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ADVANCE Outlook: Lab Professionals

CLC Files Lawsuit Against Government

Published January 29, 2008 7:00 PM by Matthew T. Patton

We received this press release today from CLMA: 

The Clinical Laboratory Coalition (CLC), of which CLMA is an active member, announced its support for a lawsuit filed today by San Diego area clinical laboratories and health systems in an attempt to stop the federal government from moving forward in its plan to limit San Diego laboratory services.

Filed by Internist Laboratory of Oceanside, Sharp Healthcare of San Diego, and Scripps Healthcare of San Diego against the HHS Secretary Michael Leavitt, the lawsuit also seeks to require public notice and comment on this project, as mandated by federal law. CMS, as part of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, chose San Diego as the first of two demonstration project locations to use so-called "competitive bidding" for clinical laboratory services. The agency will accept bids on laboratory services and select only a very limited number of labs to perform tests that will be reimbursed under Medicare Part B services. Those labs that don't win the bid can not bill for reimbursement of Medicare lab testing services. Rather than creating competition, it will result in fewer labs, less competition and the government in essence picking winners and losers. Bids are due to CMS by Feb. 15, 2008.

"Although a lawsuit is an unusual approach, we believe it is important to use every avenue available to stop competitive bidding from going forward because of the potential negative impact on patient care," said Dana Procsal, CLMA's CEO. "CLMA stands solidly behind this action."

"CLMA stands committed behind the more than 4,000 clinical laboratory managers and leaders it represents in their efforts to protect their laboratories and health care systems from a government mandate which could do serious harm," said JoAnne Milbourn, President of CLMA. "Competitive bidding threatens the viability of our nation's laboratories and their capacity to provide needed services to the very patients they exist to serve.

"CLMA believes a more rational approach to the financial difficulties facing government programs such as Medicare and Medicaid will best preserve the clinical laboratories ability to deliver the type of care our beneficiary population deserves."

Internist, Sharp HealthCare and Scripps Healthcare are fighting to be able to continue to serve San Diego residents. These laboratories will either be forced to shut down all together or close their laboratory outreach services if they aren't selected as winning bidders. The lawsuit was filed in the United States District Court for the Southern District of California. The Clinical Laboratory Coalition is comprised of the following organizations: Advanced Medical Technology Association (AdvaMed), American Association of Bioanalysts (AAB), American Association for Clinical Chemistry (AACC), American Clinical Laboratory Association (ACLA), American Medical Technologists (AMT), American Society for Clinical Laboratory Science (ASCLS), American Society for Clinical Pathology (ASCP), American Society for Microbiology (ASM), Clinical Laboratory Management Association (CLMA), College of American Pathologists (CAP), and National Independent Laboratory Association (NILA).

1 comments

This lawsuit was filed January 29. As of today, February 12, there has been no response regarding this lawsuit from the US District Court Southern District of California. Interested parties were hoping for a stay that would put the demonstration project on hold. It is troublesome that the Court has not enjoined Department of HHS to delay the project and hold public hearings. Generally in cases such as these the courts will say "hold off" until they review the issue and decide how to proceed. Absent a response -preferably a stay- from the Court in the next 72 hours or so, labs in San Diego will have to submit bids for the performance of approximately 303 tests commonly ordered for Medicare recipients. The deadline for submission of bids is February 15 and CMS will announce "winners" by April 11Laboratorians all over the cuntry should be interested in how this all turns out.

Glen McDaniel February 12, 2008 1:33 PM
Atlanta GA

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