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

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

Hosted by Robert Michel
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Lab Industry Entrepreneur Launches New Lab to Offer Molecular Tests to Dentists

For the third time in the past ten years, laboratory industry entrepreneur Brian Carr is heading up a new laboratory company he helped found. Earlier this week, OralDNALabs, Inc. of Brentwood, Tennessee, announced it was open for business. Carr will be its President and Chief Executive Officer.

OralDNALabs has a unique strategy. It plans to offer genetic tests to dentists. It is starting with two proprietary molecular assays. One test, MyPerioPath, uses DNA to identify both the presence and bacterial load of pathogens associated with periodontal disease. The second test, My PerioID PST, uses technology licensed from Interleukin Genetics Inc. (AMEX:ILI) of Waltham, Massachusetts. This test is predictive of the patient’s susceptibility to periodontal disease by analyzing the Interleukin 1 genes. With these first two assays, OralDNALabs says that it will provide dentists with a more precise method for diagnosing and treating gingivitis and periodontitus.

Brian Carr was involved in starting two other laboratory companies. In 1998, he was one of the original founders of Pathology Consultants of America, Inc., (PCA) based in Brentwood, Tennessee, where he served as CEO (see The Dark Report, April 13, 1998). PCA was acquired by AmeriPath, Inc. in December 2000. Then, in April 2004, Carr formed American Esoteric Laboratories, Inc. (AEL), also headquartered in Brentwood, Tennessee (see The Dark Report, April 26, 2004). Carr was Chairman and CEO of AEL up until its acquisition by Sonic Healthcare Ltd in December 2006.

Now, with the launch of his third laboratory company in the past ten years, Carr will attempt to bring molecular diagnostics to the dental profession. As careful readers of Dark Daily will recall, we have written in recent months about research studies that are using saliva specimens to diagnose a variety of diseases, including cancer (see Advances in Salivary Diagnostics Point to New Ways to Detect Cancer and Other Diseases). Experts predict that many of these emerging diagnostic technologies will find ready application in oral health. Newly-formed OralDNALabs may be the first laboratory company organized specifically to serve dentists and other oral health professionals. As they do, they must answer a fundamental question: are dentists ready to order laboratory tests as a regular part of their daily routine?

Related Articles:
Dental and Laboratory Veterans Form Specialty Diagnostics Laboratory Focusing on Dental Related Disease

Medicare Laboratory Competitive Bid Repeal Passed by Senate Yesterday

Yesterday was big news for the lab industry as Senate passed the “The Medicare Improvement for Patients and Providers Act of 2008″ (HR 6331).” This bill includes repeal of the Medicare Laboratory Competitive Bidding Demonstration Project. Because the House passed this bill last month, it means the bill now moves to the President for his signature or veto.

Also included in this Medicare funding bill for 2008 are a reversal of the 10.6% cut in Medicare physician reimbursement and an 18-month extension of the “TC Grandfather clause” (which covers independent laboratories located outside a hospital that provide technical component [TC] pathology services furnished to hospital patients). On July 1, 2008, the Medicare physician fee cut of 10.6% took effect. Also on July 1, the Centers for Medicare and Medicaid Services (CMS) implemented “a policy to pay only the hospital for the technical component (TC) of physician pathology services furnished to hospital patients.”

Thus, this Medicare funding bill represents a significant victory for pathologists and the laboratory industry. It is known that the President opposes this Medicare bill, as passed, because it would cut funding for Medicare Advantage insurance plans. However, both the vote in the Senate (69-30 in favor) and the House (355 to 59 in favor) indicates the likelihood that, were the President to veto this bill, there enough votes to probably override that veto.

In the meantime, some attorneys have advice to independent laboratories that provide TC services to Medicare inpatients. They suggest that these labs hold claims originated since July 1, 2008. Once the Medicare funding bill, with the 18-month extension of the TC grandfather clause becomes law, they should be able to submit those claims and be reimbursed.

Dark Daily observes that this legislative outcome is evidence that the collective lobbying effort of the laboratory industry and various associations in Washington, DC, has achieved a degree of effectiveness unseen in more than two decades.

Related Items:

Senate Passes Medicare Package, Lab Competitive Bidding Repeal-ACLA Thanks Senate for Passing HR 6331 & Urges President Bush to Sign the Bill

Senate passes doctor reimbursement bill