News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Congress Passes Law Changing How Medicare Sets Prices for Clinical Laboratory Tests; Lab Industry Groups Differ on Which Labs Will Be Winners and Losers

Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law

Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists remain unaware of the significant negative financial impact this law will have on their lab’s revenue and fiscal stability.

On April 1, President Barack Obama signed H.R. 4302: Protecting Access to Medicare Act of 2014. The law’s primary purpose is to extend the Sustainable Growth Rate (SGR) formula for 12 months. The House had passed the bill on the previous Thursday and the Senate passed the bill on the following Monday, March 31. (more…)

Providers, Payers and CMS Gear Up for ICD-10 Implementation, but Will They Be Prepared for Launch by October 1, 2014?

Pathologists and medical laboratory managers have only nine months to prepare their labs for ICD-10 implementation

Most clinical laboratory managers and pathologists know that October 1, 2014, is the date for implementation of ICD-10. After that date, each Medicare claim submitted by a medical laboratory must include the ICD-10 code provided by the referring physician.

This is a unique reason why clinical laboratories and pathology groups have keen interest in a smooth transition from ICD-9 to ICD-10. Medicare will reject clinical laboratory test claims that either don’t have an ICD-10 code or have an incorrect ICD-10 code. Thus, labs hope that their client physicians make a smooth transition from ICD-9 to ICD-10. (more…)

Clinical Pathology Laboratories File Petition Against Threat of Regulation of Laboratory-Developed Tests

FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg

FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs.

Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use new technologies to address unmet clinical challenges. As a result, these medical laboratory tests are critically important to the growth of personalized medicine. (more…)

New Guidelines Aim to Raise Standards for Laboratory-Acquired Infections in Clinical Pathology Laboratories

Medical laboratory directors and pathologists are likely to find their lab’s safety standards increasingly under the spotlight

Clinical laboratories and pathology groups should be aware of new safety guidelines that address the risk of laboratory-acquired infections (LAI). A panel of experts convened by the Centers for Disease Control and Prevention (CDC) recently released safety guidelines for medical laboratory workers.

The guidelines are intended to improve safety specifically in diagnostic laboratories that handle specimens from humans and animals. Statistics indicate the clinical laboratory workers have infection rates for certain diseases that can be up to 20 times greater than that of the general population! It is believed current data understate the true rate of laboratory-acquired infections within the nation’s medical laboratories and pathology groups. (more…)

In Fixing Physician Medicare Pay, Congress Enacts Yet Another Cut in Clinical Laboratory Test Fee Schedule

A part of this legislation, the grandfather clause on Technical Component (TC) anatomic pathology services was extended through June 1, 2012.

Last Friday, clinical laboratories got bad news about new cuts to the Medicare Part B medical laboratory test fee schedule. Congress voted on a temporary funding fix to keep Medicare physician fees at current levels for 10 more months and a reduction in lab test fees was one source of the money that Congress used to fund this bill.

Pathologists and clinical laboratory managers will be disappointed to learn that the Medicare Clinical Laboratory Fee Schedule (CLFS) was cut by 2% when Congress voted on Friday, February 17, to approve a deal to extend the payroll tax cut for nine months. President Obama could sign the bill into law today (Monday, February 20). The cuts to lab test fees are estimated to total $2.7 billion over 10 years.

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