New Study Provides Most Comprehensive Overview of Genetic Test Development, Usage and Spending
From - Diagnostic Testing & Emerging Technologies
As might be expected, there has been rapid growth in genetic test availability and spending on these tests since 2014. But, comprehensive new collaborative analysis conducted by…
Compliance Perspectives: The 12 Things to Include in Your Drug & Alcohol Testing Policy
From - G2 Compliance Advisor
No! No! No! The truth is that state laws on marijuana use and possession have little to no direct impact on workplace drug policies and the testing methods used…
PAMA Reimbursement: CMS Explains How to Get ADLT Status for New Lab Tests
From - National Intelligence Report
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new PAMA Part B payment rules for lab tests remains…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The pace of deal making has picked up a bit, but deal volume remains relatively low on both the M&A and strategic alliance fronts. As usual, smaller molecular and genomics firms are…
Market Trends: Genetic Testing Becoming a Hot New Employee Benefit
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DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - National Intelligence Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Agilent, Bio-Techne and Mission Bio were among the producers launching multiple products. Here's a rundown of the key diagnostic product launches from…