Millennium Laboratories Commends Florida's Governor Scott For Strengthening Regulation of Clinical Laboratories

SAN DIEGO, April 30, 2012 /PRNewswire/ -- Millennium Laboratories congratulated Florida Governor Rick Scott today for signing into law House Bill (HB) 787, the Health Care Facilities Bill, which includes significant provisions affecting the licensing and operations of clinical laboratories. The new law seeks to stem kickbacks and inducements offered by certain clinical laboratories operating in the state that can put physicians and patients at risk while wasting health care dollars. The bill was delivered to the Governor's desk after passing both houses of the Florida legislature with overwhelming margins.

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Florida HB 787 addresses a comprehensive list of issues related to the Florida Agency for Health Care Administration (AHCA), which among other responsibilities regulates clinical laboratories conducting business in the state.  The law was motivated by the practices of several licensed and unlicensed clinical laboratories operating in Florida within the pain medication monitoring industry.

"Prescription drug abuse in Florida and throughout the United States is taking a toll on families, communities and the healthcare system.  While Federal and State governments try to get control of this national epidemic, certain drug testing companies continue to exploit the situation, diverting needed resources and attention away from the real problem," explained Howard Appel, President of Millennium Laboratories.

"Florida's lawmakers acted decisively in addressing flagrant violations by laboratories that compromise honest and unsuspecting doctors and their patients in the name of profit," said Appel.  "Despite previous multiple warnings, regulatory clarifications, and cease and desist letters from Florida's AHCA, these bad behaviors continued. With last Friday's signing by Governor Scott, violators will be forced to either quit their irresponsible conduct or quit the state entirely."

The primary relevant provisions of the new legislation are:

• Converting an often-ignored AHCA regulation into broad statutory language outlawing the placement of laboratory personnel in physician offices under any circumstances.
• Further aligning Florida's statutes with Federal Stark and anti-kickback laws and prohibiting a clinical laboratory from leasing space in a physician's office or otherwise paying "rent" to the physician in return for better access to patients and office staff. 
• Authorizing fines of $5,000 for each separate violation and/or revocation of the laboratory's state license upon two violations.
• Referring unlicensed laboratories operating in the state to local law enforcement as a second degree misdemeanor and fines up to $5,000 per day.

Appel noted that the urgent need for tighter regulation of irresponsible laboratory practices extends beyond Florida and is a national concern. For example, last month a clinical laboratory based in Massachusetts agreed to a $20 million settlement arising out of a Medicaid fraud and kickback scheme involving sham sober houses and pushing of unnecessary and excessive urine drug testing. This settlement resulted after a grand jury returned a 42-count criminal indictment against the laboratory and several of its executives and co-conspirators.  According to the Massachusetts Attorney General, the case "was one of the most egregious abuses of the Medicaid program" that her office has ever handled. In another major case, a Maryland-based clinical laboratory agreed in November 2010 to a $16.3 million settlement with the U.S. Department of Justice arising out of a whistleblower lawsuit filed in Tampa, FL that involved cash payments to physicians as well as other free services and kickbacks. 

Commitment to Compliance

Millennium's vigorous support for the new Florida law is reflective of a broader initiative to highlight the need for ethics and compliance in the industry "by whatever means necessary, including advocacy, legislation, and if required litigation," said Appel. He added that the company allocates proceeds resulting from certain industry-related litigation to support non-profit organizations committed to those suffering from pain, prescription drug addiction or other health concerns, including Angel Flight, The Pathway Home, National Veterans Summer Sports Clinic and others.   

In February, the company called on all clinical drug testing companies to immediately adopt OIG guidelines for clinical laboratories, and announced a grant to Dr. Richard Payne, Professor of Medicine and Divinity, Duke University to chair a stakeholder's summit to establish clear and specific operating standards to which each laboratory can be held accountable. Last month the company unveiled the Clinical Laboratory Responsibility Pledge, a declaration that outlines the business principles to which Millennium adheres and to which the company challenges every clinical laboratory in the pain management industry to adopt. Millennium's Commitment to Compliance policy is available at www.millenniumlabs.com.

About Millennium Laboratories:

Millennium Laboratories is the leading research-based clinical diagnostic company dedicated to improving the lives of people suffering from pain. The company provides healthcare professionals with scientific data, clinical tools and services that help personalize treatment plans to improve clinical outcomes and patient safety.

The company utilizes leading technology and proprietary methodologies to provide some of the fastest and most reliable medication monitoring and drug detection results via both urine drug testing (UDT) and oral fluid testing. Test results are backed by expert toxicologists, clinical guidance and dedicated customer service.

Millennium's commitment to advancing the science and the field of pain management also includes a strong focus on the advancement of industry research, education and advocacy. Through its association with the Millennium Research Institute, a nonprofit national research center, it quickly has gained respect as a leader in toxicology, pharmacology and pain management research and education, providing healthcare professionals with innovative research to advance the assessment and management of chronic pain.

SOURCE Millennium Laboratories