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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
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
Diagnostic Deals: Illumina/PacBio Merger Derails & Qiagen Takes Itself Out of Play
As 2019 came to a close, the biggest story in DX deal making was the pair of anticipated M&A deals that suddenly seem unlikely to happen. As a result, two major genetic testing companies will apparently continue as stand-alones in the coming year, one because it wants to and the other because it has to.
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…
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