TAG:
the clinical laboratory
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
Labs Hope to Renegotiate 1.75% Medicare Fee Cuts
CEO SUMMARY: As Congress crafted its reform of the nation’s healthcare system last year, it asked healthcare providers to contribute substantially to the cost of the Patient Protection and Affordable Care Act. The lab industry will see a 1.75% cut in reimbursement for Medicare …
Pathology Records Found At Massachusetts Dump
CEO SUMMARY: Pathologists at four Massachusetts hospitals got a powerful reminder recently that a breach of protected health information (PHI) can occur at any time for the most unexpected reason. Earlier this month, the Boston Globe reported that the pathology reports and patien…
AAB’s Suit Prevails over NY State Following 11 Years of Litigation
SCORE A BIG WIN FOR THE GOOD GUYS! An appeals court in New York state has upheld a lower court ruling that the New York State Department of Health (NYSDOH) intentionally overcharged clinical laboratories for the costs of regulating clinical laboratories and blood banks, possibly goin…
Patient Privacy Laws Create Legal Risk for Labs
CEO SUMMARY: Before the nation’s healthcare system can achieve the integrated universal EHR, it must fix the crazy contradictions in state and federal laws governing patient privacy. There is discordance between federal law and state law that defines the role and responsibility…
June 21, 2010 “Intelligence: Late Breaking Lab News”
Early in June, exactly 96 customers of 23andMe, Inc., were notified that they had received the wrong genetic test results. It was particularly bad timing, since the company had just been sent a letter from the FDA asserting its authority to regulate genetic testing. Bloggers reported…
Social Networking Is New Lab Marketing Channel
CEO SUMMARY: Using social marketing sites on the Web allows labs and IVD manufacturers to interact with customers in ways that were not possible years ago. Marketers use these interactive web sites to supplement traditional methods of advertising. Inviting customers to discuss your compan…
Pre-authorization Coming For Pricey Molecular Tests
CEO SUMMARY: In response to the steep ramp-up in the utilization of genetic and molecular testing, the nation’s largest health insurers are preparing to institute new guidelines for coverage and reimbursement. These will include pre-authorization by physicians, a more effective genetic …
Predict 2010 To Be Busy For Lab Owners & Buyers
CEO SUMMARY: Along with a recovering economy, the possibility of an increase in the capital gains tax rate for 2011 may encourage owners of clinical labs and anatomic pathology companies to sell their businesses during 2010. That could make 2010 a busy year for laboratory…
Anatomic Pathology’s Likely Path of Transformation
RECENT DEALS INVOLVING PRIVATE EQUITY FIRMS and several of the nation’s larger pathology groups hint at a major transformation soon to come to the pathology profession. No one should be surprised that pathologists of the baby boomer generation will be an important trigger in this transformation. I…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.