Sep 3, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs
After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.
If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)
Mar 31, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement, Management & Operations, News From Dark Daily
Failing finances at technical pathology laboratories may be the most immediate concern for many pathology group practices
Many clinical laboratories and anatomic pathology groups now recognize the new reality of the American healthcare system: less reimbursement for laboratory testing. On one hand, the fee-for-service prices for lab tests paid by government and private payers have been aggressively slashed.
On the other hand, all payers have become stubbornly resistant to issuing coverage guidelines and setting adequate prices for the flood of new molecular assays and gene tests coming to market.
These trends have already brought a handful of medical laboratories and pathology practices to the point of bankruptcy, sale, or closure. This is definitely true for the technical laboratories owned by many local pathology groups, which have become unprofitable due to fee cuts. (See below.) (more…)
Oct 22, 2010 | Laboratory News, Laboratory Pathology, News From Dark Daily
Pathologists and medical laboratory managers should be alert to compliance changes
CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories.
Laboratory management consultants tell Dark Daily that, for the most part, well-run medical laboratories are having few problems when CLIA inspectors show up on site. Because these laboratories are diligent about compliance with legal requirements, the CLIA inspection seldom turns up a serious deficiency nor identifies a major compliance failure within the laboratory.
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Jun 22, 2010 | Laboratory News, Laboratory Pathology, News From Dark Daily
Lab-savvy lawyers tackle overlooked issues involving non-compete covenants, protection of client lists, and effective partnership agreements
Unbeknownst to many owners of clinical laboratories and pathology groups, several developments have created new risks for the most important business assets of these organizations. Experts involved in legal and financial consulting for laboratories advise their clients to take definitive steps to prevent direct loss or any significant erosion in the value of these valuable business assets.
Too often, laboratory owners and the pathologist-partners of group practices find the value of their business needlessly reduced because they failed to take simple—but necessary—actions to fully protect their assets. That is not surprising, because many of a laboratory’s highest-value assets are represented by contracts with employees and partners, agreements on trade secrets, non-compete covenants with executives and sales representatives, and even something as basic as employee handbooks.
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Mar 26, 2010 | Laboratory News, Laboratory Pathology
“Securing” Protected Health Information (“PHI”) allows medical laboratories to avoid HITECH breach notification requirements
As of February 22, 2010, clinical laboratories, pathology groups, and other health providers have new breach notification requirements relating to protected health information (PHI). This is mandated in the legislation known as the HITECH ACT.
Dark Daily reported extensively on the breach notification requirements imposed by the HITECH ACT. Under the breach notification requirements a covered entity—such as a clinical laboratory or pathology group—is obligated to notify patients and the Department of Health & Human Services (HHS) of the breach. In some cases, the entity must also notify the media.
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