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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Physician Referrals: New Rules Offer Some Stark Law Relief but Not Nearly Enough
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New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
From - National Intelligence Report
Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite…
Testing Guidelines at a Glance
From - Diagnostic Testing & Emerging Technologies
New Recommendations Simplify Testing for Chronic Kidney Disease
In late February, The National Kidney Foundation, the American Society for Clinical Pathology, and leading laboratories and…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
How about an Alexa for verbally querying genetic data? The Amazon Alexa-compatible "digital genetic assistant" from OptraGuru was among…
CMS to OIG: Get Back the $66.3 Million You Improperly Paid to Labs for Urine Validity Tests
From - G2 Compliance Advisor
As if times were not already tense enough for labs that bill Medicare for urine drug tests, the OIG ratcheted up the pressure another notch on…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
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Theranos & Its CEO Settle Stock Fraud Charges with SEC
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Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
Based on the early returns, the market analysts that predicted 2018 would see a slowdown in strategic Dx deal making appear to be right. But while…
Evidence for Liquid Biopsy Lacking, Expert Panel Finds
From - Diagnostic Testing & Emerging Technologies
There is not enough evidence, currently, to support the routine adoption of liquid biopsy tests for any of its promising clinical uses, according to a joint review published…
You Make the Call: Do Cost-Savings Payments to Referring Physician Violate Kickback Laws?
From - G2 Compliance Advisor
SITUATION
XYZ Consultants recommends that a hospital client cut costs by making 34 changes to its OR spinal fusion surgeries procedures…
