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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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
Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million
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Texas Scammer Gets 20 Years for Role in $50 Million Lab Test Ripoff
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Kickbacks: Millennium Free Test Cup Physicians Crackdown Yields First 7-Figure Settlement
The federal crackdown against the physicians and medical practices that accepted free point-of-care test cups from Millennium Health continues. On Oct. 2, 2019, the OIG dropped a bombshell by announcing that
Compliance Perspectives: 5 Ways to Avoid Kickback Risks When Placing Phlebotomists in Ordering Physician’s Offices
It’s not uncommon for labs to place a phlebotomist in a physician’s office to collect and process samples for testing. While not strictly illegal, this practice raises bright red flags under kickback laws. So, it’s imperative to carefully vet your in-office phlebotomist arrangements to ensure they don’t cross any kickback lines.
Why Cleaning Up Your Dirty Data is Critical to Clinical Interoperability and Financial Survival
By Gregg Church bio
Hospital-based and commercial labs are flooded with all types of mismatched patient data. However, disparate systems coupled with a lack of universally mandated data standards and protocols means that big data just gets bigger—and clinical interoperability challenges just get larger…
Feds Take Down Florida Substance Abuse Clinic Principles for Drug Test Fraud
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The DX Pipeline: A roundup of the month’s key new product launches
The last quarter is typically the busiest of the year for new product launches and 2019 is no exception. The DX pipeline was churning at a high pace from late October to mid-November. Here’s a rundown of the key product launches
FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of
DX Earnings Report: Lab Market Consolidates but Survivors Stay Strong
PAMA and private payor rate cuts and increased market competitiveness are fueling consolidation and driving smaller, independent labs (other than specialty labs) into near extinction. But the big, established companies continue to chug along, not only via acquisition revenues but
Mergers, Acquisitions & Asset Sales Analysis – November 2019
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