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       Headlines - January 21, 2008
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R. Lewis Dark: "Here's to Plain Talk and Clear Understanding!"

"WELL, SIR, HERE'S TO PLAIN TALK AND CLEAR UNDERSTANDING." That's a wellknown line in the classic 1941 detective movie, "The Maltese Falcon." It's spoken by the Kasper Gutman character, played by Sidney Greenstreet, to San Francisco private eye, Sam Spade, played by Humphrey Bogart. Gutman thinks Spade has the pricelessMaltese Falcon statue and he wants to get to the answers quickly.

I've been reminded of that line during the past seven months, every time the Centers for Medicare & Medicaid Services (CMS) has stepped into the public arena and discussed the impending Medicare Clinical Laboratory Competitive Bidding Demonstration Project or released documents about the pilot demonstration it plans to conduct in the San Diego-Carlsbad-San Marcos MSA (metropolitan statistical area). Officials from CMS have absolutely failed to meet the standards outlined by Kasper Gutman, when he asked for "plain talk and clear understanding."

To the contrary, officials from CMS and its minions at RTI International, Inc. (the contractor which has done development work for the past 12 years on the laboratory competitive bidding project) have done the opposite of “plain talk and clear understanding." They refuse to speak in a clear, understandable manner. They decline to offer objective, frank, and easy-to-understand insights about the requirements of the laboratory competitive bidding demonstration project. What makes this doubly insulting to the laboratory profession is that these same officials are public servants, chartered by the Constitution and various statutes to serve in the interest of the American public, with due process, and respect for the concepts of fair play that make this Republic an example of freedom and the rule of law.

Against the morass of obfuscation, complexity, and deliberate negative bias that marks the way CMS is proceeding with the lab competitive bidding demonstration, I think it is refreshing how at least one leader in the lab industry is willing to boldly use "plain talk and clear understanding" to state the obvious. As you will read on the following pages, Alan Mertz, President of the American Clinical Laboratory Association (ACLA) inWashington, DC, declared that the laboratory competitive bidding demonstration is "coerced bidding to force labs to bid below the true cost of providing the service... and that’s not a bid demonstration which is objective and competitive." Kudos to Mr. Mertz. Let's hear more plain talk and clear understanding from our lab industry leaders!



Labs Face "Coercive" Bid, Not Competitive Bidding

Lab coalition plans next strategy to change most egregious aspects of Medicare Bidding Demo

CEO SUMMARY: In the weeks since the December 5 bidders’ conference in San Diego, where Medicare officials took the wraps off the complete requirements for the Laboratory Bidding Demonstration Project, the Clinical Laboratory Coalition has begun to consider strategies to delay or cancel the project. Options include litigation in court to stop the submission of bids on February 15, as well as continued education of members of Congress about the poor design and bias of the bidding demo.



FDA Approves New Test For Respiratory Viruses

Using non-invasive specimens, multi-analyte assay can detect 12 viruses and viral subtypes

CEO SUMMARY: Respiratory viruses are responsible for 75% of all visits to physicians and yet physicians struggle to identify whether an infection is viral or bacterial. Now there is a new molecular assay with FDA clearance that allows physicians to test for 12 common viral infections. It is the xTAG Respiratory Viral Panel (RVP) from Luminex Molecular Diagnostics. Beaumont Hospital in Royal Oak, Michigan, is one of the first hospitals to offer this test.



CMS Spotlights AP as It Delays Anti-Markup Rule

Anti-Markup rule implemented on January 1 targets one specific type of anatomic path lab

CEO SUMMARY: When Medicare officials postponed implementing a new anti-markup rule late last month, it did so because of questions about how the new rule will be applied. However, the Centers for Medicare & Medicaid Services (CMS) did implement an aspect of the anti-markup rule on January 1, 2008, that affects one anatomic pathology laboratory model. Attorney Rick Hindmand offers fives steps to help pathologists comply with the newly implemented anti-markup rule.



New Study Demonstrates How Lean Labs Outperform Peers

Analysis shows Lean labs consistently do better than conventional labs

CEO SUMMARY: A new study provides powerful evidence that laboratories using Lean, Six Sigma, and similar process improvement methods consistently outperform conventionally managed laboratories. Using data sets from 100 laboratories, including 14 Lean/Six Sigma laboratories, consultant Thomas P. Joseph, of Management Insight, LLC, demonstrated that Lean labs have dramatically improved turnaround times and consistently produce common results in less than an hour. They also have significantly fewer defects per million opportunities and operate with 40% less technical staff in key testing work cells, when compared with conventional labs. THE DARK REPORT provides a first look at some of the significant findings of this study.



Healthcare Trends: Total Health Spending Rises 6.7%, Tops $2.1 Trillion during 2006



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